MiMedx Notified By FDA That It Can Proceed With Phase 2B Investigational New Drug Clinical Trial For Osteoarthritis Of The Knee
MARIETTA, Ga., Oct. 17, 2017 /PRNewswire/ — 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 its Investigational New Drug (IND) Phase 2B clinical study for osteoarthritis of the knee may proceed.
The clinical study consists of a Phase 2B, prospective, double-blinded, randomized controlled trial of MiMedx’s AmnioFix® Injectable (micronized dehydrated Human Amnion Chorion Membrane), compared to saline placebo in the treatment of knee osteoarthritis. The trial will enroll approximately 318 patients and the Company expects patient enrollment to commence in the next quarter.
In the Company’s press release of September 19, 2017, MiMedx announced that it had filed for this IND Phase 2 to be initiated. In that press release, the Company indicated the IND Phase 2 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 osteoarthritis of the knee. The primary efficacy endpoints of this study will be the change in Visual Analog Scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index for patients between baseline and Day 90 between the AmnioFix Injectable group versus the placebo-control group. The primary safety endpoint will be the proportion of product-related Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during 12 months following injection in the AmnioFix Injectable group versus the placebo-control group.
Parker H. “Pete” Petit, CEO, said, “This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable. We are pleased to receive the FDA’s notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area. We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised 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.”
Bill Taylor, President and COO, stated, “The first two ‘Biologics License Application (BLA) indications for use’ we are currently targeting for AmnioFix Injectable are General Tendonitis and Osteoarthritic Knee Pain, which represent approximately 80% of the more than 15 million injections done each year to treat musculoskeletal pain. We believe the results of our BLA clinical trials and safety profile will demand a price per dose of $1,000 or more. This expands the musculoskeletal degeneration market for our first two BLA products to more than a $12 billion U.S. market opportunity. We believe the non-degenerative aspect and potential reduction in opioid use due to our Amniotic Injectable product will drive significant adoption. We expect the study results to be compelling, and we look forward to the prospects of clinicians utilizing AmnioFix Injectable in the treatment of these debilitating conditions.”
About MiMedx
MiMedx® is 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. “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 Company’s belief that AmnioFix Injectable is an ideal treatment alternative for osteoarthritis of the knee, expectations as to pricing and market opportunity, and expectations that study results will be compelling. 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 results or concerns may arise from data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies or may fail to approve or may delay approvals; reimbursement decisions by public and private payers may not occur as expected; and market opportunities may not materialize or may change in the future. For more detailed information on the risks and uncertainties, 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, Inc.
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