Convatec Group Plc (LON:CTEC) has welcomed the postponement by the Centers for Medicare & Medicaid Services (CMS) of the LCDs for Skin Substitute Grafts/Cellular and Tissue-Based Products for the treatment of Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs), which was announced late-afternoon UK-time on Friday 11 April 2025. This action by the US Administration means that Medicare patients with DFUs and VLUs will continue to benefit from access to InnovaMatrix®.
InnovaMatrix® is an excellent product delivering strong real-world results for patients and is trusted by clinicians. Convatec remains committed to evidence-based medicine to improve outcomes for patients and choice for HCPs. Our randomised controlled trials (RCTs) in DFU and VLU are on track to report in 2026. These will complement our published real-world evidence (RWE), including RWE published in December 2024.
We believe any future policies for skin substitute products should focus on serving the best interests of patients, protecting patient and provider choice, and delivering value for payors. It is vital that responsible and innovative companies like Convatec can continue to invest in pioneering skin substitute products in the US. Convatec is committed to continuing to work collaboratively with the US Administration and CMS on the development of future policies.
Financial guidance
We previously guided to InnovaMatrix® revenue of approximately $50m in FY25. As a result of the postponement of the LCD, and reflecting the ongoing uncertainty in the market, we now expect InnovaMatrix® sales of approximately $75m in FY25. There is no change to any other financial guidance. Our four-month trading update is 22 May 2025.
