Cresilon receives FDA clearance for haemostatic gel technology

Cresilon, a Brooklyn-based biotechnology company focused on haemostatic medical device technologies, has announced that it has been granted 510(k) clearance from the US Food and Drug Administration for Cresilon Haemostatic Gel (CHG).

This marks Cresilon's first FDA clearance for human use.

CHG utilises Cresilon's haemostatic gel technology that rapidly controls bleeding when applied to a wound ‒ without the need for manual pressure. In addition to its versatility, the plant-based gel is designed to be easy-to-use and work instantaneously to both stop and control bleeding at the point of care

"The combination of these unique attributes will allow our technology to fill a critical unmet medical need while creating a significant and positive impact in helping to save lives and dramatically improving the standard of care in wound treatment." said Cresilon CEO and co-founder Joe Landolina. "The FDA clearance sets the predicate for our advanced technology and marks Cresilon's first step towards actualising our long-term goal of expanding our technology within the broader human health market."

As the first product in the Cresilon portfolio approved for human use, CHG is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.