Axogen’s Avance Nerve Graft Receives Regenerative Medicine Advanced Therapy Designation (BioFlorida)

AxoGen, Inc., a global leader in developing and marketing innovative surgical solutions for damage or discontinuity to peripheral nerves, reported that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Avance® Nerve Graft. AxoGen is a UF startup and graduate of UF Innovate | Sid Martin Biotech.

The RMAT designation, under the 21st Century Cures Act, aims to streamline development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions. A regenerative medicine therapy is eligible for the designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such a disease or condition.

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