May 15 2008
Z-Medica Corporation, a medical products company focused on innovative blood clotting nano-technologies, announced that the United States Department of Defense has selected the company's newest hemostatic product, QuikClot(R) Combat Gauze(TM) brand, for all military services as the first-line hemostatic treatment for life-threatening hemorrhage that is not amenable to tourniquet placement. Bleeding is the number one cause of death for soldiers injured in battle and QuikClot(R) products offer the most effective solution to severe blood loss outside the operating room setting. They have been proven in battlefield use and, with more than one million units deployed, are the leading hemostatic agents in the field.
The Committee on Tactical Combat Casualty Care (CoTCCC) made the decision to recommend QuikClot(R) Combat Gauze(TM) after reviewing test reports on a number of hemostatic products. QuikClot(R) Combat Gauze(TM) was the only one of these products tested by both the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. In addition to test efficacy, the committee sited a number of other factors in according QuikClot(R) Combat Gauze(TM) the number one position:
- Preference for the gauze delivery format, which is familiar to combat medical personnel.
- Ability of QuikClot(R) Combat Gauze(TM) to be shaped to any wound and to reach bleeding vessels in penetrating wounds.
- Ease of removal once hemostasis has been achieved.
"Z-Medica's approach to product innovation has always been to listen to the voice of our customer and to focus our research & development efforts on delivering life-saving products that meet their needs," said Z-Medica CEO Raymond J. Huey. "With QuikClot(R) Combat Gauze(TM) we have provided a product that is virtually 100% effective in a very intuitive format that can be applied quickly and simply by anyone."
QuikClot(R) Combat Gauze(TM) combines surgical gauze with a proprietary inorganic material that stops arterial and venous bleeding in seconds -- even more rapidly in this format than earlier Z-Medica products. Based on a different mineral than zeolite-based QuikClot(R) products, it generates no heat. It shares the benefit of being inert and non-allergenic. QuikClot(R) Combat Gauze(TM) comes in rolls four yards long by three inches wide.
In addition to the military testing, the new product was tested in pre-clinical trials at the University of California, Santa Barbara, the University of Massachusetts Medical School and at various field facilities. It has 510(k) clearance from the U.S. Food & Drug Administration. The United States Department of Defense has awarded Z-Medica a $3.2 million grant for large-scale testing of the product on penetrating wounds. These multi-center clinical trials will take place during 2008.
Earlier QuikClot(R) products are in use by all branches of the U.S. Military, by first responders and security agencies across the U.S. and in 36 countries worldwide, with more than a million units in distribution. Z-Medica recently launched its first products for consumers.