The U.S. regulatory watchdog told MiMedx that the company provided sufficient preliminary evidence that AmnioFix could address unmet needs for patients with osteoarthritis of the knee.
“The FDA’s RMAT designation for AmnioFix Injectable is an important milestone for MiMedx and highlights the importance of introducing promising therapies in areas of considerable unmet medical need,” chairman & CEO Parker Petit said in prepared remarks. “We are especially pleased that the FDA will meet to discuss expediting our development and manufacturing of this product to serve the needs of patients suffering from OA of the knee. We look forward to discussions with the FDA.”
“AmnioFix Injectable has been shown to have the potential to reduce pain and improve function in patients with OA of the knee. Given the lack of treatment options for patients with this condition, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new front-line therapy,” Bill Taylor, president & COO, said.
“In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially exceeding $4 billion for musculoskeletal pain management within the more than $12 billion addressable U.S. joint pain injection market,” Taylor added.
Thanks to the RMAT designation, MiMedx will have access to early interaction with the regulatory agency and the possible for accelerated approval.
MiMed’x AmnioFix product is a micronized dehydrated human amnion/chorion membrane (dHACM) injection.
MiMedx shares lost nearly a third of their value in a single day last month, after the company announced it would delay the release of its 2017 financial results in light of an internal investigation into alleged issues with sales and distribution practices at the company.
The Marietta, Ga.-based company said that its board’s audit committee has tapped a group of independent legal and accounting advisors to conduct an internal investigation into the matters, and that company executives are also reviewing the “accounting treatment of certain distributor contracts.”
Earnings results will be delayed until the internal investigation is complete, MiMedx said in its press release, but added that it is hopeful that the investigation will not have a material impact on its revenue guidance for the coming year.
MDXG shares were trading at $7.50 apiece in pre-market activity today, up 1.1%.