UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 20-F

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2025

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report ____________

For the transition period from ____________ to ____________

Commission File No.: 001-43033

Pulsenmore Ltd.

(Exact name of registrant as specified in its charter)

Translation of registrant’s name into English: Not applicable

Dr. Elazar Sonnenschein

Chief Executive Officer

8 Omarim St.

Omer, Israel

Tel: +972-526062075

Fax: +972 8 690 0466

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

0000 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

Securities registered or to be registered pursuant to Section 12(g) of the Act: None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None

Number of outstanding shares of each of the issuer’s classes of capital or common stock as of December 31, 2025 and March 15, 2026: 6,502,844 ordinary shares.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act of 1934. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months. Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company.

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing.

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18

If this is an annual report, indicate by check mark whether the registrant is a shell company. Yes ☐ No ☒

TABLE OF CONTENTS

INTRODUCTION

We are an emerging medical device company focused on research, development, manufacture, marketing, and sale of innovative, non-invasive portable ultrasound solutions that provide significant healthcare benefits by utilizing next-generation technology for home use. We currently have two primary products, the Pulsenmore ES and the Pulsenmore FC, and an additional third portable ultrasound solution that is in earlier developmental stages, the Pulsenmore MC. We collectively refer to our products as the “Pulsenmore Products”. The Pulsenmore Products open the door to a new market in the field of ultrasound – performing home scans in gynecology as well as in various other fields such as pulmonary, cardiology, and urology.

We were incorporated under the laws of the State of Israel in 2014. Our ordinary shares have been listed on the Nasdaq Capital Market, or Nasdaq, since January 21, 2026 under the symbol “PLSM”. Our ordinary shares have been listed on the Tel Aviv Stock Exchange, or TASE, since June 16, 2021 under the symbol “PLSM”.

PRESENTATION OF FINANCIAL AND OTHER INFORMATION

On December 28, 2025, we effected a one-for-eight (1-for-8) consolidation of our issued and outstanding ordinary shares, or the Reverse Split, and on such date, our ordinary shares began trading on a post-Reverse Split basis on the TASE. Unless the context expressly indicates otherwise, all references to shares and per share amounts referred to herein reflect the amounts after giving effect to the Reverse Split.

Unless the context otherwise requires, references in this Annual Report on Form 20-F, or this Annual Report, to the “Company,” “Pulsenmore,” “we,” “us,” “our” and other similar designations refer to Pulsenmore Ltd.

Financial Statements

Our financial statements were prepared in accordance with International Financial Reporting Standards, or IFRS Accounting Standards, as issued by the International Accounting Standards Board. Our reporting currency and functional currency is the New Israeli Shekel. In this Annual Report, the terms “shekel,” “Israeli shekel” and “NIS” refer to New Israeli Shekels, the lawful currency of the State of Israel, and the terms “dollar,” “U.S. dollar” or “$” refer to United States dollars, the lawful currency of the United States of America. Unless derived from our financial statements or otherwise indicated, U.S. dollar translations of NIS amounts presented in this Annual Report as of December 31, 2025, and December 31, 2024, are translated using the rate of NIS 3.19 to US$1.00, the exchange rate reported by the Bank of Israel on December 31, 2025.

All references to “shares” in this Annual Report refer to ordinary shares of Pulsenmore Ltd., par value NIS 0.00032 per share.

Trademarks

All trademarks or trade names referred to in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report are referred to without the ^® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Market, Industry and Other Data

This Annual Report contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry and general publications, government data and similar sources. None of the reports or studies cited in this Annual Report were commissioned by the Company.

In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Note Regarding Forward-Looking Statements.”

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain information included or incorporated by reference in this Annual Report may be deemed to be “forward-looking statements”. Forward-looking statements are often characterized by the use of forward-looking terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” or other similar words, but are not the only way these statements are identified.

These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our products, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future.

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

Important factors that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below:

These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this Annual Report in greater detail under the heading “Risk Factors” and elsewhere in this Annual Report. You should not rely upon forward-looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this Annual Report.

PART I

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

Not applicable.

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

ITEM 3. KEY INFORMATION

A. [Reserved]

B. Capitalization and Indebtedness

Not applicable.

C. Reasons for the Offer and Use of Proceeds

Not applicable.

D. Risk Factors

You should carefully consider the risks described below, together with all of the other information in this Annual Report. If any of these risks actually occurs, our business and financial condition could suffer and the price of our ordinary shares could decline.

Risk Factors Summary

Investing in our ordinary shares and our ability to successfully operate our business and execute our growth plan each are subject to numerous and substantial risks. You should carefully consider the risks described in the risk factors below before deciding to invest in our ordinary shares. If any of these risks actually occurs, our business, financial condition or results of operations could be materially and adversely affected. In such case, the trading price of our ordinary shares would likely decline, and you may lose all or part of your investment. The following is a summary of some of the principal risks we face:

Risks Related to Our Financial Condition and Capital Requirements

Risks Related to Our Business and Operations

Risks Related to Government Regulation and Other Legal Compliance Matters

Risks Related to Our Intellectual Property

Risks Related to Israeli Law and Our Operations in Israel

Risks Related to Ownership to Our Ordinary Shares

Risks Related to Our Financial Condition and Capital Requirements

We have a limited operating history on which to assess the prospects for our business, we have generated limited revenue from sales of our products, and we have incurred losses since inception.

Since inception, we have devoted substantially all of our financial resources to develop our products and related services. We have financed our operations primarily through the issuance of equity and partially from the Israel Innovation Authority, or IIA and Korea Israel Industrial, or KORIL, grants. We have generated limited revenue from the sale of our products and services to date and have incurred significant losses. The amount of our future net losses will depend, in part, on sales and on-going development of our products and related services, the rate of our future expenditures and our ability to obtain funding through the issuance of our securities to cover our operating activity, strategic collaborations or grants. We expect to continue to incur significant losses for at least the next several years as we continue to commercialize our existing products and services and seek to develop and commercialize new products and services.

Our ability to generate future revenue from product and service sales depends heavily on our success in many areas, including, but not limited to:

We have incurred significant losses since inception. As such, you cannot rely upon our historical operating performance to make an investment decision about us.

Since our inception, we have engaged in research and development, or R&D, activities and launched our first products, Pulsenmore ES and Pulsenmore FC in 2020 and 2022, respectively. Since commercialization of the Pulsenmore ES and Pulsenmore FC, we also engaged in the continued development of the Pulsenmore MC and the Pulsenmore ES-assisted service for performing biophysical profile tests, or BPP for high-risk pregnancy patients. We have financed our operations primarily through the issuance of equity securities and partially from IIA and KORIL grants. We have incurred net losses of NIS 15.9 million (approximately $5.0 million), NIS 36.7 million (approximately $11.5 million), and NIS 58.6 million (approximately $18.4 million), in the years ended December 31, 2025, 2024, and 2023, respectively. We do not know whether or when we will become profitable. Our ability to generate revenue and achieve profitability depends upon our ability to accelerate the commercialization of our products and service offerings in line with the demand from current and future customers and our aggressive growth strategy. We may be unable to achieve any or all of these goals.

We may need to raise additional funding to expand the commercialization of our products and services and to expand our R&D efforts. This additional financing may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product commercialization or development efforts or other operations.

Our operations have consumed substantial amounts of cash since inception. We expect to expend substantial additional amounts to commercialize our products and services and to develop new products and services. We will require additional capital to expand the commercialization of our existing products and services and to develop new products and services. In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned.

We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any future financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by the Company, or the possibility of such issuance, may cause the market price of our common stock to decline. The incurrence of indebtedness could result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable, and we may be required to relinquish rights to some of our technologies or products or otherwise agree to terms that are unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects. In addition, raising additional capital through the issuance of equity or convertible debt securities would cause dilution to holders of our equity securities, and may affect the rights of then-existing holders of our equity securities. Even if we believe that we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

Risks Related to Our Business and Operations

Our success depends upon regulatory approval and market acceptance of our products and services, our ability to develop and commercialize existing and new products and services and generate revenues, and our ability to identify and penetrate new markets for our technology.

We have developed, and we are engaged in the research, development, manufacture, marketing, and sale of ultrasound imaging solutions using our home ultrasound technology. We are commercializing our Pulsenmore ES ultrasound imaging device which is approved or cleared for use in several key markets including the United States, Europe, Switzerland, Australia, Brazil, Colombia and Israel while our Pulsenmore FC ultrasound imaging device is at an early stage of commercialization in Israel where it is approved for use. As we are in the early stages of commercialization of the Pulsenmore FC device in Israel, we plan to gain more real-world experience with the Pulsenmore FC before submitting for approval in the United States and other territories. Our success will depend on the receipt of and maintenance of regulatory approvals and acceptance of our products and services in the U.S. and international healthcare markets, including across Europe, Australia, South America and Japan. Even after receiving regulatory clearance, we are faced with the risk that the marketplace will not be receptive to our products and services over competing products, including traditional cart-based ultrasound devices used in hospitals, imaging centers and physicians’ offices, and that we will be unable to compete effectively. Factors that could affect our ability to successfully commercialize our current products and services and to commercialize any potential future products and services include challenges of developing (or acquiring externally developed) technology solutions that are adequate and competitive in meeting the requirements of next-generation design challenges and dependence upon physicians’ and other healthcare practitioners’ acceptance of our products.

We cannot assure investors that our current products and services or any future products and services will gain broad market acceptance particularly in the United States where we received FDA approval in November 2025. If the market for our current products and services or any future products and services fails to develop or develops more slowly than expected, or if any of the services and standards supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and adversely affected.

Medical device development is costly and involves continual technological change, which may render our current or future products obsolete.

The market for point-of-care medical devices, which includes home-use ultrasound solutions, is characterized by rapid technological change, medical advances and evolving industry standards. Any one of these factors could reduce the demand for our devices or services or require substantial resources and expenditures for research, design and development to avoid technological or market obsolescence.

Our success will depend on our ability to enhance our current technology, services and systems and develop or acquire and market new technologies to keep pace with technological developments and evolving industry standards, while responding to changes in customer needs. A failure to adequately develop or acquire device enhancements or new devices that will address changing technologies and customer requirements adequately, or to introduce such devices on a timely basis, may have a material adverse effect on our business, financial condition and results of operations.

We might have insufficient financial resources to improve existing devices, advance technologies and develop new devices at competitive prices. Technological advances by one or more competitors or future entrants into the field may result in our current devices becoming non-competitive or obsolete, which may decrease revenues and profits and adversely affect our business and results of operations.

We may encounter significant competition across our existing and future planned products and services and in each market in which we sell or plan to sell our products and services from various companies, many of which have greater financial and marketing resources than we do. Our primary competitors include the top five manufacturers of legacy cart-based incumbent ultrasound devices.

In addition, many of our competitors are well-established manufacturers with significant resources and may engage in aggressive marketing tactics. Competitors may also possess the ability to commercialize additional lines of products, bundle products or offer higher discounts and incentives to customers in order to gain a competitive advantage. If the prices of competing products are lowered as a result, we may not be able to compete effectively.

We will be dependent upon the success of our growth strategy and marketing and distribution strategies.

Our business is dependent upon the success of our growth strategy and marketing and distribution strategies. Our growth strategy to increase market penetration directly relies on our distribution strategy, and our marketing efforts are focused on developing a strong reputation with healthcare providers and increasing awareness of our products and services. If we fail to maintain a high quality of service or a high quality of device technology, we may fail to retain existing users or add new users. If we do not successfully continue our sales efforts and promotional activities, particularly to health systems and large institutions, or if existing users decrease their level of engagement, our revenue, financial results and business may be significantly harmed. Our future success depends upon continued expansion of our commercial operations, as well as entering additional markets, including the United States, Europe, Australia, South America and Japan, to commercialize our products and services. We believe that our growth will depend on the further development and commercialization of our current products and services, and marketing authorization of our future products and services. If we fail to expand the use of our products and services in a timely manner, we may not be able to expand our market share or to grow our revenue. Our financial performance will be substantially dictated by our success in adding, retaining and engaging active users of our products. If customers do not perceive our products or services to be useful, reliable and trustworthy, we may not be able to attract or retain customers or otherwise maintain or increase the frequency and duration of their engagement. As our business model is predicated on both hardware and software sales, there is risk that any decline in software renewal rates will adversely impact our business. A decrease in customer retention, growth or engagement with our products and services may have a material adverse impact on our revenue, business, financial condition and results of operations.

Any number of factors could negatively affect customer retention, growth and engagement, including:

Our research and development efforts may not succeed in developing commercially successful products and technologies, which could adversely affect our business.

Our products utilize application-dependent chips, or ASIC, dedicated digital processors for the transmission and reception of portable ultrasound imaging which has the potential to allow us to monitor patients in various care settings due to its portability and cost. We expect our development path will be directed at accessing and optimizing our technology for use in various care settings, potentially including home scanning and or wearable patient technology, subject to appropriate regulatory authorization. We face risks associated with launching such new products. If we encounter development or manufacturing challenges or discover errors during our product development cycle, the product launch dates of new products may be delayed, which will cause delays in our ability to achieve our forecasted results. The expenses or losses associated with unsuccessful product development or launch activities or lack of market acceptance of our new products could have a material adverse effect on our business or financial condition.

We expect to generate an increasing portion of our revenue from international markets in the future and may become subject to various additional risks relating to our international activities, which could adversely affect our business, operating results and financial condition.

During the years ended December 31, 2025, 2024, and 2023, approximately 95.8%, 93.9%, and 96.1%, respectively, of our product and service revenue was generated from customers located inside Israel. We believe that a substantial percentage of our future revenue will come from international sales, specifically from the United States, as we expand our sales and marketing opportunities into international markets.

A disruption in our relationships with these customers may adversely affect our results of operations. The customers’ demand for our products may fluctuate due to factors beyond our control. Any significant reduction in orders from these customers could have a material adverse effect on our business, results of operations, or financial condition, as could their failure to pay amounts owed to us.

We have limited experience of operating internationally, and engaging in international business involves a number of difficulties and risks, including:

If we dedicate significant resources to our international operations and are unable to manage these risks effectively, our business, operating results and financial condition may be adversely affected.

We are currently highly dependent on Clalit Health Services for the continued sale of our Pulsenmore ES device and for the purchase of additional Pulsenmore FC devices in the future.

Our revenue is currently highly concentrated with one customer, Clalit Health Services, or Clalit, the largest health service organization (HMO) in Israel. Given Clalit’s significance to our business, in the near term our financial performance is substantially dependent on its continued demand, performance of its contractual obligations and the satisfaction of certain conditions precedent under one of our agreements with Clalit. Any failure to meet contractual obligations, non-renewal, non-extension, early termination or modification of existing agreements, non-fulfillment of any conditions precedent, or any reduction in orders, changes in procurement policies, operational disruptions, or broader industry downturns affecting Clalit, would have a material adverse effect on our business, operating results and financial condition.

If we are unable to attract, recruit, train, retain, motivate and integrate key personnel, we may not achieve our goals.

There is substantial competition for key personnel, senior management, and qualified employees in the healthcare industry, and we may face increased competition for such a highly qualified scientific, technical, clinical, and management workforce in a highly competitive environment. While the increased availability of flexible, hybrid, or work-from-home arrangements has afforded us the ability to attract and retain talent from geographies remote from our physical offices, it has also expanded competition by allowing qualified employees within those same regions to pursue job opportunities throughout the country without the need to relocate. To help attract, retain, and motivate qualified employees in senior roles, we use equity-based awards and performance-based cash incentive awards. Sustained declines in our stock price, or lower stock price performance relative to competitors, can reduce the retention value of our equity-based awards, which can impact the competitiveness of our compensation. There can be no assurance that we will be successful in retaining existing personnel or recruiting new personnel.

From time to time, our efforts to attract, recruit, train, retain, integrate and motivate key personnel may also subject us to litigation or other legal proceedings that may adversely affect our business. These legal proceedings may involve claims brought by current or former employees, government agencies or others, through private actions, class actions, administrative proceedings or other litigation. These legal proceedings may involve allegations of illegal, unfair or inconsistent employment practices, including wage and hour, discrimination, harassment, wrongful termination, retaliation, violations of law or other concerns. Even if the allegations against us are unfounded or we ultimately are not held liable, we may experience related negative publicity resulting in damage to our reputation. Further, the costs to defend ourselves may be significant and the litigation may subject us to substantial settlements, fines, penalties or judgments against us and may consume management’s bandwidth and attention, some or all of which may negatively impact our financial condition and results of operations.

Having diverse representation and an inclusive workplace can also impact our ability to attract and retain talent and is an important driver of our ability to compete and innovate. As such, our ability to attract and retain diverse talent can impact our corporate reputation and have adverse consequences to our business.

The loss of one or more key employees, our inability to attract or develop additional qualified employees and any delay in hiring key personnel could have a material adverse effect on our business results, cash flows, financial condition, or prospects.

We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected.

We have limited experience marketing and selling our products and related services. We currently sell our products to Israel’s largest health maintenance organization (HMO), as well as to hospitals/clinics (both in Israel and outside of Israel). Future sales of our products will depend in large part on our ability to effectively market and sell our products and services, successfully manage and expand our sales force, and increase the scope of our marketing efforts. We may also enter into additional distribution arrangements in the future. Because we have limited experience in marketing and selling our products, our ability to forecast demand, the infrastructure required to support such demand and the sales cycle to customers is unproven. If we do not build an efficient and effective marketing and sales force, our business and operating results will be adversely affected.

We rely on subcontractors for the assembly of our finished products.

We rely on a few subcontractors to manufacture our products while maintaining control over the overall production and assembly process. These manufacturing subcontractors provide us with partially assembled products. If such subcontractors fail to fulfill their obligations under the existing contractual arrangements with us or do not perform satisfactorily or if we fail to meet our obligations to the subcontractor and consequently it becomes necessary to utilize a different subcontractor, our ability to source our devices could be affected as the production may be delayed. In the event it becomes necessary to utilize a different subcontractor for our component products, we would experience additional costs, delays and difficulties in obtaining such components as a result of identifying and entering into an agreement with a new subcontractor as well as preparing such new subcontractor to meet the logistical requirements associated with manufacturing our devices, and our business would suffer.

We may experience pricing pressures from contract suppliers or subcontractors on which we rely.

Our suppliers may try to raise prices in the future, which we may not be able to offset through manufacturing efficiencies or pricing actions. Such pricing pressures could increase our costs and force us to increase the prices of our products if we are unable to enter into alternative arrangements with other suppliers or subcontractors, potentially leading to decreased customer demand.

We may experience manufacturing problems or delays that could limit the growth of our revenue or increase our losses.

We may encounter unforeseen situations that would result in delays or shortfalls in our production as well as delays or shortfalls caused by our outsourced manufacturing suppliers and by other third-party suppliers who manufacture components for our products. The FDA (and comparable foreign regulatory authorities) has comprehensive and prescriptive guidelines for medical device component manufacturers, requiring these manufacturers to establish and maintain processes and procedures to adequately control environmental conditions that could adversely affect product quality and impact patient safety. Clean room standards are an example of these requirements. Failure of component manufacturers or other third-party suppliers to comply with applicable standards could delay the production of our products. If we are unable to keep up with demand for our products, our revenue could be impaired, market acceptance for our products could be adversely affected and our customers might instead purchase our competitors’ products. Our inability to successfully manufacture our products would have a material adverse effect on our operating results.

We rely on limited or sole suppliers for some of the materials and components used in our products, and we may not be able to find replacements or immediately transition to alternative suppliers, which could have a material adverse effect on our business, financial condition, results of operations and reputation.

We rely on limited or sole suppliers for certain materials and components that are used in our products. While we periodically forecast our needs for such materials and enter into standard purchase orders with them, we do not have long-term contracts with some of these suppliers. If we were to lose such suppliers, or if such suppliers were unable to fulfill our orders or to meet our manufacturing specifications, there can be no assurance that we will be able to identify or enter into agreements with alternative suppliers on a timely basis or on acceptable terms, if at all. If we are able to find an alternative supplier, such alternative supplier would need to be qualified and may require additional regulatory inspection or approval, which could result in further delay and more expenses.

An interruption in our operations could occur if we encounter delays or difficulties in securing these materials and components, or if the quality of the materials and components supplied do not meet our requirements, or if we cannot then obtain an acceptable substitute. The time and effort required to qualify a new supplier and ensure that the new materials and components provide the same or better quality results could result in significant additional costs. Any such interruption could significantly affect our business, financial condition, results of operations and reputation. To mitigate this risk, we typically carry significant inventory of critical components. While we believe that our level of inventory is currently sufficient for us to continue the manufacturing of our products without a disruption to our business if we must replace one of our suppliers, there can be no assurance that we can maintain this level of inventory in the future.

