Tuesday, June 3, 2008

Plasma Derived Products:Pathogen Safety of EVITHROM™


Here is a link through to a presentation by Bernard Horowitz, Ph.D. discussing the safety of (Omrix manufactured) J&J's Evithrom, you have to register first.
Omrix do concede that "Our products are derived from human plasma, and are therefore subject to the risk of biological contamination inherent in plasma-derived products. This risk could adversely affect our ability to obtain raw materials and market our products. " In THIS document
Info from Omrix Biopharmaceuticals tells us Bernard Horowitz, Ph.D. has served as a member of our Board since February 2006. Since January 2000, he has been a principal of Horowitz Consultants, LLC, a company providing assistance in strategic planning, process development, viral safety, clinical trial design and new product regulatory compliance. From 1995 to 1999, Dr. Horowitz served as chief scientific officer, executive vice president and director of V.I. Technologies, Inc., now Panacos Pharmaceuticals, Inc., a now publicly held company he helped found as a spin-out from the New York Blood Center. Dr. Horowitz has served as a scientific consultant to the National Institutes of Health, the Food and Drug Administration, the National Hemophilia Foundation, the International Association of Biological Standardization, and the World Health Organization. Dr. Horowitz is a co-inventor of over 25 issued U.S. patents. Dr. Horowitz received his B.S. in biology from the University of Chicago and his Ph.D. in biochemistry from Cornell University Medical College. He is a director of Protein Therapeutics, Inc.

US Department of Defense Recommends Soldiers Carry WoundStat™


BETHESDA, Md.--(BUSINESS WIRE)--TraumaCure Inc. announced today that the DOD Joint Committee on Tactical Combat Casualty Care (CoTCCC) has recommended that U.S. soldiers from all services carry the company’s hemostatic agent, WoundStat™. The CoTCCC based its recommendations upon the results of extensive studies conducted by both the Army’s Institute for Surgical Research (ISR) and the Naval Medical Research Center (NMRC). In those studies, no other product was as effective across the board in terms of survival, post treatment blood loss, and duration of hemostasis.
This is the first time ever that all branches of the military have come together and jointly recommended the same product for the most severe injuries involving high-pressure bleeding.
“Severe bleeding is the number one cause of death for soldiers injured in battle. The ISR study clearly shows WoundStat works consistently to stop serious bleeding quickly. In light of these study results, WoundStat will be a critical product in the field available to all soldiers in harm’s way, where and when it is needed most,” said Ron Blanck, retired US Army Surgeon General. “Approximately 80% of injuries in the current conflict are from improvised explosive devices (IEDs), which result in the severe and irregular wounds that WoundStat is specifically designed to treat. In those situations, WoundStat works in seconds, not minutes.”
Four different studies—including the one conducted by the Army’s ISR, along with others conducted at Virginia Commonwealth University, the Air Force, and NAMSA—have now proven that WoundStat is the most effective hemostat available for high pressure arterial wounds. In each of these studies, WoundStat was the only product that resulted in 100% survival. The novel wound treatment works through standing blood and has the added advantage that, should re-bleeding occur, a wound can be re-packed with the WoundStat already present—a real advantage in combat conditions.
“The Joint Committee on TCCC recognized WoundStat’s overall advantage in both effectiveness and safety. It is now clearly proven that, with its consistent reliability and efficacy, combined with its speed of use, WoundStat offers the highest level of operational field capability for our warfighters,” noted Devinder S. Bawa, CEO of TraumaCure.
TraumaCure has enough WoundStat in stock to equip every soldier currently deployed in the Middle East theater. The cost of WoundStat is about one-third that of the product the Army has been using for the past several years. WoundStat is also available for domestic use by emergency responders and others who need to be prepared for treating traumatic injuries.