FDA approves hydrogel to stop severe, life-threatening bleeding
The U.S. Food and Drugs Administration (FDA) has approved a hemostatic gel that can stop life-threatening bleeding from traumatic wounds within seconds, clearing its use by emergency medical services and clinicians.
Traumagel is delivered to the wound site via a syringe, where it rapidly forms a barrier to stop bleeding, even from major wounds caused by a stabbing or gunshot. It works by temporarily stopping the flow of blood, and does not require pressure to be placed on the wound, nor an additional bandage.
It’s manufactured by Cresilon, a New York-based biotechnology company.
In its decision, the FDA has classified Traumagel as a medical device, as approval includes both the gel and the applicator. An earlier version of the gel has been approved since 2023, but its use was limited to smaller wounds. Traumagel, however, has now been cleared for use on serious injuries.
“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 and inventor of the technology, said in a statement. “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. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”
Cresilon said it hopes to entice the military into using Traumagel, given its effectiveness against shrapnel and gunshot wounds.
Approval for Traumagel was based on results from multiple studies showing its safety and efficacy, including a preclinical study conducted with the U.S. Department of Defense where the technology could stop bleeding and reduce trauma for injuries of the skull.
Traumagel and its syringe applicator are set to be released to market later this year.
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