As filed with the U.S. Securities and Exchange Commission on September 25, 2026.

Registration Number 333-       

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

RegenLab USA, Inc.

(Exact Name of Registrant as Specified in its Charter)

RegenLab USA, Inc.

95 Greene Street

Jersey City, New Jersey 07302

1 (800) 220–9082
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Antonino Turzi

Chairman and President

95 Greene Street

Jersey City, New Jersey 07302

1 (800) 220–9082
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

with Copies to:

Approximate date of commencement of proposed sale to public: As soon as practicable after the effective date hereof.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act, check the following box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, 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 to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to Section 8(a), may determine.

The information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

RegenLab USA, Inc.

[●] Shares of Common Stock

This is a firm commitment underwritten initial public offering by RegenLab USA, Inc. a Delaware corporation (the “Company”) of [●] shares of the Company’s common stock, par value $0.001 per share. Prior to this offering, there has been no public market for our common stock. We anticipate that the initial public offering price of our shares will be between $[●] and $[●] and the number of shares of common stock offered hereby is based upon an assumed offering price of $[●] per share, the midpoint of such estimated price range.

We have applied to have our common stock listed on the Nasdaq Stock Market under the symbol “RGNA.” No assurance can be given that our application will be approved. If our common stock is not approved for listing on the Nasdaq, we will not consummate this offering.

Mr. Antonino Turzi, our principal stockholder, currently controls approximately 98.64% of the voting power of our capital stock (based on shares of common stock outstanding as of September 21, 2026) and will control approximately [___]% of the combined voting power of our capital stock upon completion of this offering, and we are therefore a “controlled company” as defined under Nasdaq Marketplace Rules. We do not intend to rely on the controlled company exemptions provided under Nasdaq Marketplace Rules.

We are an emerging growth company under the Jumpstart our Business Startups Act of 2012, or JOBS Act, and, as such, may elect to comply with certain reduced public company reporting requirements for this prospectus and future filings. See “Summary — Implications of Being an Emerging Growth Company.”

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 26.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

We have granted a 30-day option to StoneX Financial Inc. the representative of the underwriters to purchase up to [●] additional shares of common stock solely to cover over-allotments, if any. If the representative of the underwriters exercises the option in full, the total underwriting discounts and commissions will be $       and the additional proceeds to us, before expenses, from the over-allotment option exercise will be $        .

The underwriters expect to deliver the shares to purchasers on or about        , 2026.

Sole Book-Running Manager

The date of this prospectus is        , 2026

Table of Contents

About this Prospectus

We and the underwriters have not authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses prepared by us or on our behalf or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares of common stock offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. We are not making an offer to sell these shares of common stock in any jurisdiction where the offer or sale is not permitted or where the person making the offer or sale is not qualified to do so or to any person to whom it is not permitted to make such offer or sale. The information contained in this prospectus is current only as of the date on the front cover of the prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

Persons who come into possession of this prospectus and any applicable free writing prospectus in jurisdictions outside the United States are required to inform themselves about and to observe any restrictions as to this offering and the distribution of this prospectus and any such free writing prospectus applicable to that jurisdiction. See “Underwriting” for additional information on these restrictions.

Industry and Market Data

Unless otherwise indicated, information in this prospectus concerning economic conditions, our industry, our markets and our competitive position is based on a variety of sources, including information from third-party industry analysts and publications and our own estimates and research. Some of the industry and market data contained in this prospectus are based on third-party industry publications. This information involves a number of assumptions, estimates and limitations.

The industry publications, surveys and forecasts and other public information generally indicate or suggest that their information has been obtained from sources believed to be reliable. None of the third-party industry publications used in this prospectus were prepared on our behalf. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors” in this prospectus. These and other factors could cause results to differ materially from those expressed in these publications.

Trademarks

This prospectus contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent possible under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by any other companies.

Risk Factors

Any investment in our securities involves a high degree of risk. You should carefully consider the risks described below, which we believe represent certain of the material risks to our business, together with the information contained elsewhere in this prospectus, before you make a decision to invest in our shares of common stock. Please note that the risks highlighted here are not the only ones that we may face. For example, additional risks presently unknown to us or that we currently consider immaterial or unlikely to occur could also impair our operations. If any of the following events occur or any additional risks presently unknown to us actually occur, our business, financial condition and operating results may be materially adversely affected. In that event, the trading price of our common stock could decline and you could lose all or part of your investment.

Risks Relating to Our Business, Strategy and Industry

The success of our business model depends on obtaining and maintaining regulatory approvals and clearances to market our products

We have invested a significant portion of time and financial resources in the development of our medical devices. Our business is dependent on our ability to successfully complete development of, obtain regulatory approval for, and, if approved, successfully commercialize our medical devices in a timely manner. Failure to receive or maintain necessary regulatory clearances and approvals through the various frameworks we pursue, including CE marking under the EU Medical Device Regulation (MDR), FDA 510(k) clearance, Premarket Approval (PMA), or other regulatory pathways in the United States, Europe, China, Asia, and other jurisdictions, could materially and adversely affect our business, financial condition, and results of operations. Such failure would prevent or significantly delay our ability to commercialize our products in key markets, limit revenue generation, result in the loss of substantial investments in product development, and could force us to abandon or delay planned commercialization efforts.

We may face unforeseen challenges in our product development strategy, and we can provide no assurances that our medical devices will be successful in clinical trials, will ultimately receive regulatory approval from any or all of the agencies from which we seek such approval, and will be commercially successful in their target markets.

While the Company has obtained regulatory approvals in major markets for some of its products, such as RegenKit^® in 2003 in the EU and in 2010 in the United States, CellularMatrix^® and ArthroVisc in 2014 in the EU, RegenKit WoundGel^® in 2009 in the EU, in 2016 in China and in 2022 in the United States and since April 2023, full EU-MDR certifications for its lead products, we may not be able to obtain regulatory approval, at all or in all of the desired markets, of the medical devices we are currently developing or may seek to develop in the future.

The time required to conduct clinical trials and obtain approval or other marketing authorizations by the regulatory authorities is unpredictable and typically takes many years and depends upon numerous factors, including the discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during a medical device’s development and may vary among jurisdictions. Regulators may also subsequently limit or revise the indicated uses for which the product was originally marketed, which could significantly impact our sales.

Prior to obtaining approval to commercialize any medical device in the EU, the United States or any other geographies, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the notified body, FDA or other regulatory authorities, that such medical device is safe and effective for its intended uses. Results from pre-clinical studies and clinical trials can be interpreted in different ways. Even if we believe that the pre-clinical or clinical data for our devices are promising, such data may not be sufficient to support approval. Additionally, the notified body, FDA or other regulatory authorities may also require us to conduct additional pre-clinical studies or clinical trials for our medical devices either prior to or post-approval or may object to elements of the clinical development program, requiring their alteration.

Even if we complete clinical testing and receive approval for a medical device, the FDA or other comparable regulatory authorities may grant approval or other marketing authorization contingent on the performance of costly additional clinical trials, including post-market clinical trials or for a more limited indication or patient population than we originally requested.

If the regulatory authorities discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or if a regulatory authority disagrees with the marketing or labelling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or the Company. In addition, regulatory authorities may prohibit the use of PRP in certain indications, for example in the esthetic field in France. These restrictions could include requesting a recall or requiring withdrawal of the product from the market, suspension of manufacturing or suspension, variation or withdrawal of the related approval. Any delay in obtaining, inability to obtain or withdrawal of any applicable regulatory approval would delay, inhibit or prevent commercialization of that medical device and would adversely impact our business, results of operations and future prospects.

The successful continued commercialization of our products and any other product candidates will depend on obtaining reimbursement of our medical devices from third party payors.

The Company’s activities fall within the healthcare sector and are affected by the regulatory and economic environment of this sector which also differs in each country. The Company’s ability to obtain acceptable reimbursement levels from governmental authorities or public and private entities could have an impact on the sale of its medical devices and therefore on its ability to generate revenues.

There is continuing economic, regulatory and political pressure to limit the cost of medical devices and medical procedures involving medical devices. Third party payers are increasingly questioning the prices of medical devices, and many of them may reduce or refuse to reimburse certain medical devices. As a result, the Company could be required to reduce the price of its products to win bids from public hospitals.

Currently, RegenKit Wound Gel^®, which was approved by the FDA in 2022, is covered by a Center for Medicare Services (CMS) decision giving rise to a reimbursement but the Company cannot guarantee that such reimbursement will not be challenged in the future. Further legislative reforms of reimbursement systems (including price regulation) could also reduce reimbursement of medical devices or medical procedures involving medical devices. The Company cannot guarantee that it will obtain optimal reimbursement in other countries in which it intends to market its products. In addition, the Company’s products may not obtain reimbursement in certain indications, for example in the esthetic or the comfort care fields. The absence or insufficiency of coverage / reimbursement for our products or adoption of new legislation that is more restrictive could limit the revenue generated by the sale of our products and thus have a significant adverse effect on the Company’s business, financial position and operating results.

Our business and product sales may be impacted by alternative technologies and the emergence of new technologies.

The medical devices market in which the Company operates is subject to technological change. The areas of application of PRP are very broad and in many cases doctors and surgeon have therapeutics solutions. Our medical devices could be less competitive or even obsolete due to other therapies, research, discoveries or inventions made by third parties including competitors. For illustration purposes, new biological products or else may show a superior efficacy over the products prepared with our medical devices.

The Company cannot guarantee that it will maintain its commercial advantage in case that new medical devices, new technologies or new treatment appear and become more useful and efficient than the medical devices developed by the Company. As a result, the success of the Company depends on its ability to, among others, maintain its technological lead by developing new medical devices that address the changing needs of the medical community and improve the effectiveness, safety and reliability of its existing medical devices. In this purpose, the Company has implemented a technology monitoring with periodic reports.

Developing medical devices involves significant business risks and substantial costs. The Company may not guarantee that it will be able to improve or adapt its existing technologies and treatment to changing medical standards and practices in a timely or cost-effective manner. If the Company is unable to maintain its technological lead by creating new medical devices or improving its existing medical devices in particular in terms of ease of administration, effectiveness and/or safety, the Company could face market losses or obsolete inventory which could reduce the competitiveness of the Company and have a significant adverse effect on its business, financial position and operating results.

