Cresilon's Hemostatic Gel, an innovative gel that effectively controls bleeding without manual pressure, has obtained FDA clearance for human use, marking a significant milestone for the company as it paves the way to extend its advanced technology within the wider human health sector, according to Co-Founder and CEO Joe Landolina.
"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," Landolina said in a press release. "The FDA clearance has set 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."
The National Library of Medicine's Medline Plus wrote applying pressure on a wound stops blood loss from the affect limb.
Cresilon, the developer of Cresilon Hemostratic Gel (CHG), announced FDA clearance for its innovative plant-based gel, which effectively stops and controls bleeding without requiring manual pressure. This easy-to-use gel can be applied directly at the point of care and can instantly stop bleeding.
Cresilon is a Brooklyn-based biotechnology company who makes hemostatic medical devices.
"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," Landolina said in a release. "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."
The Texas Department of Insurance warned against using a tourniquet without medical training.
Last year, Cresilon raised approximately $25 million in financing to support its expansion into human health. According to the company, it already produces a similar gel, Vetigel, for use in animals.
The Harvard Medical School's Harvard Health Publishing wrote a guide that outlined how to give pressure to a person's bleeding wound, adding to call 911.
MedTech Dive reported CHG, following an agreement between Cresilon and the U.S. Defense Department's Walter Reed Army Institute of Research, is being studied for its potential in treating traumatic brain injuries, with the aim of developing a treatment that offers hemostatic and neuroprotective support for penetrating brain injuries. Cresilon's 510(k) clearance has been granted several months after the formation of this partnership.
