IR-MED Awarded $500,000 Grant from the Israel Innovation Authority to Advance AI-Powered DiaSafe(TM) Device for Diabetic Foot Ulcer Assessment

Rhea-AI Summary

IR-MED (OTCQB: IRME) has secured a $500,000 grant from the Israel Innovation Authority (IIA) to advance the development of DiaSafe™, an AI-powered device for diabetic foot ulcer assessment. The grant is part of a $1.24 million total budget, with 40% funded by IIA. DiaSafe™ uses noninvasive spectrographic technology to provide real-time optical readings of biomarkers for early detection of diabetic foot ulcers. The device addresses a $10 billion global treatment market, targeting a condition that affects up to 183 million people worldwide. This marks IR-MED's third IIA grant, demonstrating continued confidence in their "Sensing the Invisible" technology platform. The company plans to initiate its first in-human clinical trial as part of the development process. DiaSafe™ complements IR-MED's FDA-listed lead device, PressureSafe™, which assesses pressure injuries before skin breakage.

Positive

• Secured $500,000 grant from Israel Innovation Authority, marking third successful grant approval
• Addresses a substantial $10 billion global treatment market
• Technology targets a large patient population with up to 183 million potential users
• Company already has FDA-listed product (PressureSafe™) using same technology platform
• Plans to initiate first in-human clinical trials, advancing product development

Negative

• Still in development phase with no immediate revenue generation
• Requires successful clinical trials and regulatory approvals before commercialization
• Significant competition expected in the $10 billion market

• DiaSafe™, IR-MED's second product, is being developed to provide safe, real-time optical readings of biomarkers for assessment of diabetic foot ulcers

• The most common cause of amputation, diabetic foot ulcers can be prevented with early assessment, improving patient care and healthcare economics in a $10 billion global treatment market

• $500,000 grant underscores continued confidence in IR-MED's noninvasive "Sensing the Invisible" technology platform

Rosh Pina, Israel--(Newsfile Corp. - May 5, 2025) - IR-MED Inc. (OTCQB: IRME) ("IR-MED" or the "Company"), a developer of noninvasive artificial intelligence (AI)-driven spectrographic technology to address critical healthcare challenges, today announced that the Company has received a third grant from the Israel Innovation Authority ("IIA"). This grant, totaling approximately $500,000, was awarded following a rigorous peer review process, further demonstrating the IIA's continued confidence in IR-MED's groundbreaking technology.

This latest grant will support the ongoing development of IR-MED's platform technology for a new indication, a decision support device for the assessment of diabetic foot ulcers. The IIA funding will support the next stage of the development of the DiaSafe™, and includes a total budget of $1.24 million, with 40% funded by the IIA. We believe that this sustained support by the IIA underscores the importance of IR-MED's work in enhancing clinical decision-making for diabetic foot ulcers, a condition that affects millions worldwide and often leads to severe complications, including amputations.

During the development period covered by the grant, IR-MED will continue advancing the hardware and software of its DiaSafe™ device, aligning with the agreed-upon development roadmap. Additionally, the Company plans to initiate its first in-human clinical trial, a significant step toward bringing this innovative solution to the market.

By sensing the invisible, DiaSafe™, IR-MED's newest handheld device, is being designed to non-invasively evaluate the biomarkers of blood and tissue, at the point of care, to help healthcare professionals and caregivers better assess patients for diabetic foot ulcers. The Company believes an effective assessment device can reduce healthcare costs, save limbs, and save lives. Diabetic foot ulcers are more cost effective to manage in their initial stages. Assessing and treating diabetic foot ulcers early can significantly improve quality of life by reducing pain and increasing mobility.

Diabetic foot ulcers are a major cause of preventable death for people with diabetes, according to an article published in Diabetes Care, the journal of the American Diabetes Association. An estimated 537 million people globally have diabetes, and 19% to 34% of these, or up to 183 million people, will develop a diabetic foot ulcer during their lifetime. Of these, 20%, or up to 37 million people, will require lower-extremity amputation, and 10%, or 18 million people, will die within one year of their first diabetic foot ulcer diagnosis. Early intervention can reduce death rate associated with diabetic foot complications.

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IR-MED's DiaSafe™ is based on the same platform technology as the Company's lead device, PressureSafe™, a decision support device for the assessment of pressure injuries before skin breakage, which is U.S. Food and Drug Administration ("FDA") listed.

"We are honored to receive continued support from the IIA for the third time," said Ran Ziskind, Chief Executive Officer of IR-MED. "We believe that this grant serves as a strong validation of both the scientific merit and commercial potential of our proprietary sensing platform, which is engineered to assess physiological changes under the skin surface prior to skin breakdown. We remain committed to advancing our development pipeline, with the integration of DiaSafe™ alongside ongoing usability studies of PressureSafe™ in the United States."

About Israel Innovation Authority

The Israel Innovation Authority, responsible for the country's innovation policy, is an independent and impartial statutory public entity that operates for the benefit of the Israeli innovation ecosystem and Israeli economy as a whole. Its mission is to invest in innovation in order to promote sustainable and inclusive growth.

