STB Lifesaving Technologies: Successful Pre-IND FDA Filing for STB's FAST(R) Dressing Propels Lifesaving Technology Forward
10/18/2010 9:13:03 AM
ROCKVILLE, Md., Oct. 18 /PRNewswire/ -- STB Lifesaving Technologies® today announced that is has completed a successful pre-Investigational New Drug (pre-IND) submission to the U.S. Food and Drug Administration (FDA) for its lead product, the Fibrin Adhesive STat®, or (FAST®) dressing.
STB® has conducted successful animal studies for the FAST® dressing with both military and commercial partners and is further supported by published data from the American Red Cross. In these published comparative animal studies, Fibrin Adhesive STat®, or (FAST®) dressing has proven to be functionally superior in significantly reducing blood loss. The FAST® dressing contains large quantities of the human blood clotting proteins fibrinogen, thrombin, and Factor XIII in a dry form. Once in contact with the wound, the components in the FAST® dressing are instantly activated to form a fibrin clot similar to that which results from the body's own clotting process.
"The FDA provided us with some very helpful and substantive comments," said Richard Moscarello, CEO of STB®. "We have incorporated them and now are finalizing our development plan and partner relationships, so we can go forward with our IND filing as soon as possible. This will a very significant milestone in the strategic plan we've set for STB®, and will allow us to penetrate the multi-billion dollar hemostatic market and begin saving lives." The Company has the remaining pre-IND development work and animal studies for the FAST® dressing underway.
STB Lifesaving Technologies® is a biotechnology company that is developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. Its flagship product, Fibrin Adhesive STat (FAST®) dressing, is designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding.
SOURCE STB Lifesaving Technologies