Biotechnology firm Cresilon Inc. has received a US Food and Drug Administration (FDA) 510(k) clearance for its Traumagel external bleeding solution for warfighters.
Traumagel is a plant-derived hemostatic gel developed to control and mitigate life-threatening bleeding in seconds upon application to the wound.
The technology uses Cresilon’s proprietary hemostatic hydrogel formula, which combines algae and fungi compounds to rapidly treat moderate to severe blood loss from gunshot wounds or injury-related hemorrhage.
According to the Brooklyn-based company, Traumagel is pre-filled in a syringe and requires no complex preparations to support quick and convenient applications compared to traditional gauze wraps and tourniquets.
“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,” Cresilon CEO Joe Landolina explained.
“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 emergency medicine.”
‘Game-Changer’
Traumagel serves as Cresilon’s second FDA-cleared product for human use. It follows the initial Hemostatic Gel approved in June 2023 for local bleeding management on minor cuts, abrasions, and lacerations.
Currently, the company is working with the Pentagon’s Walter Reed Army Institute of Research for the potential fielding and prehospital treatment of the new gel for life-threatening brain hemorrhage and neuroprotection associated with penetrating traumatic brain injury.
In addition to military use, the substance will be offered to government health agencies, medical professionals, and emergency medical service systems.
“Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used,” Landolina stated.
The CEO added in a Reuters interview that “91% of battlefield mortality relates to what we call preventable hemorrhage, meaning that if there were only a better product to stop bleeding, countless lives could be saved.”
After the recent milestone, Cresilon is expected to launch Traumagel on the US market by late 2024.
