ALACHUA, Fla. and TAMPA, Fla., July 01, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced making an inducement grant on July 1, 2024, under NASDAQ listing rule 5635(c)(4) in connection with the hire of a new non-executive employee. In connection with the commencement of employment on June 17, 2024, and as a material inducement of employment, an award was made under the Company’s Inducement ...

AxoGen (AXGN) recently announced the full launch of its latest product, Avive+ Soft Tissue Matrix. Avive+ is a resorbable, multi-layer amniotic membrane allograft designed for use as a soft tissue barrier. It offers temporary tissue separation and protection during the crucial stage of peripheral nerve recovery.With the introduction of Avive+ Soft Tissue Matrix, Axogen is likely to enhance its comprehensive solutions for nerve protection and address a significant need for patients with compression or non-tr ...

ALACHUA, Fla. and TAMPA, Fla., June 24, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announces the launch of its newest product, Avive+ Soft Tissue Matrix™. Avive+™ is intended for use as a soft tissue barrier and is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing. Avive+ is proces ...

ALACHUA, Fla. and TAMPA, Fla., June 24, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announces the launch of its newest product, Avive+ Soft Tissue Matrix™. Avive+™ is intended for use as a soft tissue barrier and is a resorbable, multi-layer amniotic membrane allograft that provides temporary protection and tissue separation during the critical phase of peripheral nerve healing. Avive+ is proce ...

Company Overview - AxoGen (AXGN) shares increased by 5.4% to $7.38 in the last trading session, with a notable trading volume, and have gained 20.9% over the past four weeks [1] - The company announced the opening of the Axogen Processing Center (APC) in Vandalia, Ohio, scheduled for June 12, 2024, which will process its Avance Nerve Graft, indicating potential for significant future growth [1] Financial Expectations - AxoGen is expected to report a quarterly loss of $0.06 per share, reflecting a year-over-year change of -100%, while revenues are projected to be $43.35 million, an increase of 13.6% from the previous year [1] - The consensus EPS estimate for AxoGen has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [2] Industry Context - AxoGen is part of the Zacks Medical - Instruments industry, where another company, Artivion (AORT), saw a 0.6% increase in its stock price to $23.40, with a return of 0.3% over the past month [2] - Artivion's consensus EPS estimate for the upcoming report is unchanged at $0.03, representing a -50% change from the previous year, and it also holds a Zacks Rank of 3 (Hold) [3]

ALACHUA, Fla. and TAMPA, Fla., May 28, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will celebrate the opening of its Axogen Processing Center (APC) with leaders of the Ohio community on June 12, 2024. APC is designed to process Avance Nerve Graft®, a regenerative peripheral nerve scaffold indicated for the treatment of peripheral nerve functional deficit and used by surg ...

ALACHUA, Fla. and TAMPA, Fla., May 28, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that it will celebrate the opening of its Axogen Processing Center (APC) with leaders of the Ohio community on June 12, 2024. APC is designed to process Avance Nerve Graft®, a regenerative peripheral nerve scaffold indicated for the treatment of peripheral nerve functional deficit and used by surge ...

Core Viewpoint - AxoGen, Inc. has initiated a rolling submission of a Biologics License Application (BLA) for its Avance Nerve Graft to the FDA, with completion expected by Q3 2024, aiming for potential approval by mid-2025 [1][4]. Company Developments - The initial submission includes a complete non-clinical data package, with remaining clinical and manufacturing components to be submitted in the coming months [1]. - The Avance Nerve Graft is designed to bridge severed peripheral nerves without the complications of a second surgical site [1]. - The product received Regenerative Medicine Advanced Therapy designation from the FDA in 2018, allowing for a priority review that could shorten the FDA review period from 10 months to 6 months [4]. Product Portfolio - AxoGen offers several products aimed at restoring nerve function, including: - Axoguard Nerve Connector, used for tensionless repair of severed peripheral nerves [5]. - Axoguard Nerve Protector, which protects damaged peripheral nerves and reinforces nerve reconstruction [5]. - Axoguard Nerve Cap, designed to protect peripheral nerve ends and reduce the development of symptomatic neuroma [6]. - Avive+ Soft Tissue Matrix, a multi-layer amniotic membrane allograft for tissue protection during healing [6][7]. Market Performance - Over the past six months, AXGN shares have increased by 1.5%, while the industry has risen by 24.9% and the S&P 500 by 17.5% [2].

Core Insights - Axogen, Inc. has initiated the rolling submission process for a Biologics License Application (BLA) for Avance Nerve Graft, marking a significant regulatory milestone [1] - The initial submission includes a complete non-clinical data package, with remaining clinical and Chemistry, Manufacturing and Controls (CMC) components to be submitted in the coming months [1][3] - The Avance Nerve Graft has received Regenerative Medicine Advanced Therapy (RMAT) designation, which may allow for priority review and a reduced review timeline from 10 months to 6 months [2] Regulatory Process - The rolling submission process allows for pre-agreed components of the BLA to be submitted as they are completed, potentially streamlining the regulatory review [1] - Following the final component submission, the FDA will notify Axogen of formal acceptance and the review timeline approximately 45 to 60 days later [3] - The BLA filing is anticipated to be completed in the third quarter of 2024, with potential approval expected around mid-2025 [3] Company Overview - Axogen is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring nerve function and quality of life for patients [4] - The company offers a comprehensive portfolio of products for various applications, including traumatic injuries and surgical treatments, addressing both scheduled and emergent procedures [5] - Key products include Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, among others, which are designed to facilitate nerve repair and protection [6][7]

ALACHUA, Fla. and TAMPA, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ:AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced that Karen Zaderej, chairman, chief executive officer, and president, will participate in a fireside chat at the Leerink Partners Healthcare Crossroads Conference in Austin, TX, on Wednesday, May 29, 2024, at 3:40 p.m. CT / 4:40 p.m. ET. Webcast events can be accessed live through the Investors pag ...