S-1/A: IR-Med Inc. Files Amendment No. 1 to S-1 Registration Statement for Resale of 80 Million Shares

IR-Med Inc. has filed an amendment to its registration statement for the resale of up to 80 million shares of common stock by Williamsburg Venture Holdings, LLC.

Summary

• IR-Med Inc., a Nevada corporation, has filed an amendment to its S-1 registration statement with the SEC.
• The filing pertains to the resale of up to 80,000,000 shares of the company's common stock by the selling stockholder, Williamsburg Venture Holdings, LLC.
• These shares were issued to Williamsburg under an equity purchase agreement and a registration rights agreement, both dated March 11, 2025.
• IR-Med will not receive any proceeds from the sale of these shares by Williamsburg.
• The company's common stock is traded on the OTCQB Market under the symbol IRME, with the last reported sale price on May 20, 2025, at $0.12 per share.
• As of the date of the prospectus, the Company had 72,018,144 shares of common stock outstanding of which 28,248,769 shares were held by affiliates.
• Therefore, the Companys public float is 43,769,375 shares and the number of shares being registered hereunder is approximately 182% of the public float.
• The company is classified as an emerging growth company and is subject to reduced public company reporting requirements.
• IR-Med is developing point-of-care decision support devices based on infrared spectroscopy and AI analysis, focusing on PressureSafe for pressure injuries and DiaSafe for diabetic foot ulcers.
• Initial sales of the commercial version of the PressureSafe device are planned for the second half of 2025.
• The company has received grants from the Israeli Innovation Authority (IIA) to support the development of DiaSafe.
• On April 6, 2025, the Company received an amount of NIS 644,551 (approximately $171,468), as an advance payment from the IIA to fund the development of a device for the assessment of diabetic foot ulcers before skin breakage among diabetic patients.
• The IIA approved the Companys program with a budget in total amount NIS 4,603,938 (approximately $1,222,786), which includes a grant of 40% or NIS 1,841,575 (approximately $489,035).
• The IIA grant will be distributed in tranches based on specific milestones and the progress of the product development, from January 1, 2025 to December 31, 2025.
• The company faces risks related to its financial position, capital requirements, medical device development, regulatory approvals, intellectual property protection, and operations in Israel.

Sentiment

Score: 5

Explanation: The document presents a mix of positive developments (FDA listing, grants) and significant risks (financial instability, going concern warning). The sentiment is neutral, reflecting the inherent uncertainties of a development-stage company.

Positives

• PressureSafe decision support device received FDA listing certification.
• PressureSafe detected Stage 1 pressure injuries with 92% sensitivity and 88% specificity in a study.
• The company has received grants from the Israeli Innovation Authority (IIA) to support the development of DiaSafe for diabetic foot ulcers.
• The IIA grant will be distributed in tranches based on specific milestones and the progress of product development, from January 1, 2025 to December 31, 2025.

Negatives

• IR-Med will not receive any proceeds from the sale of shares by the selling stockholder.
• The company has a history of operating losses and may never achieve profitability.
• The company will need substantial additional funding to continue its operations.
• The company's independent registered public accounting firm has included an explanatory paragraph relating to the company's ability to continue as a going concern.
• The company's technology development is headquartered in Israel and, therefore, its results may be adversely affected by economic restrictions imposed on, and political and military instability in Israel, including Israels multi-front war.

Risks

• The company may not be able to raise capital when needed, which could force it to delay, reduce or eliminate its product development programs or commercialization efforts.
• Medical device development involves a lengthy and expensive process with an uncertain outcome.
• The size and future growth in the market for the company's planned devices under development has not been established with precision and may be smaller than estimated.
• The company may be subject to numerous and varying privacy and security laws, and its failure to comply could result in penalties and reputational damage.
• If the company is unable to protect its intellectual property rights, its competitors could develop and commercialize technology similar to its own.
• The company's technology development is headquartered in Israel and, therefore, its results may be adversely affected by economic restrictions imposed on, and political and military instability in Israel, including Israels multi-front war.

