Q&A 心玮医疗 20260106 摘要 新微医疗脑机接口技术采用介入式路线，通过颈静脉穿刺采集运动皮层 信号，具有微创、安全性高、信号强度与半侵入式相当等优势，并计划 于 2026 年下半年启动人体实验，与头部医院合作。 新微医疗脑机接口产品已基本定型，但为满足临床需求，仍需进行局部 改善。公司计划在 2026 年上半年完成行检，并进行更多动物实验，为 后续临床试验做准备。 新微医疗脑机接口初期适应症主要针对卒中后上肢功能丧失患者，未来 计划扩展到渐冻症和瘫痪患者的运动功能恢复，以及消费类应用场景。 新微医疗的介入式脑机接口手术与传统脑卒中手术类似，医生学习曲线 较快，手术时间预计约为 30 分钟，且电极支架植入后能与血管壁结合， 保证信号长期稳定。 新纬医疗 2025 年主营业务收入预计超过 4 亿元，利润 7,000-8,000 万 元，缺血性取栓充气导管实现翻倍增长，出血性动脉瘤辅助支架收入超 过 6,000 万元，预计 2026 年收入增速为 35%左右。 新微医疗在脑机接口领域的布局情况如何？ 新微医疗自 2021 年开始布局脑机接口技术，最初处于探索阶段。公司借鉴了 国外 Synchron 公司 ...

Summary of Key Points from the Conference Call Company Overview - **Company**: 新为医疗 (New Medical) - **Industry**: Neurointervention and Brain-Computer Interface (BCI) Core Insights and Arguments 1. **Product Development**: New Medical's invasive brain-computer interface (BCI) collects brain signals via intravascular electrode stents, with plans to start small-scale exploratory clinical trials by the end of 2026, primarily for post-stroke motor function recovery [2][3][5] 2. **Market Potential**: Approximately 1.5 to 2 million new stroke cases occur annually in China, with an estimated 4 to 5 million patients needing rehabilitation training in the next three years, representing a significant potential user base for BCI products [2][5] 3. **Technical Advantages**: The invasive BCI technology offers advantages over non-invasive methods, including less trauma and higher signal strength, although the precise wall-adhesion technology for electrode stents remains a key challenge [2][6] 4. **Financial Projections**: For the first half of 2025, the company expects profits of 15 to 18 million, with a full-year target of 30 million and revenue goals of 380 million, aiming for a long-term gross margin of 65% and a net margin of 15% to 20% [2][20] 5. **Strategic Planning**: The company aims to achieve profitability by 2025, with annual revenue growth of 30% over the next three to five years, leveraging collective procurement and product launches to capture market share [4][27] Additional Important Insights 1. **Clinical Research and Collaboration**: New Medical has partnered with Nankai University for clinical applications in stroke recovery, focusing on motor function restoration [5][18] 2. **Regulatory Environment**: The company is closely monitoring policy developments from regulatory bodies to facilitate product registration and inclusion in medical insurance reimbursement systems [10][12] 3. **Market Expansion**: New Medical is actively pursuing overseas market expansion, currently limited by FDA and EU certification processes [15][21] 4. **Product Pipeline**: The company plans to submit for regulatory review of its self-expanding drug-eluting stent by Q4 2025, with expectations for approval within a year [17] 5. **Industry Trends**: The collective procurement policy has significantly increased the market share of domestic neurointervention products, with projected growth in ischemic and hemorrhagic surgery volumes of 15%-20% and 10%-15%, respectively, in 2025 [4][22] Conclusion - New Medical is positioned to capitalize on the growing demand for neurointervention and BCI technologies, with a robust product pipeline and strategic partnerships aimed at enhancing recovery for stroke patients. The company is focused on achieving profitability and expanding its market presence while navigating regulatory challenges and industry dynamics.