If we do not successfully optimize and operate our sales and distribution channels or we do not effectively expand and update infrastructure, our operating results and customer experience may be negatively impacted.

We must continue to optimize our sales and marketing organization and enter into partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to market and sell our products to maintain our commercial success and to achieve commercial success for any of our future products. Developing and managing a direct sales organization is a difficult, expensive and time-consuming process. If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, our future revenue may be reduced and our business may be harmed.

If we are unable to continue the development of an adequate sales and marketing organization and/or if our partner-directed sales organization is not successful, we may have difficulty achieving market awareness and selling our products in the future.

We must continue to develop and grow our sales and marketing organization. This includes using marketing efforts to attract future partnerships or other arrangements to market and sell our products and/or collaborate with third parties, including distributors and others, to market and sell our products to maintain our commercial success and to achieve commercial success for any of our future products. Developing and managing a direct sales organization is a difficult, expensive and time-consuming process. We focus on partner-directed sales organization and focus on establishing strategic partnerships that assist with facilitating our product distribution.

To continue to develop our sales and marketing organization to successfully achieve market awareness and sell our products, we must:

We may not be able to successfully manage our sales force or increase our product sales at acceptable rates.

If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmed.

We cannot guarantee that we will be able to maintain our current volume of sales in the future. A substantial reduction in sales could have a material adverse effect on our operating performance. To the extent that we enter into additional arrangements with third parties to perform sales or marketing services in the United States, Europe or other countries, our product margins could be lower than if we directly marketed and sold our products. To the extent that we enter into co-promotion or other marketing and sales arrangements with other companies, any revenue received will depend on the skills and efforts of others, and we cannot predict whether these efforts will be successful. In addition, the growth of market acceptance of our products by healthcare practitioners outside of Israel will largely depend on our ability to continue to demonstrate the relative safety, effectiveness, reliability, cost-effectiveness and ease of use of such products. If we are unable to do so, we may not be able to increase product revenue from our sales efforts in Europe or other countries. If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, our future revenue may be reduced and our business may be harmed.

We incorporate artificial intelligence, or AI and ML, into some of our products. This technology is new and developing and may present both compliance and reputational risks.

We enable AI assistance in the scan assessment workflows. The AI models that we use are trained using various data sets. If our AI models are incorrectly designed or implemented or do not receive pictures or visual data, they may produce inaccurate or unreliable results, negatively impacting the application to suggest reliable and accurate assistance for scan assessments. Additionally, failure of our AI to perform reliably, or to comply with evolving regulations, could result in significant legal liability, including claims related to property damage or personal injury, reputational damage, and a material adverse effect on our business and financial results.

We operate in highly competitive markets, competition may increase in the future, and our industry may be further disrupted.

Healthcare markets are characterized by rapidly evolving technology, frequent introduction of new products, intense competition, and pricing pressures. We face competition from international and domestic companies of all sizes. Competition is primarily focused on cost effectiveness, price, service, product performance, and technological innovation. Our ability to compete successfully may be adversely affected by factors such as:

Our inability to obtain and maintain regulatory authorizations for and supply commercial quantities of our offerings as quickly and effectively as our competitors could limit market acceptance. Furthermore, our markets are continually evolving and thus revenues and income are difficult to forecast. Any of these competitive factors could adversely affect our pricing, margins, and market share and have a material adverse effect on our business results, cash flows, financial condition, or prospects.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets, including changes in inflation, interest rates and overall economic conditions and uncertainties. To the extent inflation or other factors increase our business costs, it may not be feasible to pass price increases on to our customers or offset higher costs through manufacturing efficiencies. Inflation could also adversely affect the ability of our customers to purchase our products. An economic downturn could result in a variety of risks to our business, including weakened demand for our products and our inability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also result in further constraints on our suppliers or cause future customers to delay making payments for our products. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely affect our business.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States or Israel.

Other than our headquarters and other operations which are located in Israel, our business strategy incorporates significant international expansion, particularly in anticipated expansion of regulatory approvals of our products. Doing business internationally involves a number of risks, including but not limited to:

Any of these factors could significantly harm our future international expansion and operations and, consequently, our results of operations.

Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.

Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade.

The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain products, on certain trade partners, including Israel. On February 20, 2026, the Supreme Court ruled that the International Emergency Economic Powers Act, or IEEPA, does not authorize a U.S. President to impose tariffs during peacetime national emergencies and that the challenge to the legality of the tariffs imposed under IEEPA (the “incremental tariffs”) was within the exclusive jurisdiction of the U.S. Court of International Trade. In response to this ruling, the U.S. President signed a proclamation imposing a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026, and subsequently increased these tariffs to 15% on February 21, 2026. Section 122 tariffs are subject to a 150-day statutory limit unless extended by Congress. In addition, the Office of the U.S. Trade Representative has announced it will initiate new Section 301 investigations into trading partners’ unfair practices, which could result in additional tariffs.

Tariffs, economic sanctions and other changes in U.S. trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S. goods. Further, any emerging protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries could affect the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). We cannot predict whether, and to what extent, trade policies will change in the future. If tariffs or other trade restrictions are imposed on products manufactured in Israel while we remain dependent on Israeli manufacturing, our cost of goods sold for the U.S. market may increase materially, which could negatively impact our gross margins and limit our pricing flexibility. Additionally, changes to trade agreements or customs regulations between the U.S. and Israel could increase lead times, introduce logistical complexities, or require modifications to our supply chain planning. These or similar trade-related developments may have a material adverse effect on our business, financial condition, and results of operations.

Scrutiny of sustainability and environmental, social, and governance, or ESG, initiatives could increase our costs or otherwise adversely impact our business.

Public companies have recently faced scrutiny related to ESG practices and disclosures from certain investors, capital providers, shareholder advocacy groups, other market participants and other stakeholder groups. Such scrutiny may result in increased costs, enhanced compliance or disclosure obligations, or other adverse impacts on our business, financial condition, or results of operations. Scrutiny may come from stakeholders both supporting and opposing ESG initiatives, adding complexity to our compliance and communication efforts.

If our ESG practices and reporting do not meet investor or other stakeholder expectations, we may be subject to investor or regulator engagement regarding such matters. Failure to comply with applicable ESG rules or regulations could lead to penalties, enforcement actions, adverse publicity, or could negatively affect our reputation, access to capital, or employee retention.

Evolving ESG-related regulations, such as sustainability reporting requirements, supply-chain diligence obligations, and international frameworks (including the EU Corporate Sustainability Reporting Directive (CSRD)), may also affect our contract manufacturers, suppliers, and other third parties. Any inability of such third parties to comply with applicable ESG standards may disrupt our supply chain or otherwise negatively affect our business, financial condition, or results of operations

Risks Related to Government Regulation and Other Legal Compliance Matters

We are subject to extensive government regulation, which could restrict the development, marketing, sale and distribution of our products and could cause us to incur significant costs.

Our ultrasound imaging products and associated services are subject to extensive pre-market and post-market regulation by the FDA and various other federal, state, local and foreign government authorities. For example, our operations are subject to regulations governing packaging and labeling requirements, adverse event reporting, quality system and manufacturing requirements, clinical testing and recalls. For a discussion on the relevant regulatory regime, see Item 4.B. “Business Overview - Government Regulation”.

We are commercializing our Pulsenmore ES ultrasound imaging device which is approved or clear for use in several key markets including the United States, Europe, Switzerland, Australia, Brazil, Colombia and Israel while our Pulsenmore FC ultrasound imaging device is at an early stage of commercialization in Israel where it is approved for use. We cannot assure that any of the Pulsenmore ES or Pulsenmore FC or any other medical devices or new uses, modifications, or renewals for any approved devices will be cleared or approved in a timely or cost-effective manner, if cleared or approved at all, or that we will be able to maintain the clearance or approval of such devices. In the event we are unable to leverage existing or predicate devices for future products, we may experience delays and additional costs to obtain FDA approval for such future products. For example, during 2020, we submitted a 510(k) application to the FDA for the Pulsenmore ES. However, the FDA indicated that a de novo application is the proposed method of application for Pulsenmore ES. Even if such clearances or approvals are received, they may not be for all indications for which we pursue. Because medical devices may only be marketed for cleared or approved indications, this could significantly limit the market for that product and may adversely affect our results of operations.

Our business is subject to unannounced inspections by FDA to determine our compliance with FDA requirements. FDA inspections can result in inspectional observations on Form FDA 483s, warning letters, untitled letters or other forms of more significant enforcement action. If the FDA concludes that we failed to comply with any regulatory requirements during an inspection, it could have a material adverse effect on our business and financial condition. We could incur substantial expense and harm to our reputation, and our ability to introduce new or enhanced products in a timely manner could be adversely affected.

If we, our contract manufacturers or our component suppliers are unable to manufacture our products in sufficient quantities, on a timely basis, at acceptable costs and in compliance with regulatory and quality requirements, the manufacturing and distribution of our devices could be interrupted, and our product sales and operating results could suffer.

We, our contract manufacturers and our component suppliers are required to comply with the FDA’s Quality System Regulation, QSR, which is a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, shipping and servicing of our devices. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic, sometimes unannounced, inspections by the FDA. We cannot assure investors that our facilities or our third-party manufacturers’ or suppliers’ facilities would pass any future quality system inspection. Failure of our third-party manufacturers and component suppliers to adhere to QSR requirements or take adequate and timely corrective action in response to an adverse quality system inspection finding could delay production of our products and lead to fines, difficulties in obtaining regulatory clearances, recalls, enforcement actions, including injunctive relief or consent decrees, or other consequences, which could have a material adverse effect on our financial condition or results of operations. In addition, any of our products shipped internationally are also required to comply with the International Organization for Standardization, or ISO, quality system standards as well as EU Regulations and norms in order to produce products for sale in the EU.

The Pulsenmore Products use piezoelectric crystal technology. This technology is adopted in many ultrasound devices. We cannot predict whether any future regulation will deem the level of lead contained in these devices as hazardous or whether the exemption to the EU’s Restrictions of Hazardous Substances Directive will be revised. On September 8, 2025, the European Commission formally adopted three draft delegated directives amending Annex III of Directive 2011/65/EU (RoHS Directive), with a specific focus on updating the exemptions for lead in glass/ceramics, alloys, and high-temperature solder. These changes were subsequently published in the Official Journal of the European Union on November 21, 2025, and entered into force on December 11, 2025, meaning Member States must now apply the revised exemption provisions from that date.

In addition, many countries such as Canada and Japan have very specific additional regulatory requirements for quality assurance and manufacturing. If we fail to continue to comply with current good manufacturing requirements, as well as ISO or other regulatory standards, we may be required to cease all or part of our operations until we comply with these regulations. Maintaining compliance with multiple regulators adds complexity and cost to our manufacturing and compliance processes.

Our current or future products may be subject to product recalls even after receiving FDA and comparable foreign regulatory authorities clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

The FDA and similar governmental bodies in other countries have the authority to require the recall of our products if we or our third-party manufacturers fail to comply with relevant regulations pertaining to, among other things, manufacturing practices, labeling, advertising or promotional activities, or if new information is obtained concerning the safety or efficacy of these products. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to product liability claims, be required to bear other costs, or be required to take other actions that may have a negative impact on our future sales and our ability to generate profits.

We may be subject to enforcement action if we engage in improper or off-label marketing or promotion of our products, including fines, penalties and injunctions.

Our promotional materials and training methods must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of unapproved, or off-label, uses. However, if the FDA determines that our promotional materials or training materials promote an approved medical device in a manner inconsistent with its labeling, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an Untitled Letter, a Warning Letter, injunction, seizure, civil fine or criminal penalties. In addition to ensuring that the claims we make are consistent with our regulatory clearances or approvals, the FDA also ensures that promotional labeling for all regulated medical devices is neither false nor misleading.

It is also possible that other federal (such as the FTC), state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, or to be false, unsubstantiated, or misleading, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of our products could be impaired, in addition to legal consequences, which may include fines, penalties, product liability claims, and other legal actions.

In some instances in our advertising and promotion, we may make claims regarding our product as compared to competing products, which may subject us to heightened regulatory scrutiny, enforcement risk, and litigation risks.

The FDA requires that promotional labeling be truthful and not misleading, including with respect to any comparative claims made about competing products or technologies. In addition to FDA implications, the use of comparative claims also presents risk of a lawsuit by the competitor under federal and state false advertising and unfair competition statutes (e.g., the Lanham Act) or unfair and deceptive trade practices law, and possibly also state libel law, or other similar foreign laws. Such a suit may seek injunctive relief against further advertising, a court order directing corrective advertising, and compensatory and punitive damages where permitted by law. Further, notwithstanding the ultimate outcome of any Lanham Act or similar complaint, our reputation and relationship with certain customers or distribution partners may be harmed as a result of the allegations related to our products or our business practices more generally.

We are subject to federal, state and foreign laws prohibiting “kickbacks” and false or fraudulent claims, and other fraud and abuse laws, transparency laws, and other health care laws and regulations, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.

Our relationships with customers and third-party payors are subject to broadly applicable fraud and abuse and other health care laws and regulations that may constrain our sales, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and certain customer and product support programs, we may have with hospitals, physicians or other purchasers of medical devices. See “Item 4.B., Business Overview - Government Regulation”.

Any failure to comply with these laws and regulations could subject us or our officers and employees to criminal and civil financial penalties. We are also subject to risks relating to changes in government and private medical reimbursement programs and policies, and changes in legal regulatory requirements in the U.S. and around the world. Implementation of further legislative or administrative reforms to these reimbursement systems, or adverse decisions relating to coverage of or reimbursement for our products by administrators of these systems, could have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them.

We are subject to stringent privacy laws and information security policies and regulations.

Our products and systems receive, generate, and store significant volumes of personal and sensitive information, such as employee, customer, and patient data. Moreover, our digital ecosystem, which is intended to provide our customers with greater access to a broad array of personal and sensitive information to improve delivery of care to their patients, heightens our risks associated with the protection of such information. We have legal and contractual obligations regarding the protection of confidential and personal information and the appropriate collection, use, retention, protection, disclosure, transfer, and other processing of such data. Additionally, regulators within the United States and around the world are evaluating how best to regulate development and use of data as well as AI technologies. We are subject to various privacy law regimes in the different jurisdictions in which we operate, including comprehensive regulatory systems in Europe, South America, and sector-specific requirements in the United States. Certain international jurisdictions have enacted or are enacting data localization laws mandating that certain types of data collected in a particular jurisdiction be physically stored within that jurisdiction.

There are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information. In particular, regulations promulgated pursuant to HIPAA establish privacy and security standards that limit the use and disclosure of protected health information, or PHI, require the implementation of safeguards to protect the privacy and security of PHI and ensure the confidentiality, integrity, and availability of electronic PHI, and require the provision of notice in the event of a breach of PHI. If we are unable to properly protect the privacy and security of PHI, we could face liability for breach of our contracts with our customers. Further, if we fail to comply with applicable HIPAA privacy and security standards, we could face civil and criminal penalties. In addition, there are also various state-level laws (e.g., the California Consumer Privacy Act), both enacted and proposed, that we must monitor for applicability and impact to our business and for which we must implement necessary controls and other requirements (if applicable).

In addition, we are subject to the laws and regulations of foreign jurisdictions including, without limitation, the GDPR in the EU. The GDPR is supplemented by national laws and guidance from the European Data Protection Board. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to having a legal basis for processing personal data, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors. It is particularly relevant that most of the data we process is healthcare data. According to Art. 9 GDPR, this is a distinct category of personal data, the processing of the data is subject to increased requirements.

In addition, the GDPR requires companies to comply with accountability obligations (Art. 5(2) GDPR). This means that we must document in a comprehensible manner that all processing operations comply with the requirements of the GDPR, including internal processes, technical and organizational measures, and regular inspections and evidence. In addition, we are bound by the principles of data minimization and storage limitation (Art. 5 (1) (c) and (e) GDPR). Personal data may therefore only be processed to the extent necessary for the respective purpose and must be deleted as soon as its storage is no longer necessary. To this end, robust deletion concepts and clear storage periods must be implemented. We must also ensure that data subjects can exercise their rights under the GDPR—including access, erasure, rectification, restriction of processing, and objection—effectively and within the statutory time limits. This requires clear internal processes to review and respond to requests in a timely manner.

The GDPR permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 million or 4% of annual global revenues, whichever is greater. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. If we fail to comply with the GDPR, we could face fines, penalties, and harm to our reputation.

The GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the United States. The European Commission has issued standard contractual clauses for data transfers from controllers or processors in the EU to controllers or processors established outside the EU. Before transferring personal data to a third country under the Standard Contractual Clauses (SCCs), it is essential that the data exporter conducts a thorough assessment of the transfer. In particular, the exporter in collaboration with the data importer must determine whether the level of data protection provided by the GDPR is effectively maintained in the destination country, taking into account the specific circumstances of the transfer and any supplementary safeguards that may be implemented. Should the exporter conclude that an adequate level of protection cannot be ensured, they are obliged to suspend the transfer and/or terminate the contractual arrangement with the importer.

The EU and United States have adopted their adequacy decision for the EU-U.S. Data Privacy Framework, or Framework, which entered into force on July 11, 2023. This Framework provides that the protection of personal data transferred between the EU and the United States is comparable to that offered in the EU. This provides a further avenue to ensuring transfers to the United States are carried out in line with GDPR. The Framework could be challenged like its predecessor frameworks. This complexity and the additional contractual burden increases our overall risk exposure. There may be further divergence in the future, including with regard to administrative burdens.

Increased cybersecurity requirements, vulnerabilities, threats, and more sophisticated and targeted computer crimes pose a risk to our systems, networks, products, solutions, services, and data, as well as our reputation, which could adversely affect our business.

We manufacture and sell products that rely upon software and computer systems to operate properly and process and store confidential information. Our products often are connected to, and reside within, our customers’ information technology, or IT, infrastructures. In some jurisdictions, we are expected to design our products to include appropriate cybersecurity protections, and regulatory authorities may review such protections when granting marketing authorizations. While we seek to protect our products and IT systems from unauthorized access, these measures may not be effective, particularly because techniques used to obtain unauthorized access or to sabotage systems change frequently, increase in sophistication, and often are not identified at the time that they are launched against a target. These risks apply to our installed base of products, products we currently sell, new products we will introduce in the future, and older technology that we no longer sell or service but remains in use by customers. Additionally, we offer software and cloud products that are developed by, controlled by, or are hosted by third-party providers. A cybersecurity breach of our systems or products, of our customers’ or service providers’ network security and systems, or of other third-party services could disrupt treatment being delivered to patients or interfere with our customers’ operations, and could lead to the loss of, damage to, or public disclosure of our employees’ and customers’ stored information, including personal data, such as PHI. Such an event could have serious negative consequences, including alleged customer or patient harm, obligations to notify enforcement authorities or users of our products, voluntary or forced recalls of or modifications to our products, regulatory actions, fines, penalties and damages, reduced demand for or use of our offerings by customers, harm to our reputation, and time-consuming and expensive litigation, any of which could have a material adverse effect on our business results, cash flows, financial condition, or prospects.

There are increasingly large volumes of information, including patient data, being generated that need to be securely processed and stored by healthcare organizations. There has been an increase in the frequency and sophistication of the cybersecurity threats we and our service providers face, and we expect these activities to continue to increase. Geopolitical tensions or conflicts, such as the conflict between Russia and Ukraine, and the increased adoption of AI technologies, may further heighten the risk of cyber-attacks. Additionally, leveraging AI capabilities to potentially improve internal functions and operations presents further risks and challenges, including the possibility of creating new attack methods for adversaries. The use of AI to support business operations carries inherent risks related to data privacy, IP, and security, such as intended, unintended, or inadvertent transmission of proprietary, confidential, or sensitive information, as well as challenges related to implementing and maintaining AI tools, such as developing and maintaining appropriate datasets for such support. If we fail to implement adequate safeguards, the use of AI may introduce additional operational vulnerabilities by producing inaccurate outcomes based on flaws in the underlying data or methodologies, or unintended results.

