FDA Clears Cresilon’s Traumagel Hemostatic Agent

Cresilon has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Traumagel for temporary external use to control moderate to severe bleeding.
 
The Brooklyn-based biotech company’s plant-based hemostatic gel stops and controls life-threatening bleeding in seconds when applied to a wound. Traumagel uses Cresilon’s proprietary hydrogel tech and is a first-of-its kind hemostatic medical device with its indicated FDA clearance.
 
The gel is supplied in a prefilled syringe and requires no preparation. Traumagel is Cresilon’s second FDA clearance for human use—the first was awarded in June 2023 for Cresilon Hemostatic Gel (CHG) to locally manage bleeding wounds such as minor cuts, lacerations, and abrasions.
 
Cresilon plans to develop and manufacture Traumagel for the needs of the U.S. military, government health agencies, emergency medical services systems, and clinicians who routinely encounter traumatic wounds and need a solution to quickly stop and control severe bleeding.
 
The company expects to begin Traumagel’s strategic launch in late 2024. It also reported promising results from a cooperative R&D agreement with the U.S. Defense Department’s Walter Reed Army Institute of Research (WRAIR) from a study of Cresilon’s gel technology as a potential field and prehospital treatment to mitigate life-threatening brain hemorrhage and provide neuroprotection after a penetrating traumatic brain injury (TBI).
 
“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 wounds,” said Joe Landolina, CEO and co-founder of Cresilon and inventor of the technology. “The 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 wound treatment. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”