15th Nov 2024 08:04
(Sharecast News) - Medical products group Convatec has expressed disappointment with a ruling which excludes its InnovaMatrix product from Medicare coverage in the US, but says it is confident of securing coverage in the future.
The Medicare Administrative Contractors has published so-called Local Coverage Determinations (LCDs) for skin substitute grafts, and cellular and tissue-based products for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU), but did not name InnovaMatrix.
"This is disappointing, but as expected," Convatec said in a statement on Friday.
"InnovaMatrix is an excellent product which is delivering strong real-world results for patients and is trusted by clinicians. Convatec remains confident of securing DFU/VLU coverage and as such, we expect any exclusion from the LCDs to be temporary."
The company it will continue to serve patients with other indications, which comprise 55% of its US wound biologics market and 25% of Convatec's InnovaMatrix sales this year.
"Convatec remains confident of securing coverage. We continue to build our clinical evidence portfolio in DFU/VLU including through real-world evidence and have already initiated randomised controlled trials which we expect to report in 2026," the company said.
Despite the disappointment, Convatec said its guidance for 2024 remains unchanged.
Shares were down 1.5% at 243.8p by 0816 GMT.