IR-MED, a developer of a spectrographic analysis technology platform, said that its PressureSafe device has shown 92% efficacy in early, non-invasive, skin colour agnostic detection of pressure injuries.

PressureSafe is a non-invasive handheld optical monitoring device. It leverages infrared optical spectroscopy and an artificial intelligence (AI)-based algorithm to detect early-stage pressure injuries for all skin tones.

The single arm, bi-centre study of the device was conducted at two medical centres owned by Clalit, a health maintenance organisation.

The 14-day efficacy portion of the study was intended to assess the sensitivity, specificity, and usability of PressureSafe.

It was compared against the standard of care in the detection of early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage.

IR-MED assessed 38 patients at high risk of pressure injury development. On 154 body sites, 924 scans were performed in total.

The highly favourable proof of efficacy data showed that PressureSafe was able to identify Stage 1 / sDTI pressure injuries with 92% sensitivity and 88% specificity.

The study also assessed device calibration and validation in addition to safety. A total of 1,493 scans yielded no safety signals, out of the 66 patients whose data was acquired for safety study.

Additionally, the rate of incidence of pressure injuries diminished by 50% during the study period.

The medical device firm concluded that PressureSafe is a useful, effective, and safe decision support device for the early diagnosis of pressure injuries based on these results.

IR-MED CEO Tzur Di-Cori said: “This robust and impressive data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the US market with PressureSafe.

“We believe the 92% efficacy findings in real-world data settings at two world-class hospitals will be a big factor in driving adoption in the US.”

The handheld optical monitoring device is currently in usability trials at various medical centres.