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DiaSafe is being developed to provide safe, real-time optical readings of biomarkers to detect the early presence of diabetic foot ulcers.
August 20, 2024
By: Michael Barbella
Managing Editor
The Israel Innovation Authority (IIA) has awarded a $500,000 grant to IR-MED Inc. so the firm can further develop its platform technology for early diabetic foot ulcer detection. 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 13-month development plan agreed upon with the IIA. “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,” IR-MED Chief Technology Officer/Interim CEO Ronnie Klein said. “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.” By sensing the invisible, IR-MED’s newest handheld device—DiaSafe—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. Diabetic foot ulcers are more cost effective to manage in their initial stages, according to IR-MED. Detecting and treating diabetic foot ulcers early can significantly improve quality of life by reducing pain and increasing mobility, and 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 are living with diabetes, and 19% to 34% of this total (up to 183 million people) will develop a diabetic foot ulcer during their lifetime. Of that 183 million populous, 20% (up to 37 million) will require lower-extremity amputation, and 10%—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 pressure injury detection, which is expected to launch in the United States in the second half of 2024. 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.
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