UPDATE: MiMedx Issues Document Related to Misinterpretations of FDA's Proposed Homologous Use Draft Guidance

MiMedx Group, Inc.

, 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, announced today that it will post a document to rectify misinterpretations arising from the publication of the Food and Drug Administration's ("FDA's") October 28, 2015 proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps"). The document entitled "Discussion of FDA's Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products" will be posted by mid-day today and will be accessible on the home page of the MiMedx website at www.mimedx.com. Parker H. "Pete" Petit, Chairman and CEO, said, "As we have emphasized in our earlier communications on this topic, we assert that our products are in compliance with the homologous use positions taken by the FDA. We have further asserted that the proposed Draft Guidance position on homologous use is an instruction related to the marketing of HCT/Ps, as reflected by the labeling, advertising, or other indication of the manufacturer's objective intent for its products. The FDA has stated that its focus is on the promotion or labeling of HCT/Ps, rather than on their actual use. Although we have previously articulated these pertinent points, we decided to furnish a document that provides links to various FDA websites that confirm our position. We offer this document as a resource to assist with clearing up misconceptions, misunderstandings and misinformation on this subject and allow investors to verify the information themselves." Bill Taylor, President and COO, added, "The myriad of FDA regulations, public statements and opinions from the Tissue Reference Group (TRG) can be confusing. Specifically, a statement on amniotic membrane appearing in this recent Draft Guidance apparently originated from the TRG 2014 annual report. This statement was a response from the TRG to an inquiry from another company requesting a determination based on their input to the FDA for the specific product they described. In fact, the request could have come from a competitor or a company that does not even market amniotic tissue. Regrettably, there is no requirement that submissions to the TRG be for a company's own products. This statement in question was not in reference to any MiMedx products. We realize that these types of statements meant for a specific product can be extremely confusing when not understood in the context in which they were made." When publishing its product-specific recommendations, the TRG clearly states "Please keep in mind that updates to the TRG Annual Reports are stated in general terms in order to avoid revealing confidential information protected from disclosure. The TRG's recommendations are based on specific facts, which may not be provided in the updates. For these reasons, it may not be appropriate to generalize broadly from the updates." "We market our products for homologous uses that have been recognized by the FDA. Amniotic membrane has been used in numerous wound covering and wound healing applications for over 100 years. These applications have been highly publicized over a long period of time and have been repeatedly referenced by the FDA. These references form the basis for MiMedx's position on marketing, labeling and intended use. In our document, we have also provided a compilation of the pertinent websites and sources to review the prior FDA communications," commented Petit. The FDA issued this Draft Guidance in accordance with the time frame it had previously communicated. "We anticipated this Draft Guidance would be issued in the fall, and that the FDA would follow the proper protocol for industry and other involved parties to be advised of the scheduled hearing and provided adequate time in which to prepare and submit comments. The content of the Draft Guidance is as we expected, and we are satisfied that our practices are in full conformity," concluded Petit.