Other autologous biologic preparation methods or technologies from the bone marrow or adipose tissue are actively monitored, and considered within RegenLab scope of research, product and development. In addition, other autologous blood derivates, that exposed some specific areas but failing from the time being to establish sufficient advantage cost/risk/efficacy advantage, for example Biomet nSTRIDE. Several drug candidates from the pharmaceutical sector, remaining widely out of reach.

The Company’s commercial deployment is highly dependent upon relationships with healthcare professionals.

Despite the fact that the Company’s medical devices are already accepted and used by the medical community in the EU and the United States for a variety of indications, including musculoskeletal and skincare, and in China for chronic wound, there is no guarantee that the medical devices currently in development will be accepted by the healthcare professionals in the future. The commercial success of the current and future Company’s medical devices depends upon the medical community acceptance, especially in terms of safety, effectiveness and/or ease of use.

While the Company continues its efforts to obtain convincing results in the field of skincare, musculoskeletal and advanced wound care, healthcare professionals may be reluctant to change their surgical practices in order to use the medical devices proposed by the Company, in particular for the following reasons:

Without the support of healthcare professionals, the pace of large-scale deployment of the products developed by the Company could be slowed down considerably.

Our success will depend on our ability to develop an internal sales force and external distributor arrangements, the failure of which could negatively impact our business strategy and results of operations.

The Company’s commercial strategy consists in deploying its medical devices internationally. The commercial deployment of the technology to health care institutions (hospitals or private clinics) and practitioners has been carried out by a combination of two sales forces: (a) a direct sales force (B2C); and (b) a targeted sales force relying on local distributors and agents (B2B). The success of our deployment strategy will depend on our ability to increase and develop our sales forces in particular by attracting, recruiting and retaining a qualified sales force and strengthening and entering into distributorship agreements in the geographical areas in which our Company intends to operate in order to market its current and future medical devices.

In order to increase the marketing of its medical devices, the Company has entered into more than 120 distributorship agreements which contain several commitments for the distributors (including compliance with applicable laws and regulations and ensuring a high quality of storage, delivery and transport of the products). For example, the Company has entrusted the distribution of its products in the United States to the Stryker group. RegenLab has also entered into agreements with distributors in Taiwan, Russia, Spain, Italy, Netherlands, Canada, Australia and Czech Republic. The distributorship agreements grant to the distributors the exclusive right to market the Company’s products in defined areas. As distributors account for a large percentage of the Company’s yearly revenue, distributors’ bad selling performance could impact the Company’s ability to generate revenue and could have a material impact on our business, financial condition, and results of operations. In case a distributor fails to meet its commitments, the Company could be compelled to change such distributor, which could be lengthy and costly, and there is no guarantee that the Company will be able to find a new distributor with the required qualities.

In addition, the Company cannot guarantee that it will be able to enter into new distribution agreements to be able to market its products in all countries with sales potential, or that these distributors or agents will have the necessary expertise in regenerative therapy, or that they will devote the necessary resources to the commercial success of its products. If any such event were to occur, it could have an impact on the sale of its medical devices which would be likely to have a material adverse effect on the Company, its business, financial condition, results, development and prospects.

Uncertainties in regulatory and other matters in emerging markets could complicate the Company’s marketing strategy internationally.

The Company’s strategy includes continuing to pursue growth opportunities in sales internationally, including in emerging markets, which could expose it to additional risks associated with international sales and operations. For example, the Company intends to develop its sale forces in order to commercialize RegenKit and Cellular Matrix in Africa. Our international operations are, and will continue to be, subject to a number of risks and potential costs, including changes in foreign medical reimbursement policies and programs, differences in and changes to foreign regulatory requirements, in particular regarding regulatory clearance of products, differing local product preferences, diminished protection of intellectual property in some countries, and trade protection measures, which may prevent the Company from shipping products to or receiving products from a particular market or restrict its access to certain sources of raw materials. Foreign sales may also face difficulty in staffing and managing foreign operations, potentially negative consequences from changes in tax laws, and labor, political, social and economic instability and uncertainty, including wars, other conflict and sovereign debt issues. Violations of foreign laws or regulations could result in fines or other criminal sanctions against the Company, its officers or employees.

Wars and other conflicts may increase certain of these risks and may adversely affect our business and financial performance, including by limiting our ability or our distributors’ ability to operate in, or export from, certain markets. In particular, in February 2022, armed conflict escalated between Russia and Ukraine. In response thereto, the United States and other North Atlantic Treaty Organizations member states, as well as certain non-member states, announced targeted economic sanctions, embargoes and export controls on Russia and Belarus. The Company’s dependence on distributors located in Russia and Belarus for a significant portion of its turnover puts it at risk of losing revenue due to actual or potential wars involving these countries. As drugs and medical technologies are not under embargo, the Company continues to distribute its products in Belarus and Russia in compliance with the applicable sanctions. The Company has no other activities or operations in Belarus or Russia. Disruptions in these regions could impact the ability of the Company’s distributors to operate effectively, leading to a decrease in sales and revenue.

Our products have existing competition in the marketplace and we may not be able to compete effectively.

We operate in a rapidly changing sector in which it faces significant competition, both from established competitors and from more recent competitors and could in the future face competition from new entrants. We face strong competition from several companies that also offer PRP preparation devices and systems such as Terumo and Crown Laboratories Inc., Emcyte which are acting in the PRP market, or Arthrex and Zimmer Biomet which are providing solutions for knee pathology. We may also be exposed to competition from certain companies already present in the medical devices market which may (i) have greater financial, marketing and human resources than us or from competitors which may respond more quickly to the expectations of health professionals by offering a new or different technology or (ii) adopt more aggressive pricing policies or (iii) be more successful in attracting potential customers, employees and strategic partners.

Our medical devices could be rendered uneconomical by technological advances of current or future competitors or by other new therapies. For instance, there are several companies such as Zimmer Biomet which are developing medical devices or treatment at varying stages of development intended to treat arthrosis and especially articular pain in the knee. Although several of our products have successfully completed clinical trials and have been approved by regulatory authorities in several countries, it could be considered less effective or obsolete and sales may decline if other medical devices demonstrate superior efficacy, safety, and/or cost-effectiveness. Therefore, the successful commercialization of a particular product will depend in part upon the Company’s ability to complete clinical studies and/or obtain the required marketing clearances or approvals prior to our competitors, or, if regulatory clearance or approval is not obtained prior to our competitors, to identify markets for our products that may be sufficient to permit meaningful sales of our products.

If the company fails to adapt to the competitive environment by offering new or more efficient medical technologies, it could cause the Company to have difficulty maintaining or increasing sales of its medical devices and thus have a significant adverse effect on the Company’s business, financial position and operating results.

The results of preclinical studies and early-stage clinical trials may not be predictive of future results.

The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through preclinical studies and initial clinical trials. There can be no assurance that any of our current or future clinical trials will ultimately be successful or support further clinical development of any of our product candidates. There is a high failure rate for drugs proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies. Even if our clinical trials are completed, the results may not be sufficient to obtain regulatory approval of any products.

We may be unable to attract a strategic partner for the further development of our product candidates.

Even if positive clinical data is eventually achieved in any future clinical trials, we may not be able to enter into strategic partnerships, out-licensing, or other similar arrangements that we may consider necessary or appropriate to commercialize product candidates successfully, or even have the resources necessary to seek such arrangements. Furthermore, even if such a strategic relationship regarding any of our products or product candidates is reached, development milestones, clinical data, or other such benchmarks may not be achieved. Therefore, our product candidates may never proceed toward commercialization or drive cash infusions for us, and we may ultimately not be able to monetize the patents, existing clinical data, and other intellectual property.

Our efforts to secure commercial partners may not be successful.

From time to time, we engage in discussions with larger companies regarding potential strategic partnerships involving the broad commercialization of our devices. The resources and expertise of such a partner would greatly facilitate the capture of market share within the wound care market, but would require that the economic benefits of such a broad penetration would be shared with said partner. We may not be successful in securing such a partner. Furthermore, even if a partner is secured, the partnership may not attain the market penetration contemplated, and the profits ultimately realized by us, if any, may not be sufficient to allow us to execute our business strategy.

We may use third-party collaborators and service providers to help us support, develop or commercialize our product candidates, and our ability to commercialize such candidates may be impaired or delayed if such collaborations or engagements are unsuccessful.

We do presently and may in the future selectively pursue strategic collaborations or engagements for, among other purposes, development, data collection, analysis, and/or commercialization of our product candidates, domestically or otherwise. There can be no assurance as to our ability to utilize the data from such engagements to their potential. Nor can there be any assurance, in general, that we will be able to identify future suitable collaborators or negotiate collaboration agreements on terms that are acceptable to us or at all. In any current or future third-party collaborations, we are and would be dependent upon the success of the collaborators in performing their responsibilities and their continued cooperation and engagement. For a variety of reasons outside of our control, our collaborators or third-party providers may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to performing their responsibilities under our agreements with them. Our collaborators may choose to pursue alternative technologies in preference to those being developed in collaboration with us. The development and commercialization of our product candidates will be delayed if collaborators fail to conduct their responsibilities in a timely manner or in accordance with applicable regulatory requirements or if they breach or terminate their collaboration agreements with us. Disputes with our collaborators could also result in product development delays, decreased revenues and litigation expenses.

We depend on the experience and expertise of our senior management team and the loss of any executive officer, or the inability to identify and recruit executive officers in a timely manner, could harm our business, operating results, and financial condition.

Our success depends largely upon the continued services of our key executive officers. We rely on our executive officers in the areas of business strategy, research and development, marketing, sales, services, and general and administrative functions. From time to time, there may be changes in our executive management team resulting from the hiring or departure of executives, which could disrupt our business. We do not maintain key-man insurance for any member of our senior management team or any other employee. We do not have employment agreements with our executive officers or other key personnel that require them to continue to work for us for any specified period and, therefore, they could terminate their employment with us at any time. The loss of one or more of our executive officers or key employees could have a material adverse effect on our business.

If product liability lawsuits are brought against us, we may incur substantial liabilities.

