FDA approves device that stops severe bleeding in seconds

Traumagel can stop bleeding for injuries as severe as gunshot wounds.
traumagel
Posted

The Food and Drug Administration approved a device that can stop life-threatening bleeding in seconds.

Traumagel, developed by Cresilon, is a medical device utilizing the company’s plant-based hemostatic gel technology to stop bleeding for injuries as severe as gunshot wounds.

The device consists of a pre-filled syringe that is easy-to-apply, requires no preparation, and is designed to work across all types of bleeds, Cresilon said. In comparison, other options like hemostatic agents and gauze bandages can be hard to apply, require a lengthy application time, and don’t treat all types of bleeds, the company said.

Traumagel is intended for external use.

"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 wounds," said Joe Landolina, CEO and co-founder of Cresilon and inventor of the technology, in a press release.

"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 wound treatment. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used,” Landolina said.

RELATED STORY | FDA approves new epinephrine nasal spray to treat severe allergic reactions

It can take just minutes for a person to die of severe bleeding, Cresilon said. A person dies from injury every three minutes, with 40% of those deaths due to a major hemorrhage or its consequences, said the company.

Cresilon plans to launch trauma gel in late 2024.

RELATED STORY | FDA approves colon cancer blood test, but some will still need colonoscopies