• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

MiMedx wins FDA regenerative med status for AmnioFix

March 12, 2018 By Sarah Faulkner

MiMedxMiMedx (NSDQ:MDXG) won regenerative medicine advanced therapy status from the FDA for its injectable osteoarthritis drug, AmnioFix, the company announced this week.

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%.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Orthopedics, Pharmaceuticals, Regenerative Medicine, Regulatory/Compliance, Wall Street Beat Tagged With: mimedx

IN CASE YOU MISSED IT

  • Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent
  • Senseonics closes public offering, private placement with Abbott
  • Embecta eyes shift from insulin delivery to broader medical supplies focus
  • Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
  • Sequel Med Tech to pair automated insulin delivery system with Abbott’s future dual glucose-ketone sensor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS