Axogen’s Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged a month or older with sensory, mixed, and motor peripheral nerve discontinuities.
Shares of Axogen Inc. (AXGN) were up more than 8% in Thursday’s pre-market trade after the company announced that it had received approval from the U.S. Food and Drug Administration (FDA) for its nerve repair graft.
Axogen announced on late Wednesday that the FDA had approved its Biologics License Application for Avance, which is an acellular nerve scaffold for the treatment of adult and pediatric patients aged a month or older with sensory, mixed, and motor peripheral nerve discontinuities.
Retail sentiment on Stocktwits around the AXGN stock soared, entering the ‘extremely bullish’ territory from ‘bullish’ a day ago, while message volumes increased to hover at ‘extremely high’ levels from ‘normal’ a day ago.
Why Is This Important?
Axogen’s Avance nerve graft is a human-tissue-based solution for repairing damaged peripheral nerves. It eliminates the need for a secondary nerve-harvesting surgery, helping reduce the risk of complications and enabling faster recovery.
“This milestone clarifies and strengthens our regulatory footing and confirms approval for use of Avance as an acceptable therapeutic option for treating peripheral nerve discontinuities in all of Axogen’s present nerve repair use cases,” said Michael Dale, CEO, Axogen.
When Will It Be Available?
The company expects the commercial availability of the licensed Avance nerve graft product in the second quarter of 2026. Until then, the company will continue to offer Avance under the current tissue framework.
Axogen cautioned that since Avance is made from human donor tissue, there is a risk of transmitting infectious agents such as viruses.
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