IR-MED receives funding for detection of diabetic foot ulcers

17 Jul 2024

Grant from Israel Innovation Authority assists commercialization of spectrographic platform.

Israel's IR-MED medical device developer has received a grant of $500,000 to assist development of its device for early detection of diabetic foot ulcers.

The funding from the Israel Innovation Authority will support IR-MED's plan to commercialize the DiaSafe device in the second half of 2025, according to the company, and will fund a 13-month program of work.

Diabetic foot ulcers are the most common cause of foot amputation, and prevention through early detection and improved patient care could be worth $10 billion worldwide, commented IR-MED.

Since blood circulation is a key element in ulceration and ulcer development, improved infra-red optical techniques for imaging blood flow and blood vessels have been a focus of interest for medical device developers.

Previous work has included a device based around structured light developed by California's Modulim, in which spatial frequency domain imaging (SFDI) measures tissue oxygenation and perfusion at the point-of-care, identifying those diabetes patients likely to develop foot ulcers resulting from poor vascular circulation. The company's work has also expanded to apply SFDI to patients treated for pressure ulcers and burns.

The forthcoming IR-MED DiaSafe device is a development of its PressureSafe platform, itself scheduled for launch in the second half of 2024, which combines infra-red sensing and AI data processing for early detection of pressure injuries to the skin and underlying tissue. This approach should allow detection of conditions which are latent or invisible to the naked eye, in particular for patients with dark skin tone.

Pressure injuries reduced by 50 percent during trial

According to IR-MED product data, the infra-red reflectance spectroscopy in PressureSafe "detects the differences in absorption and reflection of diseased tissues compared to healthy tissues, evaluating light intensity and patterns reflected from the different layers beneath the skin's surface."

The platform's second element is an AI-powered decision support system intended to answer clinical questions at the point of care. This compares bioinformation acquired by the device to a condition-specific biomarker profile, determining whether a certain area is healthy or diseased.

Earlier in 2024 the company reported that a usability study carried out in two medical centers owned by Israel's Clalit HMO found that the PressureSafe device detected Stage 1/suspected deep tissue injury (sDTI) pressure injuries with 92 percent sensitivity and 88 percent specificity. During the study period incidences of pressure injuries were reduced by 50 percent in comparison to the levels prior to the study, said IR-MED. A further clinical study in the US is underway.

The same infra-red spectroscopy principles could eventually see the PressureSafe platform applied to other scenarios, including detection of viral vs. bacterial ear infections and non-invasive monitoring of drug levels during therapeutic drug treatments.

"This $500,000 covers 50 percent of our $1 million investment budget for the development of DiaSafe for our second indication in diabetic foot ulcers," commented IR-MED CTO Ronnie Klein.

"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 US."