Firm wins FDA approval for wound product

The FDA last week cleared a wound treatment product from Bethesda-based TraumaCure Inc. that is designed to quickly and easily stem the leading cause of death among soldiers in combat — high-pressure bleeding.

The company says WoundStat, a mineral-based granular formula that pours out of a pouch and conforms to the shape of a wound, can be used on injuries in places where a tourniquet is not effective, such as the groin or the shoulder area.

“The No. 2 trauma killer for civilians — and No. 1 for soldiers — is bleeding to death from a wound,” said Dr. Gregory Jurkovich, chief of trauma at Harborview Medical Center in Washington state. “You can only lose about half of your blood volume suddenly before you die from it.”

While similar hemostatic products exist, including Z-Medica’s popular QuikClot, TraumaCure CEO Devinder Bawa said they are designed to stem lower-pressure bleeding.

“There really has not been in the past a product that can address high-pressure arterial bleeding,” he said.

The venture-funded company licensed the patent-pending technology from Virginia Commonwealth University, whose Reanimation Engineering Shock Center trains U.S. military special forces medics.

The company said the Army is conducting full-scale testing on the product, which will be available in mid-December, but that the treatment could also be marketed to backpackers and hikers.

TraumaCure was formed around the WoundStat product in 2006 and is currently entering its second round of funding. The company has other products in development, Bawa said.

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