Product liability risk is the Company’s exposure when defective medical products and devices produced by the Company cause death or bodily injury to any person and/or damage or destruction of a product ordinarily intended for private use, and which has been used primarily for private purposes by the victim. Manufacturing or selling defective products is one of the biggest concerns for the Company. The Company could be exposed to liability risks, in particular liability for defective products, during clinical development and during the manufacture and marketing of its various medical devices. The liability of the Company could also result from actions by its partners, licensees, co-contractors or subcontractors, over which the Company has no control. Such liability could materially and adversely affect its reputation and the sale of its medical devices.

Medical care and clinical studies and trials involve risks, particularly for the patients and participants who may suffer unexpected adverse effects due to the product or medical devices developed by the Company. The Company could be held liable by patients and participants because of unexpected adverse effects. Furthermore, the Company acting as a sponsor or investigator of a clinical trial might be liable for damages suffered by participants in connection with the trial. There is no guarantee that suits relating to the use of its products and medical devices will not be asserted against the Company in the future and the Company may not be able to obtain and maintain sufficient and affordable insurance coverage, including coverage for significant legal expenses.

Our products are subject to governmental regulation which requires us to constantly maintain compliance with such regulations to be in position to sell our products.

Our current technology and products are subject to extensive regulation by numerous governmental authorities in the U.S., both federal and state, and in foreign countries by various regulatory agencies. Specifically, our devices are subject to regulation by the FDA and state regulatory agencies. The FDA regulates drugs, medical devices, and biologics that move in interstate commerce and requires that such products receive clearance or pre-marketing approval based on evidence of safety and efficacy. The regulations of government health ministries in foreign countries are analogous to those of the FDA in both application and scope. In addition, any change in current regulatory interpretations by, or positions of, state regulatory officials where our products are used could materially and adversely affect our ability to sell products in those states. The FDA will require us to obtain clearance or approval of new or modified devices when used for treating specific wounds or marketed with specific wound-healing claims, or for other products under development.

We believe all our products for sale are legally marketed. As we expand and offer and/or develop additional products in the U.S. and in foreign countries, clearance or approval from the FDA and comparable foreign regulatory authorities prior to introduction of any such products into the market may be required. We provide no assurance that we will be able to obtain all necessary approvals from the FDA or comparable regulatory authorities in foreign countries for these products. Failure to obtain the required approvals would have a material adverse impact on our business and financial condition.

Compliance with FDA and other governmental requirements imposes significant costs and expenses. Further, our failure to comply with these requirements could result in sanctions, limitations on promotional or other business activities, or other adverse effects on our business.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Affordable Care Act, or the ACA, was passed, which substantially changes the way healthcare is financed by both governmental and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA, among other things, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and creates a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges, as well as efforts by the U.S. presidential administration to repeal or replace certain aspects of the ACA. By way of example, the Tax Cuts and Jobs Act, or the TCJA, included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030. In addition, in January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for any product candidate we develop or complementary diagnostics or companion diagnostics or additional pricing pressures.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

In addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business. For example, the results of the 2024 presidential election may impact our business and industry. It is difficult to predict whether or how any new executive orders will be interpreted and implemented, or whether certain FDA regulations from the Biden administration will be rescinded and replaced under the Trump administration. Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose additional costs or lengthen FDA review times for our product candidates. We cannot determine how changes in regulations, statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future.

Disruptions at the FDA and other government agencies caused by new administration policies or funding shortages could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result.

Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities, and recent efforts by the Department of Government Efficiency have brought scrutiny to waste in agency spending, resulting in numerous lawmakers calling for the codification of relevant funding cuts. Further, if a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Failure to comply with the United States Physician Payment Sunshine Act could lead to substantial monetary penalties to the Company.

We are required to comply with the United States Physician Payment Sunshine Act, which requires certain manufacturers of drugs, medical devices, biologicals and medical supplies that participate in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to report this information annually to CMS. The period between August 1, 2013 and December 31, 2013 was the first reporting period for which manufacturers were required to report aggregate payment data to CMS by March 31, 2014. Manufacturers are required to report aggregate payment data to CMS by the 90th day of each subsequent calendar year. We cannot assure you that we will collect and report all data timely and accurately. If we fail to accurately and timely report this information, we could suffer severe penalties.

Any applicable manufacturer that fails to timely, accurately, or completely report the information required in accordance with the rules of the Sunshine Act is subject to a civil monetary penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported timely, accurately or completely (up to $150,000). For “knowing” failures to report, the penalties increase to not less than $10,000, but not more than $100,000, for each such failure (up to $1,000,000). The amount of civil monetary penalties imposed on each applicable manufacturer or applicable group purchasing organization is aggregated separately. Subject to separate aggregate totals, the maximum combined annual total is $1,150,000.

Several of the U.S. states have parallel reporting laws, sometimes accompanied with “gift bans” prohibiting manufacturers from making gifts or other remunerations to prescribers. Massachusetts and Vermont are two such states. There are various penalties associated with noncompliance with the state laws, as well.

If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Our product candidates are subject to the risks of failure inherent in the development of biotherapeutic products. The results of early-stage clinical trials do not necessarily predict the results of later-stage clinical trials. Product candidates in later-stage clinical trials may fail to demonstrate desired safety and efficacy traits despite having successfully progressed through initial clinical testing. Even if we believe the data collected from clinical trials of our product candidates is promising, this data may not be sufficient to support approval by the U.S. or foreign regulatory agencies. Pre-clinical and clinical data can be interpreted in different ways. Accordingly, the regulatory officials could reach different conclusions in assessing such data, which could delay, limit or prevent regulatory approval. In addition, the U.S. regulatory authorities, or we, may suspend or terminate clinical trials at any time. Any failure or delay in completing clinical trials for product candidates, or in receiving regulatory approval for the sale of any product candidates, has the potential to materially harm our business, and may prevent it from raising necessary, additional financing that may be needed in the future.

Before obtaining regulatory approval for the sale of our product candidates, we must conduct, at our own expense, extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including the following:

A disruption in healthcare provider networks could have a material adverse effect on our current operations and ability to be profitable.

Our operations and future profitability are dependent, in large part, upon the ability to contract with healthcare providers on favorable terms. In any particular service area, healthcare providers could refuse to contract with us or take other actions that could result in higher healthcare costs, or create difficulties in meeting our regulatory requirements. In some service areas, certain healthcare providers may have a significant market presence. If healthcare providers refuse to contract with us, use their market position to negotiate unfavorable contracts or place us at a competitive disadvantage, our ability to market services or to be profitable in those service areas could be adversely affected. Provider networks could also be disrupted by the financial insolvency of a large healthcare provider group. Any disruption in provider networks could adversely impact our business, results of operations and financial condition.

We may be unable to attract and retain key personnel.

Our future success depends on the ability to attract, retain and motivate highly skilled management, including sales representatives. Our inability to retain existing or add new personnel will materially and adversely affect the business prospects, operating results and financial condition of the Company. Our ability to maintain and provide additional services to our customers depends upon our ability to hire and retain business development and scientific and technical personnel with the skills necessary to keep pace with continuing changes in regenerative biological therapy technologies. Competition for such personnel is intense; we compete with pharmaceutical, biotechnology and healthcare companies with greater access to resources. Our inability to hire additional qualified personnel may lead to higher recruiting, relocation and compensation costs for such personnel. These increased costs may reduce our profit margins or make hiring new key personnel impractical.

In addition, we have maintained a small financial and accounting staff, and our reporting obligations as a public company, as well as our need to comply with the requirements of the Sarbanes-Oxley Act of 2002, and the rules and regulations of the SEC will continue to place significant demands on our financial and accounting staff. As we grow, we will need to add additional financial and accounting staff in order to fulfill our reporting responsibilities and to support expected growth in our business. Our current and planned personnel, systems, procedures and controls may not be adequate to support our anticipated growth or management may not be able to effectively hire, train, retain, motivate and manage required personnel. Our failure to manage growth effectively could limit our ability to achieve our marketing and commercialization goals or to satisfy our reporting and other obligations as a public company.

We rely on key subcontractors for the manufacture of our products.

For certain of our medical devices, such as RegenKit^®, we outsource the gamma sterilization of our medical devices in Switzerland and in the United States. If, for any reasons, our contractors are unable to sterilize the Company’s finished products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, the Company may not be able to find a solution in a timely or cost effective manner, which could have a material impact on its results of operations and financial condition.

The Company’s success depends on its ability to identify, build and maintain long-term relationships with its subcontractors and to obtain from them high-quality services in compliance with regulatory requirements and at acceptable prices. In case of non-performance by a subcontractor for any reasons, this could result in delays in manufacturing processes, which could generate additional costs. In addition, in the event that the Company would need to change its subcontractors, it would be necessary to find a subcontractor that complies with the standards required to maintain the CE marking or other regulatory approval. Finding a new subcontractor could also cause delays and increase manufacturing costs. Moreover, obtaining approvals (including CE Marking) may require that all steps in the manufacturing process be carried out by subcontractors holding an ISO certification. The withdrawal of this certification by one or more of the subcontractors could have an impact on the manufacturing of the Company’s medical devices.

The Company cannot guarantee that it will be able to maintain existing subcontracts or enter into new agreements on acceptable commercial terms, given the limited number of specialized companies which have the required infrastructure and experience. In case of a termination or deterioration of its relationship with its subcontractors, it could adversely affect its ability to manufacture and market its medical devices.

We rely on third parties to conduct clinical studies and trials.

We rely on third parties to conduct clinical trials and clinical studies for our medical devices for managing and carrying out these trials and studies, with special emphasis on contract research organizations, University hospitals and healthcare institutions. Although we rely on third parties to conduct clinical trials or studies, we are still responsible for ensuring that these clinical trials and studies are conducted in accordance with required protocol and other requirements, including regulatory requirements for conducting, monitoring, and reporting the results of medical studies or trials to ensure that the data and results are accurate and that the rights, integrity and confidentiality of trials participants are protected. Consequently, if these third parties do not successfully carry out their duties under the research agreements or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to clinical studies or clinical trial protocols or to regulatory requirements, the clinical studies or trials of our products may not meet regulatory requirements. If clinical trials and studies do not meet regulatory requirements or if these third parties need to be replaced, clinical studies or trials may be delayed, suspended or terminated. If any of these events occur, it could generate additional costs and have a material adverse effect on the Company’s business, financial position and results of operations.

