FDA OKs Kerecis’ Fish Skin Implant for Surgery

Kerecis, a company pioneering the use of fish skin and fatty acids in cellular therapy, tissue regeneration, and protection, received FDA authorization to market Kerecis Omega3 SurgiBind. The product, which is available now in the U.S., is an implantable fish-skin graft for use in plastic and reconstructive surgery. The product is indicated for implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
 
Vascular surgeon Dr. Hector Crespo Soto of the Sanger Heart and Vascular Institute of Atrium Health is the first physician to use SurgiBind commercially outside of a study. “I used the product in a ray amputation surgery, and I was pleased with the outcome. There were no post-op complications; the incision stayed closed and healed quickly. The Kerecis product compliments surgical procedures, provides a bacterial barrier and reinforces the body’s healing mechanism.”
 
Kerecis Omega3 SurgiBind helps practitioners better manage the risk of complications and improve outcomes. The fish-skin technology provides rapid incorporation and cell ingrowth, accelerated neovascularization and faster wound closure, all of which speed full tissue remodeling. Potential applications include reinforcement of soft tissues in abdominal incisions, surgical flaps and hip arthroplasty.
 
“This new product re-enforces our entry into the surgical market and demonstrates that the benefits of our technology extend beyond treating severe wounds and preventing amputations,” said Kerecis founder and CEO Fertram Sigurjonsson.
 
Kerecis Omega3 is intact fish skin that, when grafted onto damaged human tissue, recruits the body’s own cells and ultimately is converted into living tissue. Because no disease-transfer risk exists between cold-water fish and humans, the Kerecis fish skin is only gently processed and retains its similarity to human tissue. The gentle processing preserves the skin’s original three-dimensional structure, with its inherent natural strength, complexity and molecules (such as Omega3 and other fatty acids) maintained. Clinical studies have found that the Kerecis products heal wounds faster than competitive products.
 
Kerecis Omega3 SurgiBind is the company’s first implantable medical device aimed at the surgical market. In addition to SurgiBind, Kerecis has three other products for surgical applications: Kerecis Omega3 SurgiClose, SurgiClose Micro, and GraftGuide.
 
The introduction of SurgiBind further strengthens the entry of Kerecis into the surgical market and demonstrates the wider applicability of the Kerecis Omega3 technology beyond skin grafts for severe wound care.