Furthermore, we may also be exposed to a more significant risk if such actions are taken by state or state-affiliated actors. The objectives of these cyber-attacks vary widely and may include, among other things, unauthorized access to personal, customer, or third-party information, disruptions in operations and the provision of services to customers, or theft of IP or other sensitive assets or information belonging to us, our business partners, or customers. As such attacks become more effective, the risks in this area continue to grow. The back-up systems we have in place may not be adequate in the event of a failure or interruption. We may not have current capabilities to identify all vulnerabilities, which may allow others to exploit persistent potential exposures within our IT systems and products. We could suffer significant business disruption, including transaction errors, supply chain or manufacturing interruptions, processing inefficiencies, data loss, loss of customers, reputational damage, the loss of or damage to IP or other proprietary information, litigation, investigation, and possible liability to employees, customers, suppliers, patients, and regulatory authorities as a result of a successful cyber-attack. Further, our ability to effectively plan, forecast, and execute our business plan and comply with applicable laws and regulations may be impaired by such cyber-attacks. Any of the above could have a material adverse effect on our business results, cash flows, financial condition, or prospects, and on the timeliness of reporting our operating results.

We rely on software, SaaS, hardware, and other material components from a number of third parties to manufacture our products. If a material cyber incident impacting a supplier were to result in its prolonged inability to use, manufacture and/or ship such components, this could impact our ability to manufacture and/or use our products. In addition, third-party sourced software components, malicious code, or a critical vulnerability emerging within such software could expose our customers to increased cyber risk. While we have undertaken efforts to mitigate cybersecurity risks, these efforts may not prevent all incidents.

If we were to experience a significant cybersecurity breach of our information systems or data, the costs associated with the investigation, remediation, and potential notification of the breach to customers, regulators, and counterparties, as well as any related litigation expenses, fines, penalties, or damages, could be material. In addition, our remediation efforts may not be successful. The data privacy and IT security insurance coverage we currently maintain may be inadequate. In addition, the market for such insurance continues to evolve and, in the future, our data privacy and IT security insurance coverage may be prohibitively expensive or not available on acceptable terms or in sufficient amounts, or at all.

Broad-based domestic and international government initiatives to reduce spending, particularly those related to healthcare costs, may reduce reimbursement rates for medical procedures, which will reduce the cost-effectiveness of our products and services.

Healthcare reforms, changes in healthcare policies and changes to third-party coverage and reimbursements, including legislation enacted reforming the U.S. healthcare system and both domestic and foreign healthcare cost containment legislation, and any future changes to such legislation, may affect demand for our products and services and may have a material adverse effect on our financial condition and results of operations. The ongoing implementation of the Affordable Care Act, in the United States, as well as state-level healthcare reform proposals could reduce medical procedure volumes and impact the demand for medical device products or the prices at which we can sell products. The impact of this healthcare reform legislation, and practices including price regulation, competitive pricing, comparative effectiveness of therapies, technology assessments, and managed care arrangements are uncertain. There can be no assurance that current levels of reimbursement will not be decreased in the future, or that future legislation, regulation, or reimbursement policies of third parties will not adversely affect the demand for our products and services or our ability to sell products and provide services on a profitable basis. The adoption of significant changes to the healthcare system in the United States, the EEA or other jurisdictions in which we may market our products and services, could limit the prices we are able to charge for our products and services or the amounts of reimbursement available for our products and services, could limit the acceptance and availability of our products and services, reduce medical procedure volumes and increase operational and other costs.

Healthcare industry cost-containment measures could result in reduced sales of our products and services.

Most of our customers rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all of the cost of the procedures in which our products are used. The continuing efforts of governmental authorities, insurance companies and other payers of healthcare costs to contain or reduce these costs could lead to patients being unable to obtain approval for payment from these third-party payers. If third-party payer payment approval cannot be obtained by patients for procedures that use our products, sales of our products may decline significantly and our customers may reduce or eliminate purchases of our products. The cost-containment measures that healthcare providers are instituting, both in the U.S. and outside of the U.S., could harm our ability to operate profitably. For example, GPOs and IDNs have also concentrated purchasing decisions for some customers, which has led to downward pricing pressure for medical device companies.

We are subject to certain U.S. and foreign anticorruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.

Among other matters, U.S. and foreign anticorruption, anti-money laundering, export control, sanctions and other trade laws and regulations, which are collectively referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting or receiving, directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. We also expect our non-U.S. activities to increase over time. We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals, and we can be held liable for the corrupt or other illegal activities of our personnel, agents or partners, even if we do not explicitly authorize or have prior knowledge of such activities.

We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other things.

Our business exposes us to the risk of product liability claims that are inherent in the testing, manufacturing and marketing of medical devices, including those which may arise from the misuse (including system hacking or other unauthorized access by third parties to our systems) or malfunction of, or design flaws in, our hardware and software products. This liability may vary based on the FDA classification associated with our devices and with the laws of the state or other applicable jurisdiction governing product liability standards applied to specification developers and/or manufacturers in a given negligence or strict liability lawsuit. We may be subject to product liability claims if our products cause, or merely appear to have caused, an injury. Claims may be made by patients, healthcare providers or others selling our products. The risk of product liability claims may also increase if our products are subject to a product recall, whether voluntary or mandatory, or government seizure. Product liability claims may be brought by individuals or by groups seeking to represent a class.

Although we have insurance at levels that we believe to be appropriate, this insurance is subject to deductibles and coverage limitations. Our current product liability insurance may not continue to be available to us on acceptable terms, if at all, and, if available, the coverage may not be adequate to protect us against any future product liability claims. Further, if additional medical device products are approved or cleared for marketing, we may seek additional insurance coverage. If we are unable to obtain insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may harm our business. A product liability claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business.

We may be subject to claims against us even if the apparent injury is due to the actions of others or misuse of the device or a partner device. Healthcare providers may use our products in a manner that is inconsistent with the products’ labeling and that differs from the manner in which they were used in clinical studies and authorized for marketing by the FDA. Off-label use of products by healthcare providers is common, and any such off-label use of our products could subject us to additional liability, or require design changes to limit this potential off-label use once discovered. Defending a suit, regardless of merit, could be costly, could divert management attention and might result in adverse publicity, which could result in the withdrawal of, or result in reduced acceptance of, our products in the market.

Additionally, we have entered into various agreements where we indemnify third parties for certain claims relating to our products. These indemnification obligations may require us to pay significant sums of money for claims that are covered by these indemnification obligations. We are not currently subject to any product liability claims; however, any future product liability claims against us, regardless of their merit, may result in negative publicity about us that could ultimately harm our reputation and could have a material adverse effect on our business, financial condition or results of operations.

Changes in applicable tax laws and regulations could adversely affect our business.

We are subject to income and other non-income taxes (including sales, excise, and value-added) in the United States and foreign jurisdictions. Thus, the tax treatment of transactions we execute is subject to changes in tax laws or regulations, tax treaties, or positions by the relevant authority regarding the application, administration, or interpretation of these tax laws and regulations. These factors, together with the ambiguity of tax laws and regulations, the subjectivity of factual interpretations, and uncertainties regarding the geographic mix of earnings in any period, can affect our estimates of our effective tax rate and income tax assets and liabilities, result in changes in our estimates and accruals, and have a material adverse effect on our business results, cash flows, or financial condition. Recently, legislation commonly known as the One Big Beautiful Bill Act (OBBBA) was signed into law in July 2025, which enacts significant changes to U.S tax and related laws, including but not limited to current deduction of domestic research expenses, increasing the limit of the deduction of interest expense to thirty percent of EBITDA and one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. We are unable to predict what tax reforms may be proposed or enacted in the future or what effect such changes would have on our business; however, such changes could potentially result in higher tax expense and payments, along with increasing the complexity, burden, and cost of compliance.

Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.

We may be subject to rules and regulations in the United States and non-U.S. jurisdictions relating to our Pulsenmore ES and Pulsenmore FC systems or any future products. In some countries, including countries in Europe, Japan, or China each of which has developed its own rules and regulations, pricing may be subject to governmental control under certain circumstances. In these countries, pricing negotiations with governmental agencies can take considerable time after the receipt of marketing approval for a medical device candidate. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available products. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability.

Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and clear or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may also slow the time necessary for new medical devices or modifications to cleared or approved medical devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. Most recently, the federal government was shut down for approximately 43 days from October 1 to November 12, 2025, due to a lapse in appropriations, during which federal employees were furloughed and many agencies, including components of the HHS, operated with reduced staffing or suspended activities. Prior shutdowns, such as the 35-day shutdown beginning December 22, 2018, similarly resulted in furloughs and delays in regulatory review activities. Any future government shutdowns, funding lapses, continuing resolutions, or similar events could result in reduced agency staffing, delays in regulatory reviews, interruptions to critical government functions, or uncertainty in agency operations, each of which could materially and adversely affect our business, financial condition, and results of operations.

Risks Related to Our Intellectual Property

If we are unable to protect our intellectual property, our ability to maintain any technological or competitive advantage over our competitors and potential competitors would be adversely impacted, and our business may be harmed.

We rely on patent protection as well as trademark, copyright, trade secret and other intellectual property rights protection and contractual restrictions to protect our proprietary technologies, all of which provide limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. As of the date of this Annual Report, we owned approximately 94 issued patents and pending patent applications in the United States and foreign jurisdictions, including Australia, Canada, Europe, Japan, China, South Korea and India. These issued patents and pending patent applications (if they were to be issued as patents) have expected expiration dates ranging between approximately 2034 and 2045. If we fail to protect our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.

We cannot assure investors that any of our currently pending or future patent applications will result in granted patents, and we cannot predict how long it will take for such patents to be granted or whether the scope of such patents, if granted, will adequately protect our products from competitors. It is possible that, for any of our patents that have been granted or that may be granted in the future, others will design alternatives that do not infringe upon our patented technologies. Further, we cannot assure investors that other parties will not challenge any patents granted to us or that courts or regulatory agencies will hold our patents to be valid or enforceable. We cannot guarantee investors that we will be successful in defending challenges made against our patents and patent applications. Any successful third-party challenge to our patents could result in the unenforceability or invalidity of such patents, or such patents being interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological or competitive advantage over our competitors may be diminished because of these uncertainties. For these and other reasons, our intellectual property may not provide us with any competitive advantage. For example:

Filing, prosecuting and defending patents on current and future products in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, regardless of whether we are able to prevent third parties from practicing our inventions in the United States, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from competing. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.

If we fail to protect our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property. For these and other reasons, our intellectual property may not provide us with any competitive advantage.

If we or any of our partners are sued for infringing the intellectual property rights of third parties, such litigation would be costly and time consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on our business. We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Our success also depends on our ability to develop, manufacture, market and sell our products and perform our services without infringing upon the proprietary rights of third parties. Numerous U.S. and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing products and services. As is common in the medical device industry, we also engage the services of specialized consultants and employees who are currently providing or previously provided services to our competitors and we may become subject to claims that we, an employee, a consultant or an independent contractor inadvertently or otherwise used or disclosed trade secrets, intellectual property or other information proprietary to their former employers or their former or current clients. As part of a business strategy to impede our successful commercialization and entry into new markets, competitors may claim that our products and/or services infringe their intellectual property rights and may suggest that we enter into license agreements.

Even if such claims are without merit, we could incur substantial costs and the attention of our management, and technical personnel could be diverted in defending us against claims of infringement made by third parties or settling such claims. Any adverse ruling by a court or administrative body, or perception of an adverse ruling, may have a material adverse impact on our ability to conduct our business and our finances. Moreover, third parties making claims against us may be able to obtain injunctive relief against us, which could block our ability to offer one or more products or services and could result in a substantial award of damages against us. In addition, since we sometimes indemnify customers, collaborators or licensees, we may have additional liability in connection with any infringement or alleged infringement of third-party intellectual property.

There is a substantial amount of litigation involving patent and other intellectual property rights in the medical device space. As we face increasing competition and as our business grows, we will likely face more claims of infringement. If a third party claims that we or any of our licensors, customers or collaboration partners infringe upon a third party’s intellectual property rights, we may have to:

Competitors may infringe our patents or the patents that we license. In the event of infringement or unauthorized use, we may file one or more infringement lawsuits, which can also be expensive and time-consuming. An adverse result in any such litigation proceedings could put one or more of our patents at risk of being invalidated, being found to be unenforceable or being interpreted narrowly and could put our patent applications at risk of not being issued. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

Patent litigation can be very costly and time consuming. Many of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation longer than we could. In addition, the uncertainties associated with litigation, or an adverse outcome, could have a material adverse effect on our ability to raise any funds necessary to continue our operations, continue our internal research programs, in-license needed technology, expose us to significant liabilities, or enter into development partnerships that would help us bring our products to market.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products.

The America Invents Act, or AIA, was signed into law on September 16, 2011, and many of the substantive changes under the AIA became effective on March 16, 2013 is the primary governing legislation in the United States and many of the countries we operate within have similar governing legislation. Additionally, courts and administrative bodies often issue rulings on matters related to patent and intellectual property enforcement actions, which may either adversely or beneficially impact our ability to enforce our patent and intellectual property rights within the United States and elsewhere. The laws governing patent prosecution and enforcement are subject to change in unpredictable ways and such changes may be influenced by rulings of courts and other administrative bodies. These changes may weaken our ability to obtain new patents and/or enforce the rights of our existing patents.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

We may use third-party open source software components in future products, and failure to comply with the terms of the underlying open source software licenses could restrict our ability to sell such products.

We have chosen, and we may choose in the future, to use open source software in our products. Use and distribution of open source software may entail greater risks than use of third-party commercial software, as open source licensors generally do not provide warranties or other contractual protections regarding infringement claims or the quality of the code. Some open source licenses may contain unfavorable requirements that could allow our competitors to create similar products with less development effort and time and ultimately could result in a loss of product sales.

Although we intend to monitor any use of open source software to avoid subjecting our products to conditions we do not intend, the terms of many open source licenses have not been interpreted by U.S. courts, and there is a risk that any such licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our products. Moreover, there is no assurance that our processes for controlling our use of open source software in our products will be effective. If we are held to have breached the terms of an open source software license, we could be required to seek licenses from third parties to continue offering our products on terms that are not economically feasible, to re-engineer our products, to discontinue the sale of our products if re-engineering could not be accomplished on a timely basis, or to make generally available, in source code form, our proprietary code, any of which could adversely affect our business, operating results and financial condition.

We use third-party software that may cause errors or failures of our products that could lead to lost customers or harm to our reputation.

We use software licensed from third parties in our products. Any errors or defects in third-party software or other third-party software failures could result in errors or defects or cause our products to fail, which could harm our business and be costly to correct. Many of these providers attempt to impose limitations on their liability for such errors, defects or failures, and if enforceable, we may have additional liability to our customers or third-party providers that could harm our reputation and increase our operating costs.

We will need to maintain our relationships with third-party software providers and to obtain software from such providers that does not contain any errors or defects. Any failure to do so could adversely impact our ability to deliver reliable products to our customers and could harm our reputation and results of operations.

Risks Related to Israeli Law and Our Operations in Israel

Our headquarters and other significant operations are located in Israel, and, therefore, our results may be adversely affected by political, economic and military instability in Israel.

Our executive offices, research and development laboratories are located in Ramat Gan, Israel while our production site is located in Omer, Israel. In addition, the majority of our key employees, officers and directors are residents of Israel. Accordingly, political, geopolitical, economic and military conditions in Israel may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and groups in its neighboring countries, and between Israel and terrorist organizations active in the region, including the Hamas (an Islamist militia and political group in the Gaza Strip) and, Hezbollah (an Islamist militia and political group in Lebanon) and other terrorist organizations active in the region. While Israel has entered into peace agreements with both Egypt and Jordan and has entered into several normalization agreements in 2020, known as the Abraham Accords, with the United Arab Emirates, Bahrain, Sudan and Morocco, Israel has no peace agreement or normalization arrangements with any other neighboring or Arab country. Further, all efforts to improve Israel’s relationship with the Palestinians have failed to result in a permanent peaceful solution.

In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on the Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in thousands of deaths and injuries, and kidnapping of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and commenced a military campaign against Hamas and these terrorist organizations in parallel continued rocket and terror attacks. On January 19, 2025, a temporary ceasefire went into effect, however during March 2025, the ceasefire collapsed. As of October 9, 2025, Israel and Hamas entered into a renewed ceasefire agreement calling for a permanent end of the war. However, there are no assurances that such an agreement will hold. While the conflict has created heightened security concerns, disruptions to business operations, and economic instability, the ceasefire may contribute to improved regional stability. However, the security situation remains fluid, and any renewed military actions, restrictions, or government-imposed measures could adversely affect our operations, supply chains, and financial condition.

Since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq. In October 2024, Israel began limited ground operations against Hezbollah in Lebanon, and in November 2024, a ceasefire was brokered between Israel and Hezbollah. In March 2026, hostilities resumed along Israel’s northern border with Lebanon, when Hezbollah resumed its attacks as part of a broader regional escalation. In response, Israel resumed military operations against Hezbollah in Lebanon.

As a result of the events of October 7, 2023, the Israeli military called-up reservists for active duty. As of the date of this Annual Report, three of our employees, our Chief Financial Officer, our General Counsel and our Controller are serving in reserve duty while remaining actively engaged in the management of the Company. While our Chief Financial Officer, our General Counsel and our Controller continue to perform their duties, their availabilities may be reduced from time to time due to their ongoing reserve service. Military service call ups that result in absences of personnel from us for an extended period of time may materially and adversely affect our business, prospects, financial condition, and results of operations.

In addition, in April 2024 and October 2024, Iran launched direct attacks on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons. Further, in response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 13, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders. While a ceasefire was reached in June 2025 following 12 days of hostilities, on February 28, 2026, the United States and Israel launched coordinated military strikes against Iran, including attacks on strategic military infrastructure and leadership targets, with the stated aim of degrading Iran’s capacity to conduct or support hostile operations against them. In response, Iran has fired missiles and drones toward population centers and military installations in Israel, Europe and neighboring countries in the Gulf region, and also launched counter-strikes against U.S. forces and allied bases throughout the Gulf region. Iran is also restricting passage through the Strait of Hormuz which is disrupting global supply chains, including for oil and gas, and is impacting global economies. Continued military escalation, retaliatory actions, or broader regional involvement may adversely affect economic conditions, disrupt markets, and create uncertainty that could negatively impact our business, financial condition and results of operations. A broader regional conflict involving additional state and non-state actors remains a significant risk. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq. These situations may potentially escalate in the future to more violent events which may affect Israel and us.

Since the start of the war with Iran in February 2026, we have experienced disruptions to our our daily operations. While the intensity and duration of the security situation in Israel have been difficult to predict, as are the economic implications on our business and operations and on Israel’s economy in general. If the war extends for a long period of time or expands to other fronts, our operations may be adversely affected. We monitor closely the directives of relevant Israeli authorities and, where needed, make required adjustments to our operations in accordance with such directives, including by instructing our workforce to work remotely. To address potential challenges resulting from the security situation, we have adopted a Business Continuity Plan, which includes, among other things, transitioning to a cloud-based ERP system and establishing an alternative production site in South Korea in case of disaster.

Parties with whom we do business may decline to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in order to meet our business partners face to face. In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. Further, in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating results, financial condition or the expansion of our business. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could adversely affect our operations and results of operations.

Our insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East or for any resulting disruption in our operations. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or, if maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on our business, financial condition and results of operations. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.

Political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest. Actual or perceived political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.

We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of operations.

We incur expenses in U.S. dollars, NIS and Euros, but our financial statements are denominated and presented in NIS, which is our functional currency. The NIS is the currency that represents the principal economic environment in which we operate. As a result, we are affected by foreign currency exchange fluctuations through translation risk. As a result, we are exposed to the risk that the NIS may appreciate relative to the dollar, or, if the NIS instead devalues relative to the dollar, that the inflation rate in Israel may exceed such rate of devaluation of the NIS, or that the timing of such devaluation may lag behind inflation in Israel. In any such event, the dollar cost of our operations in Israel would increase and our dollar-denominated results of operations would be adversely affected.

Foreign exchange rates may fluctuate due to many factors, including interest-rate differentials between markets, capital flows, monetary policy decisions, geopolitical events, global macroeconomic developments, and investor sentiment toward Israel and regional markets. These factors may cause the NIS to appreciate or depreciate against the U.S. dollar or the Euro independent of local inflation levels. If the NIS strengthens without a corresponding increase in our foreign-currency revenues, our U.S. dollar-measured costs will rise.

The value of the NIS relative to the Euro, the U.S. dollar, and other currencies has fluctuated significantly. For example, the shekel appreciated on average by 12.5% relative to the U.S. dollar in 2025, after depreciating by 0.4% in 2024 and by 3.1% in 2023, thereby increasing, in 2025, the U.S. dollar cost of our shekel-denominated expenses. The Euro also appreciated relative to the dollar in 2025 on average, by 11.3%, thereby increasing the U.S. dollar cost of our Euro-denominated expenses. Any significant revaluation of the NIS may materially and adversely affect our cash flows, revenues, and financial condition. Fluctuations in the NIS exchange rate, or even the appearance of instability in such exchange rate, could adversely affect our ability to operate our business.