We are reliant on suppliers of raw materials for the manufacture of our medical devices.

Our medical devices are manufactured with certain raw materials such as HA, thixotropic gel, glass tube, PETG, rubber stopper and Tyvek. Certain of these raw materials can only be obtained from a single or a limited number of suppliers due to quality considerations, expertise, costs and constraints resulting from regulatory requirements. Hyaluronic acid is a key component of our products such as CellularMatrix, ArthroVisc, Skinvisc and RegenMatrix, and the thixotropic gel is a key component of RegentKit^®, CellularMatrix^® or RegenMatrix^®. If the Company is unable to obtain hyaluronic acid or thixotropic gel from its suppliers, the Company may not be able to produce certain of its medical devices, which could result in delays and have a material adverse effect on the Company business, financial position and results of operations.

In addition, the Company also relies on other suppliers for the products composing its kits. If a supplier fails to provide raw materials or products in accordance with the Company’s quality, quantity or cost conditions, the Company may have to replace one of its strategic suppliers. In this situation, the Company would have a limited number of options and this could lead to disruptions in the manufacture of its medical devices. A reduction or interruption in the supply of materials or products used in manufacturing the Company’s products, due to one or more suppliers experiencing reductions in operations and/or worker absences due to a pandemic or otherwise; an inability to timely develop and validate alternative sources if required; or a significant increase in the price of such materials or components could adversely affect the Company’s business, financial condition and results of operations.

Further, in the current context of global economic instability (including inflation), suppliers could increase their prices. Fluctuations in purchase prices of raw materials used for the manufacture of the Company’s medical devices could lead to significant variations in cost prices and/or not be fully covered by a correlative increase in the price of the Company’s medical devices/ products. In addition, delivery times for raw materials could be longer than usual and the Company could be forced to build a significant stock, which would impact its working capital requirements. These uncertainties may impair the Company’s development or profitability. The limited number of suppliers as described above may create a risk of dependence on the Company’s suppliers and loss of any of them could adversely affect the Company’s business, financial position and results of operations.

Differences in the regulatory regimes of various jurisdictions in which we currently sell and intend to sell our products will create difficulties in standardization of marketing or sales and can result in additional expenditures for compliance.

Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative effect on the marketing approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we may charge for our products is also subject to approval.

In the European Union, medical devices are governed by the EU-MDR which harmonizes the conditions for the sale and free movement of our products within the European Economic Area. This regulation requires manufacturers to obtain authorization from regulatory bodies for the marketing in the EU of all medical devices. Once obtained, the CE markings are valid for a period of five years. The U.S. market is governed by the regulations established by the Food and Drug Administration, which regulates the quality of testing, manufacturing, labelling and design, design of products and materials, their labelling, quality assurance, storage, and the packaging, distribution and promotion of medical devices.

Current products developed by the Group have already obtained the CE marking or the FDA approval, such as Class IIb CE marking for RegenKit in 2003 and Class II FDA approval in 2010, Class III CE marking for CellularMatrix in 2014, Class II FDA approval in 2022 for RegenKit WoundGel, Class III for Arthrovisc 40 in 2014. The Company’s lead products recently obtained full EU-MDR certifications, however there is no guarantee that all such approvals will be maintained. Products under development will be subject to the applicable regulations and the Company will have to demonstrate the safety and efficacy of its products in order to obtain the approvals in the EU and the United States.

In addition, developing and obtaining regulatory approvals for combination products, such as CellularMatrix which combines PRP and HA poses unique challenges because they involve components that are regulated under different types of regulatory requirements in some territories such as in the United States. These regulations are broad in scope and are subject to evolving interpretation. The Company could be required to incur substantial costs to investigate, audit, and monitor compliance or to alter its practices, to the extent that it is subject to government scrutiny under these regulations. Any failure to comply with these regulations could subject the Company to significant liabilities, which could have a material adverse effect on its business, financial condition, and results of operations. In addition, requests for renewal of CE marking certificates require, among other things, that the quality system be maintained in compliance, that regulatory changes be taken into account, that risk management be updated, and that compliance with the essential requirements of the applicable European directives, as well as the national provisions transposing these directives, be ensured.

If we are unable to obtain the renewal of the certificates required for CE marking of our existing products within the required timeframe, the marketing of our products will be interrupted until such certification is obtained. The CE markings or the FDA approvals obtained by the Company’s products can be withdrawn by regulatory agencies for several reasons, including the failure to comply with ongoing regulatory requirements or the occurrence of unforeseen issues following initial approval. Regulatory authorities could also limit or prevent the manufacture or distribution of the Company’s products. Any regulatory limitations on the use of the Company’s products or any withdrawal or suspension of approval or rescission of approval or reclassification by the regulatory authorities could have a material adverse effect on the Company’s business, financial condition, and results of operations.

As a manufacturer of sterile medical devices, the Company also has to comply with regulatory requirements in terms of quality and safety in order to market its products. In particular, we must comply with the strict quality management system (QMS) rules which require the existence of a quality policy and procedures. The Company may also be subject to inspection from regulatory authorities in countries where it has a production unit such as in the United States, in France and in Switzerland. For instance, the Company has been subject to an inspection by the Food and Drug Administration in 2014 and in 2018, and the Company is regularly audited by BSI.

We are subject to foreign currency risk.

A substantial portion of our foreign revenues is generated in U.S. dollars and in Euros. As a result, the Company is exposed to the exchange rate risk of the Swiss Franc (CHF) against the Euro (EUR) and against the U.S. dollar, as most of its operating expenses are incurred in the Swiss Franc (CHF). The Company has not yet taken any hedging measures to protect its business against exchange rate fluctuations. The Company will monitor its exposure to foreign exchange risk as its situation evolves. If the Company is unable to make effective hedging arrangements in the future, the results of its operations could be adversely affected.

Disruptions at the FDA and other government agencies caused by new administration policies or funding shortages could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. Disruptions at the FDA and other agencies may also slow the time necessary for new devices to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA and other government employees and stop critical activities, and recent efforts by the Department of Government Efficiency (DOGE) have brought scrutiny to waste in agency spending, resulting in numerous lawmakers calling for the codification of relevant funding cuts. Further, if a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, the violation of which can result in serious consequences.

Among other matters, U.S. and foreign anti-corruption, 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 are subject to stringent data privacy laws, information security policies and contractual obligations governing the use, processing and transfer of personal information.

We may receive, generate and store significant and increasing volumes of sensitive information, such as health information, insurance information and other potentially personally identifiable information. We face a number of risks relative to protecting this critical information, including loss of access risk, inappropriate use or disclosure, inappropriate modification and the risk of our being unable to adequately monitor, audit and modify our controls over our critical information. This risk extends to the third-party vendors we use to manage this sensitive data.

We are subject to a variety of local, state, national and international laws, directives and regulations that apply to the collection, use, retention, protection, disclosure, transfer and other processing of personal data in the different jurisdictions in which we operate, including comprehensive regulatory systems in the U.S. and Europe. Further, various states have implemented certain data privacy and security laws and regulations that impose restrictive requirements regulating the use and disclosure of health information and other personally identifiable information. All 50 U.S. states have laws including obligations to provide notification of security breaches of computer databases that contain personal information to affected individuals, state officers and others.

State laws and regulations are not necessarily preempted by federal laws and regulations, such as the Health Insurance Portability and Accountability Act of 1996, or HIPAA, particularly if a state affords greater protection to individuals than federal law. Where state laws are more protective, we have to comply with the stricter provisions. In addition to fines and penalties imposed upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused. The interplay of federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and data we receive, use and share, potentially exposing us to additional expense, adverse publicity and liability. Legal requirements relating to the collection, storage, handling, and transfer of personal information and personal data continue to evolve and may result in increased public scrutiny and escalating levels of enforcement, sanctions and increased costs of compliance.

The collection and use of personal data in the European Union, or EU, and the European Economic Area, or the EEA, are governed by the General Data Protection Regulation, or GDPR. The GDPR imposes stringent requirements for controllers and processors of personal data, including, for example, more robust disclosures to individuals and a strengthened individual data rights regime, shortened timelines for data breach notifications, limitations on retention of information, increased requirements pertaining to special categories of data, such as health data, and additional obligations when we contract with third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EU and the EEA to the United States and other third countries. In July 2020, the Court of Justice of the European Union issued a decision that struck down the EU-U.S. Privacy Shield framework, which provided companies with a mechanism to comply with data protection requirements when transferring personal data from the EU to the United States and additionally called into question the validity of the European Commission’s Standard Contractual Clauses, on which U.S. companies rely to transfer personal data from Europe to the United States and elsewhere. In September 2020, the Swiss Federal Data Protection and Information Commissioner issued an opinion that stated it no longer considers the Swiss-U.S. Privacy Shield adequate for the purposes of personal data transfers from Switzerland to the United States. These developments may result in European data protection regulators applying differing standards for, and requiring ad hoc verification of, transfers of personal data from Europe to the United States. To the extent that we engage in such transfers, including through third-party vendors, if we are unable to implement safeguards to ensure that our transfers are lawful or if any safeguards upon which we rely are invalidated, we will face increased exposure to litigation, regulatory actions, fines, and injunctions against data processing. If we are unable to engage in such transfers because there is no lawful mechanism to do so, the functionality or effectiveness of our products and services may decrease and our marketing efforts, plans and activities may be adversely impacted. In addition, the GDPR provides that EU and EEA member states may make their own further laws and regulations limiting the processing of personal data, including biometric or health data.

The GDPR applies extraterritorially, and we may be subject to the GDPR because of our data processing activities that involve the personal data of individuals located in the EEA, such as in connection with any EEA clinical trials. GDPR regulations may impose additional responsibility and liability in relation to the personal data that we process and we may be required to put in place additional mechanisms to ensure compliance with the new data protection rules. This may be onerous and may interrupt or delay our development activities.

