MiMedx Group Inc.01.06.16
Marietta, Ga.-based MiMedx Group Inc. has earned the OK from the U.S. Food and Drug Administration (FDA) to export its human cells, tissues and cellular and tissue-based products—HCT/Ps, an official FDA product designation.
“There has been some measure of confusion in the market related to FDA’s position regarding our sheet allografts, particularly EpiFix and AmnioFix,” said Chairman and CEO Parker H. Petit said. “We have stated all along that while we are in discussion with the FDA regarding our micronized allografts, the FDA has indicated that they have no issues with our sheet allografts and that they do, in fact, qualify as HCT/P’s. As we continue to expand our International efforts, many foreign governments require a CFG, or Certificate to Foreign Government. Companies request these documents from the FDA, and the FDA generated the certificate. We recently received our updated certificate and felt it was appropriate to put it on our website and resolve any confusion that may exist. The statement in the certificate referenced above is very clear that the FDA considers the MiMedx sheet allografts to be regulated as HCT/P’s.”
MiMedx is a regenerative medicine company that uses human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the wound care, surgical, orthopedic, spine, sports medicine, ophthalmic, and dental sectors of healthcare.
“There has been some measure of confusion in the market related to FDA’s position regarding our sheet allografts, particularly EpiFix and AmnioFix,” said Chairman and CEO Parker H. Petit said. “We have stated all along that while we are in discussion with the FDA regarding our micronized allografts, the FDA has indicated that they have no issues with our sheet allografts and that they do, in fact, qualify as HCT/P’s. As we continue to expand our International efforts, many foreign governments require a CFG, or Certificate to Foreign Government. Companies request these documents from the FDA, and the FDA generated the certificate. We recently received our updated certificate and felt it was appropriate to put it on our website and resolve any confusion that may exist. The statement in the certificate referenced above is very clear that the FDA considers the MiMedx sheet allografts to be regulated as HCT/P’s.”
MiMedx is a regenerative medicine company that uses human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the wound care, surgical, orthopedic, spine, sports medicine, ophthalmic, and dental sectors of healthcare.