We consult with an external financial consulting firm to manage our level of exposure to changes in foreign currency exchange rates. As of the date of this Annual Report, our policy is to hold currency reserves in accordance with our expected expense mix, thereby reducing exposure. To date, we have not engaged in any foreign currency hedging transactions.

The termination or reduction of tax and other incentives that the Israeli government provides to Israeli companies may increase our costs and taxes.

The Israeli government currently provides tax and capital investment incentives to Israeli companies, as well as grant and loan programs relating to research and development and marketing and export activities. We have received in the past, currently receives, and may be required in the future to receive grants from governmental authorities, including grants from the IIA and similar bodies, which are provided for research and development purposes. These incentives and grants impose restrictions on the activities of the recipient companies, such as limitations on manufacturing outside of Israel and on selling know-how to foreign entities. Violating these restrictions, according to the approval letters and relevant laws, may subject the violating companies to various sanctions, including financial and criminal penalties. Changes in the budgets of the aforementioned governmental bodies, which prevent or reduce the grants and/or incentives we may receive in the future, could materially impact our operations and results. Furthermore, foreign investments are influenced, among other things, by the continued encouragement of foreign investments by regulatory bodies in Israel, including in the area of taxation. If such encouragement of foreign investments is discontinued and/or restricted, it could harm foreign investments in us and consequently impair our operations.

We received Israeli government grants for certain of our research and development activities, the terms of which may require us to pay royalties and to satisfy specified conditions in order to manufacture products and transfer technologies outside of Israel. If we fail to satisfy these conditions, we may be required to pay penalties and refund grants previously received.

Our research and development efforts have been financed in part through royalty-bearing grants in an aggregate amount of NIS 15.6 million (approximately $4.9 million) that we received from the IIA as of December 31, 2025. With respect to the royalty-bearing grants, we are committed to pay royalties at a rate of 3% on sales proceeds from our products that were developed under IIA programs, up to the total amount of grants received and bearing interest rate at an annual rate of SOFR applicable to U.S. dollar deposits. Until October 25, 2023, the interest was calculated at a rate based on 12-month LIBOR applicable to US Dollar deposits. However, on October 25, 2023, the IIA published a directive concerning changes in royalties to address the expiration of the LIBOR. Under such directive, regarding IIA grants approved by the IIA prior to January 1, 2024 but which are outstanding thereafter, as of January 1, 2024, the annual interest is calculated at a rate based on 12-month Secured Overnight Financing Rate, or SOFR, or at an alternative rate published by the Bank of Israel plus 0.71513%; and, for grants approved on or following January 1, 2024, the annual interest shall be the higher of (i) the 12 months SOFR interest rate, plus 1%, or (ii) a fixed annual interest rate of 4%. Additionally, if the IIA’s research committee grants us approval to transfer manufacturing rights or part of them outside of Israel, according to the provisions of the Research Law and the relevant benefit track, we will be required to pay royalties up to a total amount equal to 300% of the IIA grant amount plus annual interest, as determined by the IIA and according to the manufacturing rights which transfer outside of Israel is approved by the IIA. We do not anticipate being required to pay royalties at the increased rate. Furthermore, if the IIA’s research committee grants us approval to transfer know-how outside of Israel, according to the provisions of the Research Law and the relevant benefit track, we will be required to pay royalties up to a total amount equal to up to six times the total grants received by us under the Research Law and other IIA support tracks, regarding that know-how, plus annual interest.

We are further required to comply with the requirements of the Israeli Encouragement of Industrial Research, Development and Technological Innovation Law, 5744-1984, as amended, and related regulations, or the Research Law, with respect to those past grants. When a company develops know-how, technology or products using IIA grants, the terms of these grants and the Research Law restrict the transfer or license of such know-how, and the transfer of manufacturing or manufacturing rights of such products, technologies or know-how outside of Israel, without the prior approval of the IIA. Therefore, the discretionary approval of an IIA committee would be required for any transfer or license to third parties inside or outside of Israel of know-how or for the transfer outside of Israel of manufacturing or manufacturing rights related to those aspects of such technologies. We may not receive those approvals. Furthermore, the IIA may impose certain conditions on any arrangement under which it permits us to transfer technology or development. As part of the conditions for receiving the IIA grant, we committed, among other things, to comply with the provisions of the Research Law and the intellectual property laws as they may be in effect from time to time in Israel. We also committed that if it is convicted of an offense under the intellectual property laws of Israel, in a final and conclusive judgment in an Israeli court, the IIA may cancel any benefit we received from it, including a grant, loan, tax benefit, or any other financial advantage, or part of such benefit, and demand their return with interest and linkage differentials as required by law. Additionally, we and our controlling shareholder or interested party (as defined in the Securities Law), as applicable, should report to the IIA’s research committee on any change in control of the company and any change in the holding of control means (as defined in the Securities Law) in the company, which makes someone who is not an Israeli citizen or resident or a corporation incorporated in Israel, a direct interested party in the company. Upon such reporting, the interested party will sign an undertaking towards the IIA to comply with the provisions of the Research Law in the form published by the IIA.

The transfer or license of IIA-supported technology or know-how outside of Israel and the transfer of manufacturing of IIA-supported products, technology or know-how outside of Israel may involve the payment of significant amounts, depending upon the value of the transferred or licensed technology or know-how, our research and development expenses, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions and requirements for payment may impair our ability to sell, license or otherwise transfer our technology assets outside of Israel or to outsource or transfer development or manufacturing activities with respect to any product or technology outside of Israel. Furthermore, the consideration available to our shareholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.

We may be required to pay monetary remuneration to our Israeli employees for their inventions, even if the rights to such inventions have been duly assigned to us.

We generally enter into agreements with our Israeli employees pursuant to which such individuals agree that any inventions created in the scope of their employment are either owned exclusively by us or are assigned to us, depending on the jurisdiction, without the employee retaining any rights. A portion of our intellectual property has been developed by our Israeli employees during their employment for us. Under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee during the course of his or her employment and within the scope of said employment are considered “service inventions. Service inventions belong to the employer by default, absent a specific agreement between the employee and employer otherwise. The Patent Law also provides that if there is no agreement regarding the remuneration for the service inventions, even if the ownership rights were assigned to the employer, the Israeli Compensation and Royalties Committee, or the Committee, a body constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for these inventions. The Committee has not yet determined the method for calculating this Committee-enforced remuneration. While it has previously been held that an employee may waive his or her rights to remuneration in writing, orally or by conduct, litigation is pending in the Israeli labor court is questioning whether such waiver under an employment agreement is enforceable. Although our Israeli employees have agreed that we exclusively own any rights related to their inventions, we may face claims demanding remuneration in consideration for employees’ service inventions. As a result, we could be required to pay additional remuneration or royalties to our current and/or former employees, or be forced to litigate such claims, which could negatively affect our business.

We have non-competition agreements with our employees, all of which are governed by Israeli law. These agreements prohibit our employees from competing with or working for our competitors, generally during their employment and for up to 12 months after termination of their employment. However, Israeli courts are reluctant to enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions for relatively brief periods of time in restricted geographical areas, and only when the employee has obtained unique value to the employer specific to that employer’s business and not just regarding the professional development of the employee. If we are not able to enforce non-compete covenants, we may be faced with added competition.

Provisions of Israeli law and our articles of association may delay, prevent or otherwise impede a merger with, or an acquisition of, us, which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.

Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to such types of transactions. For example, a merger may not be consummated unless at least 50 days have passed from the date on which a merger proposal is filed by each merging company with the Israel Registrar of Companies and at least 30 days have passed from the date on which the shareholders of both merging companies have approved the merger. In addition, a majority of each class of securities of the target company must approve a merger. Moreover, a tender offer for all of a company’s issued and outstanding shares can only be completed if the acquirer receives positive responses from the holders of at least 95% of the issued share capital. Completion of the tender offer also requires approval of a majority of the offerees that do not have a personal interest in the tender offer, unless, following consummation of the tender offer, the acquirer would hold at least 98% of the Company’s outstanding shares. Furthermore, the shareholders, including those who indicated their acceptance of the tender offer, may, at any time within six months following the completion of the tender offer, claim that the consideration for the acquisition of the shares does not reflect their fair market value, and petition an Israeli court to alter the consideration for the acquisition accordingly, unless the acquirer stipulated in its tender offer that a shareholder that accepts the offer may not seek such appraisal rights, and the acquirer or the company published all required information with respect to the tender offer prior to the tender offer’s response date.

In addition, Israeli corporate law requires special approvals for certain transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to these types of transactions. Israeli corporate law does not provide for shareholder action by written consent for public companies, thereby requiring all shareholder actions to be taken at a general meeting of shareholders.

Provisions in our articles of association may discourage, delay, prevent or otherwise impede a merger, acquisition or other change in control of us that shareholders may consider favorable, including transactions in which they might otherwise receive a premium for their ordinary shares. On May 20, 2025, we amended our articles of association to establish a staggered board of directors, which divides the board into three groups, with directors in each group serving a three-year term. The existence of a staggered board can make it more difficult for shareholders to replace or remove incumbent members of our board of directors. As such, these provisions could also limit the price that investors might be willing to pay in the future for our ordinary shares, thereby depressing the market price of our ordinary shares. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our shareholders to replace or remove our current management by making it more difficult for shareholders to replace members of our board of directors.

Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose country of residence does not have a tax treaty with Israel exempting such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no disposition of the shares has occurred. These provisions could delay, prevent or impede an acquisition of us or our merger with another company, even if such an acquisition or merger would be beneficial to us or to our shareholders.

As a corporation incorporated under the laws of the State of Israel, we are also subject to the Israeli Economic Competition Law, 1988 and the regulations promulgated thereunder (formerly known as the Israeli Antitrust Law, 1988), under which we may be required in certain circumstances to obtain the approval of the Israel Competition Authority (formerly known as the Israel Antitrust Authority) in order to consummate a merger or a sale of all or substantially all of our assets.

Rights and responsibilities of shareholders will be governed in key respects by Israeli laws, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.

The rights and responsibilities of the holders of our ordinary shares are governed by our articles of association and by Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders in U.S. companies. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and other shareholders, and to refrain from abusing its power in such company, including, among other things, in voting at a general meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and related party transactions requiring shareholder approval, as well as a general duty to refrain from discriminating against other shareholders. In addition, a shareholder who is aware that it possesses the power to determine the outcome of a vote at a meeting of the shareholders or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company. There is limited case law available to assist us in understanding the nature of these duties or the implications of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our ordinary shares that are not typically imposed on shareholders of U.S. companies.

Our articles of association provide that unless we consent to an alternate forum, the federal district courts of the United States shall be the exclusive forum of resolution of any claims arising under the Securities Act or Exchange Act which may impose additional litigation costs on us or our shareholders and may discourage claims or limit the ability of shareholders to bring a claim in a forum they find favorable.

Our articles of association provide that the federal district courts of the United States shall be the exclusive forum for the resolution of any claims arising under the Securities Act or the Exchange Act, or the Federal Forum Provision. While the Federal Forum Provision does not restrict the ability of our shareholders to bring claims under the Securities Act or the Exchange Act, nor does it affect the remedies available thereunder if such claims are successful, we recognize that it allows claims under the Securities Act or Exchange Act in any federal court of competent jurisdiction in the United States, subject to determination by applicable courts of competent jurisdiction. Further, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all claims brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. This exclusive choice of forum provision (in federal district courts for claims under the Securities Act or Exchange Act and referenced state courts in the U.S.) may lead to our shareholders incurring increased costs if they were to bring a claim against us, and may limit our shareholders’ ability to bring a claim in a judicial forum they find favorable for disputes with us or our directors, officers, or other employees or agents, which may discourage claims against us and our directors, officers and other employees and agents. The enforceability of similar forum provisions (including exclusive federal forum provisions for actions, suits or proceedings asserting a cause of action arising under the Securities Act) in other companies’ organizational documents has been challenged in legal proceedings and there is uncertainty as to whether courts would enforce the exclusive forum provisions in our articles of association. If a court were to find the choice of forum provision contained in our articles of association to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could materially adversely affect our business, financial condition and results of operations.

It may be difficult to enforce a U.S. judgment against us, our officers and directors in Israel or the United States, or to assert U.S. securities laws claims in Israel or serve process on our officers and directors.

Most of our directors or officers are not residents of the United States and most of their and our assets are located outside the United States. Service of process upon us or our non-U.S. resident directors and officers and enforcement of judgments obtained in the United States against us or our non-U.S. directors and executive officers may be difficult to obtain within the United States, although our articles of association provide that unless our consent to an alternate forum, the federal district courts of the United States shall be the exclusive forum of resolution of any claims arising under the Securities Act or the Exchange Act. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws against us or our non-U.S. officers and directors because Israel may not be the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel addressing the matters described above. Israeli courts might not enforce judgments rendered outside Israel, which may make it difficult to collect on judgments rendered against us or our non-U.S. officers and directors.

Moreover, among other reasons, including but not limited to, fraud or absence of due process, or the existence of a judgment which is at variance with another judgment that was given in the same matter if a suit in the same matter between the same parties was pending before a court or tribunal in Israel, an Israeli court will not enforce a non-Israeli judgment if it was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional cases) or if its enforcement is likely to prejudice the sovereignty or security of the State of Israel.

Risks Related to Ownership of Our Ordinary Shares

The market price of our ordinary shares may be highly volatile, and you could lose all or part of your investment.

The market price of our ordinary shares may be volatile. This volatility may prevent you from being able to sell your ordinary shares at or above the price you paid for your securities. Our share price could be subject to wide fluctuations in response to a variety of factors, which include:

In addition, the stock market in general, and the stock of publicly-traded medical device companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our ordinary shares, regardless of our actual operating performance, and we have little or no control over these factors.

Our principal shareholders have significant influence over us.

As of March 15, 2026, our principal shareholders each holding more than 5% of our outstanding ordinary shares collectively beneficially own approximately 43.19% of our outstanding ordinary shares. See “Item 7.A. Major Shareholders”. These shareholders or their affiliates will be able to exert significant influence over us and, if acting together, will be able to control matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions, including a merger, consolidation or sale of all or substantially all of our assets and the issuance or redemption of equity interests in certain circumstances. The interests of these shareholders may not always coincide with, and in some cases may conflict with, our interests and the interests of our other shareholders. For instance, these shareholders could attempt to delay or prevent a change in control of our company, even if such change in control would benefit our other shareholders, which could deprive our shareholders of an opportunity to receive a premium for their ordinary shares. This concentration of ownership may also affect the prevailing market price of our ordinary shares due to investors’ perceptions that conflicts of interest may exist or arise. As a result, this concentration of ownership may not be in your best interests.

Our securities will be traded on more than one market or exchange and this may result in price variations.

Our ordinary shares have been trading on the TASE since June 2021 and the Nasdaq since January 2026. Trading in our ordinary shares takes place in different currencies (U.S. dollars on the Nasdaq and NIS on the TASE), and at different times (resulting from different time zones and public holidays in the United States and Israel). The trading prices of our securities on these two markets may differ due to these and other factors. Any decrease in the price of our ordinary shares on the TASE could cause a decrease in the trading price of our ordinary shares on the Nasdaq.

If our existing shareholders sell ordinary shares, either on the TASE or Nasdaq, the market price of our ordinary shares could decline.

The sale of substantial amounts of our ordinary shares in the public market, or the perception that such sales could occur, could harm the prevailing market price of our ordinary shares on the TASE or Nasdaq. These sales, or the perception that these sales could occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate. We have a total of 6,502,844 ordinary shares outstanding. All of our outstanding shares will be freely tradable without restriction or further registration under the Securities Act, except that any shares held by our affiliates may be sold only in compliance with Rule 144 of the Securities Act.

We intend to file one or more registration statements on Form S-8 under the Securities Act to register our ordinary shares or securities convertible into or exchangeable for our ordinary shares issued pursuant to our equity incentive plans. The ordinary shares registered under such registration statements will be available for sale in the open market. We expect that the initial registration statement on Form S-8 will cover approximately ordinary shares.  

As restrictions on resale end, the market price of our ordinary shares could drop significantly if the holders of these restricted shares sell them or are perceived by the market as intending to sell them. These factors could also make it more difficult for us to raise additional funds through future offerings of our ordinary shares or other securities.

Raising additional capital or the issuance of additional equity securities would cause dilution to our existing shareholders and may affect the rights of existing shareholders or the market price of our ordinary shares.

We may seek additional capital through a combination of private and public equity offerings, debt financings and collaborations and strategic arrangements. To the extent that we raise additional capital through the issuance of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a holder of our ordinary shares.

In addition, our authorized share capital consists of 31,250,000 ordinary shares, NIS 0.00032 par value per share. As of March 15, 2026, we had 6,502,844 ordinary shares issued and outstanding. As of March 15, 2026, we also had options to purchase 383,229 ordinary shares outstanding, of which 264,786 are currently vested.

To the extent that ordinary shares are issued or options and warrants are exercised, holders of our ordinary shares will experience dilution. In addition, in the event of any future issuances of equity securities or securities convertible into or exchangeable for ordinary shares, holders of our ordinary shares may experience dilution. We also consider from time to time various strategic alternatives that could involve issuances of additional ordinary shares, including but not limited to acquisitions and business combinations, but do not currently have any definitive plan to enter into any such transaction.

If we fail to comply with the continued listing requirements of the Nasdaq Stock Market LLC, our ordinary shares could be delisted, which could adversely affect the liquidity and market price of our ordinary shares and our ability to raise additional capital.

Our ordinary shares are listed on the Nasdaq Capital Market. To maintain our listing, we are required to satisfy certain continued listing requirements, including, among other things, minimum bid price, minimum market value of publicly held shares, minimum shareholders’ equity (or other financial metrics), corporate governance requirements, and timely filing of periodic reports with the SEC.

On January 26, 2026, Nasdaq filed a rule proposal with the SEC that would permit the immediate suspension and delisting of a company listed on the Nasdaq Capital Market if its market value of listed securities remains below $5 million for 30 consecutive business days. As of the date of this Annual Report, our market value of listed securities is above $5 million.

There can be no assurance that we will be able to comply with Nasdaq’s continued listing standards in the future. If we fail to satisfy any of Nasdaq’s continued listing requirements, we may receive a deficiency notice from Nasdaq and, depending on the nature of the deficiency, may be afforded a limited period of time to regain compliance. However, certain deficiencies may not be subject to a cure period or may result in immediate delisting. If we do not regain compliance within any applicable cure period, or if Nasdaq determines that we are not eligible for a compliance period, Nasdaq may determine to delist our ordinary shares.

A delisting of our ordinary shares from Nasdaq could materially reduce the liquidity of our ordinary shares and result in a corresponding material reduction in the price of our ordinary shares. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and fewer business development opportunities and strategic alternatives. There can be no assurance that our ordinary shares, if delisted from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the Over-The-Counter Markets or the pink sheets. Delisting from the Nasdaq Capital Market, or even the issuance of a notice of potential delisting, would also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of our ordinary shares, reduce security analysts’ coverage of us and diminish investor, supplier and employee confidence. Additionally, the threat of delisting or the delisting of our ordinary shares from the Nasdaq Capital Market could reduce the number of investors willing to hold or acquire our ordinary shares, thereby further restricting our ability to obtain equity financing, and it could reduce our ability to retain, attract and motivate our directors, officers and employees. In addition, as a consequence of any such delisting, our share price could be negatively affected and our shareholders would likely find it more difficult to sell, or to obtain accurate quotations as to the prices of, our ordinary shares. Accordingly, any failure to maintain compliance with Nasdaq’s continued listing requirements could have a material adverse effect on our business, financial condition, results of operations and the value of our ordinary shares.

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or the ordinary shares, our share price and trading volume could decline.

The trading market for the ordinary shares will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding the ordinary shares, or provide more favorable relative recommendations about our competitors, the price of our ordinary shares would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our ordinary shares or trading volume to decline.

