MARIETTA, Ga., Jan. 16, 2018 /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, today announced the first patients have been randomized and enrolled in the pivotal Phase 3 Investigational New Drug (IND) clinical trial to assess the safety and efficacy of AmnioFix® Injectable in patients with recalcitrant plantar fasciitis pain.
Top-line results from this study are expected in the second half of 2019. Following the conclusion of this trial, MiMedx intends to file a Biologic License Application (BLA) with the U.S. Food and Drug Administration for AmnioFix® Injectable to treat moderate to severe plantar fasciitis pain that has failed conservative treatment for at least 30 days. The Company projects the filing of the BLA related to plantar fasciitis will be in 2020.
Plantar fasciitis is the most common cause of chronic heel pain in adults, making up 11–15% of the foot symptoms requiring professional care among adults, according to studies published in the Journal of Research in Medical Sciences. It is estimated that 1 in 10 people will develop PF during their lifetime. Plantar Fasciitis is one of the most common orthopedic complaints relating to the foot, affecting approximately 9% of the U.S. population with approximately one million people per year seeking medical treatment. The Company believes 60% of these patients could be potential candidates to receive an AmnioFix injection, which MiMedx estimates represents approximately a $450 million annual market opportunity for the Company.
This Phase 3, prospective, double blinded, randomized controlled trial will enroll approximately 164 patients at 15 centers. Patients will be randomized 1:1 into two treatment groups; a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable. The primary efficacy endpoint is the change in Visual Analog Scale (VAS) score between baseline and day 90, expressed as the difference in means between the two groups. The primary safety endpoint is the incidence of adverse events, serious adverse events, and unanticipated adverse events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-controlled group.
Parker H. "Pete" Petit, Chairman and CEO, said, "I am pleased to announce that we have commenced enrolling the first Phase 3 patients in this significant study. For a long time, physicians treating musculoskeletal degeneration pain have highlighted the need for a new safe and durable first-line therapy, especially an injectable product. We believe AmnioFix Injectable meets this need and will quickly become the physician's product of choice for the vast majority of their patients."
Bill Taylor, President and COO, added, "We expect this Phase 3 study will confirm the results seen in our Phase 2B study that showed AmnioFix Injectable has the potential to provide an effective, safe and durable relief from pain associated with chronic plantar fasciitis."
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 million 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.
Safe Harbor Statement
This press release includes forward-looking statements, including statements regarding the Company's intention and timing of the filing of its Biologic License Application with the FDA, the belief that AmnioFix Injectable meets a market need and will quickly become the product of choice for physicians, and that the Phase 3 study results will confirm the results seen in the Phase 2B study.. 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 additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; 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; and the market may not adopt the utilization of AmnioFix Injectable as anticipated and it may not become the product of choice for physicians. 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.
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SOURCE MiMedx Group, Inc.
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