From Nasdaq:

MiMedx Group Inc. (MDXG) received a warning letter from the FDA regarding its product Axiofill. The FDA asserts that the production of Axiofill involves more than “minimal manipulation.” However, MiMedx does not agree with the FDA’s position and has been actively engaged with the agency through its “Request For Designation” process. The warning letter does not relate to any of the company’s other products, nor does it assert any product safety claims or adverse events related to Axiofill. The company believes that Axiofill was developed and is manufactured to comply with the requirements for a Human Cell, Tissue or Cellular or Tissue-based Product. MiMedx closed down 1.46 percent on Friday at $8.77.



Read more: MiMedx Receives FDA Warning Letter On Axiofill Production