Gel that stops severe bleeding in seconds gets FDA approval

Cresilon, a biotechnology company based in Brooklyn, have received US Food and Drug Administration (FDA) approval for their latest product, Traumagel, designed to stop moderate to severe bleeding instantly.

From Superinnovators 13/09/24

All image credits Cresilon

Traumagel uses a plant-based hydrogel technology, which the company say makes it the first-of-its-kind hemostatic device for trauma care in the medical industry.

The FDA approval allows Cresilon to market the gel specifically for temporary external use in treating traumatic wounds that lead to dangerous levels of blood loss.

Cresilon plan to launch Traumagel in the U.S. market in late 2024, targeting sectors like military, government health agencies, and emergency medical services.

This product will be pre-filled in syringes for quick application, allowing healthcare providers to stop bleeding in seconds without requiring any preparation or manual pressure.

The company say this is an improvement on existing hemostatic agents and gauze bandages used to stop bleeding that take time to apply, and may not be effective for all types of bleeding.

Traumagel’s precursor Vetigel being applied during animal surgery

Severe blood loss can kill within minutes, and Traumagel’s fast-acting formula could be a crucial life-saving intervention in trauma care settings.

Cresilon launched their first product, Vetigel, in 2021, used in veterinary care to stop bleeding without applying manual pressure.

The company secured large-scale distribution deals across the US for Vetigel in 2024 and are looking to do the same with Traumagel in the coming years.

Last month’s FDA clearance for Traumagel follows a 2023 FDA approval for managing minor wounds like cuts and abrasions.

Cresilon’s collaboration with the U.S. military has led to promising results in testing Traumagel for treating traumatic brain injuries in battlefield and pre-hospital environments.

The company say the FDA approval marks a significant milestone in their mission to revolutionise trauma care and save lives through innovative, plant-based medical technology.