A recent clinical study published in the New England Journal of Medicine demonstrates that fish-skin grafts, developed by Kerecis, significantly outperform the standard of care in healing diabetic foot ulcers. The study, named Odinn (NCT04257370), is the largest randomized controlled trial of its kind, involving 255 patients with University of Texas grade 2 and 3 diabetic foot ulcers across multiple European countries.
Enhanced Healing Rates with Fish-Skin Grafts
After 16 weeks of treatment, the fish-skin grafts led to healing in 44% of patients, compared to only 26% in those receiving standard care, which included surgical debridement, dressings, and infection control. The fish-skin treatment also resulted in faster wound closure, approximately two weeks earlier than the standard approach.
The Odinn Study: Methodology and Results
The Odinn study enrolled patients with deep ulcers penetrating to the bones and joints. The trial was conducted across clinical sites in France, Italy, Germany, and Sweden. Most adverse events (272 out of 279) were deemed unrelated to the fish-skin treatment by the investigators.
Unique Properties of Fish-Skin Grafts
Kerecis' product utilizes fish skin sourced from Atlantic cod, which, unlike other tissue-transplant options, carries no viral transfer risk while maintaining regenerative properties. This makes it a safe and effective alternative for treating severe diabetic foot ulcers.
Expert Commentary
Kerecis Scientific Advisory Board Chairman John Lantis stated that the study "provides compelling evidence that fish skin grafts could redefine the standard of care." He added that the Odinn study's rigorous methodology and strong results pave the way for fish skin treatment to become the go-to option for managing severe diabetic foot ulcers, ultimately improving patient outcomes and quality of life.
Kerecis' Market Position and Coloplast Acquisition
Coloplast acquired Kerecis in a $1.3 billion deal, recognizing the company as one of the fastest-growing in the biologics wound care segment since its initial product launch in 2016. In the 2022/2023 financial year, Kerecis reported pro-rata revenue of DKr772m ($111m) with approximately 50% revenue growth. Kerecis recently launched Shield Standard, a new fish-skin graft with a silicon backing to maintain a moist wound-healing environment.
Wound Care Market Overview
The global wound care management market is projected to reach $38.8 billion by 2030, with a CAGR of 3.4%. The tissue-engineered skin substitutes market is expected to reach almost $3 billion by 2033.
