IR-Med to announce its 2022 objectives: expected results of the POC, request for authorization from the FDA and registration with the OTCQB | Nation / World

TEL AVIV, Israel – (BUSINESS WIRE) – January 12, 2022–

IR-Med (OTC: IRME) (“Company” or “the Company”) is proud to announce a series of corporate updates to its investors regarding the medical, financial and corporate status of the company. Among other things, IR-Med announces that starting in the first half of 2022, the Company will launch a usability test to demonstrate the capabilities of its proprietary “PressureSafe” device. The company informs that it has received approval from the IRB-Helsinki committee of one of Israel’s largest geriatric hospitals, “Beit Rivka” to perform the test at its facility.

The Company also updates its intention to request a pre-market submission from the FDA (510k) in the first half of 2022, supported by its intention to begin entering the market in the United States, subject to approval. of the FDA, targeting the fourth quarter of 2022. The Company announces that it has appointed its business development team to begin engaging with nursing homes and geriatric centers for pre-sale negotiations.

The Company announces that it has applied for OTCQB registration with OTC Markets Group, as IR-Med has audited the annual financial statements prepared in accordance with US GAAP by a PCAOB auditor and maintains a profile of ‘company verified at, must be approved.

“I am proud of our team and the progress we have made during the uncertainty of the Covid-19 pandemic in all corners of the world,” said Director General Dr Rom Eliaz and added that “as the pandemic has arisen, and continues to present, with many challenges that are beyond our control, we remain determined and focused on what is within our control, including our operational, clinical and regulatory work. We continue to make progress on all fronts and firmly believe that we are on the right track towards significant value-added milestones and catalysts for transformation ”.

The company also announces that Dolos Consultancy, LTD has been retained to provide investment and public relations and intelligence services to the business alongside the amplification of social media. Dolos Consultancy LTD is a leader in business strategy, intelligence gathering, investor analysis and capital advice in the market. Dolos works with a network of investors, family offices and venture capitalists, and is selected to support and assist IR-Med both in relations with investors and in business intelligence. Dolos has agreed to comply with all applicable securities laws and the policies of the CTA and the SEC when providing the services.

About IR-Med

IR-Med Inc. is developing non-invasive spectrographic analysis technology, allowing healthcare professionals to detect and measure different molecules in blood and human tissue in real time without any invasive procedure. The first product in development is a portable optical monitoring device which is developed to support the early detection of pressure injuries (PI) on the skin and underlying tissues, regardless of skin tone and which is personally calibrated to the skin of each patient, mainly caused by pressure associated with bed rest. IR-med skin-device-interphase development of personalized medical devices enables high-precision readings of the human body in a non-invasive method, which can Confidential Page 1 of 1 Yahalom 20, ZHR Industrial Zone PO Box 143, Rosh Pina, Israel 1231400 Tel: (+972) 04-6555054 Fax: (+972) 04-6104976 provide caregivers with the optimal decision support system in cases where uncertainties disturb physicians in their decision-making processes.

Currently, IR-med holds patents protecting its innovation in non-invasive tissue analysis, as well as in the modeling and analysis of subcutaneous tissue. The company is in preliminary examination for filing additional patent applications.

Safe Harbor Declaration / Forward-Looking Statements

The statements included in this press release, which are not historical in nature, are forward-looking statements made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future performance of IR -Med are subject to many factors including, but not limited to, sufficiency or working capital and our ability to raise the capital necessary to fund our development efforts, product development schedule, approval / FDA clearance of products in development, customer acceptance of our products in the market, introduction of competing products, impact of any product liability or other adverse litigation, difficulties in marketing and technology, successful OTCQB registration and other risks identified in the resale registration statement S -1 filed with the Securities and Exchange Commission. These statements are based on the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ from those stated in forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we assume no obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.

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CONTACT: Dr Rom Eliaz, General Manager

Phone. : (+972) 04-6555054




Copyright Business Wire 2022.

PUB: 12/01/2022 11:15 AM / DISC: 12/01/2022 11:17 AM

Copyright Business Wire 2022.

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