Aug 15 (Reuters) – The U.S. Food and Drug Administration has cleared Cresilon’s gel to quickly control bleeding, the privately held company said on Thursday, potentially giving emergency medical technicians and combat medics a tool to prevent death from blood loss.
Unlike its previously approved product for small nicks and cuts, the new gel, Traumagel, can be used for life-threatening injuries, CEO and co-founder Joe Landolina told Reuters.
“This (Traumagel) is for stab wounds, gunshot wounds, motor vehicle accidents – really anywhere where this product will stand between a patient and death.”
Current treatments, which include gauzes and other chemical agents, take more than five minutes to work, with pressure also applied to the wound, Landolina said, while Traumagel takes seconds.
Traumagel is an algae-derived gel that comes in a pre-filled syringe and requires no manual pressure on the wound to create a blood clot, according to the company.
The FDA’s clearance for the gel, expected to be launched in late 2024, is based on pre-clinical data that compared it to a standard-of-care product.
Landolina, who invented the plant-based hemostatic gel technology at the age of 17, said “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.”
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