Other jurisdictions outside the EEA are similarly introducing or enhancing privacy and data security laws, rules and regulations, which could increase our compliance costs and the risks associated with non-compliance. We cannot guarantee that we or our vendors may be in compliance with all applicable international regulations as they are enforced now or as they evolve. For example, our privacy and cybersecurity policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws, in which case we may be subject to regulatory enforcement actions, lawsuits or reputational damage. If we or our vendors fail to comply with the GDPR and the applicable national data protection laws of the EU or EEA member states, or if regulators assert we have failed to comply with these laws, it may lead to regulatory enforcement actions, which can result in monetary penalties of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. Further, following the United Kingdom’s withdrawal from the EU and the EEA, and the expiry of the transition period, companies have to comply with both the GDPR and the GDPR as incorporated into the United Kingdom national law, the Data Protection Act of 2018, the latter regime having the ability to separately fine up to the greater of £17.5 million or 4% of global turnover. The relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, for example around how data can lawfully be transferred between each jurisdiction, which exposes us to further compliance risk. Beginning in 2021, the United Kingdom will be a “third country” under the GDPR. We may incur liabilities, expenses, costs and other operational losses under the GDPR and privacy laws of the applicable EU and EEA Member States and the United Kingdom in connection with any measures we take to comply with them.

Compliance with U.S. and international data protection laws and regulations could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Penalties for violations of these laws vary and may be significant. Moreover, complying with these various laws could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. In addition, we may rely on third-party vendors to collect, process and store data on our behalf and we cannot guarantee that such vendors are or will be in compliance with all applicable data protection laws and regulations. Our or our vendors’ failure to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity.

We are vulnerable to threats to our Information Technology Systems.

Our Company has implemented security measures to monitor and protect its computer systems such as antivirus software, firewall, VPN, but these measures might not be sufficient protection from unpredicted events. Disruptions to the Company’s Information Technology (IT) systems or to its service providers such as Salesforce who provides customer relationship management software, could seriously disrupt the Company’s operations. Such potential threats include computer viruses, malicious malware, unauthorized access, telecommunication and electrical failures or other type of cyber-attacks. In case of cyber-attacks, the Company has put in place measures such as reset of passwords, interruption of the internet connection, analysis of the devices and transmission of deep analysis to IT partners. If any of these events occur, it could cause interruptions in the Company IT systems and materially disrupt the Company’s operations, and the Company may not have adequate insurance coverage to compensate for any losses associated with such events. For instance, the loss of clinical trials/studies data concerning a medical device could result in delays in regulatory approval, certification and commercialization processes and the Company may be unable to retrieve lost data or may have to mobilize significant human and financial resources in order to recover this data. In addition, a breach of the Company’s IT security protocols or cyber-attacks could lead to a breach of personal data within the meaning of Regulation (EU) 2016/679 of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) or to the theft of sensitive data, in which case the Company could be exposed to administrative, criminal or financial sanctions, and a significant loss of trust from customers, suppliers and subcontractors.

Risks related to our limited operating history and financial position

Our operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to fall below expectations.

Our quarterly and annual operating results may fluctuate significantly, which will make it difficult for us to predict our future results. These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated revenue or operating guidance we may provide.

We have a working capital deficit and a highly debt-leveraged capital structure, which could adversely affect our business, financial condition, liquidity, and results of operations.

As of December 31, 2025, we had a working capital deficit of approximately $11.57 million. A working capital deficit means that our current liabilities exceeded our current assets, which could impair our ability to satisfy short-term obligations as they come due. In addition, our capital structure is highly debt-leveraged. As of December 31, 2025, we had total indebtedness of approximately $22.16 million, with significant debt service requirements that consume a substantial portion of our cash flow. This high level of leverage and working capital deficit increases our vulnerability to adverse economic or industry conditions, limits our flexibility in planning for or reacting to changes in our business, and may impair our ability to obtain additional financing in the future on favorable terms, or at all. If we are unable to generate sufficient cash flow from operations or obtain additional financing to meet our debt obligations and working capital needs, we may be required to reduce or delay capital expenditures, sell assets, seek debt restructuring, or pursue other alternatives that could harm our business. Furthermore, our substantial debt could place us at a competitive disadvantage relative to competitors with less leverage. 

We have a history of operating losses, negative cash flows from operations, substantial indebtedness, and a working capital deficit. Our financial statements include a going concern reference.

We have incurred significant net losses and negative cash flows from operating activities in prior periods, including net losses of approximately $1.24 million for the fiscal year ended December 31, 2025. These losses were driven by increased operating expenses and investments in growth initiatives. As of December 31, 2025, we had a working capital deficit of approximately $11.57 million and total indebtedness of approximately $22.16 million, with significant debt service requirements.

These conditions raise substantial doubt about our ability to continue as a going concern. Our ability to generate sufficient cash flow from operations to service our debt obligations, including interest payments and principal repayments, and to fund our ongoing operations, capital expenditures, and other commitments depends on numerous factors, many of which are beyond our control, such as general economic conditions, consumer demand for our products or services, competitive pressures, regulatory changes, and supply chain disruptions.

The Company’s financial statements for the year ended December 31, 2025 were prepared assuming we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. These financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the uncertainty related to our ability to continue as a going concern.

We will need to raise additional capital to finance our operations and meet our debt obligations. If we are unable to improve our financial performance or obtain additional financing on favorable terms, or at all, we may be required to curtail or delay operations and growth plans, sell assets, seek debt restructuring, or pursue other alternatives. Failure to obtain necessary capital or service our debt could result in default on our debt covenants, which could trigger cross-default provisions across our debt instruments, accelerate repayment obligations, and lead to foreclosure on collateral securing our indebtedness. Furthermore, any such events could materially adversely affect our business, financial condition, results of operations, and stock price.

The net proceeds from this offering, together with our existing cash resources, may not be sufficient to fund our operations, service our debt, or maintain profitability, and we may need to raise additional capital in the future, which may not be available on acceptable terms, or at all.

We estimate that the net proceeds from this offering, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, will be approximately $[•] (or approximately $[•] if the underwriters exercise their option to purchase additional shares in full), based on an assumed initial public offering price of $[•] per share (the midpoint of the price range set forth on the cover page of this prospectus). We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents, and short-term investments, primarily for sales and marketing, machine equipment for factories in France, Switzerland and the U.S.A., R&D and regulatory expenses for clinical studies in Europe and the U.S.A., and for working capital and general corporate purposes. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned due to changes in the scope or pace of our research and development programs, unanticipated costs or delays in clinical trials or regulatory processes, higher-than-expected operating expenses, lower-than-anticipated revenues, unfavorable market conditions, or other unforeseen events. Our existing cash resources, even when combined with the net proceeds of this offering, may not be sufficient to enable us to fund our operations, meet our debt service obligations, or maintain profitability for the period of time that we anticipate.

Risks Related to OUR Intellectual Property

It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position and potential regulatory exclusivity do not adequately protect our product candidates, others could compete against us more directly, which would harm our business, possibly materially.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and future products, and their methods of manufacture and use. The patent position of medical device companies is highly uncertain and involves complex legal, scientific, and factual questions. Our ability to stop third parties from making, using, selling, offering to sell, exporting, or importing our product candidates is dependent upon the extent to which we have rights under valid and enforceable patents and/or trade secrets that cover these activities. We have devoted important resources to put on the market pioneering and diversified products constituting a complete set of tools for the medical community in the Platelet Rich Plasma (PRP) & Hyaluronic Acid (HA) tissue engineering field. Changes in either the patent laws or interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or make it more difficult, or impossible, to obtain meaningful patent protection. Accordingly, we cannot predict the breadth of claims that may be issued in relevant jurisdictions from our present or future patent filings, or those we license from third parties, and further cannot predict the extent to which we will be able to enforce such issued claims in jurisdictions important to our business. If any patents we obtain or license are deemed invalid and/or unenforceable, our ability to commercialize or license our technology could be adversely affected.

It is possible that others have filed, and in the future may file, patent applications covering products and technologies that are similar, identical or competitive to ours, or that are otherwise important to our business. We cannot be certain that any patent filings owned by a third party will not have priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference, reexamination, opposition or invalidity proceedings before United States or foreign patent offices. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, and/or could allow third parties to commercialize our technology or products and compete directly with us, without payment to us. Furthermore, third party filings may result in issued patents that are infringed by our manufacture or commercialization of our products. Licenses may not be available to such third-party patents or may be available on terms that are not commercially viable for us, and challenges to their validity or infringement may be expensive and may not succeed. If the breadth or strength of protection provided by our patents and patent applications is threatened, or if we are perceived or found to infringe intellectual property rights of others, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates, and could impede or preclude our ability to commercialize our products.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. We or our licensors may become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our or our licensors’ patent rights or the patent rights of others. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, any of which could limit our ability to stop others from using or commercializing similar or identical technology and products, and/or limit the duration of the patent protection of our technology and products.

The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. For example:

The patent prosecution process is expensive, time-consuming, and complex, and we may not be able to file, prosecute, or maintain all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection for such output. In addition, our ability to obtain and maintain valid and enforceable patents depends on whether the differences between our inventions and the prior art allow our inventions to be patentable over the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.

Without patent protection for formulations of our product candidates, our ability to stop others from using or selling our product, or other competitive products, may be limited.

Intellectual property laws differ in various jurisdictions in which our Company operates and are subject to change, which could further restrict our ability to protect our intellectual property rights, and mobilization by the Company of significant financial resources may be required to protect its intellectual property rights in certain jurisdictions.

For instance, following the Company’s patent enforcement actions in China against two Chinese companies marketing non-conforming devices, one of RegenLab’s key Chinese patents (CN103079577B) — covering the combination of PRP with hyaluronic acid — was subsequently challenged and ultimately invalidated. These companies are in vitro diagnostic (IVD) manufacturers, not authorized to commercialize Class II medical devices in China, and, we believe, have been using the term “PRP” in a misleading manner to promote and sell products that do not meet Chinese and all others’ regulatory standards.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

The term of any individual patent depends on applicable law in the country where the patent is granted. In the U.S., provided all maintenance fees are timely paid, a patent generally has a term of 20 years from its application filing date or earliest claimed non-provisional filing date. Extensions may be available under certain circumstances, but the life of a patent and, correspondingly, the protection it affords is limited. When the terms of all patents covering our product candidates expire, our business may become subject to competition from competitive products, including similar versions of our products. Products are protected by certain patents or patent applications, which expire at varying times. Therefore, we cannot be certain that we will file and, if filed, obtain patent protection for our products beyond our rights in our current patent portfolio. If we are unable to obtain additional patent protection on our products, our primary protection from similar market entries will be limited.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent process. Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on any issued patents and/or applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patents and/or applications. We have systems in place to remind us to pay these fees, and we employ outside counsel to pay these fees due to foreign patent agencies. While an inadvertent lapse may sometimes be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market with similar or identical products or technology earlier than should otherwise have been the case, which would have a material adverse effect on our business, financial condition, results of operations, and prospects.

