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MiMedx Group (MDXG) the FDA has already declared homologous use for amniotic tissue - BUY

October 30, 2015 8:08am

FDA drafts guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based products

MDXG commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products that the FDA published for comment on October 28, 2015 and the Notice of Public Hearing and Request for Comments released today indicating the agency would hold a public hearing on April 13, 2016 to obtain input on that Guidance as well as three other recently issued guidance documents on HCT/Ps.

The Bottom line: "It is our management's opinion that we are and have been in compliance with the homologous use requirements. We have always marketed our products with general intended uses that have been documented by the FDA as being homologous use for amniotic tissue. Our marketing does not reflect statements about our membranes being intended for use for specific indications such as dermal ulcers. Our materials are much more general, and reflect uses that the FDA has already declared as homologous use for amniotic tissue."

MDXG closed DOWN -$2.20 to $7.29 – another “war of words” – Maintaining BUY <on any dips>

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