MiMedx To Publish Document Regarding Misinterpretations Of The FDA's Proposed Homologous Use Draft Guidance

Nov 04, 2015, 07:30 ET from MiMedx Group, Inc.

MARIETTA, Ga., Nov. 4, 2015 /PRNewswire/ -- 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, 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arising from the publication of the Food and Drug Administration's ("FDA's") October 28, 2015 proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps"). The document entitled "Discussion of FDA's Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products" will be posted by mid-day today and will be accessible on the home page of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 We have further asserted that the proposed Draft Guidance position on homologous use is an instruction related to the marketing of HCT/Ps, as reflected by the labeling, advertising, or other indication of the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  Specifically, a statement on amniotic membrane appearing in this recent Draft Guidance apparently originated from the TRG 2014 annual report.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.

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues.  "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself.  Our biomaterial platform technologies are AmnioFix®, EpiFix®, CollaFix™ and OrthoFlo. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Through our donor program, a mother delivering via scheduled full-term Caesarean section birth can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 500,000 allografts to date for application in the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. The Company has recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by consenting mothers delivering healthy babies by scheduled full-term Caesarean section births. CollaFix™, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.  CollaFix™ is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, that there are misinterpretations of the Draft Guidance, that the Company is and has been in compliance with the homologous use requirements, that the Company's view on homologous use is a correct interpretation, that the Company's discussion paper will clear up misconceptions, misunderstandings and misinformation on this subject, that the FDA has provided industry and other stakeholders with adequate time to prepare and submit comments, and that the FDA's procedural approach is appropriate. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the public hearing on the Draft Guidance does not proceed as anticipated or at all; that the final Draft Guidance document contains rules that were not anticipated; that the FDA's application of the final Draft Guidance is not as anticipated; that the FDA changes its interpretation of other rules that impact the issues described here; that the Company is not in compliance with the homologous use requirements as it believed; that the Company's discussion paper does not clear up misconceptions, misunderstandings and misinformation; that the issues are such that the time provided to submit comments is insufficient, that the FDA's procedural approach is not appropriate as believed, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2014 and its most recent Form 10Q filing. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

 

SOURCE MiMedx Group, Inc.



RELATED LINKS

http://www.mimedx.com