Biopharma · FDA Approvals · Stock
MiMedx Group Inc develops and markets regenerative biomaterial products and bioimplants made from the human amniotic membrane, birth tissues, and human skin & bone. Its products are targeted towards the wound-care, burn, surgical, sports medicine, and orthopedics markets. MiMedx's key products are allografts processed …
Assets on file: AXIOFILL
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MiMedx Receives FTC Second Request for Sanara MedTech Merger
MiMedx and Sanara each received a Second Request from the FTC regarding the proposed merger. This extends the HSR waiting period until 30 days after substantial compliance with the request. The merger remains subject to HSR clearance and other closing conditions.
MiMedx Wins Court Ruling Vacating FDA's AXIOFILL Minimal Manipulation and Biologic Classification
Federal court vacated FDA's determinations that AXIOFILL is more than minimally manipulated and should be regulated as a biologic product. The matter is remanded to FDA for reconsideration using the correct tissue-characteristics standard relevant to recipient utility and with adequate explanation for any disparate treatment versus similar products.
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