NEW YORK, June 29, 2023 /PRNewswire/ — Cresilon, Inc. (“Cresilon”), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel™ (“CHG™”).
This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care.
CHG™ utilizes Cresilon’s proprietary 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 easy-to-use and works 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 actualizing our long-term goal of expanding our technology within the broader human health market.”
CHG leverages Cresilon’s in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only. 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. For additional important safety information, please see the CHG Instructions For Use.
Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for manual pressure. The company’s current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon’s mission is to save lives. Learn more about Cresilon at www.cresilon.com.