Entegrion, a Research Triangle Park-based company started with the help of a $150,000 Small Business Research loan from the North Carolina Biotechnology Center, has received approval from the U. S. Food and Drug Administration for non-prescription sales of its unique blood-stopping wound dressing, Stasilon FR.
Entegrion, a University of North Carolina-Chapel Hill spinout company, is initially targeting the specialized bandage at so-called first responders -- police, fire and EMS personnel. The FDA go-ahead, however, also allows it to be used by consumers, without a prescription, to control bleeding from minor cuts, scrapes and punctures. The FDA initially approved it for prescription-only use last September.
The Stasilon FR bandage was developed by Dr. Thomas Fischer, chief science officer at Entegrion and scientific director of the Francis Owen Blood Research Laboratory at UNC. It controls bleeding by rapidly activating the body's blood-clotting systems. It's woven from glass and bamboo fibers that activate blood platelets and coagulation proteins, constrict blood vessels, and rapidly wick fluids out of wounded tissues.
Pending acceptance of an amendment to the FDA approval, Entegrion plans to market another version of the dressing, called Stasilon OR, for surgical use.