In its decision, the FDA classified Traumagel as a medical device because the approval covers both the gel and the applicator. An earlier version of the gel has been approved since 2023, but its use was limited to minor wounds. However, Traumagel has now been approved for use in serious injuries.
“The ability to quickly stop bleeding at the point of care and stop life-threatening bleeding can mean the difference between life and death for people with traumatic injuries,” said Joe Landolina, CEO and co-founder of Cresilon and inventor of the technology, in a opinion“The FDA approval of Trauma Gel is a tremendous milestone for Cresilon and takes us another step forward in our mission to save lives and change the standard of care in emergency medicine. Our proprietary hemostatic gel technology is groundbreaking and unlike any other hemostatic agent currently in use.”
Cresilon expressed hope that the military could be persuaded to use trauma gel because of the agent’s effectiveness against shrapnel and gunshot wounds.
The approval of Traumagel was based on the results of several studies demonstrating its safety and effectiveness, including a preclinical study conducted in conjunction with the U.S. Department of Defense in which the technology was able to stop bleeding and reduce trauma in head injuries.
Traumagel and the associated syringe applicator are expected to come onto the market later this year.
