ALACHUA, Fla. and TAMPA, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today announced that the company will be participating in the upcoming J.P. Morgan 2026 Healthcare Conference. Axogen’s management is scheduled to present on Thursday, January 15, 2026, at 10:30 AM Pacific Standard Time. Interested parties may access a live audio webcast of the presentation by ...

Core Insights - Axogen, Inc. has received FDA approval for its Biologics License Application for AVANCE®, an acellular nerve allograft, allowing treatment for both adult and pediatric patients with peripheral nerve discontinuities [1][4] - H.C. Wainwright has set a price target of $39 for AXGN, indicating a potential price increase of approximately 15.73% from its current price of $33.70, influenced by the FDA approval [2] - The stock price of AXGN is currently at $33.74, reflecting a 2.69% increase, with a market capitalization of approximately $1.55 billion [3] Company Developments - The FDA's approval of AVANCE is a significant milestone for Axogen, enhancing its portfolio of surgical solutions and expected to drive interest in the stock [4] - The current trading volume of AXGN is 470,115 shares on the NASDAQ, indicating strong market interest following the recent FDA approval [4] Market Performance - AXGN's stock has shown volatility over the past year, with a high of $34.24 and a low of $9.22, reflecting its dynamic market presence [3] - The stock has risen by $0.885 today, with a trading range between $32.91 and $33.92 [3]

Core Insights - The FDA has approved the Biologics License Application for Axogen's AVANCE, an acellular nerve allograft, marking a significant regulatory milestone for the company [1][4] - AVANCE is indicated for treating sensory, mixed, and motor peripheral nerve discontinuities in patients aged 1 month or older [2][5] - The approval was granted under the FDA's Accelerated Approval pathway, contingent upon confirmatory studies to verify clinical benefits [3][6] Company Overview - Axogen, Inc. is focused on developing and commercializing technologies for peripheral nerve repair, aiming to establish nerve repair as a standard of care [7] - The company's product portfolio includes AVANCE, Axoguard Nerve Connector, Axoguard Nerve Protector, and others, available in multiple countries [8] Regulatory and Market Implications - The transition of AVANCE to a biologic classification strengthens Axogen's regulatory position and confirms its therapeutic use for peripheral nerve discontinuities [4] - Commercial availability of AVANCE is expected in early Q2 2026, while it remains available under the current tissue framework until then [4][6]

Core Insights - The U.S. Food and Drug Administration has granted approval for Axogen's nerve repair graft, marking a significant milestone for the company in the medical device industry [1] Company Summary - Axogen has received FDA approval for its nerve repair graft, which is expected to enhance its product offerings and potentially increase market share in the nerve repair segment [1] Industry Summary - The approval from the FDA highlights the ongoing advancements in the medical device industry, particularly in the area of nerve repair, which may lead to increased competition and innovation [1]

Axogen (NasdaqCM:AXGN) FY Conference Summary Company Overview - **Company**: Axogen - **Industry**: Medical Technology, specifically focused on peripheral nerve repair Core Points and Arguments 1. **Mission and Purpose**: Axogen aims to restore peripheral nerve function as a standard of care, improving health and quality of life for patients [2][4][12] 2. **Market Opportunity**: The company identifies a significant untapped market in nerve repair, particularly in extremities, breast, oral maxillofacial (OMF), head and neck, and prostate procedures [5][6][12] 3. **Current Business Model**: Axogen's business is currently domestic, with plans to expand globally, addressing a worldwide health condition [6][12] 4. **Causes of Nerve Injuries**: Nerve injuries primarily result from accidents, iatrogenic injuries during other procedures, and chronic diseases [6][7][8] 5. **Product Offerings**: Axogen has developed tools and algorithms for nerve repair, including connection, protection, and termination products, with a unique human allograft product called Avance [9][10][11] 6. **Awareness and Training**: The company is focused on raising awareness and providing training to healthcare providers to improve nerve repair procedures [12][18] 7. **Elective Procedures**: Axogen is targeting elective procedures in breast cancer, OMF, and prostate surgeries, where there is a high potential for benefit versus risk [13][14][18] 8. **Growth Expectations**: Axogen aims for 15%-20% year-on-year growth, with continuous improvements in gross margin and profitability, funded through organic cash flow [26][27] Additional Important Content 1. **Regulatory Progress**: Axogen is transitioning from a device-regulated product to a biological licensed product, with expected completion soon [21] 2. **Insurance Coverage**: The company currently enjoys about 64% coverage through commercial insurance and aims to close the gap to full coverage [22] 3. **Recent Developments**: CMS has introduced new payment changes, enhancing reimbursement for nerve repair, which is expected to facilitate broader care applications [23] 4. **Research and Evidence**: Over 70% of nerve repair literature has been published in the last five years, with more than 300 peer-reviewed publications related to Axogen products [25] 5. **Strategic Planning**: Axogen has established a strategic plan to guide its market development and product offerings, emphasizing the importance of establishing standard care practices [19][26] This summary encapsulates the key insights from the Axogen FY Conference, highlighting the company's strategic direction, market opportunities, and commitment to improving patient outcomes through innovative nerve repair solutions.

