FDA Clears Plant-Based Hemostatic Gel That Stops Bleeding

Cresilon, a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced it has received FDA 510(k) clearance for TRAUMAGEL, which it said can be used to temporarily control moderate to severe bleeding.

Cresilon's plant-based hemostatic gel technology is designed to stop and control life-threatening bleeding when applied to a wound at the point of care. TRAUMAGEL uses Cresilon's proprietary hydrogel technology. The company intends to develop and manufacture TRAUMAGEL to address the needs of the U.S. military, government health agencies, emergency medical services (EMS) systems, and medical professionals who routinely encounter traumatic wounds.

The company plans to initiate a strategic launch of TRAUMAGEL in the U.S. late 2024.

While several hemostatic agents and gauze bandages are currently available for applications such as trauma and surgery, many products require preparation and lengthy application time, can be difficult to apply, or are not suited to work across all types of bleeds. Cresilon's plant-based hemostatic gel is supplied in a pre-filled syringe, easy-to-apply, requires no preparation, and designed to stop bleeding quickly across all types of bleeds.

TRAUMAGEL marks Cresilon's second FDA clearance for human use. The first was granted in June 2023 for Cresilon Hemostatic Gel, which is indicated for use in the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. The recent FDA clearances follow several major advancements for the company which operates out of a 33,000-square-foot biomanufacturing facility in Brooklyn's Industry City.