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Axogen has begun the rolling submission of its Biologics License Application (BLA) for Avance Nerve Graft to the FDA as of May 15, 2024. This milestone marks a important step in transitioning Avance Nerve Graft to a biologic. The initial submission includes non-clinical data, with clinical and manufacturing data to follow. Avance Nerve Graft has received Regenerative Medicine Advanced Therapy (RMAT) designation, providing benefits such as FDA guidance and potential priority review. Axogen aims to complete the BLA filing by Q3 2024, anticipating approval by mid-2025.
Axogen, a leader in surgical solutions for peripheral nerve injuries, announced its participation in the Leerink Partners Healthcare Crossroads Conference.
CEO Karen Zaderej will engage in a fireside chat on May 29, 2024, at 3:40 p.m. CT / 4:40 p.m. ET in Austin, TX.
The event will be webcast live and later archived for 90 days on the company's Investors page.
Axogen, Inc. reported a 12.9% increase in revenue in the first quarter of 2024, reaching $41.4 million. The company's gross margin improved to 78.8%, while net loss decreased to $6.6 million. Adjusted net loss was $2.7 million, with adjusted EBITDA at $1.0 million. Cash, cash equivalents, and investments totaled $23.6 million. Axogen is focusing on reaching profitability, with upcoming product launches and submission milestones.
Axogen, Inc. (NASDAQ: AXGN) announces the first surgical implants of its Avive+ Soft Tissue Matrix™, a resorbable barrier for nerve injuries. The product aims to enhance nerve protection during healing phases. Surgeon feedback is positive, with a national launch expected in Q2 2024. Avive+ is a placenta-based allograft processed under FDA regulations to address various nerve injuries and defects, offering promising solutions for patients experiencing nerve trauma.