September 16, 2008
TraumaCure Receives Health Canada Licensure for New Hemostatic Agent That Stops Major Bleeding in Seconds
TraumaCure Inc. today announced that Health Canada has issued a medical device license for WoundStat(TM), a ground-breaking hemostatic agent for control of bleeding in high-pressure arterial wounds. The availability of WoundStat in Canada enables military, emergency medical services, law enforcement services, rescue services, and other first responders to stop arterial bleeding within seconds and stabilize an injured person, giving the time needed to seek advanced medical help and save lives.
TraumaCure also announced an exclusive distributor agreement with Canadian Tactical and Operational Medical Solutions Inc. (CTOMS), the highly regarded provider of Combat Casualty Care training and supplier of high quality medical equipment, to make WoundStat immediately available throughout Canada. CTOMS is based in Edmonton, Alberta.
"CTOMS has championed tactical combat casualty care in Canada, making them the natural choice as our distribution partner in Canada," said Devinder Bawa, CEO of TraumaCure. "CTOMS understands the needs of the Canadian military and emergency medical services and how WoundStat's speed and proven effectiveness make it ideal to treat severe bleeding. Whether in the mountains of Afghanistan, remote areas of Canada, or even in a domestic urban tactical environment, medical care can be hours away. Soldiers and civilians alike need the most powerful hemostatic agent available."
"WoundStat will be an important tool for the military, law enforcement, emergency and rescue services, and other first responders in Canada," said Chris Kopp, CEO of CTOMS. "Five different studies have shown that WoundStat is the most effective hemostat available for high pressure arterial wounds. WoundStat works in seconds, not minutes, which makes a significant difference when operating in high threat, high stress environments. We are excited to be able to bring this ground breaking product to Canada."
In comparative studies, including those by the US Army, Navy and Air Force, WoundStat consistently resulted in the least amount of blood loss and stabilized the wound for several hours. These qualities are essential to provide the time needed to seek advanced medical help and save lives.
Severe blood loss is still the leading cause of preventable death on the battlefield. Some estimates indicate that 20% of battlefield deaths could be avoided with the availability of an effective hemostatic product such as WoundStat.
Health Canada licensure comes as a direct result of the ISO 13485 certification received by TraumaCure earlier this year. Health Canada medical device licensing and ISO 13485 certification require strict adherence to standards, which are among the highest of any industry. TraumaCure has put the processes and procedures in place to ensure the global availability of a consistent, safe, and effective product.
CTOMS, based in Edmonton, Alberta, provides training in combat casualty management to the Canadian military, law enforcement and tactical EMS support teams. In addition, CTOMS supplies high quality, unique medical products to provide the best solutions to casualty management in high threat and austere environments. CTOMS is leading the way in Canada in tactical, combat and austere casualty rescue and management.
TraumaCure based in Bethesda, Maryland, supplies the most effective, reliable treatments for life-threatening bleeding wounds. TraumaCure's hemostatic products help stabilize a wounded individual prior to receiving advanced medical treatment. The company's products are made in the U.S. and are proven to save lives and improve outcomes following traumatic injury. TraumaCure is committed to providing the most trustworthy and innovative hemostasis treatments for the military, emergency responders, and civilians.