We have not yet determined whether our existing internal controls over financial reporting systems are compliant with Section 404 of the Sarbanes-Oxley Act, and we cannot provide any assurance that there are no material weaknesses or significant deficiencies in our existing internal controls.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 and the related rules adopted by the SEC and the PCAOB, starting with the second annual report that we file with the SEC after the effectiveness of the registration statement that we filed in connection with the listing of our ordinary shares on the Nasdaq, our management will be required to report on the effectiveness of our internal control over financial reporting. In addition, once we no longer qualify as an “emerging growth company” under the JOBS Act and lose the ability to rely on the exemptions related thereto discussed elsewhere in this document and depending on our status as per Rule 12b-2 of the Exchange Act, our independent registered public accounting firm may also need to attest to the effectiveness of our internal control over financial reporting under Section 404. We have not yet commenced the process of determining whether our existing internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant deficiencies in our existing internal controls. This process will require the investment of substantial time and resources, including by our Chief Financial Officer and other members of our senior management. In addition, we cannot predict the outcome of this determination and whether we will need to implement remedial actions in order to implement effective internal control over financial reporting. The determination and any remedial actions required could result in us incurring additional costs that we did not anticipate. Irrespective of compliance with Section 404, any failure of our internal controls could have a material adverse effect on our stated results of operations and harm our reputation. As a result, we may experience higher than anticipated operating expenses, as well as higher independent auditor fees during and after the implementation of these changes. If we are unable to implement any of the required changes to our internal control over financial reporting effectively or efficiently or are required to do so earlier than anticipated, it could adversely affect our operations, financial reporting and/or results of operations and could result in an adverse opinion on internal controls from our independent auditors.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

We are subject to the periodic reporting requirements of the Exchange Act. We designed our disclosure controls and procedures to provide reasonable assurance that information we disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operations could fall below the expectations of securities analysts and investors, resulting in a decline in the trading price of our ordinary shares.

The preparation of financial statements in conformity with IFRS requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. See “Item 5 –Operating and Financial Review and Prospects”, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity, revenue, and expenses that are not readily apparent from other sources. Our results of operations may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our results of operations to fall below our publicly announced guidance or the expectations of securities analysts and investors, resulting in a decline in the market price of our ordinary shares.

We have never paid cash dividends on our share capital, and we do not plan on paying any cash dividends in the foreseeable future.

We have never declared or paid cash dividends, and we do not plan on paying cash dividends in the foreseeable future. Therefore, you should not rely on an investment in ordinary shares as a source for any future dividend income. Our board of directors has complete discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, will depend on our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual restrictions and other factors deemed relevant by our board of directors. In addition, the Israeli Companies Law, 5759-1999, or the Companies Law, imposes restrictions on our ability to declare and pay dividends.

We may be a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes in the current taxable year or may become one in any subsequent taxable year. There generally would be negative tax consequences for U.S. taxpayers that are holders of the ordinary shares if we are or were to become a PFIC.

Based on the projected composition of our income and valuation of our assets, we do not believe that we were a PFIC for 2025, and we do not expect to become a PFIC in the future, although there can be no assurance in this regard. The determination of whether we are a PFIC is made on an annual basis and will depend on the composition of our income and assets from time to time. We will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which either (1) at least 75% of our gross income is “passive income” or (2) on average at least 50% of our assets by value produce passive income or are held for the production of passive income. Passive income for this purpose generally includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and securities transactions and from the sale or exchange of property that gives rise to passive income. Passive income also includes amounts derived by reason of the temporary investment of funds, including those raised in a public offering. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into account. The tests for determining PFIC status are applied annually, and it is difficult to make accurate projections of future income and assets which are relevant to this determination. In addition, our PFIC status may depend in part on the market value of the ordinary shares. Accordingly, there can be no assurance that we currently are not or will not become a PFIC in the future. If we are a PFIC in any taxable year during which a U.S. taxpayer holds the ordinary shares, such U.S. taxpayer would be subject to certain adverse U.S. federal income tax rules whether or not we continue to be characterized as a PFIC. In particular, if the U.S. taxpayer did not make an election to treat us as a “qualified electing fund”, or QEF, or make a “mark-to-market” election, then “excess distributions” to the U.S. taxpayer, and any gain realized on the sale or other disposition of the ordinary shares by the U.S. taxpayer: (1) would be allocated ratably over the U.S. taxpayer’s holding period for the ordinary shares; (2) the amount allocated to the current taxable year and any period prior to the first day of the first taxable year in which we were a PFIC would be taxed as ordinary income; and (3) the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such other taxable year. In addition, if the U.S. Internal Revenues Service, or the IRS, determines that we are a PFIC for a year with respect to which we have determined that we were not a PFIC, it may be too late for a U.S. taxpayer to make a timely QEF or mark-to-market election. U.S. taxpayers that have held the ordinary shares during a period when we were a PFIC will be subject to the foregoing rules, even if we cease to be a PFIC in subsequent years, subject to exceptions for U.S. taxpayers who made a timely QEF or mark-to-market election. A U.S. taxpayer can make a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance with the instructions thereto. We do not intend to notify U.S. taxpayers that hold the ordinary shares if we believe we will be treated as a PFIC for any taxable year in order to enable U.S. taxpayers to consider whether to make a QEF election. In addition, we do not intend to furnish such U.S. taxpayers annually with information needed in order to complete IRS Form 8621 and to make and maintain a valid QEF election for any year in which we or any of our subsidiaries are a PFIC. U.S. taxpayers that hold the ordinary shares are strongly urged to consult their tax advisors about the PFIC rules, including tax return filing requirements and the eligibility, manner, and consequences to them of making a QEF or mark-to-market election with respect to the ordinary shares in the event that we are a PFIC (see “Item 10.E. Taxation—Certain Material U.S. Federal Income Tax Considerations—Passive Foreign Investment Companies” for additional information).

We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our ordinary shares less attractive to investors.

For so long as we remain an “emerging growth company” as defined in the JOBS Act, we may take advantage of certain exemptions from various requirements that are applicable to public companies that are not “emerging growth companies.” These provisions include, among other exemptions, that:

We intend to take advantage of these exemptions until we are no longer an “emerging growth company.” We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our first sale of common equity securities pursuant to an effective registration statement under the Securities Act, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, as defined in the rule under the Exchange Act, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

We cannot predict if investors will find our ordinary shares less attractive because we may rely on these exemptions. If some investors find our ordinary shares less attractive as a result, there may be a less active trading market for the ordinary shares, and the trading price may be more volatile and may decline.

As a “foreign private issuer” we are subject to less stringent disclosure requirements than domestic registrants and are permitted, and decided to elect to follow certain home country corporate governance practices instead of otherwise applicable SEC and Nasdaq requirements, which may result in less protection than is accorded to investors under rules applicable to domestic U.S. registrants.

As a foreign private issuer and emerging growth company, we may be subject to different disclosure and other requirements than domestic U.S. registrants and non-emerging growth companies. For example, as a foreign private issuer, in the United States, we are not subject to the same disclosure requirements as a domestic U.S. registrant under the Exchange Act, including the requirements to prepare and issue quarterly reports on Form 10-Q or to file current reports on Form 8-K upon the occurrence of specified significant events, the proxy rules applicable to domestic U.S. registrants under Section 14 of the Exchange Act. Section 8103 of the National Defense Authorization Act for Fiscal Year 2026, named the “Holding Foreign Insiders Accountable Act”, which was signed into law on December 18, 2025, requires directors and officers of foreign private issuers to make insider reports under Section 16(a) of the Exchange Act, effective March 18, 2026. Our principal shareholders continue to remain exempt from the reporting under Section 16(a) of the Exchange Act and our directors, officers and principal shareholders continue to remain exempt from the short-swing profit recovery provisions contained in Section 16(b) of the Exchange Act. In addition, we intend to rely on exemptions from certain U.S. rules which will permit us to follow Israeli legal requirements rather than certain requirements applicable to U.S. domestic registrants.

We follow Israeli laws and regulations that are applicable to Israeli companies. However, Israeli laws and regulations applicable to Israeli companies do not contain any provisions comparable to the U.S. proxy rules, the U.S. rules relating to the filing of reports on Form 10-Q or 8-K or the U.S. rules relating to liability for insiders who profit from trades made in a short period of time, as referred to above.

Furthermore, foreign private issuers are required to file their annual report on Form 20-F within 120 days after the end of each fiscal year, while U.S. domestic registrants that are non-accelerated filers are required to file their annual report on Form 10-K within 90 days after the end of each fiscal year. Foreign private issuers are also exempt from Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information, although we will be subject to Israeli laws and regulations having substantially the same effect as Regulation Fair Disclosure. As a result of the above, even though we are required to file reports on Form 6-K disclosing the limited information which we have made or are required to make public pursuant to Israeli law, or are required to distribute to shareholders generally, and that is material to us, you may not receive information of the same type or amount that is required to be disclosed to shareholders of a U.S. registrant.

These exemptions and leniencies will reduce the frequency and scope of information and protections to which you are entitled as an investor.

The determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, the next determination will be made with respect to us on June 30, 2026. In the future, we would lose our foreign private issuer status if a majority of our shareholders, directors or management are U.S. citizens or residents and we fail to meet additional requirements necessary to avoid loss of foreign private issuer status. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic registrant may be significantly higher.

We may be subject to securities litigation, which is expensive and could divert management attention.

In the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Litigation of this type could result in substantial costs and diversion of management’s attention and resources, which could seriously hurt our business. Any adverse determination in litigation could also subject us to significant liabilities.

We incur significant increased costs as a result of being a public company in the United States. Our management will be required to devote substantial time to new compliance initiatives as well as compliance with ongoing U.S. requirements.

As a public company in the United States, we incur additional significant accounting, legal and other expenses. We also incur costs associated with corporate governance requirements of the SEC, as well as requirements under Section 404 and other provisions of the Sarbanes-Oxley Act. We expect these rules and regulations to increase our legal and financial compliance costs, introduce new costs such as investor relations, stock exchange listing fees and shareholder reporting, and to make some activities more time consuming and costly. The implementation and testing of such processes and systems may require us to hire outside consultants and incur other significant costs. Any future changes in the laws and regulations affecting public companies in the United States, including Section 404 and other provisions of the Sarbanes-Oxley Act, and the rules and regulations adopted by the SEC, for so long as they apply to us, will result in increased costs to us as we respond to such changes. These laws, rules and regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees, or as executive officers.

The estimates of market opportunity and forecasts of market growth included in this Annual Report may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, or at all.

The estimates of market opportunity and forecasts of market growth included in this Annual Report may prove to be inaccurate. Market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate, including as a result of any of the risks described in this Annual Report.

In addition, the variables that go into the calculation of our market opportunity are subject to change over time, and there is no guarantee that any particular number or percentage of addressable users or companies covered by our market opportunity estimates will purchase our offerings or generate any particular level of revenue for us. In addition, our ability to expand in any of our target markets depends on a number of factors, including the cost, performance, and perceived value associated with our platform and those of our competitors. Even if the markets in which we compete meet the size estimates and growth forecasted in this Annual Report, our business could fail to grow at similar rates, or at all. Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many risks and uncertainties. Accordingly, the forecasts of market growth included in this Annual Report should not be taken as indicative of our future growth.

ITEM 4. INFORMATION ON THE COMPANY

A. History and Development of the Company

Our legal and commercial name is Pulsenmore Ltd. We are a company limited by shares organized under the laws of the State of Israel and was incorporated on October 27, 2014. Our principal executive offices are located at 7 Begin St., Ramat Gan, Israel, and our telephone number is +972 526062075. Our wholly owned subsidiary, Pulsenmore Americas LLC, was incorporated in Delaware on March 10, 2022, and is located at 100 Summer Street, Suite 1600, Boston, MA 02110, and its telephone number is 1-978-994-0692. In February 2023, we established Pulsenmore Korea LLC.

We completed our initial public offering in Israel in June 2021 and our ordinary shares are traded on the TASE under the symbol “PULS”. Our ordinary shares have been listed on the Nasdaq since January 21, 2026 under the symbol “PLSM”.

Our capital expenditures for the years ended December 31, 2025, 2024, and 2023 were NIS 135 thousand (approximately $42 thousand), NIS 509 thousand (approximately $160 thousand), and NIS 3,926 thousand (approximately $1,231 thousand), respectively. Our current capital expenditures involve acquisitions of computers, software, laboratory equipment and machines.

The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers like us that file electronically with the SEC. The address of that site is www.sec.gov. We maintain a corporate website at www.pulsenmore.com. Information contained on or accessible through our website is not a part of this Annual Report, and the inclusion of our website address herein is an inactive textual reference only.

We use our website (http://www.pulsenmore.com) as a channel of distribution of Company information. The information we post through this channel may be deemed material. Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. The contents of our website are not, however, a part of this Annual Report.

We have not had any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies.

B. Business Overview

We are an emerging medical device company focused on research, development, manufacture, marketing, and sale of innovative, non-invasive portable ultrasound solutions that provide significant healthcare benefits by utilizing next-generation technology for home use. We currently have two primary products, the Pulsenmore ES and the Pulsenmore FC, and an additional third portable ultrasound solution that is in earlier developmental stages, the Pulsenmore MC. We collectively refer to our products as the “Pulsenmore Products”. The Pulsenmore Products open the door to a new market in the field of ultrasound – performing home scans in gynecology as well as in various other fields such as pulmonary, cardiology, and urology.

The Pulsenmore ES is a non-invasive home ultrasound device that is clinically proven to support prenatal care by allowing expectant mothers to perform self-scans and telehealth guided scans at home. The device is approved for use in several key markets including the United States, Europe, Switzerland, Australia, Brazil, Colombia and Israel. Another product, the Pulsenmore FC is intended for self-examination of ovarian follicles and endometrial tissue in women undergoing in vitro fertilization (IVF) or fertility preservation. The Pulsenmore FC device is approved for use in Israel and has been supplied for clinical research purposes in other territories. As we are in the early stages of commercialization of the Pulsenmore FC device in Israel, we plan to gain more real-world experience with the Pulsenmore FC before submitting for approval in the United States and other territories. We are also developing the Pulsenmore MC which is engineered for daily monitoring of fluids in the lungs in patients with various pulmonary conditions, end stage renal disease, or congestive heart failure. The Pulsenmore MC is in the early stages of development, and we are conducting clinical feasibility trials.

Our flagship product, the Pulsenmore ES, has had a significant technological impact. In a recent survey of Pulsenmore ES users, approximately 98.1% of scans were suitable for clinical evaluation, approximately 86.3% of users reported a better pregnancy experience overall, 63% reported shorter clinical visits, and 90% reported a reduction in pregnancy-related anxiety and stress. As a result, we have observed reductions in hospitalization days in certain instances, including at a single hospital utilizing a hybrid care model incorporating Pulsenmore solutions (together with other devices), where approximately 1,200 hospitalization days were saved. With each sonogram taking approximately 74 seconds and over 220,000 home scans performed to date globally, the Pulsenmore ES enables better access and continuity of care with earlier detection of warning signs and alerts on risk conditions that may require intervention.

The Pulsenmore Products utilize proprietary ultrasound technology to generate high-quality ultrasound images that can be easily shared with healthcare providers for remote monitoring and consultation. The Pulsenmore Products are compact, hand-sized devices that make use of smart mobile phones to enable the relevant exams to be performed without the need for a physical visit in a clinic or hospital. The Pulsenmore Products include a software application for smart mobile phones that can be downloaded and installed by end users to help facilitate the remote physical examination or remote monitoring using telehealth technology. The software application allows the ultrasound images to be directly transferred to attending physicians, medical staff, or call center clinics. The distinction between the Pulsenmore Products and its peers lies in the Pulsenmore Products’ ability to provide reliable scans while ensuring user safety and comfort through a user-friendly interface and design. This enables users to achieve peace of mind and continuity of care without the need for frequent clinic visits, reducing the associated time spent and financial costs.

We focus on developing cutting-edge technologies to better meet the needs of patients and providing compelling value to our partners. In Israel, we have established partnerships with Clalit, as well as Sheba Medical Center, or Sheba, Israel’s largest hospital accounting collectively for more than NIS 9.1 million (approximately $2.9 million) in sales of Pulsenmore ES units in Israel for the year ended December 31, 2025.

The Pulsenmore Products address significant and growing markets that we believe will sustain our long-term growth. Factors such as an increase in the demand for remote-access health solutions, the growing awareness of preventive diagnostics, and the influence of digital health trends are driving the growth of the home ultrasound market. We are increasing our focus on brand awareness and partnerships with healthcare providers which we believe will increase product utilization and expand our presence in existing and our penetration to new geographies. We believe our compelling product offering, coupled with an attractive business model premised on attractive economic benefits for our partners, effectively positions us to sustain and empower our future growth.

At the end of October 2025, we received FDA approval of the Pulsenmore ES as a Class II device to enable the acquisition of ultrasound images that allow interpreting healthcare providers to determine fetal heartrate. While we are currently focused on expanding our operations in the United States as well as Israel, we are also focusing on penetrating additional geographic markets with the Pulsenmore ES device. We received CE approval for the sale of the device in Europe. In 2024, we signed a distribution agreement with a distributor in Italy. We received purchase agreements in France and Poland in the second quarter and are engaged in identifying opportunities to partner with Europe-based healthcare providers. In South America, the Pulsenmore ES is currently approved for sale in Brazil and Colombia however with the recent receipt of FDA approval in the Unites States, we are currently focused on expanding our commercial footprint in the United States. In the Asia-Pacific region, we have received regulatory approval for Pulsenmore ES in Australia, where we started commercial operations in the first quarter of 2025 and partnered with a health-provider in the third quarter of 2025. We cannot assure that any of the Pulsenmore ES or Pulsenmore FC or any other medical devices or new uses, modifications, or renewals for any approved devices will be cleared or approved in a timely or cost-effective manner, if cleared or approved at all, or that we will be able to maintain the clearance or approval of such devices.

To enhance our market position and sustain our track record of innovation, we continuously invest in research and development (R&D) of our products. Our innovation is supported by a portfolio of over 21 families of patents and patent applications invented by our experienced and committed R&D team. Our ability to effectively innovate is enhanced by our senior management and employees who have extensive expertise in the field of medical ultrasound devices. This allows us to incorporate critical feedback and emerging trends in real-time, supporting our continuous and iterative development processes.

We currently have an emerging pipeline of enhancements that we believe will allow us to increase our offerings to existing customers and to attract new customers. We believe that introducing new products and product enhancements is important to satisfy customer demand and respond to evolving technological developments.

Our Competitive Strengths

We believe the following strengths have been instrumental to our progress so far. We intend to foster these strengths in order to position us for future growth and to drive our profitability:

Operating in large, growing mobile diagnostics imaging market

According to BIS Research, diagnostic imaging exams are performed in more than 75% of medical cases, and mobile imaging solutions are expected to grow at a compound annual growth rate (CAGR) of about 8% by 2029 according to the Business Research Company. Within the broad diagnostic imaging, we operate in the home-use ultrasound which is closely connected to telehealth advancements and particularly relevant to prenatal care., Our flagship product, the Pulsenmore ES is a home-use prenatal ultrasound device, best categorized within the obstetrics and gynecology ultrasound devices market—a segment that includes cart-based ultrasound machines, portable and handheld ultrasound devices, and specialized probes used for imaging the female reproductive system and monitoring fetal development. This is distinct from the broader non-invasive prenatal market, which includes not only prenatal ultrasound devices but also products like non-invasive prenatal testing (NIPT) for genetic screening (such as cell-free fetal DNA tests), maternal serum screening kits, and wearable fetal monitors; similarly, the fertility services market encompasses ovulation test strips, home fertility monitors, and in-clinic diagnostic imaging such as transvaginal and pelvic ultrasound systems, as well as sperm analysis kits and related services. Our device is not aimed at genetic screening, ovulation tracking, or fertility prediction, but rather ongoing prenatal monitoring from home. The global prenatal, fetal, and neonatal equipment market, which includes ultrasound devices as well as incubators, monitors and other supportive equipment, was valued at approximately $4.2 billion in 2024 and is projected to reach $7.1 billion by 2033, growing at a CAGR of 6.5% from 2026 to 2033, according to Verified Market Reports. While the market includes various prenatal monitoring devices, such as fetal dopplers, wearable fetal monitors, and in-clinic ultrasound systems, to our knowledge there are currently no approved or commercially available remote home-use ultrasound solutions designed for patient self-scanning, providing us with what we believe to be a unique competitive advantage in this segment as our products enable patient-initiated prenatal imaging at home, complementing but not replacing in-clinic visits.

Compelling value proposition of our products to both patients and partners

According to a survey conducted by Grand Review Research, the global market for portable ultrasound devices, including those used with mobile phones, such as our Pulsenmore ES and Pulsenmore FC devices, was valued at approximately USD 5.7 billion in 2024 and is projected to grow at a CAGR of 4.5% from 2025 to 2030. The market growth is being driven partially by patients’ preference for home-based diagnostic solutions, concerns about frequent clinic visits, potential and rising health care costs, and the need for continuous monitoring.

