FDA grants 510(k) clearance to hemostatic gel for moderate to severe bleeding

The FDA has granted 510(k) clearance to a plant-based, hemostatic gel to treat moderate to severe bleeding, according to the manufacturer.

Traumagel (Cresilon), which is applied from a pre-filled syringe, is designed to quickly stop and control significant bleeding from a traumatic injury when applied to a wound at the point of care, the company said in a press release.

It is the second time the FDA has granted 510(k) clearance to Cresilon. The company in June 2023 received the clearance for its hemostatic gel to address bleeding from minor cuts, lacerations and abrasions, according to the release.

In July, Cresilon reported positive results from preclinical testing of Traumagel, conducted with the Walter Reed Army Institute of Research, to treat bleeding that occurs as a result of traumatic brain injury sustained in combat.

The company said it plans to launch of Traumagel in the United States late this year, with marketing intended for the military, government health agencies, emergency medical services and other trauma-centered medical professionals.

“The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” Joe Landolina, CEO and co-founder of Cresilon, said in the release. “FDA clearance for Traumagel is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in emergency medicine. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”