IR-MED Receives $500,000 Grant from the Israel Innovation Authority to Develop its Platform Technology for the Early Detection of Diabetic Foot Ulcers

Rhea-AI Summary

IR-MED Inc. (OTCQB:IRME) has received a $500,000 grant from the Israel Innovation Authority to develop DiaSafe™, a device for early detection of diabetic foot ulcers. This marks the company's second IIA grant after peer review. DiaSafe™ uses AI-driven spectrographic analysis to provide non-invasive, real-time optical readings of biomarkers. The 13-month development is on schedule, with computer simulations completed and hardware construction underway.

Diabetic foot ulcers affect up to 183 million people globally, with 37 million potentially requiring amputation. Early detection can significantly improve patient outcomes and reduce healthcare costs in a $10 billion global treatment market. IR-MED's platform technology also powers PressureSafe™, a device for early pressure injury detection, expected to launch in the U.S. in H2 2024.

Positive

• Received $500,000 grant from Israel Innovation Authority
• Development of DiaSafe™ for early detection of diabetic foot ulcers on schedule
• Addressing a $10 billion global treatment market
• PressureSafe™ expected to launch in U.S. in second half of 2024

Negative

• None.

• DiaSafe^™, IR-MED’s second product, is being developed to provide safe, real-time optical readings of biomarkers to detect the early presence of diabetic foot ulcers with high accuracy
• The most common cause of amputation, diabetic foot ulcers can be prevented with early detection, improving patient care and healthcare economics in a $10 billion global treatment market
• This marks the second grant that IR-Med has received from the Israel Innovation Authority after peer review of IR-MED's technology platform
  

Rosh Pina, Israel, July 15, 2024 (GLOBE NEWSWIRE) -- IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, announced it has received a grant from the Israel Innovation Authority (IIA) in the amount of approximately $500,000, to develop its platform technology for a new indication, a decision support device for the early detection of diabetic foot ulcers. The grant’s 13-month development timeline is proceeding on schedule with IR-MED having achieved its mid-point milestones. Computer simulations of infrared light reflectance from lesions under the skin surface have been completed, and based on these data, the Company is building the DiaSafe™ device’s hardware in accordance with the development plan agreed upon with the IIA.

By sensing the invisible, DiaSafe^™, IR-MED’s newest handheld device, is being designed to non-invasively analyze the biomarkers of blood and tissue, at the point of care, to help healthcare providers prevent diabetic foot ulcers from developing in their diabetic patients.

The Company believes an effective early detection device can reduce healthcare costs, save limbs, and save lives. Diabetic foot ulcers are more cost effective to manage in their initial stages. Detecting and treating diabetic foot ulcers early can significantly improve quality of life by reducing pain and increasing mobility. Early intervention can reduce death rate associated with diabetic foot complications.

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.

IR-MED’s DiaSafe^™ is based on the same platform technology as the Company’s lead device, PressureSafe^™, a decision support device for the early detection of pressure injuries, which is expected to launch in the U.S. in the second half of 2024.

Ronnie Klein, IR-MED’s Chief Technology Officer and Interim Chief Executive Officer, commented, “We are honored to be selected by the IIA for a second grant. This $500,000 covers 50% of our $1 million investment budget for the development of DiaSafe^™ for our second indication in diabetic foot ulcers. Our powerful platform technology has the potential to change treatment paradigms and economics in a large number of multi-billion-dollar indications. We are eager to advance our development pipeline with the addition of DiaSafe^™, while PressureSafe^™ is under usability study in the U.S.”

About IR-MED

IR-MED Inc. is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, the first product under useability studies, is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone as it calibrates personally to each patient’s skin.

IR-MED’s technology is being developed to allow readings of biomarkers in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes.

IR-MED holds patents protecting its technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.

PressureSafe is currently undergoing usability studies at multiple medical centers.

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 development of the DiaSafe^™ device and its potential advantages, that the PressureSafe^™ device is expected to be launched in the U.S. in the second half of 2024, and that the $500,000 grant from the IIA will cover 50% of the Company' $1 million investment budget for the development of the DiaSafe^™ device. Statements relating to the future performance of IR-Med are subject to many factors including, but not limited to, the sufficiency or working capital and our ability to raise the capital needed to fund our development efforts, completion of the development and design of PressureSafe device, results of clinical/useability studies and trials, timing of product development, FDA approval/clearance of products in development, customer acceptance of our products in the market, the introduction of competitive products, the impact of any product liability or other adverse litigation, commercialization and technological difficulties, and the other risks identified in our most recent annual report on Form 10-K/A filed on April 8, 2024 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:
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

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FAQ

What is the purpose of the $500,000 grant IR-MED (IRME) received from the Israel Innovation Authority?

The grant is to develop IR-MED's platform technology for DiaSafe™, a decision support device for the early detection of diabetic foot ulcers.

When is IR-MED (IRME) expected to launch PressureSafe™ in the United States?

IR-MED expects to launch PressureSafe™, their device for early detection of pressure injuries, in the U.S. in the second half of 2024.

How large is the global treatment market for diabetic foot ulcers that IR-MED (IRME) is targeting?

The global treatment market for diabetic foot ulcers that IR-MED is targeting is estimated at $10 billion.

What technology does IR-MED's (IRME) DiaSafe™ use for detecting diabetic foot ulcers?

DiaSafe™ uses a noninvasive artificial intelligence (AI) driven spectrographic analysis technology to provide real-time optical readings of biomarkers for early detection of diabetic foot ulcers.