MARIETTA, Ga., Dec. 15, 2016 /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 Dental sectors of healthcare, today expressed its endorsement of the 21st Century Cures Act that cleared the U.S. Senate last week with bipartisan support and received Presidential signature on Tuesday, December 13th.
Parker H. "Pete" Petit, Chairman and CEO, stated, "We are excited about the passage of this groundbreaking medical innovation and research legislation that will help millions of Americans with life-threatening diseases and their families. The 21st Century Cures Act contains a vast array of provisions that will significantly advance medical innovation in this country. We are especially pleased that this legislation will increase regulatory clarity, improve the regulation of regenerative cell therapies and provide for a regenerative medicine therapy designation in U.S. law. We have long supported this important legislation, and we are very gratified that specific language was included in the Bill for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) definitions. Companies will now be able to apply to the Food and Drug Administration (FDA) for a new designation, 'regenerative advanced therapy' that makes them eligible for several existing types of special treatment, provided that their product targets a serious disease, and based on preliminary clinical evidence, has the 'potential to address unmet medical needs.' We expect this will be advantageous to our new product submissions."
Bill Taylor, President and COO, said, "Another of the key components of this act that will be extremely beneficial to MiMedx is the accelerated approval pathway. By extending the existing FDA accelerated pathway to now include regenerative cell therapy, will greatly improve the FDA's trajectory for finding new cures and treatments for patients, it will also preserve the gold standard for safety and efficacy, and the new legislation gives MiMedx an optimized pathway that we can build on. This is a very positive development for us and other companies in regenerative medicine since this new FDA change allows a drug to reach the market based on what are called intermediate or surrogate clinical trial endpoints or measures that are predictive of longer term disease outcomes. Compared with the standard approval pathway, that could mean fewer, shorter, or smaller clinical trials."
"This is an important step in the right direction for regenerative medicine. The 21st Century Cures Act provides much needed reform of how the FDA handles regenerative medicine. We are looking forward to witnessing its positive effects on the medical advances coming out of our sector of healthcare," concluded Petit.
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 21st Century Cures Act will help millions of Americans with life-threatening diseases, significantly advance medical innovation in the U. S., increase regulatory clarity, improve the regulation of regenerative cell therapies, greatly improve the FDA's trajectory for finding new cures and treatments, and give MiMedx an optimized regulatory pathway to build on, and that the Company expects the "regenerative advanced therapy" designation will be advantageous to MiMedx new product submissions. 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 legislation may not have the expected impact on life-threatening diseases, providing regulatory clarity and improving the FDA's trajectory for finding new cures and treatments, the regulatory pathways for MiMedx may not be an optimized one to build on, that the "regenerative advanced therapy" designation may not be as advantageous to MiMedx new product submissions as expected, 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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SOURCE MiMedx Group, Inc.