AxoGen Touts FDA BLA Win, Targets 18% Growth and Wider Nerve Repair Adoption

Company outlines mission to make nerve function restoration a standard of care at Raymond James conference

Published on Mar. 8, 2026

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AxoGen (NASDAQ:AXGN) used its presentation at the 47th annual Raymond James Institutional Investors Conference to outline its mission to make restoration of peripheral nerve function an expected standard of care, while also providing updates on growth expectations, reimbursement progress, and the implications of its recently secured FDA Biologics License Application (BLA) for its AVANCE Nerve Graft.

Why it matters

AxoGen is working to address a significant unmet need in nerve care, as nerve injuries from trauma or surgical procedures often do not regenerate on their own and require specialized repair and reconstruction to restore function. The company's products and strategic focus aim to drive wider adoption of nerve repair solutions and establish it as a standard of care.

The details

CEO Mike Dale described peripheral nerve function as foundational to everyday motor and sensory activity, but said nerve care is often not systematically addressed after trauma or during other surgical interventions. He highlighted two primary sources of nerve injury: trauma and iatrogenic injury resulting from surgeries that transect or damage nerves. Dale said nerves do not regenerate on their own and require repair and reconstruction to restore function. AxoGen's portfolio includes the AVANCE Nerve Graft, which Dale called the foundational product of the business and 'the first-ever approved biologic therapeutic solution' for treating nerve discontinuities, with a generalized indication for use throughout the body.

  • AxoGen expects to draw conclusions on its prostate procedure in the second half of 2026, toward the end of the third quarter and into the fourth quarter.
  • AxoGen provided guidance for the year, including at least 18% growth, or $266 million in total revenue, with gross margin of 74% to 76% and net free cash flow positive for the year.

The players

AxoGen, Inc.

A Florida-based medical technology company that develops and commercializes surgical solutions for peripheral nerve damage, focusing on restoring nerve function and improving patient outcomes through innovative biologic and engineered products.

Mike Dale

CEO of AxoGen, who outlined the company's mission to make restoration of peripheral nerve function an expected standard of care.

Lindsey Hartley

CFO of AxoGen, who discussed gross margin dynamics tied to the biologics manufacturing transition and addressed a recent $142 million financing.

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What they’re saying

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