In major news released today, MiMedx Group announced that their AmnioFix® Injectable was awarded RMAT status by the U.S. FDA. This is the third RMAT designation awarded by the FDA this year and the 15th RMAT overall since the designation was introduced by the 21st Century Cures Act. The “Regenerative Medicine Advanced Therapy” (RMAT) Designation was introduced on December 13, 2016, when Congress included several provisions in the 21st Century Cures Act, an act signed into law by the 114th United States Congress authorizing $6.3 billion in funding, the bulk of which is allocated for programs supported by the National Institutes of Health (NIH).
The 21st Century Cures Act has had a profound effect on the regenerative medicine industry, supporting expansion of this industry to 600+ companies worldwide. The act also accompanies accelerated regulatory pathways that have been introduced in several other countries worldwide, including Japan, South Korea, and the E.U.
Within the U.S., sponsors of cell and gene therapies are eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs.
As announced in the press release issued March 9, 2018, by MiMedx Group:
MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx’s micronized amniotic tissue, AmnioFix® Injectable, the Regenerative Medicine Advanced Therapy (RMAT) designation for use in the treatment of Osteoarthritis (OA) of the knee.
In its letter to the Company, the FDA confirmed its determination that MiMedx Allogeneic Micronized Dehydrated Human Amnion/Chorion Membrane (micronized dHACM) for the treatment of OA of the knee meets the criteria for RMAT designation. The FDA further stated that MiMedx has provided clinical information to demonstrate preliminary clinical evidence to indicate that the drug has the potential to address unmet medical needs for this condition.
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