FDA Grants 510(k) Clearance to Cresilon’s Traumagel for Temporary External Control of Moderate to Severe Bleeding

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The FDA has granted 510(k) clearance to Traumagel, Cresilon’s plant-based gel designed for temporary external control of moderate to severe bleeding. According to the company, the gel is expected to be a valuable tool for military, emergency medical services, and healthcare professionals. Additionally, Cresilon stated that Traumagel requires no preparation and is effective across all types of bleeds.¹

“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 injuries,” said Joe Landolina, CEO, co-founder, Cresilon, 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 emergency medicine. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”

The FDA clearance marks the second for Cresilon, which was previously given clearance for Cresilon Hemostatic Gel, which was indicated for use in the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. According to Cresilon, the clearance follows 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. The company is planning for a strategic United States launch in late 2024, partnering with the Defense Department's Walter Reed Army Institute of Research to explore the gel's potential in treating traumatic brain injuries.

A person suffering from severe blood loss, whether from a gunshot wound or a massive injury-related hemorrhage, dies every three minutes. 40% of these deaths are due to major hemorrhage or its consequences. Additionally, up to 60% of hemorrhage deaths occur within the first three hours of injury. While most current treatments take time to apply and prevent continuous bleeding, Cresilon’s plant-based hemostatic gel is supplied in a pre-filled syringe, easy-to-apply, requires no preparation, and is designed to stop bleeding quickly across all types of bleeds.¹

Reference

Cresilon Receives FDA Clearance for TRAUMAGEL. Cresilon. August 15, 2024. Accessed August 16, 2024. https://cresilon.com/2024/08/15/cresilon-receives-fda-clearance-for-traumagel/