MiMedx Enrolls First Patient In Its Phase 2B Clinical Trial Of RMAT Designated AmnioFix® Injectable For The Treatment Of Osteoarthritis Of The Knee
OA of the knee is a degenerative and irreversible condition that is associated with pain, restricted mobility, and ultimately joint instability. For many, the disease significantly limits day-to-day function and can only be treated with joint replacement surgery. According to the
Parker H. "Pete" Petit, Chairman and Chief Executive Officer, said, "The enrollment of our first patient in this Phase 2B clinical study is another important milestone for
By granting the RMAT designation to AmnioFix Injectable for use in the treatment of OA of the knee, the
"Given the lack of treatment options for patients with knee OA, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new, safe, effective and durable front-line therapy for treating OA knee pain," added
Clinical Study Design
This Phase 2B, prospective, double blinded, randomized controlled trial will enroll approximately 318 patients at 20 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 co-primary efficacy endpoints are the change in Visual Analog Scale (VAS) score and the change in
MiMedx® is a 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 the Company's mission to give physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization.
Safe Harbor Statement
This press release includes forward-looking statements that may be identified by words such as "believe," "expect," "may," "plan," "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.
Actual results may differ from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company's most recent annual report or quarterly report filed with the
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