With the release of new clinical data, the treatment method using whole fish skin for transplantation is gaining wider acceptance from U.S. insurance companies. Kerecis recently announced that, through policy updates with several national and regional insurance companies and state Medicaid programs, its fish skin transplantation product has added more than 40 million insured individuals to its U.S. insurance coverage.

This change was directly driven by a new study on patients with severe burns. The study analyzed treatment data from 61 burn centers in the United States and found that patients receiving Kerecis intact fish skin grafts had significantly shorter hospital stays (average 24.2 days) compared to those using recombinant cross-linked collagen and synthetic polyurethane materials, compared to 33.5 days in the synthetic material group. Furthermore, the fish skin group also had lower rates of sepsis, graft failure, venous thromboembolism, and hospital-acquired pressure ulcers. Specifically, the graft failure rate was 3.2% in the fish skin group and 8.3% in the synthetic material group.

Kerecis' complete fish skin graft products retain the original structure and biochemical composition of fish skin, aiming to promote cell ingrowth and tissue regeneration. Unlike over-processed or synthetic materials, this fish skin does not simply serve as a temporary covering, but participates in wound preparation and closure. In addition to burns, this product has also gained a leading position among skin replacement materials for diabetic foot ulcers.

Regarding insurance coverage, Kerecis is currently integrated into the policy framework established by Blue Cross Blue Shield. This association represents more than 30 independent health plans, and coverage may be further expanded in the future. Simultaneously, the company has expanded the accessibility of fish skin grafts through Medicaid programs in multiple states, and this treatment is now available in almost all states.

Kerecis founder and CEO Fetram Sigurjonsson stated that payers' evaluation methods for biologics are changing, with health insurance decisions increasingly emphasizing clinical efficacy, ease of use, and the ability to reduce the subsequent burden on the healthcare system. Fish skin transplantation's performance in these areas has driven the expansion of its coverage.

Gunnar Johannsson, the company’s senior vice president and chief medical officer, pointed out that major payers require biologics to provide reliable evidence of tissue regeneration, and efficacy data for severe ulcers have established a new clinical reference standard for this product.

The study employed a retrospective, propensity score matched cohort design, using data from the American Burn Association's Burn Care Quality Platform database. A total of 465 patients were included, with adjustments made for age, sex, total burn area, burn severity, inhalation injury, and trauma diagnosis. Sigurjonsson stated that the real-world comparative data demonstrates that fish skin that retains its natural tissue structure has quantifiable advantages in shortening hospital stays and reducing complications.