The Authority functions as an enabler with all things related to the Israeli innovation ecosystem. It provides conditional grants to support disruptive technological innovations as well as engaged in creating the groundwork and infrastructure to prepare for future technologies in order to maintain both technological and economical leadership as well as improve productivity and global competitiveness of the Israeli economy.

Innovation is by far the most valuable resource for the State of Israel, serving as a national asset crucial to economic prosperity. Israel Innovation Authority seeks to further develop and support technological innovation in Israel through various support tools. Its mission is to strengthen the innovation ecosystem and promote innovation, entrepreneurship, and disruptive technologies as leverage for inclusive and sustainable economic growth.

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About IR-MED

IR-MED Inc. is developing a cutting-edge infrared spectroscopy and AI analysis platform technology as a basis for point-of-care decision support devices. The infrared spectroscopy technology allows harmless and non-invasive gathering of bio-information from patient blood and tissue. Bioinformation is then analyzed using the company's AI based process to provide healthcare professionals with decision support in the assessment of various medical conditions.

PressureSafe™, the company's first platform product, is a handheld device designed to revolutionize the assessment of pressure injuries (PI) affecting skin and underlying tissue. Pressure Injury in the US alone accounts for $26.8B in healthcare spending and results in 60,000 deaths annually. PressureSafe offers healthcare professionals a real-time evaluation of skin , regardless of patient skin tone. The potential assessment of pressure injuries using PressureSafe holds significant promise in addressing this widespread healthcare challenge and potentially reducing its burden worldwide.

IR-MED holds patents protecting its innovation in noninvasive tissue assessment.

PressureSafe is currently undergoing usability studies at multiple medical centers and is not yet available for commercial use.

Safe Harbor Statement / Forward-Looking Statements

Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For example, IR-Med is using forward-looking statements when it discusses the Company's plans to continue advancing both the hardware and software of its DiaSafe™ device in alignment with a defined development roadmap; the Company's plans to initiate its first in-human clinical trial for DiaSafe™, marking a key step toward eventual market introduction; the future benefits of the DiaSafe™ product, including its potential to reduce healthcare costs, prevent amputations, and save lives by enabling early detection and treatment of diabetic foot ulcers; that DiaSafe™ is expected to complement the Company's existing FDA-listed PressureSafe™ device, as part of a broader platform of AI-powered, noninvasive diagnostic tools; the Company's market opportunities in the $10 billion global diabetic foot ulcer treatment space and commercial prospects for DiaSafe™; the expansion of the Company's product pipeline and clinical validation efforts, including continued usability studies of PressureSafe™. Statements relating to the future performance of IR-Med are subject to many factors including, but not limited to, the accuracy of the Company's estimates regarding expenses, future revenues, uses of cash, capital requirements and the need for additional financing; the initiation, cost, timing, progress and results of our development activities, usability studies, preclinical studies and any clinical trials that it may be required to undertake; the timing of and the Company's ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that it may develop, and any related restrictions and/or limitations; the company's plans to research, develop and commercialize its current and future product candidates; the Company's ability to attract collaborators with development, regulatory and commercialization expertise; the company's ability to obtain and maintain intellectual property protection for its product candidates; the Company's ability to successfully commercialize its product candidates; the size and growth of the markets for its product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing devices that are or may become available; regulatory developments in the United States and other countries; the performance of its third-party suppliers and manufacturers and its ability to obtain alternative sources of raw materials; the impact of global inflationary pressures; its ability to obtain additional financing; use of the proceeds from its securities offerings; any restrictions on its ability to use its net operating loss carry-forwards; the impact of Israel's multi-front war on its results, including potential economic restrictions imposed on and political and military instability in Israel; its ability to attract and retain key personnel, and the other risks identified in our most recent annual report on Form 10-K filed on April 4, 2025 with the Securities and Exchange Commission. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.

Contact:
Hanover International, Inc.
Kathy Cusumano, President
Contact@ir-medical.com

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FAQ

What is the purpose of IR-MED's DiaSafe device and how does it work?

DiaSafe is a handheld device that uses noninvasive AI-driven spectrographic technology to provide real-time optical readings of biomarkers for assessment of diabetic foot ulcers, aiming to enable early detection and prevention of complications.

How much funding did IRME receive from the Israel Innovation Authority?

IR-MED received a $500,000 grant from the Israel Innovation Authority, which is part of a larger $1.24 million total budget, with IIA funding 40% of the project.

What is the market size for diabetic foot ulcer treatment that IRME is targeting?

IR-MED is targeting a $10 billion global treatment market for diabetic foot ulcers, with up to 183 million potential patients who may develop diabetic foot ulcers in their lifetime.

What stage of development is IR-MED's DiaSafe device currently in?

DiaSafe is in development phase, with plans to initiate its first in-human clinical trial using the recent IIA grant funding.

How does DiaSafe relate to IR-MED's other products?

DiaSafe is IR-MED's second product, built on the same technology platform as their FDA-listed lead device PressureSafe, which assesses pressure injuries before skin breakage.