MiMedx Comments on Recent FDA Draft Guidance on Homologous Use of HCTPs

MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing 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Orthopedic, Spine, Sports Medicine, Ophthalmic, and the Dental sectors of healthcare, commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps") that the Food and Drug Administration ("FDA") published for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.
Parker H. "Pete" Petit, Chairman and CEO, stated, "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."
Bill Taylor, President and COO continued, "It also seems that the market does not understand that the homologous use element of the regulation is related only to marketing.  It specifically references that the HCT/P be 'intended for homologous use only, as reflected by the labeling, advertising, or other indication of the manufacturer's objective intent.'  In instances where companies have labeling outside of those requirements, the companies generally have not been required to remove their products from the market if a labeling change could bring them back into compliance with the requirements."
Parker H. "Pete" Petit, Chairman and CEO, stated, "We view the announcement of the April 13 meeting as a positive.  This meeting is designed to allow industry and outside sources to communicate with the FDA relative to the issues highlighted in their Guidance Documents.  This is part of the FDA's formal process of 'notice and comment' which we believe is appropriate to use in this situation.  We look forward to providing our comments on the Homologous Use Guidance Document, and we have previously provided comments on the Minimal Manipulation Guidance Document that was published late last year."
"In terms of the impact to MiMedx, we find the significant price decline in our stock today to be an overreaction of the market to this issue, likely because the market misunderstands the significance of the documents and the lengthy process that is involved in bringing matters to closure," continued Petit.  "What has been released by the FDA is an initial proposed draft, which is subject to modification as comments are received and testimony is submitted.  Additionally, a determination will need to be made as to whether the process will involve rulemaking and legislative oversight, which will further extend the process."
"We do not see issues related even to this version of the Draft Guidance that will be materially disruptive to our business," commented Bill Taylor, President and COO.  "These are highly complex regulatory issues, and should not be read without some broader understanding of this regulatory category.  To that end, we spent some time this morning on our earnings call clarifying these matters, and we hope that the market will take these facts under advisement in assessing the implications of the Draft Guidance," said Taylor.