在 2025年11月于美国圣地亚哥举行的 第十二届国际神经工程大会 （ IEEE EMBS Neural Engineering Conference, NER 2025 ）上，中国 脑科学 创新企业 深圳市 应和脑科学 有限公司 （ Amygdala Neuro ，下文简称 "应和脑科学" ）正式报告 其自主研发的 介入脑机接口 ——颅内 血管支架电极 脑机 系统在大型动物模型中实现 长期植入 的关键成果 。该研究题为 《 Evaluation of a Novel Endovascular Electrode Array for Long-Term Cortical Recording and Stimulation 》 ，标志着应 和 脑科学介入脑机接口 在脑机接口（ BCI）核心技术领域取得实质性突破 ， 该工作不仅验证了 介入脑机接口 架构的长期可 行性，也为未来 BCI系统的临床转化提供了新路径。 本研究的核心在于首次在大型动物模型中验证了一种机械架构的颅内血管支架电极阵列具备近半年的双模态（ 记录 +刺激 ） 功能稳定性。相较于现有技术，其机械编织结构成本更低、工艺更灵活，有望加速国产化 BCI ...

Core Viewpoint - The A-share market experienced a collective decline, with the Shanghai Composite Index down 0.44%, Shenzhen Component Index down 0.84%, and ChiNext Index down 1.04. The medical device ETF showed resilience, increasing by 1.00% amid mixed performances from constituent stocks, highlighting potential growth in the medical device sector driven by regulatory approvals and market trends [1]. Group 1: Market Performance - The medical device ETF (562600) rose by 1.00%, with the latest price at 0.91 yuan and a trading volume of 0.14 billion yuan, reflecting a turnover rate of 6.14% [1]. - The medical device ETF has seen a scale increase of 0.42 billion yuan over the past week, reaching a new high since its launch [2]. - The medical device ETF has recorded net inflows for six consecutive trading days, with a maximum single-day net inflow of 0.15 billion yuan, totaling 0.48 billion yuan in net inflows [2]. Group 2: Company Developments - Lepu Medical's subsidiary received regulatory approval for a rechargeable implantable deep brain stimulation (DBS) system, marking a significant breakthrough in China's neuroregulation field and expected to enhance performance while mitigating the impact of centralized procurement [1]. - The global DBS market is anticipated to grow rapidly, with an increasing trend towards alternatives [1]. Group 3: Valuation and Sector Composition - The latest price-to-earnings ratio (PE-TTM) for the medical device ETF is 47.48, which is below the 63.83% percentile of the past decade, indicating a moderate valuation [2]. - The ETF's index weight is heavily concentrated in the pharmaceutical and biological sectors (95.14%), with smaller allocations to beauty care (4.60%) and light manufacturing (0.26%) [2]. - Within the secondary industry classification, the ETF's index weight is primarily in medical devices (90.28%), followed by medical services (4.36%) and medical beauty (3.30%) [2].

Core Insights - Lepu Medical's rechargeable implantable deep brain stimulation (DBS) system has received approval from the National Medical Products Administration (NMPA), marking a significant breakthrough in China's neurostimulation field, traditionally dominated by international giants [2][4]. Product Approval - The approved DBS system consists of three components: a rechargeable implantable DBS device, an electrode component, and an extension lead kit, aimed at treating symptoms in advanced primary Parkinson's disease patients who do not respond effectively to medication [2]. - This approval is expected to contribute to Lepu Medical's revenue in the coming year, as indicated in their recent earnings presentation [2]. Market Potential - The global deep brain stimulation system market is projected to grow from approximately $1.738 billion in 2024 to $3.919 billion by 2031, with a compound annual growth rate (CAGR) of 12.5% from 2025 to 2031 [5]. - The rechargeable implantable DBS market is expected to generate around $690 million in revenue in 2024, reaching nearly $940 million by 2031, with a CAGR of 4.7% during the same period [5]. Competitive Landscape - The DBS market is currently dominated by major international players such as Boston Scientific, Medtronic, and Abbott, while domestic competitors like Lepu Medical and Beijing Pinchi Medical are emerging in the Chinese market [5]. - The rise of domestic neurostimulation devices is seen as a potential opportunity for import substitution, providing patients with more treatment options and enhancing competition in the high-tech medical device sector [6]. Industry Trends - The neuroprosthetics market is expected to grow at a CAGR of 13% from 2025 to 2031, driven by the increasing prevalence of neurological diseases due to global aging [6]. - Future advancements in neuroprosthetic devices are anticipated to leverage artificial intelligence and machine learning, improving functionality and precision in brain-computer interfaces [6].

