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dehydrated human 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) standards, and is considered a tissue product 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 product, AmnioFix® does not need such clearance or approval in the United States.
Re: AmnioFix (amniotic membrance) injections for plantar fasciitis
Anyone else think this is ridiculous? Injecting a product made from human amniotic membrane for a condition that has a predominantly biomechanical cause?
Check out all the registered trademarks. Anyone else creeped out by the concept of research to assess the effectiveness of using human tissue to establish a market for the sale of this tissue? For bloody plantar fasciitis! I mean, corneal transplants and other organs, ok that makes sense. But amniotic membrane for heel pain? Crazy.
Mackay, Queensland Australia