Kerecis: A New Player in Diabetic Foot Ulcer Treatment

Kerecis, a pioneering company in the use of fish-skin and fatty acids for tissue regeneration and protection, has made a significant stride in the wound care market. The company's fish-skin grafts, MariGen and Kerecis Shield, have been included on the list of covered products for Diabetic Foot Ulcers (DFUs) in the final Local Coverage Determination (LCD) policy. This policy, effective in Q4 2024 or Q1 2025, will significantly boost demand for Kerecis' products and solidify its position in the wound care industry.

Kerecis' inclusion in the final LCD policy is a testament to the company's strong clinical evidence and cost-effectiveness compared to standard care. The Odinn study, published in NEJM Evidence, demonstrated that fish-skin grafts significantly outperform the standard of care in closing University of Texas grade 2 and 3 diabetic foot ulcers. Additionally, an independent analysis by Avalere Health concluded that the Lantis 2023 study is of comparable quality to the evidence base for the draft list of products recommended for coverage in the draft policy.

The final policy's implementation timeline allows Kerecis to continue covering diabetic foot ulcers in the out-patient setting, ensuring no disruption to business in the coming months. Once the policy is finalized, Kerecis' products will be covered, driving long-term growth. Kerecis' manufacturing capacity and logistics are in place to meet the anticipated increase in demand, ensuring a steady supply of its innovative, sustainable, and scalable fish-skin technology.

Kerecis' inclusion in the final LCD policy is expected to significantly boost the company's revenue and market share in the diabetic foot ulcer treatment segment. With Medicare beneficiaries accounting for a substantial portion of DFU patients, the policy change will open up access to a broader patient base. As a result, Kerecis is well-positioned to capture a larger share of the market, driving revenue growth and solidifying its position in the wound care industry.

The inclusion of Kerecis in the final LCD policy could have significant financial implications for competitors like MiMedx and Organogenesis. Kerecis' fish-skin grafts have demonstrated superior healing rates and cost-effectiveness compared to standard of care in treating diabetic foot ulcers (DFUs). With Kerecis now covered for DFU treatment, payors may shift towards Kerecis products, reducing market share for competitors. MiMedx and Organogenesis may face increased pressure to innovate and demonstrate clinical efficacy to maintain their market position.

In conclusion, Kerecis' inclusion in the final LCD policy is a significant milestone for the company, opening up new opportunities for growth and market share expansion. With strong clinical evidence and a robust manufacturing capacity, Kerecis is well-positioned to capture a larger share of the diabetic foot ulcer treatment market. As competitors adapt to the changing landscape, Kerecis' enduring business model and innovative fish-skin technology will continue to drive its success in the wound care industry.