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

As is the case with other medical device companies, our success is heavily dependent on intellectual property, particularly on obtaining and enforcing patents. Our patent rights may be affected by developments or uncertainty in United States or foreign patent statutes, patent case law, USPTO rules and regulations or the rules and regulations of foreign patent offices. Obtaining and enforcing patents in the medical device industry involves both technological and legal complexity, and is therefore costly, time- consuming and inherently uncertain. In addition, the United States may, at any time, enact changes to its patent law and regulations, including by legislation, by regulatory rule-making, or by judicial precedent, that adversely affect the scope of patent protection available and weaken the rights of patent owners to obtain patents, pursue patent infringement claims and obtain injunctions and/or damages. For example, the scope of patentable subject matter under 35 U.S.C. 101 has evolved significantly over the past several years as the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court issued various opinions, and the USPTO modified its guidance for practitioners on multiple occasions. Other countries may likewise enact changes to their patent laws in ways that adversely diminish the scope of patent protection and weaken the rights of patent owners to obtain patents, enforce patent infringement claims, and obtain injunctions and/or damages.

Further, the United States and other governments may, at any time, enact changes to law and regulation that create new avenues for challenging the validity of issued patents. For example, the America Invents Act created new administrative post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings that allow third parties to challenge the validity of issued patents. This applies to all of our U.S. patents, even those issued before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third-party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

We may not be able to protect our intellectual property rights throughout the world, which may harm our business.

Patents are of national or regional effect. Filing, prosecuting, and defending patents on our product candidates, and other proprietary technologies we develop in all countries throughout the world would be prohibitively expensive. In addition, the laws of some foreign countries do not protect intellectual property rights in the same manner and to the same extent as laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcement of such patent protection is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

The requirements for patentability may differ in certain countries. For example, some countries may have heightened requirement for patentability as compared to the U.S. In addition, certain countries in Europe and developing countries, including China, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. Also, some countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third-party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology or pharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may be subject to claims that former employees, collaborators or other third parties have an interest in our patent rights, trade secrets, or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. For example, we may have inventorship disputes arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our product candidates or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business, financial condition, results of operations and prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming, and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court, and we may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.

Third parties including competitors may infringe, misappropriate or otherwise violate our patents, patents that may issue to us in the future, or the patents of our licensors that are licensed to us. To counter infringement or unauthorized use, we may need to or choose to file infringement claims, which can be expensive and time-consuming. We may not be able to prevent, alone or with our licensors, infringement, misappropriation, or other violations of our intellectual property, particularly in countries where the laws may not protect those rights as fully as in the United States, or if we require, but do not receive, the consent or cooperation of our licensors to enforce such intellectual property.

If we choose to go to court to stop another party from using the inventions claimed in our patents, that individual or company has the right to ask the court to rule that such patents are invalid, unenforceable, or should not be enforced against that third-party for any number of reasons. In patent litigation in the United States, defendants routinely assert counterclaims alleging that the asserted patents are invalid and/or unenforceable. Grounds for a validity challenge include an alleged failure to meet any of several statutory requirements for patentability, including lack of novelty, obviousness, lack of written description, indefiniteness, or non-enablement. Grounds for an unenforceability assertion could include an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution, i.e., committed inequitable conduct. Third parties may also raise similar claims before the USPTO, even outside the context of litigation. Similar mechanisms for challenging the validity and enforceability of a patent exist in foreign patent offices and courts and may result in the revocation, cancellation, or amendment of any foreign patents we or our licensors hold now or in the future. The outcome following legal assertions of invalidity and unenforceability is unpredictable, and prior art could render our patents or those of our licensors invalid. If a defendant were to prevail on a counterclaim or other legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on such product candidate(s). Such a loss of patent protection would have a material adverse impact on our business.

Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology. Our defense of litigation or opposition or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue our research programs, license necessary technology from third parties, or enter into development or manufacturing partnerships that would help us bring our product candidates to market.

We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace. Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions, or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our Common Shares. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing, or distribution activities. 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.

Our ability to enforce our patent rights depends on our ability to establish standing in a court of competent jurisdiction. Whether a patent holder or licensee of a patent has standing can be uncertain and the considerations complex. However, if a licensor is required to be joined, and they are unwilling to do so, we may be unable to proceed with an infringement action.

Our ability to enforce our patent rights depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities and have a harmful effect on the success of our business.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could adversely impact the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials and internal research programs. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace, including compromising our ability to raise the funds necessary to continue our research programs, license necessary technology from third parties, or enter into development collaborations that would help us commercialize our current or future product candidates, if approved.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might harm our ability to develop and market our products.

We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is or may be relevant to or necessary for the commercialization of our product candidates in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. In addition, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Therefore, patent applications covering our products could have been filed by others without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product candidates or the use of our products.

The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.

If we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our products that are held to be infringing. We might, if possible, also be forced to redesign products or services so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

Risks Relating to Our Securities and this Offering

Our directors, executive officers and principal stockholders will continue to have substantial control over our company after this offering, which could limit your ability to influence the outcome of key transactions, including a change of control.

Upon completion of this offering, our executive officers, directors and principal stockholders and their affiliates will own [___] shares of our common stock, or approximately [___]% of the outstanding shares of our common stock, based on the number of shares outstanding as of the date of this prospectus and assuming the sale of [___] shares in this offering at an assumed initial public offering price of $[___] per share, which is the midpoint of the price range set forth on the cover page of this prospectus, and underwriters’ over-allotment option is not exercised. As a result, these stockholders, and Mr. Antonino Turzi, our Founder and Chief Executive Officer, in particular, will be able to exercise a significant level of control over all matters requiring stockholder approval, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions. They may also have interests that differ from yours and may vote in a way with which you disagree and which may be adverse to your interests. This concentration of ownership may have the effect of delaying, preventing or deterring a change of control of our company, could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of our company and might ultimately affect the market price of our common stock.

Our management will have broad discretion in how we use the net proceeds of this offering and might not use them effectively.

Our management will have considerable discretion over the use of proceeds from this offering. You will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used in a manner which you may consider most appropriate. Our management might spend a portion or all of the net proceeds from this offering in ways that our stockholders do not desire or that might not yield a favorable return. The failure by our management to apply these funds effectively could harm our business. Furthermore, you will have no direct say on how our management allocates the net proceeds of this offering. Until the net proceeds are used, they may be placed in investments that do not produce significant income or that may lose value.

Antonino Turzi, our Founder, Chairman and CEO, beneficially owns greater than 50% of our outstanding shares of common stock, which will cause us to be deemed a “controlled company” under the rules of Nasdaq.

Antonino Turzi, our Founder, Chairman and CEO, currently controls approximately 98.64% of the voting power of our capital stock and will control approximately [___]% of the combined voting power of our capital stock upon completion of this offering. As a result, Mr. Turzi owns more than 50% of our outstanding shares (and will continue to own more than 50% of our outstanding shares upon consummation of the offering), and as such, we are a “controlled company” under the rules of Nasdaq. Under these rules, a company of which more than 50% of the voting power is held by an individual, a group or another company is a “controlled company” and, as such, can elect to be exempt from certain corporate governance requirements, including requirements that:

As a “controlled company,” we may elect to rely on some or all of these exemptions, however, we do not intend to take advantage of any of these exemptions. Despite the fact we do not intend to take advantage of these exemptions, our status as a controlled company could make our common stock less attractive to some investors or otherwise harm our stock price.

Separately, we are permitted to phase-in our compliance with the independent audit committee requirements set forth in Nasdaq rules, as follows: (1) one independent member of the audit committee at the time of listing, (2) a majority of independent members of the audit committee within 90 days of listing, and (3) all independent members of the audit committee (i.e., at least three members) within one year of listing. During these phase-in periods, our stockholders would not have the same protections afforded to stockholders of companies who have more ‘independent’ members of its audit committee and, if, within the phase-in periods, we are not able to recruit additional directors who would qualify as independent, or otherwise comply with the Nasdaq listing requirements, we may be subject to enforcement actions by Nasdaq.

Future sales of our common stock may adversely affect the market price of our securities and our ability to raise funds in new offerings.

Sales of our common stock in the public market following this offering or at the conclusion of any required lock-up periods could lower the market price of our common stock. Sales may also make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that our management deems acceptable or at all. Of the [___] shares of common stock outstanding as of [___], 2026, [___] shares are, or will be, freely tradable without restriction immediately after the consummation of this offering, and approximately [___] of these shares, representing shares not held by our “affiliates,” generally may be resold under SEC Rule 144 beginning 90 days from the effectiveness of the registration statement of which this prospectus forms a part, subject to any lock-up agreements entered into between such stockholder and StoneX Financial Inc.

Additionally, we intend to register shares of common stock that are reserved for issuance under our Equity Incentive Plan.

Sales of substantial amounts of our common stock in the public market after this offering, or the perception that such sales will occur, could adversely affect the market price of our common stock and make it difficult for us to raise funds through securities offerings in the future. Of the shares to be outstanding after this offering, the shares offered by this prospectus will be eligible for immediate sale in the public market without restriction by persons other than our affiliates.

You will experience immediate and substantial dilution as a result of this offering and may experience additional dilution in the future.

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the sale by us of [___] shares in this offering at a public offering price of $[___] per share (the mid-point of the range appearing on the front cover of this prospectus), and after deducting underwriting commissions and estimated offering expenses payable by us, investors in this offering can expect an immediate dilution of $[___] per share at the assumed public offering price. Additionally, to the extent that these warrants, or options we will grant to our officers, directors and employees, are ultimately exercised, you will sustain future dilution. We may also acquire new businesses or finance strategic alliances by issuing equity, which may result in additional dilution to our stockholders. Following the completion of this offering, our board of directors has the authority, without action or vote of our stockholders, to issue all or any part of our authorized but unissued shares of common stock, including shares issuable upon the exercise of options, or shares of our authorized but unissued preferred stock. Issuances of common stock or voting preferred stock would reduce your influence over matters on which our stockholders vote and, in the case of issuances of preferred stock, would likely result in your interest in us being subject to the prior rights of holders of that preferred stock. See the section entitled “Dilution.”

