Entegrion, a medical firm that utilizes technology developed at the University of North Carolina at Chapel Hill and East Carolina University, has received Food and Drug Administration approval for one of its wound treatment products.
Stasilon FR is a hemostatic dressing that is designed to promote blood coagulation. It will be available over the counter as well as through prescriptions.
Entegrion is also seeking FDA approval for a hemostatic surgical pad.
The company, which was launched in 2002, has worked with the Office of Naval Research in developing its technology.
Entegrion focuses on therapeutics to limit bleeding that results from combat as well as other trauma, surgery and disease. Entegrion was formed as Hemocellular Therapeutics.
“This is a remarkable technology. It’s so powerful in controlling problem bleeding that it was approved by the FDA for use by medical professionals, yet so easy to use that it’s also approved for Dr. Mom,” said Stan Eskridge, Entegrion’s chief executive officer, in a statement.
“This is a cost-effective North Carolina medical textile technology, and it’s a first-in-class product that is demonstrating effectiveness in everything from skinned knees and nose bleeds to management of bleeding in severe burns and trauma,” he continued.
The bandage contains fibers that activate coagulation proteins and also help constrict blood vessels. According to the company, Stasilon FR also is designed to prevent “rebleeding” when the bandage is removed.
The Office of Naval Research has worked with Entregion in seeking wound dressings that would be effective in treatment of wounds suffered in battle.
“While examining the military’s medical case studies from Iraq and Afghanistan on excessive bleeding through gauze wrappings, I became determined to design a common textile that could work with our hemostatic system to stop blood loss,” said Thomas Fisher, Entegrion’s chief science officer.
The company is developing distribution channels for sales of the bandages and also plans to sell them to consumers through Internet ordering.
Entegrion is also developing other hemorrhage control technology, including gels and sprays for tissue repair, infusible treatments for control of internal hemorrhage and targeted drug delivery to tumors and internal bleeding.