MARIETTA, Ga. - MiMedx Group, Inc. (NASDAQ:MDXG), a biopharmaceutical company, has announced its intention to keep its wound dressing product, AXIOFILL, on the market following a determination by the U.S. Food and Drug Administration (FDA) that the product does not meet the criteria for classification as a Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) under Section 361 of the Public Health Service Act.
The FDA's decision reaffirmed through the Request for Designation (RFD) process, classifies AXIOFILL as a Section 351 biologic product, which requires a more stringent approval process. MiMedx's CEO, Joseph H. Capper, expressed disappointment with the FDA's stance, citing an "inconsistent approach to regulating AXIOFILL and other human-derived particulate products."
In response to the FDA's determination, MiMedx has filed a lawsuit in the U.S. District Court for the Northern District of Georgia, aiming to challenge the FDA's ruling. The company plans to utilize all legal and regulatory avenues to maintain AXIOFILL's market presence. Despite the legal proceedings, MiMedx will continue marketing AXIOFILL, alongside at least two other similar products that have received different regulatory treatments from the FDA.
MiMedx has also taken steps to mitigate potential market disruptions by acquiring exclusive rights to a bovine-derived collagen particulate from Regenity Biosciences, with plans to launch this new product later in the year.
The company has reiterated its financial outlook for 2024, expecting net sales growth in the low double digits and an adjusted EBITDA margin above 20%. This guidance was initially provided during the earnings conference call on February 28, 2024, and the ongoing FDA dispute is not anticipated to necessitate a revision of these projections.
This news is based on a press release statement from MiMedx Group, Inc.
InvestingPro Insights
As MiMedx Group, Inc. (NASDAQ:MDXG) navigates the challenges posed by the FDA's classification of its AXIOFILL product, investors and stakeholders may find solace in some of the company's financial metrics and market performance. According to real-time data from InvestingPro, MiMedx boasts a robust Gross Profit Margin of 83.01% for the last twelve months as of Q4 2023, reflecting the company's ability to efficiently manage production costs relative to its revenue. This is particularly relevant as the company continues to market AXIOFILL while also expanding its product line with new offerings such as the bovine-derived collagen particulate.
Furthermore, InvestingPro Tips highlight MiMedx's financial resilience, noting that the company's liquid assets exceed short-term obligations, which may provide some assurance to investors concerning the company's ability to meet its immediate financial responsibilities despite the FDA's recent ruling. Additionally, the company has been profitable over the last twelve months, a positive sign for potential profitability this year, as analysts have predicted. These factors may contribute to the company's steadfast financial outlook for 2024, with expected net sales growth in the low double digits and an adjusted EBITDA margin above 20%.
Investors interested in a deeper dive into MiMedx's performance and potential can explore further with InvestingPro, where there are six additional InvestingPro Tips available at https://www.investing.com/pro/MDXG. For those considering a subscription, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking even more valuable insights to guide investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.