Healthcare providers and clinics are also facing capacity constraints, including limited space and staffing shortages, resulting in longer patient wait times, which average approximately 42 days according to AMN Healthcare. In addition, shortages of obstetricians and gynecologists (OB/GYNs) are also contributing to increased demand for home-care solutions. While advanced maternal age and an increasing prevalence of high-risk pregnancies have contributed to a greater demand for prenatal care services and increased visit frequency, At the same time, disparities in access to prenatal care persist, particularly among rural populations and ethnic minority women. These challenges may contribute to inefficiencies in care delivery, as evidenced by an estimated 750,000 avoidable pregnancy-related emergency department visits annually, representing approximately $1 billion in costs to the U.S. healthcare system, based on our internal analysis of publicly available data published in a report by AMN Healthcare entitled “2025 Survey of Physician Appointment Wait Times and Medicare and Medicaid Acceptance Rates” and a December 2021 report by the Healthcare Cost and Utilization Project entitled “Emergency Department and Inpatient Utilization and Cost for Pregnant Women: Variation by Expected Primary Payer and State of Residence, 2019.

We designed the Pulsenmore Products to provide a superior customer experience, overcoming each of these concerns with a solution that is affordable, completely non-invasive, ensures minimal disruption to daily life, and offers compelling results. Due to these advantages, we believe the Pulsenmore Products are appealing to existing customers who have previously used mobile ultrasounds solutions, including for prenatal care services, and to new customers who are seeking more convenient and continuous monitoring options for health conditions including those unrelated to prenatal care. For partners, the Pulsenmore Products provide high customer satisfaction due to ease of repeat usage and simplicity.

Short term growth fueled by established agreements with strategic partners

We focus on developing cutting-edge technologies to meet patient needs and provide value to our partners. We have established partnerships with a major HMO in Israel, Clalit, and Sheba, a major hospital in Israel.

Our strategic partnership with Clalit, allows it to purchase, sell, and market the Pulsenmore ES. For the year ended December 31, 2025, we supplied approximately 6,915 of Pulsenmore ES to Clalit for distribution to pregnant patients. Additionally, we have agreements with Sheba to supply units of Pulsenmore ES to their pregnant patients. For the year ended December 31, 2025 we supplied 110 units of Pulsenmore ES to Sheba for distribution to pre-natal patients. These partnerships enhance patient accessibility and visibility of our products.

As we continue to focus on the innovation and expansion of our product range and application, our strategic partnerships with Clalit and Sheba generate a growing base of revenue through its distribution of Pulsenmore ES units which accounted for approximately 96% of our overall revenue for the year ended December 31, 2025.

Broad research and development capabilities and a robust intellectual property portfolio.

For over a decade, we have invested in establishing strong research and development capabilities, including integrating hardware and software to create an exceptional user and customer experience. We believe that our focus on this experience will allow us to continue to bring new upgrades, capabilities, and new additional products to market, allowing us to maintain our competitive positioning. We have a broad patent portfolio, across 21 categories including 31 issued patents and 63 pending patent applications as of March 15, 2026. We believe our intellectual property and know-how present a significant barrier to entry for our competitors.

Highly experienced global management team with deep ultrasound expertise.

We are led by a highly experienced management team and board with a successful track record of building businesses by identifying and providing solutions in the field of ultrasound devices. Our team is led by founder and CEO, Dr. Elazar Sonnenschein, who has successfully led and managed dynamic growth phases in medical device-developing organizations and commercialized products in markets with established incumbents, by addressing the unmet needs of the healthcare providers and customers whom they serve. Our senior management team has vast experience in the field of medical devices for home use.

Our Growth Strategy

We believe we are well-positioned to enhance our position as a leading global provider of non-invasive portable ultrasound medical devices for home use. To achieve this goal, our significant growth opportunities include:

Build and expand on our global scale by deepening our presence in key existing geographies and expanding into attractive new markets

Following the recent FDA approval of Pulsenmore ES, our primary strategic focus is on expanding in the United States, which has approximately 3.6 million annual births according to the U.S. Centers for Disease Control and Prevention, or CDC . We are actively working to launch Pulsenmore ES in the U.S. market and are prioritizing the establishment of robust partnerships with leading healthcare providers, distributors, and telemedicine organizations to ensure broad adoption and rapid growth. 35% of U.S. counties are maternity care deserts (areas without a single birthing facility or obstetric clinician), according to March of Dimes, including limited ultrasound access in rural and underserved regions where nearly two thirds of maternity care deserts are rural. In addition, according to the CDC, the rate of severe maternal morbidity exceeded 80 cases per 10,000 deliveries in 2019 and has continued to increase, in part due to limited access to adequate healthcare services.

As a result, we believe that the U.S. market represents the most significant opportunity for Pulsenmore ES and are allocating substantial resources to support our commercial expansion in this key territory.

In addition to our U.S. expansion, we continue to sell products in Israel through health care providers and remain committed to strengthening our position in the Israeli market. We also believe we have significant opportunities to continue our growth in major markets such as Europe, Australia and in the future in Brazil and Colombia, which are the territories in which we have already received regulatory approvals for the marketing of Pulsenmore ES. About 140 million births take place every year, according to the World Health Organization, which we believe may lead to a greater addressable market as we look to extend our product reach to additional markets. We are also highly focused on growing our global network by expanding our distribution networks in existing markets and select new international markets based on our assessment of size and opportunity, among other factors.

In response to these trends, we intend to deploy prenatal care solutions designed as single-patient-use devices, with a targeted price point of approximately $1,000 per pregnancy, initially focused on high-risk pregnancies, which represent approximately 20% of births, with the potential to expand into broader prenatal care populations. In addition, our U.S. business model is expected to incorporate recurring revenue components, including software-as-a-service offerings, and we are targeting that approximately 40% of revenue will be derived from clinician dashboard subscription fees, providing ongoing monitoring, data analytics and care management capabilities. 

We believe the Pulsenmore ES is well-aligned with strong growth prospects and customer trends in these markets, and we are currently in contact with various health care providers and distributors in the available markets, including telemedicine service providers in European countries, with the aim of integrating Pulsenmore ES into the services already offered by them. In addition, we continue to supply Pulsenmore ES units for clinical trials that are carried out in Israel and Europe in accordance with our growth strategy which aims to incentivize growth by demonstrating the advantage to health systems, patients and insurers. To sustain this growth, we intend to continue investing in our sales organizations and sales networks in these markets.

Our go-to-market strategy contemplates an initial commercial launch in the United States in 2026, alongside ongoing and expanded commercialization efforts in Europe and the Asia-Pacific region. In the United States, we intend to focus on partnerships with obstetrics networks and hospitals, as well as collaborations with telehealth providers and employer groups seeking to reduce healthcare costs and improve access to prenatal care.

We expect that our solutions will be supported by existing reimbursement pathways, including CPT code 76815, which we anticipate will be available at launch, and we plan to pursue expansion to additional reimbursement codes, including biophysical profile assessments under CPT code 76819. In addition, evolving clinical practices and guidelines, including support from the American College of Obstetricians and Gynecologists for hybrid prenatal care models, may further facilitate adoption of our solutions. 

Strengthen, expand and establish additional partnerships with health care providers

In addition to Clalit and Sheba we plan to establish additional strategic partnerships with healthcare organizations operating in Israel such as Maccabi Healthcare Services, or Maccabi and in other markets where we shall choose to expand.

Continue to invest in research and development to enhance a comprehensive ultrasound offering and expand our addressable market

We have an experience in developing and commercializing the Pulsenmore ES in Israel. We think that our capabilities allow us to expand the types of CE-marked ultrasound solutions that we offer. We plan to continue investing in research and development in order to expand our products to other areas of medical care outside of prenatal care. Our development activity is focused on the completion of the development of additional ultrasound devices intended for home use and the invention and protection of intellectual property in the field of ultrasound devices, and the development of automatic production of piezoelectric transducers.

Strategically pursue attractive opportunities to expand the manufacturing and production of our products

We are committed to enhancing our production and manufacturing capabilities in order to support our growth and meet increasing demand. To achieve this, we plan to continue to invest in advanced manufacturing technologies, integrate state-of-the-art automation and precision engineering, and optimizing production lines. Additionally, we intend to lease additional production space for an array of automatic production machines in order to efficiently increase the supply of our products.

We continue to pursue opportunities with existing contractors and new contractors to ensure that we have the guaranteed capacity to assemble hundreds of thousands of units per year of the Pulsenmore ES product, and in the near future, the new products. Entering into exclusive relationships with our assembly contractors allows us to scale production with minimal additional logistical costs ensuring that we can meet the growing demand for the Products.

Market Opportunity

Mobile ultrasound devices are a fast-growing category within the broader imaging diagnostics sector including X-ray, CT, MRI, PET and Ultrasounds. Ultrasound devices use high-frequency sound waves to create images of organs inside the body and are commonly used for monitoring fetal development during pregnancy, examining organs like the liver, kidneys, and heart, and guiding procedures such as needle biopsies. Ultrasounds provide a reliable solution while being non-invasive and by providing cost-effective real-time imaging. The rapid growth in the mobile ultrasound device industry and the increasing customer demand, incentivize new customers to incorporate mobile healthcare solutions into their practices.

The mobile ultrasound market is segmented into various applications such as routine health monitoring, emergency care, and chronic disease management. Traditionally, advanced cart-based ultrasound technology costs between $45,000 and $100,000 per device plus the expense of specialized training for use of the technology. There are various non-invasive, ultrasound-based technologies designed to monitor health conditions. Among these technologies, there are Point-of-Care Ultrasound (POCUS) systems, which are portable and provide quick diagnostic information at the point of care. These devices range from $3,000 to $7,000 per unit with one ultrasound probe, often requiring multiple probes to adequately use the POCUS systems.

Alongside these technologies, the Pulsenmore mobile ultrasound devices allow patients to perform self-scans at home, providing high-quality ultrasound images that can be easily shared with healthcare providers for remote monitoring and consultation. The uniqueness of this technology lies in its ability to provide accurate and reliable scans while ensuring user safety and comfort through a user-friendly interface and design and while providing a more cost-efficient solution relative to other ultrasound systems.

According to Markets and Markets, the global ultrasound market, which includes home-based, mobile ultrasound devices, such as our Pulsenmore ES and Pulsenmore FC devices, was valued at $8.6 billion in 2023 and is projected to grow at a CAGR of 6.8% reaching $13.9 billion by 2030. This market encompasses a wide range of medical devices and technologies designed to support various healthcare needs. In recent years, ultrasound imaging has seen a shift from traditional clinic-based approaches to more portable, user-friendly solutions. This increase in customer preference for non-invasive, mobile, and convenient monitoring options has fueled industry growth. In addition to being more affordable, solutions like the Pulsenmore ES and Pulsenmore FC devices offer the additional advantage of reducing the need for frequent clinic visits while still providing continuous medical monitoring. Growing demand for mobile healthcare solutions combined with a surge in the availability of advanced technologies continues to accelerate growth in the industry.

Additionally, there has been a significant increase in need for at home ultrasound solutions for pre-natal women and women undergoing IVF. It is estimated that about 2.5 million IVF cycles are performed annually worldwide, of which 300,000 are in the United States. The U.S. non-invasive prenatal market, which includes our Pulsenmore ES and Pulsenmore FC devices, since they are able to be used from home by the patient in a non-invasive manner, was estimated at $1.6 billion according to Grand View Research and is expected to grow at a CAGR of 8.2% from 2023 to 2030. Furthermore, the U.S. fertility services market, including IVF ultrasounds, is projected to grow at a CAGR of 7.5% from 2024 to 2040. Given the concentration of potential clients in the United States, this market remains a key focus for us.

Other tailwinds driving industry growth include:

Products & Services

Pulsenmore ES

The Pulsenmore ES device provides digital, prenatal care indicators (such as heartbeat, level of amniotic fluid, movements and in some cases placenta location) using a hand-sized ultrasound system designed for home use by pregnant women. The cradle connects to a mobile phone (Android or iOS) and allows the user to perform ultrasound scans without prior medical training. In the app-guided home ultrasound option, a user-friendly mobile app guides the expectant mother. In the clinician-guided home ultrasound option, the expectant mother initiates a video call through the Pulsenmore mobile application with a medical professional who guides her through the five-step procedure for generating the sonogram. In both modes the expectant mother does not need prior medical training. The device, which is one of the smallest ultrasound systems in the world, uses the mobile phone’s screen to display the scan and securely sends the results to a qualified medical professional through the cloud.

The Pulsenmore ES is a compact, portable, ultrasound device. It produces B-Mode and M-Mode, black & white ultrasound images, which are displayed on a smartphone screen. The device is used to scan, acquire, display, and transmit the ultrasound images to the cloud, and the smartphone’s processor is used to filter the raw ultrasound image and display it.

The Pulsenmore ES ultrasound system is intended to enable the acquisition of ultrasound images that allow interpreting healthcare professionals to determine amniotic fluid levels and fetal heart rates. The Pulsenmore ES system is best used when traditional scanning in a clinic is impractical or when the use of telehealth or software-guided self-scanning is in the best interests of the patient. The device is intended to be used by pregnant women with a singleton pregnancy at the gestational age of 14-40 weeks, in non-clinical environments. While the Pulsenmore ES system is intended to entirely replace standard and ordinary ultrasound sessions that are typically performed in a clinic, the Pulsenmore ES system is not intended to replace ultrasounds that require the intervention of doctors and other medical professionals.

There are two sub models to the Pulsenmore ES device – for Android phones and ES cradles for iPhones, including 3 main elements:

Figure 1: Pulsenmore ES: Type C (left) and Type iOS (right)

Patients using the Pulsenmore ES make direct skin contact with the transducer head. The Pulsenmore ES is a non-sterile, reusable device for single-patient use during one pregnancy. Its main imaging component is a probe consisting of R60 mm curved array with 64 piezo-electric elements and a silicone-coated acoustic lens. The probe is connected via an internal flex connector to the Analog Front End (AFE), which handles electrical pulses, echo amplification, and synchronization for a 58.8-degree scanning beam. In standard ultrasound, the transducer’s beam array is interpolated into a mesh grid for imaging. To visualize fetal heart activity, the transducer targets the heart, generating an M-mode image for heart rate measurement.

The Pulsenmore ES device offers two modes of operation: (a) clinician-guided operation, where a technician or physician assists the patient via telehealth, and (b) app-guided operation, where the patient performs the scan independently. In both modes, the patient does not need prior medical training for use and in the clinician guided mode a technician or physician does not need prior medical training however we may in the future implement a training program for medical professionals.

(a) Clinician-guided home ultrasound

A unique procedure key is generated for the specific patient from the Clinician dashboard. The patient connects her smartphone to the device and activates the downloaded Pulsenmore mobile application. The patient, who does not need prior medical training, then initiates a video call with a medical professional who guides her through the five-step procedure for generating the sonogram. The entire process typically takes a few minutes. The clinician reviews the scans and provides real-time feedback to the patient.

(b) App-guided home ultrasound

A unique procedure key is generated for the patient from the Clinician dashboard. The patient connects her smartphone to the device and activates the downloaded Pulsenmore mobile application. The patient follows a five-step procedure for generating the sonogram, which takes less than five minutes. The patient securely uploads the video to the cloud for a medical professional to decode and analyze it. The scans are viewed from the clinician’s secure dashboard. The clinician reviews the scans and then sends feedback to the patient.

Figure 2: Clinician-guided home ultrasound display

While the Pulsenmore ES system can be used to generate ultrasound images, we are also developing a service performing biophysical profile tests, or “BPP” for high-risk pregnant women using the Pulsenmore ES system.

BPP is a form of non-invasive prenatal testing involving ultrasound imaging often combined with a non-stress test to observe the fetus’s heart rate, breathing, movement, muscle tone, and the amount of amniotic fluid. Each of the parameters tested is assigned a score with a maximum score of ten. The test is commonly used for early detection of fetal distress and potential complications, better monitoring of high-risk pregnancies, improved management of fetal growth restriction and increased maternal reassurance. BPP tests are typically performed in the office.

We are seeking to advance Pulsenmore ES device for a patient-operated remote BPP test and to date have conducted studies in two clinical sites, as further described below under “Published Studies — Remote, modified Biophysical Profile (mBPP) using the Pulsenmore ES device”, and during 2026 plan to collect further clinical evidence that could support FDA approval of the utilization of the Pulsenmore ES device for the BPP test.

Pulsenmore FC

The Pulsenmore FC device is designed for self-examination of the size and quantity of follicles in the ovaries and the thickness of the endometrial tissue in the uterus for women undergoing in vitro fertilization (IVF) or fertility preservation. This hand-sized ultrasound system allows women to perform these examinations at home without prior medical training. The device connects to a mobile phone (Android or iOS) and uses a mobile phone’s screen to display the scan. The data and videos of the ultrasound scan can be sent directly to the treating medical professional or uploaded to the cloud for interpretation and then sent to the treatment center.

The Pulsenmore FC device potentially reduces the need for frequent visits to health centers by allowing women to perform these scans at home at their convenience to determine the most appropriate date for egg retrieval and fertilization. Similar to the Pulsenmore ES device, the Pulsenmore FC device offers both clinician-guided online operation and app-guided offline operation.

The main target customers for this product are HMOs, large private clinics, and health insurers, who will provide the device to women undergoing fertility preservation, ovary simulation and IVF procedures. Traditionally, women undergoing IVF visit clinics and hospitals to check the size and quantity of follicles via ultrasound performed by a technician or doctor. When follicles reach a certain size (usually about 18 to 20 mm) and level of hormones meet the expected levels, women receive a hormone injection, and approximately 36 hours later, eggs are extracted for fertilization or freezing. If the follicles have not reached the desired size, women must return for additional examinations.

Figure 3: Pulsenmore FC

Pulsenmore MC

We are developing an ultrasound device for lung scanning, designed for patients with various lung diseases and conditions– Pulsenmore MC.

The Pulsenmore MC device looks and operates very similarly to the Pulsenmore ES device. Once activated by the patient, the application automatically plays a video detailing the scan procedure, guides the patient through the process, and subsequently uploads the videos to a cloud server.

The Pulsenmore MC device is designed for patients with End-Stage Renal Disease (ESRD) and/or Congestive Heart Failure (CHF). Based on similar electronic technology to the Pulsenmore ES system, it features different transducers adjusted for size, scanning frequency, and software adapted to these frequencies.

Strategic Partnerships

Clalit Health Services

On August 2, 2020, we entered into an agreement with Clalit, Israel’s largest HMO, or the CHS Pulsenmore ES Agreement. Pursuant to the CHS Pulsenmore ES Agreement, Clalit had the right to purchase, sell and market the Pulsenmore ES in Israel. In exchange, we committed to provide over 20,000 units of the Pulsenmore ES for distribution to Clalit pre-natal patients. For the years ended 2025, 2024, and 2023, Clalit Health Services purchased 6,915, 7,148, and 4,987 units, respectively, of Pulsenmore ES, respectively, constituting the majority of the initial 20,000 units that we committed to provide to them. This term of the CHS Pulsenmore ES Agreement was originally for a period of two years, with either party being entitled to terminate without cause or reason upon nine months’ prior written notice to the other party. In June 2022, the parties agreed to extend the term of the CHS Pulsenmore ES Agreement to August 2023, which was subsequently extended until August 2024.

The CHS Pulsenmore ES Agreement contains customary provisions regarding the liability of the parties and the limitation of the amount of liability, including that neither party will be liable to the other party for indirect, special, punitive or consequential damages, except in connection with a breach of confidentiality, privacy and personal injuries, unless caused by an act or omission of the other party in breach of the agreement. In addition, we will not bear any liability arising from any medical diagnosis or prognosis provided or prevented by the pregnancy product (subject to compliance with the technical specifications). In addition, we are required to maintain various insurance policies, including third-party liability insurance and professional liability insurance combined with product liability.

On October 28, 2024 we entered into a new five-year agreement with Clalit Health Services extending existing terms and conditions of the CHS Pulsenmore ES Agreement, or the New CHS Pulsenmore ES Agreement. Pursuant to the New CHS Pulsenmore ES Agreement, we will provide at least 25,000 units of the Pulsenmore ES to Clalit, which will be supplied for a period of up to 60 months from the date of signing the New CHS Pulsenmore ES Agreement and includes minimum annual quantities that we are required to provide.

The New CHS Pulsenmore ES Agreement provides Clalit, at an additional cost payable by Clalit, with the option to use the product synchronously (i.e. clinician-guided), while conducting a video call with the clinician/physician, during which the ultrasound video is transmitted in real time.

