MiMedx Group, Inc. developed the proprietary PURION® Process that separates placental tissues collected after birth, cleans and reassembles layers, and then dehydrates the tissue for long term storage under sterile conditions. The PURION® Process removes free blood while retaining the amniotic membrane, leaving an intact ECM. The product can be used as a graft with natural barrier properties. PURION® processed dehydrated human allografts can be stored at ambient conditions for up to five years.
The human amniotic membrane comprised of the innermost layer of the placenta contains the amniotic fluid and the developing fetus, and lines the amniotic cavity. The membrane rich in extracellular matrix (ECM) contains collagen types I, III, IV, V, and VII, fibronectin, laminins, proteoglycans and glycosaminoglycans. In addition, embedded in the ECM, are growth factors such as epidermal growth factor (EGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), and platelet derived growth factor (PDGF) [1].
AmnioFix® is a composite amniotic tissue membrane isolated using the PURION® Process. The U.S. Food and Drug Administration (FDA) has granted MiMedx’s micronized (particulate) version of amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee [2].
RMAT designation is granted for therapies that treat, modify, reverse, or cure a serious condition, if preliminary clinical evidence indicates that it has the potential to address unmet medical needs. The FDA will provide MiMedx with intensive guidance on efficient drug development and is committed to involve senior management in facilitating the product’s development program. The RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs.
“AmnioFix Injectable has been shown to have the potential to reduce pain and improve function in patients with OA of the knee. Given the lack of treatment options for patients with this condition, 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 front-line therapy,” – Bill Taylor, President and COO.
Sources
- Lei, J. et al. Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts as a Therapy for Orthopedic Tissue Repair. 2017. Techniques in Orthopaedics. https://doi.org/10.1097/BTO.0000000000000229
- https://www.prnewswire.com/news-releases/amniofix-injectable-granted-regenerative-medicine-advanced-therapy-rmat-designation-by-the-fda-for-the-treatment-of-osteoarthritis-of-the-knee-300611583.html
