News | September 09, 2007

FDA Clears New Product to Stop Severe Bleeding on the Battlefield

September 11, 2007 - The FDA has approved TraumaCure's new WoundStat, a lightweight, pre-mixed, dressing compound, which stems high-pressure bleeding in moderate to severe wounds.
A new study published in the Journal of Trauma comparing early WoundStat technology to then existing products reveals that it succeeds where others did not. WoundStat securely stopped potentially deadly arterial hemorrhaging in three minutes, and continued to do so for at least two hours. The study was conducted by a team of researchers at Virginia Commonwealth University's Reanimation Engineering Shock Center (VCURES). Subsequent test data from a national testing laboratory reported similar success with WoundStat. In both studies there was no heat-generation or other adverse side effects reported.
"Uncontrolled bleeding continues to be the primary cause of death on the battlefield," said Kevin Ward M.D., a VCU emergency physician and associate director for VCURES. "After years of research we've developed a versatile and robust material that is specifically suited to treat the tremendously complex wounds of war under very demanding environmental conditions. The material is both very absorbent and adherent which helps to quickly stop the bleeding while simultaneously facilitating clotting."
The patent-pending technology behind WoundStat is the result of more than three years of research and development by VCURES. The university center not only conducts research on life-saving technologies, it also plays a key role in training Special Operation Combat Medics in the U.S. military.
TraumaCure anticipates that WoundStat will be available for deployment by the late fall. The company says both the U.S. military and foreign militaries have expressed interest in the new product.
"WoundStat's value goes beyond the battlefield," said retired Lt. Gen. Ronald Blanck, DO, former surgeon general of the army. "It will provide a life-saving tool in everyday civilian emergency situations as well as where advanced medical care is not immediately available, such as accidents in remote terrain and on the high seas, or in unexpected disasters such as earthquakes or explosions."
TraumaCure is continuing research for discovery and development of additional products based on the core compounds used in WoundStat. The current focus is on trauma injury care, and future products will aim at surgical, chronic wound, and burn care.

For more information: www.jtrauma.com, www.vcu.edu

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