STB completes Fibrin Adhesive STat pre-IND submission to FDA

Oct 18 2010

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.