MiMedx Group confirmed the enrollment of first patients in the Company’s Phase 3 Investigational New Drug (IND) Clinical Trial for MiMedx’s micronized amniotic tissue, AmnioFix Injectable for treating Achilles Tendonitis. The company is assessing the AmnioFix Injectable in a randomized controlled Trial of the Micronized dHACM (dehydrated Human Amnion Chorion Membrane) Injection in comparison with saline placebo injection. A biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes suited for various arenas of healthcare.
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 group versus placebo-treated group.
Parker H. “Pete” Petit, Chairman and CEO, said, “We are pleased to enroll our first patients in this important Phase 3 IND study in the Orthopedic/Sports Medicine area. Clearly, there is an unmet need in the market for this type of treatment, and we believe the efficacy and safety profile of AmnioFix Injectable meets that need. Available treatments such as corticosteroids or platelet rich plasma have not been consistently shown to be effective as a first-line therapy for this condition. This is our second Phase 3 clinical trial that has commenced patient enrollment. Yesterday, we announced the start of patient enrollment on our Phase 3 Plantar Fasciitis clinical trial.”