MARIETTA, Ga., Feb. 3, 2017 /PRNewswire/ — MiMedx Group, Inc. MDXG 2.31%, 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 Dental sectors of healthcare, commented today regarding the Food and Drug Administration’s (“FDA’s”) recently published 2017 calendar year guidance agenda. The tissue-related Guidances to be finalized in calendar year 2017 do not include Guidances on Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps), including minimal manipulation and homologous use of HCT/Ps.
Parker H. Petit, Chairman and CEO, said, “Last September when the FDA convened its hearing on the proposed Draft Guidances on minimal manipulation and homologous use of HCT/Ps, there was an overwhelming response and considerable input given to the FDA by industry, academia, healthcare practitioners and patients. The almost universal sentiment from industry and the scientific community was that these Draft Guidances should be amended significantly or withdrawn in their entirety. Certain presenters at the September 2016 hearings also noted that some provisions of the Draft Guidances were outside the scope of FDA’s authority to regulate HCT/Ps and thus would require notice and comment rulemaking.”
Petit added, “I am encouraged that the FDA has not included these Draft Guidances in their 2017 calendar of those to be finalized. The massive amount of input that the FDA received during the hearing was certainly impactful, and it seems as if the Agency is not in a position to finalize Guidances in 2017 regarding the key HCT/P guidance documents related to homologous use and minimal manipulation.”
Bill Taylor, President and COO, commented, “There was a tremendous amount of data and scientific evidence presented to the FDA at last year’s hearings on HCT/Ps. The absence of any planned finalized Guidances on the key HCT/P guidance related documents is encouraging. Their absence on this year’s calendar gives us confidence that, when eventually finalized, these Guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community.”
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 human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, 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. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
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, the input from the hearings in 2016 impacted the decision not to finalize the HCT/P guidances in 2017, the delay in finalizing the HCT/P guidances is a positive, and the absence of the HCT/P guidances on this year’s calendar gives confidence that when eventually finalized, the guidances will have taken into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that other factors may be impacting the timing of the finalization of the HCT/P guidances, the final guidances may not necessarily take into consideration the valuable input of industry, academia, practitioners, patients, and the scientific community, the delay could have a negative impact rather than a positive one, 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, 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.
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