S-1: IR-Med Inc. Files for Resale of 80 Million Shares of Common Stock

IR-Med Inc. is registering the resale of up to 80 million shares of its common stock by a selling stockholder, Williamsburg Venture Holdings, LLC, to satisfy registration rights granted under an equity purchase agreement.

Summary

• IR-Med Inc., a Nevada corporation, has filed a registration statement for the resale of up to 80,000,000 shares of its common stock by Williamsburg Venture Holdings, LLC.
• The registration is to satisfy registration rights granted to Williamsburg under an equity purchase agreement and a registration rights agreement, both dated March 11, 2025.
• Williamsburg may sell the shares in various ways and at varying prices, with all net proceeds going to Williamsburg and none to IR-Med.
• IR-Med will pay the legal, accounting, and printing expenses related to the registration.
• As of the date of the prospectus, IR-Med had 72,018,144 shares of common stock outstanding, with a public float of 43,769,375 shares.
• The 80,000,000 shares being registered represent approximately 182% of the public float.
• The company's common stock is traded on the OTCQB Market under the symbol IRME, with the last reported sale price on May 12, 2025, being $0.0817 per share.
• IR-Med qualifies as an emerging growth company and will be subject to reduced public company reporting requirements.

Sentiment

Score: 5

Explanation: The document presents a mixed sentiment. While there are positive aspects such as FDA listing certification and promising study results, the company's financial situation and dependence on future funding raise concerns.

Positives

• IR-Med has secured an equity purchase agreement with Williamsburg for up to $15 million.
• The PressureSafe device received FDA listing certification and is classified as a Class I device.
• The company has received grants from the Israeli Innovation Authority to develop a device for early assessment of diabetic foot ulcers.
• Usability studies for PressureSafe have shown promising results, including 92% efficacy in detecting Stage 1 pressure injuries.
• The company is addressing a substantial challenge of healthcare inequality in the assessment of pressure injuries in people of dark skin tones.

Negatives

• IR-Med has a history of significant operating losses and expects to continue incurring losses for the foreseeable future.
• The company will need substantial additional funding to continue its operations, and there is no guarantee that such funding will be available.
• The company's independent registered public accounting firm has included an explanatory paragraph relating to its ability to continue as a going concern.
• The company's common stock is traded on the OTCQB Market, which may result in limited trading volume and price volatility.
• The company is dependent on the successful development and commercialization of its product candidates, which is a lengthy and expensive process with an uncertain outcome.

Risks

• The company may never achieve or maintain profitability.
• The company may not be able to raise capital when needed, which could force it to delay, reduce, or eliminate its product development programs.
• Medical device development is 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 failure to comply could result in penalties and reputational damage.
• The company's technology development is headquartered in Israel, and its results may be adversely affected by economic restrictions imposed on, and political and military instability in Israel, including Israel's multi-front war.
• The sale of shares of the company's common stock to Williamsburg may cause dilution, and the subsequent resale of the shares of the company's common stock acquired by Williamsburg could cause the price of the company's common stock to fall.

Future Outlook

The company plans to use the proceeds to continue development efforts of its products, while mainly focusing on the DiaSafe device production and marketing of PressureSafe commercial units, and working capital. Initial sales of the commercial version of the PressureSafe device are planned during the second half of 2025.

Industry Context

The document highlights the increasing prevalence and cost of pressure injuries and diabetic foot ulcers, indicating a significant market opportunity for innovative diagnostic solutions. The company's focus on early assessment and equitable healthcare aligns with broader industry trends towards preventative care and addressing healthcare disparities.

Comparison to Industry Standards

• The document mentions Bruins Biometrics Provizio SEM Scanner as a competitor in the pressure injury market.
• IR-Med's PressureSafe device utilizes real-time, multi bio marker, optical monitoring device combined with AI-based capabilities for assessment of PIs in different settings, while the Bruin scanner is based on electro-resistance measurement of the skins moisture.
• The document states that the company is developing the technology and a device that will measure direct biomarkers demonstrating development of subdermal DFU, while there is no way to measure direct biomarkers associated with DFU.

Management Changes

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 (the Plaintiff) 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 suit seeks 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, IR. Med Ltd. received a loan from certain of the former IR-Med stockholders to fund its continuing operations.
• In 2017, 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 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

• Existing stockholders will experience dilution as a result of the issuance of shares to Williamsburg.
• The company's ability to execute its business plan and achieve profitability will impact its employees, customers, and suppliers.
• The company's success in addressing healthcare disparities will impact patients, particularly those with darker skin tones.

Next Steps

• Complete larger scale production of the commercial version of the PressureSafe device.
• Initiate sales of PressureSafe during the second half of 2025, following the listing under the FDA.
• Initiate a clinical study in Israel, to train the developed algorithm and test patients for DiaSafe.

Key Dates

Keywords

IR-Med, PressureSafe, DiaSafe, common stock, resale, Williamsburg Venture Holdings, equity purchase agreement, FDA, diabetic foot ulcers, pressure injuries, OTCQB, emerging growth company