Workflow
Avance Nerve Graft
icon
Search documents
Axogen, Inc. to Participate in Multiple Upcoming Investor Conferences
Globenewswire· 2025-08-27 12:00
ALACHUA, Fla. and TAMPA, Fla., Aug. 27, 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 management is scheduled to participate in four upcoming investor conferences: Cantor Global Healthcare Conference (NYC)Participation: Fireside chat and 1x1 investor meetings Date/Time: Fireside Chat Wednesday, September 3, 2025, 3:20 PM ETWebcast Link: Cantor/Axogen Firesi ...
Keurig Dr Pepper, Valneva, Venu Holding And Other Big Stocks Moving Lower On Monday
Benzinga· 2025-08-25 16:02
U.S. stocks were mixed, with the Dow Jones index falling more than 200 points on Monday.Shares of Keurig Dr Pepper Inc. KDP fell sharply during Monday's session after the company announced the acquisition of JDE Peet’s.Keurig Dr Pepper shares dipped 7.8% to $32.38 on Monday.Here are some other big stocks recording losses in today’s session.Valneva SE VALN shares fell 21% to $9.19 after the FDA suspended the license for IXCHIQ.DeFi Development Corp. DFDV dipped 18% to $16.51 after the company announced that ...
Axogen Provides Update on FDA Review Timeline for Avance Nerve Graft
Globenewswire· 2025-08-25 10:40
FDA PDUFA goal date extended by three monthsALACHUA, Fla. and TAMPA, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (Nasdaq: AXGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for Avance® Nerve Graft by three months to December 5, 2025. On August 22, 2025, the Company received a communication from the FDA indicating that the information submitted by the Company in response ...
获批FDA!全球首个免缝合周围神经修复平台
思宇MedTech· 2025-07-04 08:37
Core Viewpoint - Tissium has achieved a significant breakthrough in the field of tissue repair with the FDA approval of its Coaptium Connect nerve repair system and Tissium Light platform, marking the first approval of a medical device based on a new polymer platform since 2007 [1][3] About Coaptium Connect - Coaptium Connect is a non-invasive, suture-free peripheral nerve repair system that utilizes Tissium Light technology, eliminating the need for traditional microsuturing and reducing the risk of scarring and additional trauma [3][5] - The system employs bioabsorbable materials that naturally degrade in the body, minimizing postoperative complications as no secondary surgery is required for removal [5] - The system simplifies the surgical process for nerve repair, making it suitable for clinical applications and improving surgical efficiency [7] Clinical Data - A clinical study involving 12 patients with finger nerve injuries demonstrated a 100% surgical success rate, with all patients regaining full flexion and extension of the injured fingers after 12 months, achieving a motor function recovery score of 98.2±1.3% and reporting no pain [8] Executive Commentary - Tissium's co-founder and Chief Innovation Officer highlighted the product's demonstration of the polymer platform's versatility and potential, with plans for commercialization in the U.S. and development of other solutions for various surgical applications [9] Market Overview - The global incidence of peripheral nerve injuries has surpassed 2 million cases annually, with traditional suturing methods facing challenges such as high nerve mismatch rates and suboptimal functional recovery [10] - The global peripheral nerve repair market is projected to grow from approximately $242 million in 2024 to $574 million by 2031, with a compound annual growth rate (CAGR) of 13.4% from 2025 to 2031 [10] - North America is the largest market, expected to account for about 73% of the market share in 2024, driven by advanced medical infrastructure and R&D investments [10] Similar Products - Axogen's Avance Nerve Graft is a human decellularized nerve allograft used for bridging severed nerves, requiring surgical implantation and potentially involving suturing [13] - Polyganics' Neurocap is a bioabsorbable nerve conduit designed to protect severed nerve ends and prevent neuroma formation, made from synthetic polyester materials [14] - Integra LifeSciences' NeuraGen Nerve Guide is a collagen-based nerve conduit for guiding nerve regeneration, suitable for longer nerve defects and requiring surgical implantation [15] About Tissium - Tissium is a medical innovation technology company based in Paris, focused on developing and commercializing products derived from its unique synthetic, bioformable, and programmable polymer platform [16] - The company has raised over €170 million (approximately $197 million) since its founding in 2013 and currently offers seven products across three areas: non-invasive nerve repair, non-invasive hernia repair, and cardiovascular sealing [16]
Axogen, Inc. Reports 2025 First Quarter Financial Results
Globenewswire· 2025-05-08 11:05
