FDA Approves Clotting Gel That Could Stop Life-Threatening Bleeding Within Seconds

The Food and Drug Administration has approved a new clotting gel that could stop life-threatening bleeding within seconds.

Per Reuters, the FDA cleared TRAUMAGEL, a gel made by Cresilon to control bleeding quickly. This new tool can give emergency medical technicians and other medical professionals yet another tool in their arsenal to prevent death from blood loss.

The company’s website reports that this “revolutionary plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding in a matter of seconds when applied to a wound at the point of care. TRAUMAGEL, which utilizes Cresilon’s proprietary hydrogel technology, is a first-of-its-kind hemostatic medical device with FDA clearance for temporary external use in moderate to severe bleeding.”

Cresilon announced today it has received FDA 510(k) clearance for TRAUMAGEL for temporary external use for controlling moderate to severe bleeding.

This is a major advancement for our company and the fields of emergency medicine and trauma care. Our second FDA clearance brings… pic.twitter.com/yHNb6vDLv4

— Cresilon, Inc. (@Cresilon) August 15, 2024

“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,” said Joe Landolina, CEO and co-founder of Cresilon and inventor of the technology. “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.”

According to the Cresilon website, severe blood loss can kill in a matter of minutes, whether from a gunshot wound or a massive injury-related hemorrhage. Reportedly, 40% of these deaths are due to major hemorrhage or its consequences.

Reuters reports that this tool gel can be used for motor vehicle accidents, gunshot wounds, and stab wounds, “really anywhere where this product will stand between a patient and death.” Current treatments, including gauze and placing pressure on a wound, can take five minutes or more to work, in comparison.

The gel comes in a pre-filled syringe and requires no manual pressure on the wound to create a blood clot, according to the company. TRAUMAGEL is intended for external use only.