Bruin Biometrics (BBI) has announced results from two IRB-approved clinical trials conducted with the SEM Scanner, a Class IIA medical device that is intended to detect localized tissue edema and pressure induced tissue damage which may lead to the formation of pressure ulcers.
BBI enrolled 31 healthy subjects in a pilot study conducted in Los Angeles, Calif. to assess the reliability of the SEM Scanner. Results indicate that the SEM Scanner gives consistent readings and is reliable across different users and across different device models.
BBI also sponsored an investigational, non-significant risk study to collect data needed to analyze SEM Scanner readings at the University of Massachusetts Memorial Medical Center in Worcester, Massachusetts. Fifty subjects from the adult Critical Care Unit were enrolled in the trial 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 BBI trial. Analysis of trial data is underway, and a final study report is expected in early 2014.
BBI will sponsor additional trials throughout 2014. The first will take place in the U.S. and will evaluate SEM Scanner readings in subjects with known pressure ulcers. A second study will enroll subjects throughout the U.S. and Europe in order to evaluate the SEM Scanner's effectiveness in lowering the incidence of pressure ulcers against the current standard of care.