Under the New CHS Pulsenmore ES Agreement, we provide support and maintenance services to Clalit for 2025 onwards, at an additional cost payable by Clalit, in accordance with a service agreement entered into in connection with the New CHS Pulsenmore ES Agreement. The New CHS Pulsenmore ES Agreement includes customary provisions, including confidentiality clauses, privacy protection and information security requirements, as well as insurance and limitation of liability as is customary in such agreements. In addition, the New CHS Pulsenmore ES Agreement sets a warranty period for the products and includes provisions regarding the return/replacement of defective products and/or those found to be non-compliant with the product specifications and includes provisions regarding cooperation between the parties for the marketing and distribution of the products. The New CHS Pulsenmore ES Agreement is cancelable by either party subject to prior notice of nine months.

In December 2021, we also entered into a subsequent agreement with Clalit for the sale of the Pulsenmore FC system, or the CHS Pulsenmore FC Agreement, under which Clalit has committed to purchase a minimum quantity of Pulsenmore FC units per year over a four-year period which has an aggregate value of $10.8 million, subject to confirmation that the results of the feasibility trial of the Pulsenmore FC system at the Rabin Medical Center meet the protocol criteria. In June 2025, we received the clinical trial results report from the feasibility trial, and based on such results we believe that Clalit will begin integrating the Pulsenmore FC system as part of the remote healthcare services offered to its insured members. Under the agreement, Clalit has the right to return up to half of the minimum annual order and each of the parties has the right to terminate the agreement after 18 or 36 months, with renewal options for Clalit for two additional one-year periods, subject to certain minimum purchase requirements per any such one-year period. Although Clalit has yet to confirm that the results of the feasibility trial meet the protocol criteria, by virtue of this agreement we received our first order in November 2022 for a total value of approximately NIS 1.3 million (approximately $0.4 million) which had been provided during December 2022. To date, we have supplied the customer with 400 devices under this agreement, of which 100 devices were used for the feasibility study.

On January 21, 2026, following Clalit’s confirmation that the results of the feasibility trial met the protocol criteria, we and Clalit entered into an additional agreement, or the 2026 Clalit Agreement, pursuant to which the parties agreed to an 18-month pilot period during which the Pulsenmore FC will be sold and marketed directly by us to Clalit’s patients in Israel, with healthcare delivery and marketing support provided by Beilinson NEXT, Rabin Medical Center’s virtual hospital platform. It was further agreed that upon completion of the pilot, the engagement will continue for a five-year term, increased from the four-year term provided under the previous agreement. During this period, Clalit’s minimum annual purchase commitment will be 2,000 Pulsenmore FC units with units sold directly by us to Clalit’s patients deducted from such minimum. In addition, Clalit will be entitled to return up to 1,000 units per year and during both the pilot period and the five-year term will have a right to sell the units directly to its patients.

Sheba Medical Center

On February 29, 2024, we entered into an agreement with Sheba, or the Sheba Agreement, through the Sheba Research and Health Services Fund, the first virtual hospital in Israel pursuant to which, we will provide several hundred units of the Pulsenmore ES for distribution to Sheba’s pre-natal patients. The term of the Sheba Agreement is for a period of two years. The Sheba Agreement includes customary provisions, including warranty, cooperation for marketing and distribution, and service provisions.

In 2024, we received an order for 300 units, of which 110 units of the Pulsenmore ES were supplied during the year ended December 31, 2025 for a total value of approximately NIS 0.3 million (approximately $0.1 million).

GE Precision Healthcare

In May and June 2022, we entered into a series of agreements with affiliates of General Electric, including a Private Placement Agreement, or the Investment Agreement entered into with GE Healthcare Global Holdings, Inc or GE Healthcare or GEHC, a Strategic Alliance Distribution Agreement, or the GE Distribution Agreement, with GE Precision Healthcare LLC, or GE Precision, and a Material Commitment Agreement with GE Precision, or the Supply Agreement.

Under the terms of the Investment Agreement, GE Healthcare invested $21 million. For further information with respect to the Investment Agreement see “Item 7B. Related Party Transactions”.

Under the GE Distribution Agreement, we originally granted GE Precision exclusive distribution rights for the Pulsenmore ES for 20 selected international customers in each of the U.S., Europe, and Japan, certain non-exclusive distribution rights to all other customers in the U.S., Europe and Japan, and certain non-exclusive distribution rights in territories outside of the U.S., Europe and Japan if we operate in such territories directly (as opposed to through a distributor). In addition, we originally granted GE Precision a right of first offer for territories outside of the U.S., Europe, and Japan if we intend to operate in such territories indirectly through a distributor. The term of exclusivity for the US and Japan was originally seven years while the term of exclusivity for Europe was three years and was automatically renewable for additional one-year periods subject to early non-renewal notice. During the exclusivity period, GE Precision was subject to certain non-compete restrictions, preventing it from distributing competing products, except under specific exceptions as set forth in the GE Distribution Agreement, including until a minimum purchase order threshold for Pulsenmore ES was met and if there were problems with Pulsenmore ES or the delivery of Pulsenmore ES that were not remediated during the timeframe set forth in the GE Distribution Agreement.

The GE Distribution Agreement provided that GE Precision agreed to place an order for 20,000 Pulsenmore ES units in the first year of the agreement and 50,000 Pulsenmore ES units in the second year with a delivery plan and estimated quantities for 2024 and 2025 to be agreed in good faith. The GE Distribution Agreement has a term of seven years and automatically renews for additional one-year periods unless otherwise not renewed in accordance with the terms of the agreement. The agreement may be terminated in certain limited circumstances including, a material breach, bankruptcy or change of control of the Company.

We also entered into the Supply Agreement with GE Precision. Pursuant to the terms, GE Precision made an advance payment of $1 million for the purchase of long-lead electronic components to support our product manufacturing for the second year purchase order. In addition, the Supply Agreement provided for an additional payment by GE Precision to us for up to approximately $1.9 million for such long-lead electronic components subject to certain conditions.

During 2022, GE Precision placed an initial order for 20,000 units of Pulsenmore ES, with 5,000 delivered in that year. In November 2023, GE Precision canceled the order for 15,000 units of the initial order, citing compatibility issues with iOS product, and never placed its second year order that was contemplated. We rejected these claims, asserting that the product is iOS compatible and that GE Precision must fulfill its obligations. During 2024, we received a new purchase order from GE Precision in which we supplied 240 units compatible with iOS but reserved all our rights under the agreements.

In November 2024, we notified GE Precision that its exclusive distribution rights for the Pulsenmore ES with respect to the 20 selected customers in Europe will not be renewed and will terminate effective June 7, 2025. This was because of unsatisfactory sales results. We are not currently selling Pulsenmore ES to such selected customers and do not have any immediate plans to do so.

In August 2025, we entered into a settlement agreement with GE Precision and GE Healthcare resolving our outstanding dispute and amending the terms of the Distribution Agreement as well as terminating the Supply Agreement. Under the terms of the settlement agreement, GE Precision agreed to pay us the sum of $1 million, payable within 45 days and that we shall retain ownership of the 15,000 units that were in dispute. Furthermore, it was agreed that we shall retain ownership of the long-lead electronic components purchased under the Supply Agreement and that each party is discharged from any further obligation under the Supply Agreement such that we do not need to return the $1 million advance for the purchase of long-lead electronic components. With respect to the Distribution Agreement, all remaining exclusivity rights with respect to certain clients in the United States and Japan and the limited non-compete in such jurisdictions were terminated and accordingly, the United States and Japan were removed from the list of exclusive territories, and the provisions of the Distribution Agreement were also terminated with respect to any other product of the Company. In addition, the right of first offer granted to GE Precision under the Distribution Agreement with respect to the appointment of a distributor in additional territories was also terminated and it was agreed that all unfulfilled purchase orders of GE Precision are cancelled, and GE Precision shall have no further obligation to place any future purchase orders.

As a result of these amendments, GE Precision retains non-exclusive distribution rights to all customers in the U.S. and Europe and certain non-exclusive distribution rights in territories outside of U.S. and Europe if we operate in such territories directly (as opposed to through a distributor) until the expiration of the Distribution Agreement in June 2029 (unless otherwise extended), as long as GE Precision is not distributing a competing product in such territory.

Memorandum of Understanding with a Medical Center in Australia

On July 22, 2025, we entered into a non-binding Memorandum of Understanding, or the MOU, with GCUH (Gold Coast University Hospital), a university medical center that is part of a health maintenance organization operating in the state of Queensland, Australia, or GCUH. The MOU for the collaboration was signed between us and GCUH following an agreement to purchase 100 units of Pulsenmore ES, to be used in a commercial trial with GCUH for the purpose of evaluating prospective sales opportunities in the Australian market where it is already approved for sale. As part of the MOU, upon the purchase by GCUH of additional units beyond such 100 units, we will provide GCUH with certain discounts on future orders of units, subject to order of minimum quantities, and GCUH will serve as a “Center of Excellence” in Australia for the Pulsenmore ES, supporting clinical development, physician and midwife training, and broader integration of the Pulsenmore ES. It was also agreed in the MOU that during a period of one year from the signing of the MOU, a definite agreement will be entered into between the parties to memorialize the agreements regarding the cooperation as agreed in the MOU. The duration of the definitive agreement is intended to be 4 years extendable for two additional periods of one year each. As of December 31, 2025, 100 units have been ordered and supplied.

Center for Fetal Medicine & Women’s Ultrasound

On January 29, 2026, we entered into a services agreement with the Center for Fetal Medicine & Women’s Ultrasound, a fetal medicine and women’s ultrasound center located in LA California, or CFFM. CFFM is a prenatal diagnostic center in California that provides a wide range of specialized services and includes multidisciplinary experts in maternal-fetal medicine. The center manages approximately 1,500 pregnancies per year, operates from two locations in the Los Angeles area and specializes in obstetric care for high-risk pregnancies. Under the agreement, CFFM will purchase Pulsenmore ES home ultrasound services, enabling patients to benefit from remote monitoring while reducing unnecessary visits to the diagnostic center.

TLC Perinatal PA

In February 2026, we, through our U.S. subsidiary, Pulsenmore Americas LLC, entered into a services agreement with TLC Perinatal PA, or TLC Perinatal, which operates in Silver Spring and Germantown, Maryland. Under the agreement, TLC Perinatal will incorporate our early screening home ultrasound services into its care model, allowing patients to perform ultrasound scans at home as part of a physician-directed hybrid care pathway that incorporates telehealth and scheduled in-clinic visits. TLC Perinatal is a specialized maternal-fetal medicine practice focused on diagnostic imaging and consultative care for pregnancies. Led by Medical Director Richard Broth, MD, the practice manages approximately 2,000 pregnancies annually across its two Maryland locations and is recognized for its progressive approach to integrating new technologies into prenatal care.

Clinical Trials

Over the past few years, we have conducted and/or supported numerous clinical studies to demonstrate the safety and effectiveness of the Pulsenmore home ultrasound platform for pregnancy monitoring. Additionally, two studies have shown the feasibility of our pipeline devices designed for transvaginal ultrasound in patients undergoing fertility treatments and for pulmonary ultrasound in patients with renal and/or heart failure. Below is a summary of the clinical evidence we have gathered so far.

Feasibility, Validation and Acceptance of the Pulsenmore ES Device:

HOLA (Home Ultrasound Assessment) US based multicenter study:.

This prospective pivotal multicenter study was completed in October 2024. The study was conducted in four medical centers in the U.S. and was designed to evaluate the safety and performance of the Pulsenmore ES device when used by pregnant women at home, in both App-Guided (AG) and Clinician- Guided (CG) modes, in comparison to a conventional in-clinic scans. The study consisted of up to three ultrasound sessions over up to three consecutive weeks (one session per week). Each session consisted of three ultrasound scans performed over the course of a single day: AG scan performed by the subject at home, a clinician-guided scan performed during a telehealth visit at the subject’s home, and an in-clinic visit using a standard of care ultrasound device. A total of 188 pregnant women >14 weeks of gestation were enrolled, and 171 women completed the study. Of the enrolled women, following exclusion due to protocol deviations, data of 162 women was analyzed, yielding a total of 1,370 scans corresponding to 458 video-guided scans, 453 clinician guided scans, and 458 in-clinic scans. For the final effectiveness analysis, performed retrospectively (following study closure), 10 readers independently and ‘blindly’ interpreted AG scans and different 10 readers interpreted CG scans. Three expert readers interpreted the in-clinic scans, of which majority rule (two of three) was used to determine ground truth (GT) results.

The primary safety endpoint was incident of device related, or procedure related severe adverse events. The primary efficacy endpoint was proportion of cases in which readers using the CG and AG modes can correctly visualize fetal heart rate activity (for CG mode >90% and for AG mode >80%), and the sensitivity and specificity of normal amniotic fluid volume (AFV) in the CG and AG modes (>70%). Secondary efficacy endpoints included image quality using ACEP (American College of Emergency Physicians) image quality scale for AFV and fetal heart rate activity. Additional secondary endpoints included agreement between readers on placental position, fetal breathing (for the CG mode only, starting at >27 weeks GA), fetal movement and fetal presentation.

There were no device related or procedure related serious adverse events reported. The primary efficacy analysis found that the fetal heart rate activity was effectively visualized in >90% of cases in both CG and AG modes scans. Mean proportion for CG mode 99.2% [95% CI 96.7%, 100%] >90% and mean proportion for AG mode 97.2% [95% CI 94.3%, 99.3%] >80%). The sensitivity to determine AFV was 69.3% [95% CI 63.3%, 74.4%] < 70% the CG mode and 49.3% [95% CI 41.1%, 57.6%] < 70% for the AG mode. The specificity to determine AFV was 80% [95% CI 73.5%, 86.5%] > 70% in CG mode and 91.6% [95% CI 89.1%, 94.0%] > 70% in AG mode. Both CG and AG modes generated ultrasound scans with high image quality (>90% of the scans were graded as ACEP ≥3 (sufficient for diagnosis)). For visualizing fetal movements, placental location, and fetal breathing, CG and AG scans demonstrated comparable rates to in-clinic scans, with all three modalities achieving visualization rates exceeding 95%. Visualization of fetal presentation was significantly lower in in-clinic scans compared to CG and AG scans.

Overall, the study demonstrated that the Pulsenmore ES device produced high-quality ultrasound scans that were safe and effective at visualizing fetal heart rate activity at home for both CG and AG modes however the Pulsenmore ES device did not meet the sensitivity endpoint for AFV. Patient satisfaction was found to be very high using both CG and AG modes.

Usability (Human factor) U.S. based study:

In 2023, we completed a prospective human factors validation study, testing the usability of the Pulsenmore ES device for patient’s conducting self-operated fetal scans during pregnancy. During this study, patients completed fetal scans remotely from home using either the AG (n=15) or the CG (n=15) mode of operation, while the process was observed via video call and was recorded. Both Android and iOS-based smartphones were tested in both modes. After completing the scans, the patients were interviewed about their experience with the device. For the CG mode, a health care provider (HCP) guided the patient’ scan. Thus, two intended user populations, pregnant patients (n=15) and HCPs (n=15), were tested in this study. The HCPs were observed directing patients through the at-home fetal scanning procedure and then were interviewed about their experience with the device. The study measured whether any safety issues arose while using the device and whether there were any user errors while using the device. Results demonstrated that all patients and HCPs were able to safely use the Pulsenmore ES ultrasound device to perform ultrasound scans remotely. No user-related risks or test artifacts were identified.

Published Studies

Several studies conducted during the last years and published recently evaluated the feasibility and user acceptance of Pulsenmore remote ultrasound utilization during pregnancy.

Clalit feasibility study

A study, from Beilinson hospital, Israel, completed in 2022, evaluated the Pulsenmore ES in AG mode with 100 pregnant women (14-40 gestational weeks). Each participant received the device for a self-use period of 7–14 days and was instructed to perform one to three scans a day. Participants completed a self-assessment questionnaire to evaluate safety and usability (i.e., user experience and satisfaction). Each scan was evaluated for fetal heart activity, amniotic fluid volume, fetal tone, fetal body, and breathing movements. The primary endpoint was safety and secondary endpoints included user experience, usability, and device sensitivity. There were no device-related serious adverse events reported. Success in detection was 95.3% for fetal heart activity, 88.3% for body movements, 69.4% for tone, 92.2% for normal amniotic fluid volume, and 23.8% for breathing movements. Device use was well accepted with high user satisfaction.

Erlangen feasibility study

A prospective, single-center observational study conducted in Erlangen, Germany, completed in 2023. A total of 46 pregnant women were enrolled in gestational weeks 17+ 0 to 29 +6 weeks. The participants were enrolled in two cohorts, one using a prototype of Pulsenmore ES and the other using the Butterfly iQ.

The Butterfly iQ is a mobile ultrasound system that is certified for medical use. It has similar structure to the Pulsenmore ES device and also consists of a mobile ultrasound device that can be connected to a mobile phone or tablet by cable. The corresponding application can be downloaded and the cloud functions for saving images and videos. The preset for ultrasound in obstetrics was used. However, the Butterfly iQ device is not intended for self-scan by the patient at home and was designed for a healthcare professional utilization as a Point of Care ultrasound (POCUS).

The study found that two thirds of the women would be willing to perform the self-guided examination at home, but 87.0% would prefer live support by a professional. Concerns about their own safety and that of the child were expressed by 23.9% of the women. Success rates for locating the target structure for videos of the fetal heartbeat (n=46) were: Pulsenmore cohort (n=23) 65.2%, Butterfly cohort (n=23): 91.3%. Success rate for videos of the amniotic fluid in all four quadrants (n=46): Pulsenmore cohort (n=23) 43.5%, Butterfly cohort (n=23): 60.9%, and for videos of the fetal profile (n=28) Pulsenmore cohort (n=13) 15.4%, Butterfly cohort (n=15): 20%

Notably, this study revealed atypical results in the detection of fetal parameters using the Pulsenmore ES. We believe these findings may be attributed to the use of a prototype version of the device, which was significantly improved in later versions, or to inappropriate training of the readers.

Charite feasibility study for near term pregnancy monitoring

A prospective, observational study by Charite hospital, Germany, completed in 2024, evaluated the feasibility of Pulsenmore self-operated device for women near term. 50 women between 40 + 0 and 41 + 2 gestational weeks were included. The study aimed to evaluate whether the patient self-operated scans correlate with the routine scan. In addition, the study aimed to assess whether the mobile-based ultrasound system leads to a reduction in outpatient visits. The women completed a questionnaire as well to evaluate satisfaction, safety and the question of reduction of outpatient visits. The results showed 92% of scans were found to be adequate for analysis, 91,9% of the patients felt safe using the ultrasound device, 97.9% of women indicated that they would use such a device during pregnancy and in 81.6%, this would lead to a reduction of doctor’s consultations. Overall, the study revealed that the Pulsenmore ultrasound system is a viable solution for remote fetal assessment and could potentially lead to a cost and time alleviation.

Validation of fetal heart rate and maximal vertical pocket measurement tools

This prospective study was conducted in Belinson hospital, Israel, and completed in 2024. The aim of this study was to evaluate fetal heart rate (FHR) and maximal vertical pocket (MVP) measurements tools available on the Pulsenmore ES dashboard, for usability and accuracy. Pulsenmore ES scans were obtained by pregnant women in AG or CG mode. The scans were stored on a cloud for later interpretation by a health care professional. Each self-scan was immediately followed by a standard in-clinic US scan performed by a clinician. The asynchronous FHR and MVP measurements made on the AG and CG scans through the designated dashboard were analyzed and compared with the real-time, in-clinic measurements.

The study included 28 women. Rates of successful utilization of the Pulsenmore tool for measurement of FHR were 84.7 ± 11.24% of scans made in AG mode and 96.3 ± 6.35% of scans made in CG mode. Corresponding values for MVP were 91.7 ± 2.31% and 95.0 ± 1.73%. FHR accuracy (difference from in-clincic values) was 10.8 ± 7.5 beats per minute (bpm; 7.2%) in AG mode and 5.8 ± 5.1 bpm (4%) in CG mode. MVP accuracy was 1.3 ± 1.4 cm (22%) and 0.9 ± 0.8 cm (14%), respectively. Sensitivity (87.5% and 100% in AG and CG modes, respectively) and specificity (95% and 95.5% in AG and CG modes, respectively) were established for MVP.

Overall, the study demonstrated that FHR and MVP measurements obtained from scans captured by the self-operated Pulsenmore ES ultrasound platform are highly accurate and reliable for clinical use relative to standard in-clinic measurements.

Clalit real world data analysis

Data of Pulsenmore utilization was obtained from Clalit home ultrasound services which has implemented the Pulsenmore system in the AG mode. The established ultrasound reading center remotely interpreted over 140,000 scans through to January 2025 with over 98% precision of the following prenatal parameters: fetal cardiac activity, fetal movements and amniotic fluid volume - where each scan is designated as normal (all three parameters are observed and are OK), abnormal (at least one of the parameters is observed and is abnormal, i.e. no heartbeat, no movements or oligohydramnios/polyhydramnios), or inadequate (at least one of the parameters cannot be technically evaluated/observed). Following each scan, users are promptly contacted by healthcare professionals for either reassurance, further scanning instructions, or referral for additional follow-up care.

