Market ExclusivityAvance has been granted Regenerative Medicine Advance Therapy designation; BLA approval would grant a period of 12 years of market exclusivity in the U.S.
Regulatory MilestonesAXGN completed significant regulatory milestones related to the Avance Nerve Graft BLA, including a late-cycle meeting and inspections under the FDA’s Bioresearch Monitoring program.
Revenue GrowthAxogen reported 23.5% year-over-year revenue growth, exceeding projections and demonstrating strong financial performance.