Future Outlook

The company plans to use the proceeds from the potential sale of shares to continue development efforts of its products, focusing on the DiaSafe device, production of commercial units, marketing, and working capital, with initial sales of PressureSafe planned for the second half of 2025.

Industry Context

The company operates in the medical device industry, focusing on point-of-care decision support devices. It competes with established methods and new diagnostic technologies, with competitors potentially having greater resources.

Comparison to Industry Standards

• IR-Med's PressureSafe device will compete with Bruins Biometrics Provizio SEM Scanner, which is currently commercially available in the U.S., U.K. and the E.U.
• Bruins product is based on electro-resistance measurement of the skins moisture, a method that is significantly different from the approach contained in the PressureSafe device, which utilizes real-time, multi bio marker, optical monitoring device combined with AI-based capabilities for assessment of PIs in different settings.

Legal Proceedings

• A lawsuit was filed against the Company, the Subsidiary and Mr. Aharon Klein, a Company Director and the Companys Chief Technology Officer in the Tel Aviv District Court of Israel, by an individual who provided, on part time basis, certain consulting services to the Subsidiary between October 2015 and October 2016, before the acquisition of the Subsidiary by the Company.
• The suit alleges breach of contract by the defendants based on non-payment of amounts purportedly owed to the plaintiff in respect of the services rendered, including the market value of the Companys common stock that the plaintiff alleges should have been issued to him in respect of services.
• The lawsuit seeks a declaratory judgment that the defendants breached certain agreements with the plaintiff and claimed damages in the aggregate amount of approximately $ 2.1 million based on the current exchange rate between the U.S. Dollar and the Israeli NIS.

Related Party Transactions

• In 2015, the subsidiary IR. Med Ltd. received a loan from certain of the former IR-Med stockholders to fund its continuing operations.
• In 2017, the subsidiary IR. Med Ltd. received a loan from certain of the former IR-Med stockholder to fund its continuing operations.
• On March 6, 2018, certain of IR. Med Ltd.s shareholders advanced to it a convertible bridge loan in the principal amount of NIS 379,000 ($104,000).
• For the years ended December 31, 2024, and 2023, the Company paid to two directors an aggregate consideration of $170 thousand and US$161 thousand, respectively, in respect of research and development services.
• For the years ended December 31, 2024, and 2023 the Company paid to one shareholder of the Company and his relative an aggregate consideration of $5 thousand and $150 thousand, respectively in respect consulting services.
• For the years ended December 31, 2024, and 2023, the Company paid to three of the Parent Company non-employee directors an aggregate consideration of US$32 thousand and US$36 thousand, respectively ,with respect of their services.
• For the year ended December 31, 2024, the Company paid to four of its officers, salary and related expenses that totaled to $252 thousand.
• For the year ended December 31, 2023, the Company paid to four of its officers, salary and related expenses totaled to $439 thousand, respectively, in respect thereof.
• For the year ended December 31, 2024, the Company recorded a liability on amount of $82 thousand and for the year ended 2023, the Company paid a yearly amount of US$80 thousand to an entity in which two directors of the Company are stakeholders in the entity, for rent and office services
• Effective March 26, 2025, we entered into the Note Purchase Agreement with Mr. Ran Ziskind, Mr. Yaniv Cohen, and Mr. Oded Bashan for an aggregate amount of $31,200.

Stakeholder Impact

• Shareholders will experience dilution as a result of the potential sale of 80 million shares.
• The company's ability to execute its business plan and achieve profitability will impact shareholder value.
• Employees may be affected by cost-cutting measures or changes in development programs.
• Healthcare providers and patients could benefit from the company's innovative medical devices if they are successfully developed and commercialized.

Next Steps

• Complete development of the commercial version of the PressureSafe device.
• Initiate sales of PressureSafe in the second half of 2025.
• Continue development of DiaSafe with IIA funding.
• Conduct clinical trials for DiaSafe in Israel.
• Seek additional financing to support operations and product development.

Key Dates

Keywords

IR-Med, Williamsburg Venture Holdings, common stock, resale, registration statement, PressureSafe, DiaSafe, FDA, Israeli Innovation Authority, equity purchase agreement, OTCQB, medical devices, pressure injuries, diabetic foot ulcers, AI