In addition, a retrospective analysis of Clalit was conducted comparing maternal and neonatal outcomes among Pulsenmore ES users versus non-users between January 2020 and December 2022. The study compared two groups: 4,460 users of the Pulsenmore ES device and 102,707 non-users. Primary outcome measures were preterm delivery and a composite adverse neonatal outcome. Confounders were balanced between the groups using nearest neighbor matching with propensity scores. Multivariable analyses including the confounders were conducted in matched cohorts to obtain doubly robust estimates. A sensitivity analysis included those who began using the device before 22 gestational weeks and continued for more than 10 weeks. Safety was assessed by identifying any maternal, obstetrical, or neonatal complications plausibly linked to device use.

The study found users of Pulsenmore ES device had higher socioeconomic scores, were more primiparous and had a higher incidence of chronic disease and pregnancy complications. Preterm birth rates and adverse neonatal outcomes did not differ between groups. The median total home ultrasound scan count was 8, with a median duration of use of 13.6 weeks. Most women (91%) used the device starting from their second trimester. The study key finding was that device utilization, both overall and stratified by actual utilization degree, was safe and not associated with any maternal, obstetrical or neonatal adverse pregnancy outcomes.

Utilization of the Pulsenmore ES Device in High- Risk Pregnancy:

Hybrid model for monitoring high risk pregnant women

A study was conducted in Sheba hospital, Israel, completed in 2024, which recruited 20 women with gestational diabetes (GDM) beyond 32 gestational weeks. All women participated in a 4-week prospective study of alternating remote and in-clinic visits . The in-clinic and remote visits were compared.  Remote assessments began with women self-measuring vital signs and using a digital urine dipstick. The remote encounter started with a midwife performing anamnesis and remotely connecting women to the fetal nonstress test. A physician concluded the meeting with remote sonographic assessment of amniotic fluid maximal vertical pocket that together with the nonstress test provided the modified biophysical profile assessment (mBPP), using the Pulsenmore ES device for evaluation AFV as part of the mBPP test, and ongoing glycemic control assessment. The feasibility of remote visits were assessed, compared visit durations, evaluated women’s satisfaction using a questionnaire, examined glucose documentation adherence during hybrid care compared with the following period until birth, and assessed GD-related clinical outcomes.

Results indicated that remote visits had a success rate of 97.4% (38 of 39), with significantly shorter durations compared with in-clinic visits (median 59.0 min vs. 159.0 min). Women expressed high satisfaction (6.6 of 7), and adherence with recording fasting glucose values during the study period was 30% higher than the following period until birth (92.2% vs. 61.8%). Notably, none required induction of labor for glycemic control imbalance, and there were no cases of macrosomia, shoulder dystocia, or neonatal hypoglycemia. Overall, the hybrid approach to maternal-fetal care for GD demonstrated feasibility, safety, time efficiency, improved patient satisfaction, and enhanced glycemic control adherence.

Following this pilot, Sheba beyond, the first virtual hospital in Israel, implemented a model of Hospital at Home (HaH) for High-Risk Pregnant women offering a promising alternative to prolonged hospital admissions, empowering women while maintaining quality of care. This study investigated a hybrid model integrating remote visits and tele-home monitoring with bi-weekly hospital visits, using remote technologies including Pulsenmore fetal ultrasound. 93 women were included in the program, with good pregnancy outcome and saving 1200 hospital admission days (12.9 days per patient). High patients’ satisfaction was recorded.

Anxiety following recurrent pregnancy loss

Two RCT studies, investigated the impact of telemedicine visits, using the Pulsenmore home ultrasound, on maternal anxiety and antenatal attachment. The studies conducted in Wolfoson hospital, Israel and completed in 2024. The first study (study 1) included women with a history of recurrent pregnancy loss (2 or more prior abortions), and the second study (study 2) included women with previous late pregnancy loss (beyond 20 weeks of gestation). Each study included 50 women who were randomized 1:1 into 2 groups: Control group, which received standard high-risk prenatal care, or the study group, which received additional twice-weekly home-ultrasound sessions. The home ultrasound scans assess fetal pulse, movements and amniotic fluid volume, aiming to provide maternal reassurance. Patients performed the scans themselves using the Pulsenmore ES device, with real-time guidance from a physician (using the CG mode). Remote ultrasound session duration was 5 minutes on average. Maternal anxiety and attachment were assessed using validated questionnaires. The primary outcome measure was anxiety levels measuring the Stait Trait Anxiety Inventory (STAI) and Maternal Antenatal Attachment Scale (MAAS) score.

In both studies, there were no differences in demographics or pregnancy outcomes between groups. The primary outcome (STAI score at the last visit) was significantly lower in the device group compared to the control group (30 [20-61] vs 40 [22-78], P=.037). In study 1, the device group exhibited a greater reduction in STAI scores between the first and last visits (-14 [-44 –(13)] vs -2 [-32-(26)],P=.045) and a significantly higher MAAS score at the end of the follow-up period (78.5 [46-90] vs 75 [46-87], P=.046). In study 2, it was found that the device group had less unscheduled emergency department visits during this time compared to control. Also, it was found that the device group had less unscheduled emergency department visits during this time compared to control. Overall, it was found that incorporating home-ultrasound visits into prenatal care in patients with prior pregnancy loss may significantly reduce maternal anxiety and enhance maternal attachment. These findings suggest that home ultrasound technology can be a valuable tool in managing maternal anxiety in patients with prenatal maternal anxiety.

Remote, modified Biophysical Profile (mBPP) using the Pulsenmore ES device

A study conducted in Sheba hospital, completed in 2024 evaluated modified BPP remotely using the Pulsenmore ES device for amniotic fluid volume assessment and a remote non-stress test belt for fetal heart rate evaluation. 10 women (40 gestational weeks) were recruited in total. Nine women (90%) successfully completed the remote mBPP assessment, which included both fetal heart rate and amniotic fluid volume measurements.

Two studies evaluating remote BPP using the Pulsenmore ES device were completed in 2024 in Beilinson hospital, Israel (30 patients), and in the university of Michigan, USA (25 patients). The purpose of the studies was to assess feasibility and proof of concept that the Pulsenmore ES device can be used to complete BPP for fetal well being. Patients underwent remote BPP test evaluating the four sonographic variables of the BPP (fetal movement, fetal breathing, fetal tone, and amniotic fluid volume). Following the remote session with the Pulsenmore device in a CG mode, patients underwent a standard in-clinic BPP test by an independent physician blinded to the remote session results. The results showed that Pulsenmore ES and in-clinic standard scans showed 92.7% BPP score agreement (51/55). Amniotic fluid volume (MVP >2 cm) and fetal movement scores were 100% consistent between modalities. In addition, there was 100% agreement in evaluating cardiac activity, amniotic fluid volume, fetal presentation and placental location. The mean duration for remote BPP using Pulsenmore ES was 8.3 ± 3.54 minutes, compared to 4.6 ± 3.33 minutes for in-clinic tests. Remote scans took longer due to clinician guidance but remained under 10 minutes. Women reported high satisfaction and a positive experience with the Pulsenmore ES device. Overall the study demonstrated the feasibility of the Pulsenmore technology to conduct effectively remote BPP.

Ongoing studies

Improved usability of Pulsenmore ES mobile App

In 2024 we initiated an uncontrolled usability clinical trial in Meir hospital, Israel, to improve training and scanning instructions in the early (14 – 19 GW) and late (29 – 40 GW) weeks of pregnancy. The study is ongoing. A total of up to 50 pregnant women will participate in the study. Phase 1 was used for observation and testing of new scanning instructions. 20 subjects were already completed the study in phase 1. Based on the resulted observations, improved mobile version and scanning instructions were developed. Phase 2 is expected to be initiated soon and include testing the improved version with more 20-30 subjects before commercial release.

Pre-labor maternal pushing training using visual biofeedback by Pulsenmore home ultrasound

An ongoing randomized controlled study, initiated in 2023 in Beilinson hospital and Tel Aviv university, is evaluating the efficacy of pre-labor visual biofeedback, facilitated by Pulsenmore device, in improving maternal and neonatal outcomes in childbirth. 260 patients are expected to be recruited to the study.

Pipeline products of home ultrasound

Pulsenmore FC

During 2024, the Pulsenmore FC device was evaluated in a single-center clinical study conducted at the Rabin Medical Center in Israel under Prof Yoel Shufaro and approved by the institutional review board, or IRB, of the clinical site. The study was used to test whether patient self-scans with the Pulsenmore FC device, could be used for ovarian and endometrial monitoring. Participants were trained to visualize the uterus and ovaries using the Pulsenmore FC device. Patients independently obtained scans, which were read blindly and compared to in-clinic scans for ovaries and uterus visualization, follicles number, size, and endo material thickness (EMT). In June 2025, we received the clinical trial results report from the feasibility trial. A total of 48 patients completed the study. The primary safety endpoint was incident of device related, or procedure related serious adverse events and primary efficacy endpoint was image quality by comparing the clinician guided Pulsenmore FC scans to conventional ultrasound in in-clinic visits. There were no device related or procedure related serious adverse events reported. Overall the study demonstrated that the number and size of follicles, and the endometrial thickness as measured by the Pulsenmore FC device are comparable to those measured by the standard in-clinic ultrasound. The Pulsenmore FC scans can provide a reliable diagnosis of the appropriate timing for ovulation triggering prior to oocyte retrieval. with patients and sonographers reporting high satisfaction and good user experience.

Pulsenmore MC

During 2023, the Pulsenmore MC device was evaluated in a single center pilot study conducted at Soroka University Medical Center, Israel under Dr. Lior Fuchs and approved by the IRB of the clinical site. The study was used to test whether high-risk elderly hemodialysis patients could produce high-quality lung ultrasound images using the Pulsenmore MC device at home. Nine participants were trained to self-scan “Zone 1” of the anterior chest wall using the Pulsenmore MC device and performed self-scans at home using the device to assess for signs of fluid overload. As published in the Journal of Clinical Medicine in January 2025, patient-generated images demonstrated high reliability (92% highly reliable or reliable) and were non-inferior to ultrasound images generated by physicians with substantial B-line classification agreement. Overall the study demonstrated the feasibility of Pulsenmore MC utilization by high-risk elderly patients for self-scan and generation of reliable ultrasound images to evaluate chest fluid overload warranting further investigation through larger-scale and long term studies.

Marketing and Distribution Strategy

Our marketing strategy is focused on developing and expanding the “home” segment of the larger ultrasound prenatal care market. Our marketing campaigns, developed based on our clinical evidence, are multi-channel, regionally specific and focused on positioning the Pulsenmore ES platform as a practical, safe, and effective solution for remote sonographic fetal assessment that will lead to improved resource management, greater patient access and care, and increased patient engagement, convenience, and satisfaction.

Our customers vary depending on the country and business model. We routinely engage with multiple stakeholders, including physicians, sonographers, patients, hospital systems, third-party service providers, and insurance companies. We currently have direct sales to insurance or HMO organizations and hospitals. In the future we will expand this to include direct sales to patients, in combination with physicians, hospital systems, employers, and third-party imaging service providers.

Our distribution strategy varies depending on the regional and country needs. We believe a hybrid strategy is an effective way to develop the distribution in many countries, whereas we directly develop the initial reference accounts or with a distribution partner. We believe our products offer a significant opportunity for our partners and providers to deliver improved clinical care, cost-effectively while providing the ability to generate additional revenues.

We are marketing our Pulsenmore ES ultrasound imaging in the United States, Europe, Switzerland, Australia, and Israel where we are approved to sell. In South America, the Pulsenmore ES is currently approved for sale in Brazil and Colombia however with the recent receipt of FDA approval in the Unites States, we are currently focused on expanding our commercial footprint in the United States. We maintain our global marketing, clinical, and product management resources in our Israel Headquarters.

We received several awards including most recently winning #PM360 Innovators Submission; Two first prizes from the American Institute of Ultrasound in Medicine (AIUM); A silver medal at the 31^st Annual National Health Information Awards; The Gold Winner in the Personal Digital Health Fall 2023 Awards; 1^st Prize Winner at the UltraCon Shark Tank Awards; Top Design at the European Product Design Awards and Bronze Winner from the International Design Awards.

Service and Support

We run a technical and customer services team to address field inquiries, troubleshoot product issues, facilitate sales activities and support the commercial activities of our direct offices and our international distributors. We provide immediate technical response to our physician customers and distributors all year around. In the event that an issue arises, our technical support personnel will work with our customers to determine if a technical issue may be resolved over the telephone or requires service support. In markets where we do not have our own service engineers, the service and support of our products are managed by our independent distributors.

We warrant our products against defects in materials and workmanship under normal use and service for a period of up to 18 months from the date of delivery. If a product fails and we are unable to fix it we’ll replace it within the warranty period according to the warranty terms.

Manufacturing and Supply

The Pulsenmore ES and Pulsenmore FC products are manufactured in a state-of-the-art production facility in Omer, Israel. We rely on a number of subcontractors to manufacture the components of our products while maintaining control over the overall production and assembly process. These manufacturing subcontractors provide us with partially assembled components. Selective outsourcing allows us to carry lower inventory levels and maintain fixed unit costs without incurring significant capital expenditures that would be in place if products were entirely self-manufactured. The electronic board inside our products is assembled by subcontractors in China, Japan or South Korea, with some of the components purchased by the subcontractors and some supplied by us. The packaging of the product is supplied by different subcontractors in South Korea and Israel. We assemble the final device in Israel, adding ancillary components including software. We control and monitor the quality of our products in our headquarters in Israel, where the final assembly and packaging of products is completed. While we rely on limited or sole suppliers for certain materials and components that are used in our products, we are not heavily dependent on any of our manufacturing subcontractors, and to date, we have not experienced any significant manufacturing delays.

We believe our partially outsourced manufacturing processes complies with all applicable U.S. and international quality and safety standards, such as ISO 13485:2016, CE and the FDA GMP quality system regulations.

Research and Development

Our research and development activities are conducted internally by a team of 33 research and development staff based mainly in Israel. The focus of our R&D team is to provide technological innovation and associated intellectual property that expands the value proposition of our technologies and the Products. Our research and development efforts are focused on improving and upgrading the Products as well as the development of new applications for the existing Products for additional clinical indications.

Our R&D department plays a pivotal role in our innovation engine, driving the development of advanced medical technologies with a focus on ultrasound systems for home-use. Based primarily in Israel, our multidisciplinary team includes highly skilled professionals in hardware engineering, firmware, software, mechanics, biomedical engineering, and physics. The department operates under a quality management system certified to ISO 13485, and adheres strictly to international standards such as IEC 60601 to ensure the safety and efficacy of our medical devices.

Our expertise includes:

Our R&D is familiar with global regulatory frameworks. The R&D team actively manage and document ECOs (Engineering Change Orders), DMR (Device Master Records), risk management files, and verification/validation reports in accordance with design control and regulatory audit requirements.

In addition, the R&D team serves as our focal point for intellectual property, managing aspects of patent development, office actions, and long-term IP strategy - supporting both innovation and competitive advantage.

Our research and development expenditures for the years ended December 31, 2025, 2024, and 2023 were approximately NIS 17.4 million (approximately $5.4 million), NIS 20.1 million (approximately $6.3 million), and NIS 31.4 million (approximately $9.8 million), respectively.

Competition

Our industry is subject to intense competition, rapid changes and is highly sensitive to the introduction of new imaging diagnostics products or other market activities by ultrasound-specific industry participants. To our knowledge, the Pulsenmore ES is the only ultrasound product in the market that is intended for use by the lay person in a non-clinical setup, i.e. home. Although we believe that we do not directly compete with other companies, we compete indirectly and in the future, we may directly compete with other companies developing mobile ultrasound devices, including those that offer a complementary telemedicine and telehealth component that might facilitate remote use by the lay person. These competitors include established companies with significant financial and human resources, established reputations, brand name recognition, broader product lines, and larger customer bases and also new entrants. The market is characterized by extensive research efforts and rapid technological progress, making it highly competitive. Key competitors include companies with devices designed for remote diagnostics and patient monitoring such as the VScan marketed by GE Healthcare and the Butterfly Network IQ+. Among the largest and longest-standing ultrasound providers in the world is the GE Group, which was a former shareholder in our company. GE Precision also is subject to certain non-compete restrictions, preventing it from distributing competing products during an exclusivity period, except under specific exceptions as set forth in the GE Distribution Agreement, including until a minimum purchase order threshold for Pulsenmore ES is met and if there are problems with Pulsenmore ES or the delivery of Pulsenmore ES that are not remediated during the timeframe set forth in the GE Distribution Agreement. Any business combinations or mergers among our competitors that result in larger competitors with greater resources or distribution networks could further increase competition in the market. There are also many smaller companies, including a handful of Chinese manufacturers that compete with us in the mobile ultrasound space.

To compete effectively, we must demonstrate that our mobile ultrasound devices are attractive alternatives to other telehealth solutions by differentiating them based on performance, and price. We have encountered and expect to continue to encounter potential customers who, due to existing relationships with our competitors, are committed to or prefer the products offered by these competitors. Competitive pressures may result in price reductions and reduced margins for our products over time. To our knowledge, we have no direct competitors in the field of ultrasonic imaging products that match the performance level of our miniaturized, portable, simple to operate device, which is specifically intended for home use and is equipped to provide remote medical interpretation.

Other medical companies, academic and research institutions, or others may develop new technologies, including medical devices, telehealth platforms, and obtain regulatory approval for products utilizing such techniques that are more effective or less expensive than our current or future products.

In the field of pregnancy monitoring, we believe the Pulsenmore ES offers a solution at a more affordable price compared to our competitors whereas new wireless mobile products intended for skilled medical staff, such as those from Butterfly Network, typically cost around $2,000 plus an annual usage fee of about $400. Doppler monitors which are also available to pre-natal women and track the fetus through a mobile app, are generally unreliable and not approved by regulatory bodies unless they are used in a clinical setup.

In the field of follicle size imaging, alternative ultrasound products price range from tens to hundreds of thousands of dollars and require expert operation. Recently, companies like Clarius have developed portable and wireless compact ultrasonic products for medical staff, costing several thousand dollars. However, these devices are not yet approved for home use or for automatically transmitting ultrasound videos from home by lay user to doctors or technicians. Earlier disclosed ovulation monitors (such as that of U.S. Patent 5,209,238, published in 1993) have not found practical applications and success. Similar attempts have been made by others, such as VisOvum Ltd. in the UK (U.S publication 2023/0139828), but no commercially successful product has emerged.

Intellectual Property

Intellectual property is an important aspect of our business and we seek protection for our intellectual property rights as appropriate. To establish and protect our proprietary rights, we rely on a combination of patent, copyright, trade secret and trademark laws, know-how and continuing innovation, and contractual restrictions such as confidentiality agreements, licenses, and intellectual property assignment agreements. We strive to protect the proprietary technologies that we believe are important to our business, including seeking and maintaining patent protection intended to cover our products.

Our success depends in part on our ability to: (a) obtain, maintain, protect and enforce intellectual property and other proprietary rights for our current and future technology, inventions, improvements, and know-how we consider important to our business, (b) preserve the confidentiality of our trade secrets, (c) defend and enforce our intellectual property rights, (d) operate without infringing, misappropriating, or violating the intellectual property and other proprietary rights of others, and (e) prevent others from infringing, misappropriating, or violating our intellectual property and other proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and in jurisdictions outside of the United States related to our proprietary technology, inventions, and improvements that are important to the development and implementation of our business. Our patent portfolio is intended to cover components of our system and algorithms run thereon, their methods of use, and any other inventions that are commercially important to our business. We also rely on trademarks, trade secrets, and know-how to develop and maintain our proprietary position.

As set forth in the tabular form below, as of March 15, 2026, our patent portfolio included 31 granted patents, of which 5 are U.S. patents and 26 are foreign patents, as well as 63 pending patent applications, of which 11 are U.S. patent applications and 52 are foreign patent applications. The granted U.S. patents are expected to expire between February 7, 2037 and April 30, 2041, in each case taking into account awarded patent term adjustments and extensions and assuming payment of all appropriate maintenance, renewal, annuity or other governmental fees. The claims of these owned patents and patent applications are directed toward various aspects of our Pulsenmore System of ultrasound programs. We continue to seek to expand the scope of our patent protection for our technology.