AmnioFix® Overview
MiMedx Group's wholly-owned subsidiary, Surgical Biologics, is a market leading processor of amniotic tissue for use in a wide variety of surgical reconstructive procedures for soft tissue repair.
AmnioFix® is a biologic Amniotic Membrane processed through Surgical Biologic's proprietary Purion® process, which combines cleaning, dehydration and sterilization to produce a safe, technically sterilized tissue allowing for storage at room temperature.
AmnioFix® is processed from Human tissue according to the American Association of Tissue Banks (AATB) regulations, and is considered tissue under Section 361 of the Public Health Service Act. This means that AmnioFix® is regulated differently than the other two MiMedx platform technologies, CollaFix® and HydroFix®, which are regulated as medical devices and therefore need FDA clearances prior to marketing in the United States. Since it is regulated as a tissue, AmnioFix® does not need such clearance or approval in the United States.
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