Cresilon Inc., a Brooklyn-based biotechnology company, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for TRAUMAGEL®, a revolutionary plant-based hemostatic gel. This product is designed for temporary external use to control moderate to severe bleeding, offering a rapid solution to stop life-threatening hemorrhages in seconds when applied directly to a wound.
TRAUMAGEL utilizes Cresilon's proprietary hydrogel technology, marking it as the first-of-its-kind hemostatic medical device with FDA clearance for such applications. The gel is intended to meet the needs of the U.S. military, government health agencies, emergency medical services (EMS) systems, and medical professionals dealing with traumatic wounds.
Joe Landolina, CEO and co-founder of Cresilon, emphasized the significance of TRAUMAGEL in saving lives by quickly stopping bleeding at the point of care. The FDA clearance represents a significant milestone for Cresilon, advancing its mission to transform wound treatment standards.
Severe blood loss can be fatal within minutes, with a significant portion of trauma-related deaths attributed to major hemorrhage. TRAUMAGEL addresses this critical need by offering an easy-to-apply, pre-filled syringe solution that requires no preparation and is effective across all types of bleeds.
This clearance is Cresilon's second FDA approval for human use, following the June 2023 clearance for Cresilon Hemostatic Gel® (CHG) for minor wounds. The company operates from a state-of-the-art biomanufacturing facility in Brooklyn and has reported promising results from research with the U.S. Defense Department’s Walter Reed Army Institute of Research on treating traumatic brain injuries.
Cresilon's innovative approach to hemostatic technology aims to revolutionize trauma care, biosurgery, and animal health, with a steadfast mission to save lives.
