Startup’s fast-acting wound treatment gel gets FDA nod for use in humans

Dive Brief:

Cresilon has received 510(k) clearance from the U.S. Food and Drug Administration for a gel that is designed to quickly stop bleeding when applied to a wound.
The technology, Cresilon Hemostatic Gel (CHG), is indicated for use in the local management of bleeding wounds such as minor cuts, lacerations and abrasions.
Cresilon raised $25 million last year to support its expansion into human health. The company already sells a product, Vetigel, for use in animals.

Dive Insight:

Cresilon’s 510(k) clearance comes months after the U.S. Defense Department’s Walter Reed Army Institute of Research formed an agreement with the company to study the gel technology in the treatment of traumatic brain injuries. The goal is to develop a treatment that provides hemostatic and neuroprotective support after a penetrating brain injury, according to the company.

Cresilon’s Vetigel animal health product is made of two biopolymers that form a mechanical barrier when applied to wounds. The barrier clots the wound and stops bleeding without the application of pressure.

Last year, Cresilon signaled its intent to expand into human health by raising financing in a round that took its fundraising total up to $80 million. The company, formerly known as Suneris, has used the money to establish a 60-person team at a 25,000-square-foot manufacturing facility in New York City and to secure its 510(k) clearance, a company spokesperson wrote in an email.

CHG, Cresilon’s human use product, is a plant-based gel that, like its animal health counterpart, stops bleeding when put on a wound without the need for manual pressure. Cresilon has designed the gel to instantly stop bleeding at the point of care, giving CHG attributes that the company thinks will drive its expansion into human health.

“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,” Cresilon CEO Joe Landolina said in a statement.