Core Insights - Axogen, Inc. (AXGN) reported strong Q3 '25 results with a non-GAAP EPS of $0.12, exceeding expectations by $0.05 [1] - The company's revenue reached $60.1 million, reflecting a year-over-year increase of approximately 23.7% and surpassing estimates by $3.2 million [1] Company Overview - Axogen specializes in biotechnology, focusing on innovative solutions for nerve repair and regeneration [1] - The company has a strong foundation in scientific research, which informs its investment and analytical strategies [1] Financial Performance - Non-GAAP EPS of $0.12 indicates robust profitability and effective cost management [1] - Revenue growth of 23.7% year-over-year highlights the company's expanding market presence and demand for its products [1]

AxoGen Conference Call Summary Company Overview - **Company**: AxoGen - **Industry**: Peripheral Nerve Repair - **Key Executives Present**: Lindsey Hartley (CFO), Mike Dale (CEO) [1][2] Core Market Positioning - AxoGen is positioned as a leader in peripheral nerve repair, focusing on establishing nerve care as an expectation in the healthcare continuum [3][4] - The company identifies a significant opportunity in addressing under-treatment and under-recognition of nerve injuries, with approximately 1.5 million nerve injuries in the U.S. that could benefit from treatment [4][5] - Current treatment penetration for nerve injuries is low, ranging from 1% to 8% [4] Strategic Initiatives - AxoGen is working to change clinical guidelines and increase awareness among physicians regarding the importance of nerve care [5][6] - The company aims to engage with medical societies and payers to expand coverage and payment for nerve care [9][10] - AxoGen believes it can double its business within the strategic planning period of three to five years [10] Total Addressable Market (TAM) - The company has reassessed its TAM and found it to be larger than previously disclosed, with a focus on various care pathways [12][13] - Addressability of the TAM is complex due to heterogeneous care pathways requiring independent development [13] Sales Strategy - AxoGen is stratifying its salesforce to address different specialties, including extremities, oral maxillofacial, breast, and prostate [14][15] - The company acknowledges being undercovered in terms of market penetration, with significant growth potential in breast oncology, where only 200 out of 1,000 service sites have been developed [15][16] Growth Drivers - All segments of the business are contributing to growth, with a focus on managing business models and expanding the sales footprint [17][19] - The company is targeting 15%-20% sales growth, with all business segments performing well [17][18] Financial Outlook - AxoGen expects to achieve 66% commercial lives covered within the next three to four years, with ongoing efforts to convert Avance from an experimental to an accepted product [20][21] - The company anticipates a gross margin of at least 75%, with potential for improvement post-BLA approval [35][38] BLA Process Update - The PDUFA date for the Biologics License Application (BLA) is set for December 5, with high confidence in approval based on current communications [27][31] - Approval will allow AxoGen to unify its quality systems, leading to operational efficiencies and cost reductions [33][34] R&D and Future Investments - AxoGen is investing in R&D to enhance regenerative capabilities and ease of use for nerve repair procedures [24][25] - The company is focused on educating surgeons and increasing patient awareness regarding nerve care options [21][22] Conclusion - AxoGen is strategically positioned for growth in the peripheral nerve repair market, with a clear plan to address under-treatment, expand its salesforce, and improve operational efficiencies through the BLA process [10][20][31]

Group 1 - The strongest contributor to Fund performance for the quarter was Bel Fuse, Inc. (BELFB) [4]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Core Insights - AxoGen, Inc. specializes in developing and marketing surgical solutions for peripheral nerve injuries, operating in the healthcare sector with a focus on nerve repair and protection [1] - The company faces competition from AtriCure, Tactile Systems Technology, BioLife Solutions, AnaptysBio, and Assembly Biosciences [1] Financial Performance - AxoGen's Return on Invested Capital (ROIC) is 2.07%, which is significantly lower than its Weighted Average Cost of Capital (WACC) of 8.72%, indicating inefficient capital utilization [2][5] - AtriCure has a negative ROIC of -6.47% and a WACC of 11.01%, resulting in a ROIC to WACC ratio of -0.59, suggesting struggles in generating returns above its cost of capital [3] - BioLife Solutions and AnaptysBio also report negative ROICs of -4.85% and -28.56%, respectively, with WACCs of 12.57% and 9.10% [3] - Assembly Biosciences shows the highest inefficiency with a ROIC of -127.67% and a WACC of 6.45%, leading to a ROIC to WACC ratio of -19.80 [4][5]