The FDA has given a green light to a hydrogel applicator that can be quickly deployed to help stem severe, life-threatening bleeding within seconds.
Cresilon’s plant-derived Traumagel is delivered via a pre-filled syringe directly to the wound site, where it rapidly sticks to the body and forms a mechanical barrier that temporarily stops the flow of blood—without requiring additional pressure, such as with gauze or other bandages.
Under the FDA’s regulations, this classifies the system as a medical device as opposed to a biologic-based coagulant that would prompt the body to form solid clots. Cresilon previously received a 510(k) clearance for an earlier version of its hemostatic gel in mid-2023, which limited its use to minor cuts and abrasions.
Now, the Brooklyn, New York-based company aims to expand Traumagel’s use within the military as well as in medical services and elsewhere, as an emergency bloodstopper for gunshot wounds and other 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,” Cresilon co-founder and CEO Joe Landolina said in a statement.
Last month, the company put forward results from a preclinical study conducted with the U.S. Department of Defense’s Walter Reed Army Institute of Research, examining Traumagel’s potential to plug traumatic brain injuries that have penetrated the skull.
According to Cresilon, the study’s first phase showed successes in maintaining intracranial pressure, cerebral perfusion pressure and hemoglobin content, and additional studies will be performed at Walter Reed.
The company expects to begin rolling out Traumagel later this year.