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Note
1 - General
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A. |
Description
of Business |
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IR-Med,
Inc. (OTC QB: IRME, hereinafter: the “Parent Company”) was incorporated in Nevada in 2007. IR-Med, Inc. was previously
named International Display Advertising, Inc. and changed its name to IR-Med, Inc. in January 2021. |
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The
registered office of IR-Med, Inc. and the corporate headquarters and research facility of IR. Med, Ltd. (the “Subsidiary”)
are located in Rosh Pina, Israel. The Parent Company and the Subsidiary are at times collectively referred to as the “Company”. |
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On
April 9, 2024, the Company’s first device, the PressureSafe™, decision support system, received a U.S. Food and
Drug Administration (FDA) listing certification. PressureSafe™ is classified as a Class I device , decision
support system. Following the listing certification of the PressureSafe™ device, the Company has started
usability studies and the preparations for the commercial launch of its first device, the PressureSafe™. The
Company is developing its technology through its Subsidiary and is utilizing Infra-Red-light spectroscopy (IR) combined with an
Artificial Intelligence (AI) technology platform to develop non-invasive devices for various medical indications, by assessing
various biomarkers and molecules in the blood and in human tissue in real-time. The second product candidate, DiaSafe™ which
is currently under development is a non-invasive, user friendly devise which is designed to address the medical needs of large and
growing target patient groups by offering assessment of Diabetic Foot Ulcer (“DFU”) before skin breakage, which is
expected to reduce healthcare expenses and better patient care. |
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The
Company is starting preparations for the commercial launch of its first device the “PressureSafe™” and does not expect
to generate significant revenue until such time as the Company will start the commercialization of the PressureSafe™ and shall
complete the design and development of its other product candidates. During the year ended December 31, 2024, the Company incurred losses
of US$1,899 thousand
and had a negative cash flow from operating activities of US$ 1,386
thousand. The accumulated deficit as of December
31, 2024, is US$ 16,738
thousand. |
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Based
on the current expected level of operating expenditures, the Company’s cash resources as of December 31, 2024 will be
sufficient to meet its operating and capital needs through the second quarter of 2025 and shall not be sufficient for a period of at
least 12 months from the issuance of these consolidated financial statements. Management’s plans regarding these matters
include continued development and marketing the company’s products, as well as seeking additional financing arrangements.
Although management continues to pursue these plans, in the event financing is not obtained, the Company may pursue additional cost
cutting measures or may be required to delay, reduce the scope of, or eliminate any of its development programs, these events could
have a material adverse effect on its business. These factors raise significant doubt about the Company ability to continue as a
going concern. The consolidated financial statements do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to
continue as a going concern. |
IR-Med,
Inc.
Notes
to the Consolidated Financial Statements
Note
1 - General (Cont’d)
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C. |
Iron Swords war impact |
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In
October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of horrific
terrorist attacks on civilian and military targets. Following the attack, Israel’s security cabinet declared Iron Swords War
(“war”) and commenced a military campaign in Gaza against Hamas. Since the commencement of these events, there have been
additional active hostilities, including a campaign focused in southern Lebanon against Hezbollah, an air campaign against the
Houthi movement in Yemen and multiple airstrikes in Iran, in response to Iranian missile attacks. In October 2024, Israel began
ground operations against Hezbollah in Lebanon culminating in a 60-day cease fire agreed to between Israel and Lebanon on November
27, 2024. On January 19, 2025, a temporary ceasefire between Israel and Hamas went into effect, the result of which is uncertain. On January
27, 2025, the ceasefire between Israel and Lebanon was extended to February 18, 2025. While ceasefire agreements have been reached,
there is no guarantee that the parties will continue to comply with the terms of the agreements and, accordingly, it is possible
that these hostilities will resume with little to no warning and that additional terrorist organizations and, possibly, countries
will actively join the hostilities. Such clashes may escalate in the future into greater regional conflict.
The
Company did not experience significant changes in its activities from the continuation of the war during the reporting period. However,
the Company’s management continues to believe that the general conditions have brought further difficulties in management’s
efforts to seek additional financing arrangements.
Although
the Company’s business and operations have not been materially impacted as of the date of this financial statements, any
escalation or expansion of the war could have a negative impact on both global and regional conditions and may adversely affect the
Company’s business, financial condition, and results of operations.
Since
this is an event that is not under the control of the Company and matters such as the fighting continuing or stopping may affect
the Company’s assessments, as at the reporting date the Company is unable to assess the extent of the effect of the Iron Swords
War on its business. |
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