STB Lifesaving Technologies has concluded the submission of a pre-investigational new drug (pre-IND) to the US Food and Drug Administration (FDA) for its Fibrin Adhesive STat (FAST) dressing.
The FAST dressing contains large quantities of the human blood clotting proteins fibrinogen, thrombin and Factor XIII in a dry form, which get instantly activated to form a fibrin clot similar to that which results from the body’s own clotting process, when once in contact with the wound.
With the help of both military and commercial partners STB has conducted successful animal studies for the FAST dressing and is further supported by published data from the American Red Cross.
Reportedly, the animal studies showed that FAST dressing was superior in reducing blood loss.
STB CEO Richard Moscarello said that the FDA provided them with some helpful and substantive comments.
“We have incorporated them and now are finalising our development plan and partner relationships, so we can go forward with our IND filing as soon as possible,” Moscarello said.
STB Lifesaving Technologies is a biotechnology company that is developing a suite of products to stop serious and life threatening bleeding in trauma and surgical settings.