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Axogen, Inc. (NASDAQ: AXGN) is a leading medical products company specializing in the science, development, and commercialization of technologies for peripheral nerve repair and regeneration. The company's core mission is to restore peripheral nerve function and improve the quality of life for patients suffering from traumatic injuries or surgical procedures that impact nerve function and sensation.
Axogen's innovative product portfolio includes:
- Avance® Nerve Graft: The first and only commercially available allograft for bridging nerve discontinuities.
- Axoguard® Nerve Connector: A coaptation aid designed for the close approximation of severed nerves.
- Axoguard® Nerve Protector: A product that shields nerves during the healing process.
- Axoguard® Nerve Cap: A surgical implant to isolate and protect a peripheral nerve end, minimizing painful neuroma development.
- Axoguard HA+ Nerve Protector: A next-gen nerve protection device designed to provide both short- and long-term protection for peripheral nerve injuries.
- Avive® Soft Tissue Membrane: A biologically active product aiding in nerve healing.
- Axotouch® Two-Point Discriminator: An assessment tool for measuring the innervation density of skin surface areas.
Axogen's products are available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries. The company continues to expand its global presence and partnerships, ensuring that healthcare providers and surgeons have access to clinically and economically effective nerve repair solutions.
Recent achievements include the launch of the Axoguard HA+ Nerve Protector, which provides enhanced nerve gliding and protection for a wide range of peripheral nerve injuries. The company reported strong performance in Q4 2023, with an expected annual revenue growth of 11% to 14% and anticipated gross margins between 76% and 79%.
For more information, visit www.axogeninc.com.
Axogen has launched Avive+ Soft Tissue Matrix™, a new product designed to serve as a soft tissue barrier, aiding in peripheral nerve healing.
This resorbable, multi-layer amniotic membrane allograft conforms to FDA requirements for Human Cellular and Tissue-based Products (HCT/P). It provides temporary protection and tissue separation during the critical healing phase.
Company leadership highlighted Avive+'s role in addressing the $800 million nerve protection market composed of various injuries such as carpal and cubital tunnel syndromes and crush injuries.
Avive+ complements Axogen’s existing products like Axoguard Nerve Protector® and Axoguard HA+ Nerve Protector™. Clinical feedback suggests the product enhances patient outcomes in acute traumatic injury cases.
Axogen, a leader in peripheral nerve injury solutions, announced the opening of its Axogen Processing Center (APC) in Vandalia, Ohio. The state-of-the-art facility will process Avance Nerve Graft®, designed to treat peripheral nerve deficits. The 107,000 sq. ft. center features ISO14644 clean rooms, quality labs, and training facilities, providing three times the previous processing capacity. With plans for expansion, the center employs nearly 100 professionals, addressing FDA regulatory transitions from section 361 tissue product to section 351 biologic. The opening ceremony on June 12, 2024, will include remarks from company leaders and tours of the new facility.
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.
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