US-based biotechnology firm Cresilon secured the US Food and Drug Administration (FDA) 510(k) approval for Traumagel for temporary external use to control moderate to severe bleeding.
Traumagel is an advanced plant-based haemostatic gel technology, designed to stop and control severe bleeding within seconds after applying it to a wound at the point of care.
Cresilon developed the haemostatic gel product using its in-house hydrogel technology.
The US-based biotechnology company intends to develop and manufacture Traumagel to address the needs of the US military, government health agencies, and emergency medical services (EMS).
In addition, the company also plans to offer haemostatic gel to help medical professionals routinely facing traumatic wounds and looking for a solution to control severe bleeding.
Cresilon intends to launch its haemostatic medical device in the US later this year.
Cresilon CEO and co-founder Joe Landolina said: “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.
“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 hemostatic agent currently being used.”
Cresilon said its plant-based haemostatic gel, supplied in a pre-filled syringe, doesn’t require preparation and is designed to stop bleeding quickly across all types of bleeds.
Traumagel is the company’s second FDA approval, following the Haemostatic Gel (CHG) in June last year, for use in the local management of bleeding wounds.
The recent FDA approvals follow several major advancements for the company, which operates out of a 33,000ft2 biomanufacturing facility in Brooklyn’s Industry City.
In addition, Cresilon recently announced promising results from a study of its gel technology as a potential field and prehospital treatment to offer neuroprotection after traumatic brain injury (TBI).
