MiMedx Supports FDA's Decision to Postpone April 13th Hearing on Draft Guidance Documents

Mar 01, 2016, 07:00 ET from MiMedx Group, Inc.

MARIETTA, Ga., March 1, 2016 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic membrane and other birth tissues, human skin and bone, and patent-protected processes and proprietary platforms to develop and market advanced products and therapies, supports the decision by the Food and Drug Administration ("FDA") to postpone the April 13, 2016 hearing regarding the Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps") in order to accommodate the significant interest and response to be heard on this matter. The Company stated that the FDA's decision benefits patients, physicians, the industry and the FDA.

The FDA recently issued Draft Guidance documents regarding Minimal Manipulation and Homologous Use of Section 361 tissues, among other draft guidance documents.  The industry and public comments illustrated a very high level of public interest in the draft guidances, and therefore the FDA scheduled a public hearing for April 13, 2016.  The one-day hearing generated a great deal of interest.  In fact, there were so many persons interested in presenting at the hearing that the FDA was only able to allocate three minutes to each speaker, and six minutes to each trade association speaker.  Industry associations and companies, including MiMedx, petitioned the Agency to extend the public hearing in order to give interested parties an adequate amount of time to provide commentary.

Due to the "considerable interest" in the hearing topics, the FDA announced yesterday the postponement of the public hearing, "Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products."  In the FDA's letter to hearing participants, the agency stated, "Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined. The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics."

Parker H. "Pete" Petit, Chairman & CEO, commented, "There is a strong degree of interest in these new draft guidance documents and how they affect the regulation of human cells and tissues.  Based on our interaction with patients, physicians, other industry providers and industry associations, we knew that there would be a tremendous amount of interest in this very important matter. We suspected that the hearing would need to be extended in order for all of the key opinions and viewpoints of the stakeholders to be sufficiently heard. We are very pleased that these decisions were made by the FDA because it will allow the agency to initially benefit from the scientific evidence presented at the workshop, and subsequently apply that information to their regulatory decisions. MiMedx looks forward to participating in the scientific workshop as well as the regulatory hearing when scheduled in the future."

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 and human skin and bone.  "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®, OrthoFlo, Physio™, AlloBurn™, and CollaFix™. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may 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, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.  We recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use.  Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section.  Through the recent acquisition of Stability Biologics,  our newest proprietary platforms include Physio™, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a  demineralized bone matrix (DBM) to complement our product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns.  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.  The Company's wholly-owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA. The Company distinguishes its revenue in two primary regenerative medicine specialties of "Wound Care" and "SSO."  The Company defines SSO as surgical, sports medicine and orthopedics with spinal procedures included in orthopedics and abdominal, and lower pelvic procedures included in surgical.

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, MiMedx's participation in future scientific workshops and hearings related to draft guidances on minimal manipulation and homologous use for HCT/Ps, that the FDA will benefit from scientific evidence gathered on these topics, and that the decision to postpone the hearing will benefit patients, physicians, industry, and the FDA. 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 MiMedx may not be able to participate in future scientific workshops and hearings related to draft guidances on minimal manipulation and homologous use for HCT/Ps, the scientific evidence gathered on these topics may not benefit FDA, industry, or MiMedx, the decision to postpone the hearing may not benefit some or all patients, physicians, industry, and the FDA, , 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, 2015. 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.



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