LOS ANGELES, Nov. 26, 2013 /PRNewswire/ -- Bruin Biometrics, LLC ("BBI") today 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 thirty-one healthy subjects in a pilot study conducted in Los Angeles, California 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 United States and will evaluate SEM Scanner readings in subjects with known pressure ulcers. A second study will enroll subjects throughout the United States and Europe in order to evaluate the SEM Scanner's effectiveness in lowering the incidence of pressure ulcers against the current standard of care.
About the SEM Scanner:
The SEM Scanner is a point of care diagnostic device that measures increased fluid content within the underlying tissue of skin known as subepidermal moisture (SEM). In clinical studies, SEM 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. BBI developed the SEM Scanner in conjunction with research colleagues at the University of California at Los Angeles (UCLA), notably Barbara Bates-Jensen, PhD, RN, CWOCN, FAAN.
The SEM Scanner is not yet available for sale in the United States. For additional information, please visit www.bruinbiometrics.com.