The FDA has granted clearance for Cresilon's hemostatic gel, Traumagel, for rapid hemorrhage control. This development potentially provides emergency medical technicians and combat medics with an additional tool for managing life-threatening hemorrhage.
Traumagel, an advancement from Cresilon's previously approved product for minor lacerations, is indicated for use in severe traumatic injuries such as penetrating wounds, gunshot wounds, and injuries from motor vehicle accidents.
According to CEO and co-founder Joe Landolina, Traumagel demonstrates a faster onset of action compared to current hemostatic agents. While existing treatments, including gauzes and other chemical agents, typically require more than five minutes to achieve hemostasis with manual pressure application, Traumagel is reported to be effective within seconds.
The product is an algae-derived gel delivered via a pre-filled syringe. It is designed to induce rapid clot formation without the need for manual pressure on the wound site.
FDA clearance for Traumagel is based on pre-clinical data comparing its efficacy to a standard-of-care product. The company anticipates a commercial launch in late 2024.
Landolina, who developed the plant-based hemostatic gel technology, cites data suggesting that 91% of battlefield mortality is attributable to potentially preventable hemorrhage, highlighting the critical need for advanced hemostatic agents in combat casualty care.