FDA Clears Product to Stop Severe Bleeding
BETHESDA, Md., Sept. 10 /PRNewswire/ -- A lightweight, pre-mixed, dressing compound that is scientifically-proven to stem high-pressure bleeding in moderate to severe wounds has received FDA clearance after six weeks of review. Availability of WoundStat(TM) is good news for soldiers and civilians alike, because the product is easy to carry and can be applied on the spot.
"The FDA's speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today -- our warfighters in harm's way around the world." said Devinder S. Bawa, chief executive officer of TraumaCure, the developer of WoundStat. "The product's effectiveness is particularly important with core body wounds that a tourniquet can't reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize battlefield deaths caused by hemorrhaging."
Furthermore, a study newly published in the Journal of Trauma comparing early WoundStat technology to then existing products reveals that it succeeds where others fail -- WoundStat securely and safely stopped potentially deadly arterial hemorrhaging in three minutes, and continued to do so for at least two hours. The study was conducted by a multidisciplinary team of researchers at Virginia Commonwealth University's Reanimation Engineering Shock Center (VCURES,) and can be found at http://www.jtrauma.com. Subsequent test data from a national testing laboratory reported similar success with WoundStat. In both studies there were no heat-generating or other adverse side effects reported.
"Uncontrolled bleeding continues to be the primary cause of death on the battlefield," said Kevin Ward, MD, 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 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. Both U.S. military and foreign military allies have expressed interest in the new product.
"WoundStat's value goes beyond the battlefield," said retired Lieutenant General 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 additional information and interview requests please contact Sanda Pecina (202-367-1622, firstname.lastname@example.org.)
The mission of TraumaCure's team of seasoned life science, healthcare, and medical device professionals is to develop life-saving wound treatment products that can be used by everyone, ranging from the military to medical personnel to civilians, when there is traumatic injury, surgery, or similar need. The company is based in Bethesda, MD, and was founded in 2006. WoundStat(TM) is its first product.
About VCU and the VCUMedicalCenter
Virginia Commonwealth University is the largest university in Virginia and ranks among the top 100 universities in the country in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls more than 30,000 students in nearly 200 certificate and degree programs in the arts, sciences and humanities. Sixty-three of the programs are unique in Virginia, many of them crossing the disciplines of VCU's 15 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation's leading academic medical centers. For more, see http://www.vcu.edu.
|SOURCE TraumaCure Inc.|
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