FDA approves Va. invention used to block hemorrhaging - @ JEMS.com


FDA approves Va. invention used to block hemorrhaging


 
 

Jeffrey Kelley | | Wednesday, September 12, 2007


RICHMOND, Va. Potentially deadly, severe bleeding on battlefields and in emergencies has a new savior: a product developed at Virginia's largest university.

WoundStat has been approved for use on humans and commercial sale by the Food and Drug Administration. It looks like a cross between flour and cat litter can be shoved into wounds to quickly stop hemorrhaging.

WoundStat was developed by three researchers at Virginia Commonwealth University.

"This is a very big deal for us," said Ivelina S. Metcheva, director of VCU's Office of Technology Transfer, which works to commercialize the school's research. Metcheva said WoundStat has the largest market potential ever developed out of VCU.

In 2004, researchers began searching for a product that could stop heavy bleeding a leading cause of death during combat. A handful of the substance is smacked and massaged into wounds, sometimes into places a blood-loss-stopping tourniquet cannot go, halting severe bleeding within a couple of minutes, researchers say.

The compound was licensed to Bethesda, Md.-based TraumaCure Inc. last year. The company plans to start offering WoundStat to U.S. military forces by late fall, followed by rollouts to first responders such as firefighters and emergency medical technicians. Company officials say a conservative sales figure for the market is $200 million a year.

TraumaCure, however, has competition. The HemCon bandage, made with a blood-clotting agent derived from shrimp shells, is Army standard issue. And a substance called QuikClot, used by the Marines and Air Force, does to blood what its name implies.

WoundStat prices will fall around its competitors', at $20 to $80 per pack.

"Any new product is going to have to go up against existing standards in testing conducted by the military in order to be adopted," said Devinder S. Bawa, TraumaCure's chief executive. Now that WoundStat has FDA approval, the focus of the eight-employee company is to help the armed forces study ballistic injuries and the capabilities of the compound, "and really to get our product ready for launch."


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