Axogen Inc. Initiates Rolling Submission of Biologics License Application for Avance Nerve Graft to U.S. FDA, Boosting Investor Confidence with 1.41% Rise in Stock

Alachua, Fla. and Tampa, Fla., May 16, 2024 - Axogen Inc. (NASDAQ: AXGN), a recognized global leader in the development and marketing of innovative surgical solutions for peripheral nerve injuries, is proud to announce the commencement of the rolling submission process for a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for licensure of Avance Nerve Graft. This significant milestone was achieved on May 15, 2024.

Avance Nerve Graft, Axogen's pioneering surgical solution, has demonstrated immense potential in addressing peripheral nerve injuries. With the initiation of the BLA submission process, Axogen is taking a crucial step towards making this revolutionary treatment available to patients in need.

The rolling submission process allows Axogen to submit portions of the BLA to the FDA for review on a rolling basis, streamlining the approval process and potentially expediting the timeline to market availability. By opting for this approach, Axogen demonstrates its commitment to rapidly serve patients suffering from peripheral nerve injuries.

Axogen's decision to pursue FDA licensure for Avance Nerve Graft is founded on an excellent clinical track record. The company has conducted extensive preclinical and clinical studies to establish the safety and efficacy of the product. Avance Nerve Graft has been validated through various trials, showcasing its potential to boost nerve regeneration and recovery for patients, significantly improving their quality of life.

In light of Axogen's recent progress, investors have responded positively. Over the past week, Axogen Inc stock experienced a significant increase of 1.41%. This surge reflects the confidence of investors in the company's ability to secure FDA approval for Avance Nerve Graft, opening new opportunities for revenue generation and market expansion.

Peripheral nerve injuries often result in debilitating consequences and limited treatment options. Axogen's cutting-edge product, Avance Nerve Graft, stands at the forefront of transforming the lives of patients by providing effective and innovative surgical solutions. The initiation of the rolling submission process with the FDA marks a pivotal moment for the company and the field of peripheral nerve injury treatment.

As Axogen progresses through the BLA submission process, it looks forward to ongoing collaboration with the FDA to ensure a thorough and timely evaluation of Avance Nerve Graft. Successful FDA licensure will allow Axogen to offer this groundbreaking treatment to patients across the United States, ultimately enabling them to regain function, mobility, and a higher quality of life.

In conclusion, Axogen's initiation of the rolling submission process for Avance Nerve Graft's Biologics License Application showcases the company's dedication to introducing innovative surgical solutions for peripheral nerve injuries. With a significant rise in stock value, Axogen's progress has captured the attention of investors, who have demonstrated optimism in the company's prospects for FDA approval. This promising development brings hope for millions of patients seeking efficient and advanced peripheral nerve injury treatments.

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