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News Release - September 7, 2017
MiMedx Notified By FDA That It Can Proceed With Phase 3 Investigational New Drug Clinical Trial For Achilles TendonitisMARIETTA, Ga., Sept. 7, 2017 -- (Healthcare Sales & Marketing Network) -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has been notified by the Food and Drug Administration (FDA) that the Investigational New Drug (IND) Phase 3 Achilles Tendonitis clinical study may proceed.
The Achilles Tendonitis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 3, prospective, double blinded, randomized controlled trial of the Micronized dHACM (dehydrated Human Amnion Chorion Membrane) Injection as compared to saline placebo injection in the treatment of Achilles Tendonitis. The Company expects patient enrollment to commence in the next quarter.
The trial will enroll approximately 158 study patients with moderate to severe pain due to Achilles Tendonitis with failed conservative treatment of at least one month. The IND Phase 3 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of moderate to severe pain due to Achilles Tendonitis.
The primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.
The Achilles Tendonitis study is the second IND Phase 3 trial for MiMedx AmnioFix Injectable. MiMedx plans to submit a Biologic License Application (BLA) to the FDA for tendonitis when the Company's Plantar Fasciitis Phase 3 trial completes.
Parker H. "Pete" Petit, CEO, said, "We are pleased to receive the FDA's notification that we can proceed with another Phase 3 IND study in the Orthopedic/Sports Medicine area. In addition to this IND study, we are planning to file for another IND by the end of this quarter. This additional IND will be for the use of our micronized dHACM in the treatment of Osteoarthritis knee pain. With the commencement of the Osteoarthritis study, we will have three IND studies ongoing. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders appraised on our future study results. Later this year, we will hold a meeting in New York that will include presentations by MiMedx executives and the physicians involved with our various IND studies to better inform analysts and our shareholders of these important activities."
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. "Innovations in Regenerative Medicine" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.
Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as "believe," "except," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.
Source: MiMedx Group
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