We will incur significant increased costs as a result of operating as a public company and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, as well as rules subsequently implemented by the SEC and Nasdaq, has imposed various requirements on public companies. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, we anticipate that compliance with these rules and regulations will increase our legal, accounting and financial compliance costs substantially. A number of those requirements will require us to carry out activities we have not done previously. For example, we will create new board committees and adopt new internal controls and disclosure controls and procedures. In addition, these rules and regulations may make our activities related to legal, accounting and financial compliance more difficult, time-consuming and costly and may also place undue strain on our personnel, systems and resources. Furthermore, if we identify any issues in complying with those requirements (for example, if we or our auditors identify a material weakness or significant deficiency in our internal control over financial reporting), we could incur additional costs rectifying those issues, and the existence of those issues could adversely affect us, our reputation or investor perceptions of us. If these requirements divert the attention of our management and personnel from other business concerns, they could have a material adverse effect on our business, financial condition and results of operations. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to incur substantial costs to maintain our current levels of such coverage. These increased costs will require us to divert a significant amount of money that we could otherwise use to expand our business and achieve our strategic objectives. Advocacy efforts by stockholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase our costs.

An investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our company or your investment.

An investment in our company involves complex federal, state and local income tax considerations. Neither the Internal Revenue Service nor any State or local taxing authority has reviewed the transactions described herein and may take different positions than the ones contemplated by management. You are strongly urged to consult your own tax and other advisors prior to investing, as neither we nor any of our officers, directors or related parties is offering you tax or similar advice, nor is any such person making any representations and warranties regarding such matters.

Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of our income or other tax returns could adversely affect our financial condition and results of operations.

We will be subject to income taxes in the United States, and our domestic tax liabilities will be subject to the allocation of expenses in differing jurisdictions. Our future effective tax rates could be subject to volatility or adversely affected by a number of factors, including:

In addition, we may be subject to audits of our income, sales and other transaction taxes by federal, state and local authorities. Outcomes from these audits could have an adverse effect on our financial condition and results of operations.

Anti-takeover provisions in our charter documents and Delaware law could discourage, delay or prevent a change in control of our company and may affect the trading price of our common stock.

The anti-takeover provisions of the Delaware General Corporation Law may discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change in control would be beneficial to our existing stockholders. Our certificate of incorporation and our bylaws, upon the consummation of this offering, may discourage, delay or prevent a change in our management or control over us that stockholders may consider favorable. As a result, you may lose your ability to sell your stock for a price in excess of the prevailing market price due to these protective measures, and efforts by stockholders to change the direction or management of the company may be unsuccessful.

We do not intend to pay dividends for the foreseeable future.

We have never declared or paid any cash dividends on our capital stock, and we do not intend to pay any cash dividends in the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our capital stock will be at the discretion of our board of directors. Accordingly, you must rely on the sale of your common stock after price appreciation, which may never occur, as the only way to realize any future gain on your investment.

General Risk Factors

Failure to establish and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and stock price.

We are not currently required to comply with the rules of the SEC implementing Section 404 of the Sarbanes-Oxley Act and therefore are not required to make a formal assessment of the effectiveness of our internal control over financial reporting for that purpose. Upon becoming a publicly traded company, we will be required to comply with the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act, which will require management to certify financial and other information in our quarterly and annual reports and provide an annual management report on the effectiveness of controls over financial reporting. Though we will be required to disclose changes made in our internal controls and procedures on a quarterly basis, we will not be required to make our first annual assessment of our internal control over financial reporting pursuant to Section 404 until the year following our first annual report required to be filed with the SEC. As an “emerging growth company,” as defined in the JOBS Act, we may take advantage of certain temporary exemptions from various reporting requirements, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes Oxley Act (and the rules and regulations of the Securities and Exchange Commission thereunder). 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 above and depending on our status as per Rule 12b-2 of the Securities Exchange Act of 1934, as amended, our independent registered public accounting firm may also need to attest to the effectiveness of our internal control over financial reporting under Section 404.

Based on the number of personnel available to serve the Company’s accounting function, management believes we are not able to adequately segregate responsibility over financial transaction processing and reporting. Further, the Company does not have a formal internal control environment in place. As such, we have identified these issues as material weaknesses in our internal control over financial reporting and we may identify additional material weaknesses in the future that may cause us to fail to meet our reporting obligations or result in material misstatements of our financial statements. If our remediation of such material weaknesses is not effective, or if we fail to develop and maintain an effective system of internal controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be materially and adversely affected and the market price of our common stock could be negatively affected, which could require additional financial and management resources.

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

We are an “emerging growth company,” as defined in the JOBS Act, and we may take advantage of certain exemptions from reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Pursuant to Section 107 of the JOBS Act, as an emerging growth company, we have elected to use the extended transition period for complying with new or revised accounting standards until those standards would otherwise apply to private companies. As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make our common stock less attractive to investors. In addition, if we cease to be an emerging growth company, we will no longer be able to use the extended transition period for complying with new or revised accounting standards.

We will remain an emerging growth company until the earliest of: (1) the last day of the fiscal year following the fifth anniversary of our listing; (2) the last day of the first fiscal year in which our annual gross revenue is $1.235 billion or more; (3) the date on which we have, during the previous rolling three-year period, issued more than $1 billion in non-convertible debt securities; and (4) the date on which we are deemed to be a “large accelerated filer” under the rules of the SEC.

We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions. For example, if we do not adopt a new or revised accounting standard, our future results of operations may not be comparable to the results of operations of certain other companies in our industry that adopted such standards. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock, and our stock price may be more volatile.

If our estimates or judgments relating to our critical accounting policies prove to be incorrect, our results of operations could be adversely affected.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes appearing elsewhere in this prospectus. We base our estimates on short duration historical experience and on various other assumptions that we believe to be reasonable under the circumstances, as provided in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates.” The results of these estimates form the basis for making judgments about the carrying values of assets, liabilities, and equity, and the amount of revenue and expenses. Significant estimates and judgments involve: revenue recognition, including revenue-related reserves; legal contingencies; valuation of our common stock and equity awards; income taxes; and sales and indirect tax reserves. 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 the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

Our current insurance coverage may not be adequate, and we may not be able to obtain insurance at acceptable rates, or at all.

We currently have General Liability and Product Liability policies covering our business. These policies may not provide sufficient coverage in the face of significant claims or multiple claims. Claims exceeding our insurance coverage could create significant increases in internal costs. This could have a material adverse effect on our business, financial condition, and operating results.

We may decide to pursue strategic acquisitions to accelerate our growth. These potential acquisitions may not be successful. We may not be able to successfully integrate future acquisitions or generate sufficient revenues from future acquisitions, which could cause our business to suffer.

If we buy a company or a division of a company, there can be no assurance that we will be able to profitably manage such business or successfully integrate such business without substantial costs, delays or other operational or financial problems. There can be no assurance that the businesses we acquire in the future will achieve anticipated revenues and earnings. Additionally:

Future acquisitions may require us to obtain additional equity or debt financing, which may not be available on attractive terms. Moreover, to the extent an acquisition transaction financed by non-equity consideration results in additional goodwill, it will reduce our tangible net worth, which might have an adverse effect on our credit and bonding capacity.

Use of Proceeds

We estimate that the net proceeds from the sale of the shares of common stock we are offering will be approximately $[●] million based on an assumed offering price of $[●] per share (which represents the mid-point of the estimated range of the initial public offering price shown on the front cover of this prospectus). If the underwriters fully exercise the over-allotment option, the net proceeds of the shares we sell will be approximately $[●] million. “Net proceeds” is what we expect to receive after deducting the underwriting discount and commission and estimated offering expenses payable by us.

We intend to use the net proceeds of this offering primarily for sales and marketing, machine equipment for factories in France, Switzerland and the U.S.A., R&D and regulatory expenses for clinical studies in Europe and the U.S.A., for working capital and other general corporate purposes.

We anticipate an approximate allocation of the use of net proceeds as follows:

While we expect to use the net proceeds for the purposes described above, the amounts and timing of our actual expenditures will depend upon numerous factors, including the aggregate amount raised in this offering. The expected net proceeds from the sale of the shares offered hereby, if added to our current cash and cash equivalents is anticipated to be sufficient to fund our operations for at least the next 12 months. In the event that our plans change, our assumptions change or prove to be inaccurate, or the net proceeds of this offering are less than as set forth herein or otherwise prove to be insufficient, it may be necessary or advisable to reallocate proceeds or curtail expansion activities, or we may be required to seek additional financing or curtail our operations. As a result of the foregoing, our success will be affected by our discretion and judgment with respect to the application and allocation of the net proceeds of this offering.

Each $1.00 increase (decrease) in the assumed initial public offering price of $[___] per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $[___], assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares we are offering. An increase (decrease) of 500,000 in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $[___], assuming the initial public offering price stays the same. An increase of 500,000 in the number of shares we are offering, together with a $1.00 increase in the assumed initial public offering price of $[___] per share (the midpoint of the estimated price range set forth on the cover page of this prospectus), would increase the net proceeds to us from this offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $[___]. We do not expect that a change in the offering price or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.

Pending their use, we plan to invest the net proceeds from this offering in short- and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

Dividend Policy

We have never declared or paid any cash dividends on our equity interests and we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends, if any, in the future is within the discretion of our board of directors and will depend on our earnings, capital requirements and financial condition and other relevant facts. We currently intend to retain all future earnings, if any, to finance the development and growth of our business.

Capitalization

The following table sets forth our cash and equivalents and capitalization as of ____________, 2026:

You should read the information in this table together with our financial statements and accompanying notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.

The number of shares of our common stock to be outstanding upon completion of this offering is based on [●] shares of our common stock outstanding as of ____________, 2026, and excludes:

Each $1.00 increase (decrease) in the assumed initial public offering price of $[___] per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) would increase (decrease) the amount of cash, additional paid-in capital, total stockholders’ equity (deficit) and total capitalization on as adjusted basis by approximately $[___], assuming the number of shares, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 500,000 shares offered by us would increase (decrease) cash, total stockholders’ equity (deficit) and total capitalization on as adjusted basis by approximately $[___], assuming the assumed initial public offering price of $[___] per share (the midpoint of the estimated price range set forth on the cover page of this prospectus) remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determined at pricing.