Core Viewpoint - Axogen, Inc. reported strong financial results for Q1 2025, highlighting robust revenue growth and progress towards long-term objectives, with a focus on enhancing sales productivity and commercial execution [3][5]. Financial Results - Q1 2025 revenue reached $48.6 million, marking a 17.4% increase compared to Q1 2024 [6]. - Gross margin for Q1 2025 was 71.9%, down from 78.8% in Q1 2024, attributed to increased product costs and inventory write-offs [6][7]. - The net loss for the quarter was $3.8 million, or $0.08 per share, an improvement from a net loss of $6.6 million, or $0.15 per share, in Q1 2024 [6][20]. - Adjusted net loss for the quarter was $0.9 million, or $0.02 per share, compared to $2.7 million, or $0.06 per share, in Q1 2024 [6][20]. - Adjusted EBITDA was $2.9 million for the quarter, up from $1.0 million in Q1 2024 [6][20]. Business Highlights - Revenue growth was broad-based across the product portfolio, with double-digit growth in all markets, including Extremities, Oral Maxillofacial & Head and Neck, and Breast [7]. - The FDA accepted the filing of the Biologics License Application (BLA) for Avance® Nerve Graft, with a goal date for approval set for September 5, 2025 [7]. - Regulatory milestones completed in Q1 2025 included a mid-cycle meeting with the FDA and clinical trial site inspections [7]. - Lindsey Hartley, CPA, was appointed as the new Chief Financial Officer effective May 12, 2025, succeeding Nir Naor [7]. 2025 Financial Guidance - The company maintains its full-year revenue growth guidance in the range of 15% to 17% and expects gross margin to be between 73% and 75% [5]. - The company anticipates being net cash flow positive for the full year [5].
Axogen Announces Chief Financial Officer Transition
Globenewswire· 2025-05-08 11:00
Core Insights - Axogen, Inc. has appointed Lindsey Hartley, CPA, as the new Chief Financial Officer, effective May 12, 2025, succeeding Nir Naor, who will remain in an advisory role until July 1, 2025 [1][2] Company Overview - Axogen, Inc. is a leader in developing and marketing surgical solutions for peripheral nerve injuries, focusing on restoring health and improving quality of life through innovative technologies [3][4] - The company offers a range of products including Avance Nerve Graft, Axoguard Nerve Connector, and Axoguard Nerve Protector, which are designed to aid in the repair and protection of peripheral nerves [4][5] Leadership Transition - Michael Dale, President and CEO of Axogen, expressed gratitude for Nir Naor's contributions, highlighting improvements in operating expense and cash flow management during his tenure [2] - Lindsey Hartley brings over 19 years of financial leadership experience, having previously served as Vice President, Corporate Controller at Axogen, where she improved financial reporting processes and reduced month-end close time by 40% [2][3] Strategic Focus - Lindsey Hartley aims to emphasize financial discipline and strategic growth initiatives to support Axogen's mission of restoring nerve function and transforming patients' lives [3]
AxoGen(AXGN) - 2024 Q4 - Earnings Call Transcript
2025-02-25 21:21
Financial Data and Key Metrics Changes - Full year 2024 revenue was $187.3 million, a 17.8% increase compared to 2023 [11] - Fourth quarter revenue increased to $49.4 million, up 15.1% compared to the prior year [12] - Gross profit for the fourth quarter was $37.6 million, representing a gross margin of 76.1%, up from 74.6% in the same period last year [31] - Net income for the fourth quarter was $0.4 million or $0.01 per share, compared to a net loss of $3.9 million or $0.09 per share in the fourth quarter of 2023 [33] - Adjusted fourth quarter EBITDA was $6.7 million compared to an adjusted EBITDA of $0.6 million in the prior year [33] Business Line Data and Key Metrics Changes - The extremities business, which includes traumatic and chronic nerve injuries, represents more than half of the company's business [20] - The breast neurotization market, driven by the Resensation technique, is the fastest-growing business for the company [22] - The oral, maxillofacial, and head and neck business represents a large market opportunity with high procedural concentration in about 900 hospitals [24] Market Data and Key Metrics Changes - The total addressable market (TAM) for peripheral nerve repair is estimated at $5 billion, which is significantly higher than previous estimates [17] - The company aims for a compound annual growth rate (CAGR) of 15% to 20% over the planning period [18] Company Strategy and Development Direction - The company has established three near-term priorities: complete the submission of the BLA application, meet revenue guidance, and develop a new strategic plan [7][8] - The strategic plan focuses on expanding into markets with elective procedures, advancing the Axogen algorithm towards standard of care, and establishing leadership in the breast neurotization market [19][22] - The company plans to invest in innovation programs and operational efficiencies to improve gross margins [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed increased confidence entering 2025 due to successful completion of key commitments and the new strategic plan [6][9] - The company expects to maintain positive cash flows and self-fund its growth initiatives [35] - Management is optimistic about the BLA approval process and does not foresee delays [73] Other Important Information - The company anticipates full-year 2025 revenue growth in the range of 15% to 17% compared