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FDA gives clearance to plant-based hemostatic gel

TRAUMAGEL is designed for temporary external use for controlling moderate to severe bleeding

Cresilon-TRAUMAGEL-Hemostatic-Gel

Cresilon receives FDA 510(k) clearance for TRAUMAGEL

Cresilon

By Bill Carey
EMS1

NEW YORK — Cresilon Inc., a biotechnology company focused on hemostatic medical device technologies, received U.S. Food and Drug Administration clearance for TRAUMAGEL for the temporary external use for controlling moderate to severe bleeding.

Cresilon’s plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding, according to a press release.

“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,” Cresilon CEO and co-founder Joe Landolina said. “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.”

TRAUMAGEL is Cresilon’s second FDA clearance for human use. The first was granted in 2023 for Cresilon Hemostatic Gel for minor cuts, lacerations and abrasions.

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