Cresilon
Cresilon Inc., a Brooklyn-based biotechnology company focused on haemostatic medical device technologies, has announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TRAUMAGEL for temporary external use for controlling moderate to severe bleeding.
Cresilon's revolutionary plant-based haemostatic 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 utilises Cresilon's proprietary hydrogel technology, is a 'first-of-its-kind' haemostatic medical device with FDA clearance for temporary external use in moderate to severe bleeding.
Cresilon says it 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 and need a solution to quickly and effectively stop and control severe bleeding. The company plans to initiate a strategic launch of TRAUMAGEL in the U.S. late 2024.
"The ability to rapidly stop bleeding at the point of care and halt a life-threatening haemorrhage 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. "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 haemostatic gel technology is a game-changer and unlike any other haemostatic agent currently being used."
Read more: Cresilon receives FDA clearance for haemostatic gel technology
While several haemostatic 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 haemostatic 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 (CHG), 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 state-of-the-art 33,000-square-foot biomanufacturing facility in Brooklyn's Industry City.
Additionally, the company recently reported promising results from its cooperative research and development agreement with the U.S. Defense Department's Walter Reed Army Institute of Research (WRAIR) from a study of Cresilon's gel technology as a potential field and prehospital treatment to mitigate life-threatening brain haemorrhage and provide neuroprotection following a penetrating traumatic brain injury ("TBI").
