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HomeFDA UpdatesCresilon Announces FDA 510(k) Submission For Human Use Hemostatic Gel Technology

Cresilon Announces FDA 510(k) Submission For Human Use Hemostatic Gel Technology

Cresilon, Inc. (“Cresilon”), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced today it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for its proprietary hemostatic gel technology. This follows Cresilon’s successful launch of VETIGEL®, its revolutionary hemostatic gel for the animal health market.

“This FDA submission marks an important milestone for Cresilon in our commitment to significantly improve the standard of care in wound treatment,” said Joe Landolina, CEO of Cresilon. “Cresilon’s mission is to save lives, and we are eager for our technology to be permitted to make a significant positive impact in the human health market, just as we are already doing in the animal health market.”

Cresilon Hemostatic Gel™, the subject of Cresilon’s FDA submission, is a hemostatic gel for external use only. It is intended to be easy-to-use, non-animal derived, and to rapidly control bleeding. Cresilon expects this combination of attributes will allow the product to uniquely address critical unmet needs in the human health market.

“We see a significant opportunity for our technology in the human market, and this FDA submission is Cresilon’s first step towards seizing that opportunity,” said Joe Landolina. “We look forward to working through the FDA review process to obtain clearance for Cresilon Hemostatic Gel.”