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 ...

AxoGen, Inc. (AXGN) announced the initiation of rolling submission of a Biologics License Application (BLA) seeking licensure for its human nerve allograft candidate, Avance Nerve Graft, to the FDA on May 15.The initial submission includes the complete non-clinical data package. The company will submit the remaining Clinical and Chemistry, Manufacturing and Controls components in the upcoming months. The rolling submission is expected to be completed by the third quarter of 2024.Following a potential approv ...

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 ...

AxoGen, Inc. (NASDAQ:AXGN) Q1 2024 Earnings Conference Call May 2, 2024 8:00 AM ET Company Participants Harold Tamayo - VP, Finance and IR Karen Zaderej - Chairman, CEO and President Nir Naor - CFO Conference Call Participants Michael Sarcone - Jefferies Mike Kratky - Leerink Partners Caitlin Cronin - Canaccord Genuity Ross Osborn - Cantor Fitzgerald Operator Greetings, and welcome to the AxoGen, Inc. 2024 First Quarter Financial Results Conference Call. [Operator Instructions] As a reminder, this conferenc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to______________ Commission file number: 001-36046 Axogen, Inc. (Ex ...

AxoGen (AXGN) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 40%. A quarter ago, it was expected that this regenerative medicine company would post a loss of $0.09 per share when it actually produced a loss of $0.06, delivering a surprise of 33.33%.Over the last four quarters, the company ha ...