MiMedx Announces the Enrollment of the First Patients in the Phase 3 Clinical Trial of Amniofix Injectable for Achilles Tendonitis
January 17, 2018 at 07:45 pm IST
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MiMedx Group, Inc. announced that the first patients have been randomized and enrolled in the Company's Phase 3 Investigational New Drug (IND) clinical trial for MiMedx's micronized amniotic tissue, AmnioFix Injectable, in the treatment of Achilles Tendonitis. The Phase 3 Achilles Tendonitis clinical trial is studying MiMedx's AmnioFix Injectable in a prospective, double blinded, randomized controlled trial of the Micronized dHACM (dehydrated Human Amnion Chorion Membrane) Injection as compared to saline placebo injection. The design of the Phase 3 Achilles Tendonitis study will include approximately 158 patients. 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. The primary safety endpoint will be the proportion of product related adverse events, serious adverse events, and unanticipated adverse events during the first twelve months post injection in the AmnioFix Injectable group versus the placebo treated group.
MiMedx Group, Inc. is a placental biologics company. The Company is engaged in developing and distributing placental tissue allografts with patent-protected, processes for multiple sectors of healthcare. Its product portfolio categories include Wound Care Products, and Surgical and Other Products. Its Wound Care Products include EPIFIX, EPICORD and EPIEFFECT, which are all marketed for external use, such as in advanced wound care applications. Its Surgical and Other product offering includes AMNIOFIX, AMNIOCORD and AMNIOEFFECT, which are positioned for use in a variety of applications and surgical settings, including lower extremity repair, plastic surgery, vascular surgery and multiple orthopedic repairs and reconstructions. The Company's platform technologies include tissue allografts derived from the human placental membrane, tissue allografts derived from the human umbilical cord, and a particulate extracellular matrix derived from the human placental disc.
MIMEDX GROUP, INC. 
