MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA
MiMedx Group, Inc (MDXG)
Last mimedx group, inc earnings: 4/28 07:00 am
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Company Research
Source: GlobeNewswire
Receives Determination Letter from FDA Stating AXIOFILL Does Not Qualify for Classification as an HCT/P Under Section 361 MIMEDX Continues to Pursue All Available Options to Keep AXIOFILL on the Market Reiterates Expectations for 2024 Net Sales Percentage Growth in the Low Double Digits and 2024 Adjusted EBITDA1 Margin Above 20% MARIETTA, Ga., March 27, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has issued a determination letter in connection with the RFD process related to AXIOFILL, a human-derived particulate wound dressing. In the letter, FDA reaffirmed its position that AXIOFILL does not meet the regulatory classification requirements of a Human Cell, Tissue or Cellular or Tissue-based Product (“HCT/P”) under Section 361 of the Public Health Service Act (“PHSA”). Joseph H. Capper, MIMEDX Chief Executive Officer, commented: “We are disappointed that the FDA, through
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MDXG
News
- MIMEDX to Host First Quarter 2024 Operating and Financial Results Conference Call on April 30GlobeNewswire
- Global Advanced Wound Dressing Market is on track to reach a valuation of US$ 8,374.50 Million by 2034 at a CAGR of 2.80% | Future Market Insights, Inc. [Yahoo! Finance]Yahoo! Finance
- Spectral AI, Inc. (NASDAQ:MDAI) Q4 2023 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- MiMedx slips as FDA reaffirms position on Axiofill [Seeking Alpha]Seeking Alpha
- MIMEDX Provides Update on AXIOFILL® Request for Designation (“RFD”) from FDA [Yahoo! Finance]Yahoo! Finance
MDXG
Earnings
- 2/28/24 - Beat
MDXG
Sec Filings
- 4/24/24 - Form 4
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- MDXG's page on the SEC website