Dilution

If you purchase shares of our common stock in this offering, your interest will be diluted immediately to the extent of the difference between the assumed public offering price of $[●] per share (the mid-point of the range appearing on the front cover of this prospectus) and the as adjusted net tangible book value per share of our common stock immediately upon the consummation of this offering. As of _____________, 2026, we had a historical net tangible book value of $[●], or $[●] per share of common stock. Our historical net tangible book value per share represents total tangible assets less total liabilities, divided by the number of shares of our common stock outstanding as of _____________, 2026.

After giving effect to the sale of [●] shares of common stock in this offering at an assumed public offering price of $[●] per share, and after deducting underwriters’ commissions and estimated offering expenses, our as adjusted net tangible book value as of _____________, 2026 would have been $[●] million, or $[●] per share of common stock. This represents an immediate increase in net tangible book value of $[●] per share of common stock to existing stockholders and an immediate dilution in net tangible book value of $[●] per share to purchasers of shares in this offering.

The following table illustrates this dilution on a per share of common stock basis assuming the underwriters do not exercise their option to purchase additional shares of common stock:

The dilution information discussed above is illustrative only and may change based on the actual initial public offering price and other terms of this offering.

A $1.00 increase in the assumed initial public offering price of $       per share of common stock would increase our net tangible book value after giving effect to this offering by $       million, or by $       per share of common stock, assuming the number of shares offered by us remains the same and after deducting the estimated underwriting discount. A $1.00 decrease in the assumed initial public offering price per share would result in equal changes in the opposite direction.

If the underwriters exercise their option in full to purchase [●] additional shares of common stock in this offering at the assumed offering price of $[●] per share, the as adjusted net tangible book value per share after this offering would be $[●] per share of common stock, the increase in the as adjusted net tangible book value per share to existing stockholders would be $[●] per share of common stock and the dilution to new investors purchasing securities in this offering would be $[●] per share of common stock.

The following charts illustrate our proportionate ownership, upon completion of this offering by present stockholders and investors in this offering, compared to the relative amounts paid by each. The charts reflect payment by present stockholders as of the date the consideration was received and by investors in this offering at the public offering price. The charts further assume no changes in net tangible book value other than those resulting from the offering.

The table below assumes the underwriters’ exercise their over-allotment option in full:

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Overview

RegenLab is a vertically integrated regenerative medicine company that develops and commercializes autologous biologics and advanced tissue-engineering platforms.

Our business is built around a platform of standardized, outpatient-compatible biologics — including PRP (platelet-rich plasma), PRP combined with hyaluronic acid (HA), bone marrow–derived products, crosslinked scaffolds, and fibrin-based matrices. These are used across four distinct therapeutics: Musculoskeletal Regeneration, Advanced Wound Care, Medical Aesthetics, and Women’s Health.

We have structured our operations to achieve full control of our development cycle — spanning three manufacturing facilities (in Switzerland, France, and the United States), integrated clinical and regulatory affairs, and global intellectual property management. As of June 30, 2026, we held over 70 pending & granted patents, and our products had been validated in approximately 300 clinical studies worldwide.

Key Factors Affecting Our Results of Operations

Comparison for the fiscal years ended December 31, 2025 and 2024

Our financial performance in fiscal years 2024 and 2025 reflects disciplined execution in international markets, ongoing product innovation, and tighter operating discipline, while navigating reimbursement dynamics and commercial realignment in the United States. Total revenue increased to $49.17 million in 2025 from $48.38 million in 2024 (+1.6%). Gross profit declined to $31.88 million in 2025 from $34.47 million in 2024, and operating income declined to $0.68 million in 2025 from $3.48 million in 2024. Net loss was $(1.24) million in 2025 compared to net income of $2.3 million in 2024.

Geographic Performance

We continued to see solid growth outside the United States, with Europe and certain rest-of-world markets contributing the majority of our year-over-year revenue increase in 2024 (especially in Saudi Arabia and select other Asian countries such as Vietnam and Indonesia), driven by expansion in orthobiologics, dermatology, and wound care. U.S. sales have declined in 2025, primarily reflecting our channel and marketing strategy realignment, including a shift from direct sales to distribution through major partners. Management has begun addressing these factors through focused commercial execution and distribution arrangements. Regenlab has closed in Q1 2025 a white label contract with OPKO Health covering the commercialization of both PRP and PRP+HA combination products across Spain and Q4 2025 a substantial partnership agreement with MiMedx to cover the woundcare market in the U.S.A. As a result, we expect organic growth at the consolidated level in 2026.

Gross Profit

Gross profit declined from 71.24% margin in 2024 down to 69.63% in 2025, mainly driven by the combined impact of the operational launch of the Regenlab factories in France and USA throughout 2025.

We aim to restore this prior margin in 2026, once these two factories are operating at full efficiency.

Cost Optimization and Operating Leverage

Combined general and administrative (“G&A”) and sales & marketing expenses increased $0.32 million, contributing to a mitigation of the decrease in the gross margin.

R&D Investment and Pipeline Development

R&D expenses rose to $6.49 million in fiscal year 2025 from $4.24 million in fiscal year 2024, representing 13.19% of revenue. These investments supported the advancement of multiple high-impact programs, including:

The majority of our R&D expenditures are tracked on a project-by-project basis. Historically, all shared R&D costs have been fully allocated to individual projects, as was the case for the year ended December 31, 2024, and the first half of 2025. However, due to a significant increase in overall R&D volume during the second half of 2025, a portion of shared costs—such as equipment, management, and facilities totaling approximately $0.52 million—was not allocated to specific projects during the third and fourth quarters. We have since updated our tracking methodology to ensure these shared costs are fully allocated going forward, beginning in the first quarter of 2026.

In 2025, our three main R&D projects related to: (a) The clinical study of RegenMatrix conducted across 14 university hospitals in France. The product launch is planned for early 2027. (b) The Cellular Matrix RL-04 project relates to getting the market access of the Cellular Matrix in the US territory. (c) The development of BBI Implants, led by a global internal R&D team operating across several RegenLab entities in the United States, France, and Switzerland.

Comparison for the interim periods ended June 30, 2026 and 2025

Key Factors Affecting Our Results of Operations

Our financial performance for the six months ended June 2026 reflects disciplined execution in international markets, ongoing product innovation, and tighter operating discipline, while navigating reimbursement dynamics and commercial realignment in the United States. Total revenue increased to $29.32 million in 2026 from $24.22 million in 2025 (+21%). Gross profit increased from $15.02 million for the six months ended June 2025 to $18.27 million for the same period 2026, and experienced an operating loss of $0.77 million for the six months ended June 2025 compared to operating income of $2.10 million for the same period 2026. Net loss was $0.03 million for the six months ended June 2025 compared to $0.07 million for the same period 2026.

Geographic Performance

We incurred a significant growth in the United States over the six months ended June 2026 driven by expansion in wound care. This is the outcome of an exclusive distribution agreement for our wound care products RegenkitWoundGel with the company MiMedx. This customer has generated $4.12 million in revenues over the six months ended June 2026 which mostly explain the $5.09 million increase over the same period in 2025. As a result, the US contribution to Regenlab consolidated revenues has grown from 20% to 33% for the six months ended June 2026.

Gross Profit increased by $3.25 million for the six months ended June 2026 compared to the same period in 2025 thanks to the increase in revenues that has not inflated the Cost of Goods sold.

Components of Results of Operations

Revenue

We generate revenue through the sale of our products and through licensing and distribution agreements covering our autologous biologics, portfolio tissue engineering kits, and associated consumables. Our principal product families are:

Comparison for the fiscal years ended December 31, 2025 and 2024

For the years ended December 31, 2025 and 2024, product sales were $49.17 million and $48.38 million, respectively. Our revenues are widespread across the globe and we set up our geographical revenue analysis over three regions: Europe, North America and rest of the world, which comprises Middle East (MEA), Africa, Asia Pacific (APAC) and Latin America.

Significant domestic markets including USA, Germany, France, Spain, Switzerland, Italy are commercialized through internal sales force along with some distribution agreements. Other markets especially in APAC/ MEA/ Eastern Europe are served with local distributors specialized in our therapeutical areas.

Cost and Operating Expenses

Cost of sales consists primarily of raw materials and purchased goods, transportation and logistics, production personnel costs, depreciation, and other production overhead (including maintenance, insurance, travel, and representation). Cost of sales total $14.93 million in 2025 and $13.91 million in 2024. This increase in cost of sales resulted primarily from the operating launch of the new factory in France and USA, including personnel, raw material and equipment.

Operating expenses comprise General and Administrative, Marketing and Distribution, and Research and Development. General and administrative expense was $11.39 million in 2025 compared with $11.77 million in 2024, reflecting personnel-related costs for administrative functions, professional services (legal, consulting, audit), and facility/IT overhead. Marketing and distribution expense was $15.69 million in 2025 versus $14.98 million in 2024, covering agent commissions and fees, advertising and promotion, travel and representation, sales personnel, and related distribution costs. Research and development expense was $6.49 million in 2025 compared with $4.24 million in 2024, including R&D personnel, external services (such as subcontractors and clinical research organizations), materials and supplies, and allocated facilities. These amounts reconcile to total operating expenses of $33.56 million in 2025 and $30.99 million in 2024.

Results of Operations

The following table sets forth the significant components of our results of operations for the periods presented.

Revenue

Total revenue was $48.38 million for the year ended December 31, 2024 compared to $49.17 million for the year ended December 31, 2025, an increase of $0.79 million, or 1.6%. The year-over-year increase was driven primarily by higher volumes in Europe and selected international markets while sales in the U.S. declined due to channel realignment.

Revenue by Product

Consequently, for the fiscal year ended December 31, 2025, RegenKit PRP and Cellular Matrix collectively accounted for a significant majority of our revenues. Specifically, RegenKit PRP represented approximately 61% of our total revenues and Cellular Matrix represented approximately 29% of our total revenues, and together these two product lines represented approximately 90% of our total revenues for fiscal year 2025.

Revenue by Geography