to the prior year [34] - The company expects to incur approximately $2 million in one-time costs related to the BLA approval, impacting gross margin by about 1 percentage point [34] Q&A Session Summary Question: What is the difference in the $5 billion U.S. TAM estimate compared to previous estimates? - Management evaluated various factors and is comfortable with the new TAM estimate, which includes new opportunities like prostatectomy [41][42] Question: Can the company balance top-line growth with margin expansion? - Management believes it can balance both top-line growth and margin expansion through practical investments tied to clinical applications [46][48] Question: What are the key assumptions for the 15% to 17% sales guidance for 2025? - The guidance is based on existing momentum and investments that are expected to bear fruit throughout the year [60] Question: What is the comfort level with existing data for the breast reconstruction business? - Management is confident in the benefit-risk proposition of the Resensation technique but acknowledges the need for more data to support standard of care [109] Question: How will the company increase its sales and marketing efforts this year? - The company plans to double its sales force in the breast segment and expand market development and professional education staff [76][80]
AxoGen(AXGN) - 2024 Q4 - Earnings Call Transcript
2025-02-25 18:58
Financial Data and Key Metrics Changes - Full year 2024 revenue was $187.3 million, a 17.8% increase compared to 2023 [10] - Fourth quarter revenue increased to $49.4 million, up 15.1% compared to the prior year [11] - Gross profit for the fourth quarter was $37.6 million, representing a gross margin of 76.1%, up from 74.6% in the same period last year [30] - Net income for the fourth quarter was $0.4 million or $0.01 per share, compared to a net loss of $3.9 million or $0.09 per share in the fourth quarter of 2023 [32] - Adjusted EBITDA for the fourth quarter was $6.7 million compared to $0.6 million in the prior year [32] Business Line Data and Key Metrics Changes - The extremities business, which includes traumatic and chronic nerve injuries, represents more than half of the company's business [18] - The breast neurotization market, driven by the Resensation technique, is the fastest-growing business for the company [21] - The oral, maxillofacial, and head and neck business represents a large market opportunity with high procedural concentration in about 900 hospitals [23] Market Data and Key Metrics Changes - The total addressable market (TAM) for peripheral nerve repair is estimated at $5 billion, which is significantly higher than previous estimates [16] - The company aims for a compound annual growth rate (CAGR) of 15% to 20% over the planning period [17] Company Strategy and Development Direction - The company has established three near-term priorities: complete the submission of the BLA application, meet revenue guidance, and develop a new strategic plan [6][7] - The strategic plan focuses on expanding into markets with elective procedures, advancing the Axogen algorithm towards standard of care, and increasing investments in breast commercial infrastructure [18][21] - The company plans to drive operational efficiencies in manufacturing to optimize gross margin [26] Management's Comments on Operating Environment and Future Outlook - Management expressed increased confidence entering 2025 due to successful completion of key commitments and strategic planning [5][8] - The company expects to maintain positive cash flows and self-fund its growth initiatives [34] - Management is optimistic about the BLA approval process and does not foresee delays [72] Other Important Information - The company anticipates full year 2025 revenue growth in the range of 15% to 17% compared to the prior year [33] - The anticipated BLA approval is expected in September 2025, which will provide market exclusivity for Avance Nerve Graft [14] Q&A Session Summary Question: What is the difference in the $5 billion U.S. TAM estimate? - Management evaluated various factors and is comfortable with the new TAM estimate, which includes new opportunities like prostatectomy [40][42] Question: Can the company balance top-line growth with margin expansion? - Management believes it can balance both top-line growth and margin expansion through practical and executable plans [45][47] Question: What are the key assumptions for the 15% to 17% sales guidance? - The guidance is based on existing momentum and investments that will take time to bear fruit [59] Question: What is the comfort level with existing data for the breast reconstruction business? - Management is confident in the benefit-risk proposition of the Resensation technique but acknowledges the need for more data to support adoption [106][108] Question: How will the sales and marketing strategy change this year? - The company plans to double its sales force in the breast segment and expand market development staff [76][78] Question: What is the company's capacity to meet future demands? - Management is comfortable with current capacity and does not foresee constraints during the planning period [112]