Bruin Biometrics has reported results from the two Institutional Review Board-approved clinical trials conducted with its SEM Scanner to detect pressure ulcers.
SEM Scanner is a class IIA medical device developed by Bruin Biometrics in conjunction with University of California at Los Angeles to detect localized tissue edema and pressure induced tissue damage which may lead to the formation of pressure ulcers.
Bruin Biometrics has enrolled 31 healthy subjects in a pilot study conducted in Los Angeles, California to evaluate the reliability of the SEM Scanner. The study results indicated that the device is reliable across different users and across different device models. The device also gave consistent readings.
The company sponsored an investigational study to collect data needed to analyze SEM Scanner readings at the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts.
This non-significant risk study enrolled 51 subjects from the adult critical care unit and followed for five days.
Although the medical center reports annual pressure ulcer incidence of 5.08%, zero subjects developed a pressure ulcer during the course of the company’s trial.
Currently, analysis of the trial data is in process and a final study report is expected in early 2014.
In the clinical studies, the SEM Scanner has been shown to identify pressure-induced tissue damage – including pressure ulcers – up to 10 days before damage is visible on the skin’s surface.
Bruin Biometrics will sponsor additional trials in the US and Europe throughout 2014.
The first trial will be conducted in the US and will evaluate SEM Scanner readings in subjects with known pressure ulcers.
The second trial will be conducted in the US and Europe and will evaluate the SEM Scanner’s effectiveness in lowering the incidence of pressure ulcers against the current standard of care.
The SEM Scanner is not yet available for sale in the US.