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Orthopedic, Spine, Sports Medicine, Ophthalmic, and the Dental sectors of healthcare, commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps") that the Food and Drug Administration ("FDA") published for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.
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 the FDA's decision to conduct a public hearing is a positive event, that the price decline in the Company's stock is an overreaction to the FDA's Draft Guidance, that the market misunderstands the significance of the Draft Guidance, that there are no issues related to the Draft Guidance that would be materially disruptive to the business, that it is management's opinion that the Company is and has been in compliance with the homologous use requirements, and that companies generally have not been required to remove their products from the market for homologous use violations if a labeling change could bring them back into compliance with the requirements. 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 FDA Draft Guidance documents do 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 Company is not in compliance with the homologous use requirements as it believed; that companies will be permitted to cure homologous use issues with labeling changes,_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.