Axogen, Inc, a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for AVANCE (acellular nerve allograft-arwx).

Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

The indications for sensory nerve discontinuities >25mm and for mixed and motor nerve discontinuities were approved under the FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps ≤25mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies.