Crisilon receives FDA approval for hemostatic gel technology

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

This marks the first FDA approval of Crisilon for human use.

CHG utilizes Crisilon’s hemostatic 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 works quickly to stop and control bleeding at the point of care.

“The combination of these unique features will allow our technology to meet a significant unmet medical need while creating a significant and positive impact in helping to save lives and dramatically improving the standard of care in wound healing.” said Joe Landolina, CEO and co-founder of Cresilon. “The FDA approval sets the prognosis for our advanced technology and is Crisilon’s first step toward realizing our long-term goal of expanding our technology within the broader human health market.”

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