Workflow
Avance Nerve Graft
icon
Search documents
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
招商通知 第三届全球手术机器人大会 第二届全球医疗科技大会 近日, Tissium公司 宣布其自主研发的 Coaptium Connect神经接合系统与Tissium Light光固化平台 获得 美国食品药品监督管理局(FDA)市场准入许可 。这是自 2007年以来 FDA首次批准基于新型聚合物平台的医疗设备 ,标志着Tissium在组织修复领域的重大突破。 Tissium 联合创始人兼首席执行官 Christophe Bancel 表示:"FDA 的上市许可验证了十多年来对开发下一代组织重建解决方案的科学和临床承诺。Coaptium Connect 是我们聚合物平台变革潜力的首次展示,也是为患者提供无创组织修复的重要一步。" # 关于 Coaptium Connect Coaptium Connect 是Tissium公司开发的一种 无创伤、无缝合的周围神经修复系统 ,结合了Tissium Light技术。具有以下特点: 无缝合设计 :Coaptium Connect通过 光激活的生物可吸收外科聚合物和3D打印的聚合物保护腔实现神经连接 ,消除了传统显微缝合的需求,从而降低瘢痕 形成和额外创伤的风险。 生物 ...
Axogen, Inc to Participate at Goldman Sachs Global Healthcare Conference
Globenewswire· 2025-05-28 12:00
Company Overview - Axogen, Inc. (NASDAQ: AXGN) is a leader in developing and marketing surgical solutions for peripheral nerve injuries [1][3] - The company focuses on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair [3] - Axogen's products aim to restore peripheral nerve function and improve the quality of life for patients with nerve damage [3] Product Portfolio - Axogen offers a comprehensive portfolio of products for various applications, including traumatic injuries, oral and maxillofacial surgery, breast reconstruction, and pain treatment [3] - Key products include: - Avance Nerve Graft®: a processed human nerve allograft for bridging severed peripheral nerves [3] - Axoguard Nerve Connector®: an extracellular matrix coaptation aid for tensionless repair of severed nerves [3] - Axoguard Nerve Protector®: a product used to protect damaged nerves and reinforce reconstruction [3] - Axoguard HA+ Nerve Protector™: designed to enhance nerve gliding and provide protection for peripheral nerve injuries [3] - Avive+ Soft Tissue Matrix™: an amniotic membrane allograft for tissue protection during repair [3] - Axoguard Nerve Cap®: used to protect a peripheral nerve end and reduce the development of painful neuromas [3] Market Presence - Axogen's products are available in the United States, Canada, the United Kingdom, South Korea, and several other international markets [3] - The company addresses both scheduled and emergent procedures, highlighting its vital role in peripheral nerve repair [3]
AxoGen(AXGN) - 2025 Q1 - Earnings Call Transcript
2025-05-08 13:02
AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Michael Dale - President, CEO & Board DirectorNir Naor - Chief Financial OfficerJens Schroeder Kemp - Chief Marketing OfficerCaitlin Cronin - DirectorChris Pasquale - Partner - Medical Devices & SuppliesBrett Gasaway - VP - Equity ResearchMatthew Park - Equity Research AssociateRick Ditto - VP, Global Health Economics, Reimbursement & PolicyJayson Bedford - Managing Director - Medical Technology Conference Call Participants Mi ...
AxoGen(AXGN) - 2025 Q1 - Earnings Call Transcript
2025-05-08 13:00
AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Good morning, everyone. Joining me on today's call is Michael Dale, AxoGen's Chief Executive Officer and Director Nir Naor, Chief Financial Officer and Jens Kemp, Chief Marketing Officer. Michael will discuss first quarter twenty twenty five financial results and corporate highlights. Nir will then provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question and answer session. ...
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
Lindsey Hartley, CPA, appointed as Chief Financial Officer to succeed Nir NaorALACHUA, Fla. and TAMPA, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Lindsey Hartley, CPA, as Chief Financial Officer, effective May 12, 2025. Ms. Hartley, who currently serves as Vice President, Corporate Controller at Axogen, will succeed Nir Naor, who is departing to ...
Axogen, Inc. to report 2025 first quarter financial results on May 8, 2025
Globenewswire· 2025-04-24 12:04
ALACHUA and TAMPA, Fla., April 24, 2025 (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 report 2025 first quarter financial results on Thursday, May 8, 2025, before the market opens. Axogen management will host an investment-community conference call and webcast at 8 a.m. ET following the release. Investors interested in participating in the conference call by phone may do s ...
AxoGen(AXGN) - 2024 Q4 - Earnings Call Transcript
2025-02-25 18:58
Axogen, Inc. (NASDAQ:AXGN) Q4 2024 Earnings Conference Call February 25, 2025 8:00 AM ET Company Participants Michael Dale - Chairman and Chief Executive Officer Nir Naor - Chief Financial Officer Jens Kemp - Chief Marketing Officer Conference Call Participants Chris Pasquale - Nephron Research Michael Sarcone - Jefferies Caitlin Cronin - Canaccord Genuity Mike Kratky - Leerink Partners Jayson Bedford - Raymond James Ross Osborn - Cantor Fitzgerald Dave Turkaly - Citizens JMP Operator Good morning everyone. ...