Core Viewpoint - Lepu Medical's newly approved rechargeable implantable deep brain stimulation (DBS) device marks a significant breakthrough in China's neuroregulation field, traditionally dominated by international giants, providing new treatment options for Parkinson's disease patients [2][3][8] Product Approval - Lepu Medical announced that its subsidiary has received NMPA registration approval for its rechargeable implantable DBS system, which includes the stimulator, electrode components, and extension lead kit, aimed at assisting late-stage primary Parkinson's disease patients whose symptoms are not effectively controlled by medication [3] - The DBS device is expected to contribute to revenue growth in the coming year, with plans for additional products like the implantable cardiac contractility modulator (CCM) to be submitted for approval in early 2024 [3] Treatment Mechanism - Deep Brain Stimulation (DBS) involves implanting electrodes in specific brain areas to deliver electrical pulses, helping to alleviate symptoms of Parkinson's disease, which affects over 5 million patients in China as of 2021 [4] - The new product is positioned as a key component of Lepu Medical's neuroregulation business, expected to drive performance growth [4] Market Potential - The global deep brain stimulation system market is projected to grow from approximately $1.738 billion in 2024 to $3.919 billion by 2031, with a CAGR of 12.5% from 2025 to 2031 [6] - The rechargeable implantable DBS market is expected to reach around 690 million yuan in 2024, with a projected CAGR of 4.7% until 2031 [6] Domestic Market Landscape - The global DBS market is currently dominated by companies like Boston Scientific, Medtronic, and Abbott, while domestic competitors include Lepu Medical and Beijing Pinchi Medical [7] - The neuroprosthetics market is anticipated to grow at a CAGR of 13% from 2025 to 2031, driven by the rising prevalence of neurological diseases due to an aging population [7] Industry Trends - The increasing incidence of neurological diseases such as Parkinson's and Alzheimer's is expected to boost demand for neuroprosthetic devices [7] - Future advancements in neuroprosthetic devices are likely to incorporate AI and machine learning technologies to enhance functionality and precision [7]

Core Viewpoint - Lepu Medical's subsidiary, Lepu Medical Electronics, has received NMPA registration approval for its rechargeable implantable deep brain stimulators and related components, marking a significant advancement in the field of neuroregulation and providing new treatment options for Parkinson's disease patients [1] Group 1 - The approved products include a rechargeable implantable deep brain stimulator, implantable deep brain stimulation electrode components, and implantable deep brain stimulation extension lead kits [1] - Deep brain stimulation (DBS) technology involves neurosurgical procedures where electrodes are implanted in specific brain locations to deliver constant or intermittent electrical currents, modulating abnormal neural electrical activity [1] - The successful approval of the rechargeable implantable deep brain stimulator system is a key achievement for the company in the neuroregulation sector [1]

Core Viewpoint - Lepu Medical Technology (300003.SZ) has received approval from the National Medical Products Administration (NMPA) for its self-developed rechargeable implantable deep brain stimulators and related components, marking a significant achievement in the field of neuroregulation [1] Group 1: Product Approval - The rechargeable implantable deep brain stimulator system is now approved for market launch, representing a key milestone for the company in the neuroregulation sector [1] - The approval includes the implantable deep brain stimulation electrode components and the extension lead kit [1] Group 2: Market Impact - This product provides a new treatment option for patients with Parkinson's disease, enhancing the company's product offerings in the medical device field [1] - The successful launch of this product is expected to strengthen the company's overall competitiveness in the medical device industry and lay a solid foundation for future stable growth [1]

Core Viewpoint - Lepu Medical's subsidiary, Lepu Medical Electronics, has received NMPA registration approval for its rechargeable implantable deep brain stimulators and related components, marking a significant advancement in the neuroregulation field and providing new treatment options for Parkinson's disease patients [1] Group 1 - The approved products include a rechargeable implantable deep brain stimulator, implantable deep brain stimulation electrode components, and implantable deep brain stimulation extension lead kits [1] - Deep brain stimulation (DBS) technology involves neurosurgical procedures where electrodes are implanted in specific brain locations to deliver constant or intermittent electrical currents, thereby modulating abnormal neural electrical activity [1] - The successful market approval of the rechargeable implantable deep brain stimulator system is a key achievement for the company in the neuroregulation sector [1]

Core Insights - The company reported a revenue of 4.939 billion yuan for the first three quarters of 2025, representing a year-over-year increase of 3.2%, with a net profit of 982 million yuan, up 22.35% year-over-year [1] - In Q3 2025, the company achieved a revenue of 1.569 billion yuan, marking an 11.97% year-over-year growth, and a net profit of 291 million yuan, which is a significant increase of 176.18% year-over-year [1] Group 1: Financial Performance - The medical device segment generated revenue of 2.57 billion yuan, showing a slight increase of 0.33%, with the cardiovascular intervention segment growing by 7.45% to 1.79 billion yuan [2] - The pharmaceutical segment's revenue reached 1.57 billion yuan, up 6.37%, with the formulation business recovering to 1.36 billion yuan, reflecting a 14.32% increase [2] - The medical services and health management segment reported revenue of 796 million yuan, a growth of 6.79%, with new products like the "童颜针" and "水光针" contributing to nearly 30% growth in Q3 [2] - The company's gross margin improved to 64.21%, an increase of 1.41 percentage points, while the net profit margin rose to 20.17%, up 3.8 percentage points [2] - Cash flow for the first three quarters totaled 1.01 billion yuan, a significant increase of 139%, with expectations to reach 1.4 to 1.5 billion yuan for the full year [2] Group 2: Growth Drivers - The aesthetic medicine segment is accelerating, with the "童颜针" achieving approximately 100 million yuan in revenue since its launch in early August, covering over 80% of major brand chains and smaller institutions [3] - The innovative drug segment is progressing with various pipelines, including MWN109 and MWN105, with ongoing clinical trials and plans for business development collaborations [3] - The neuro-regulation and brain-machine interface segment is expected to see the approval of the deep brain stimulation device soon, with revenue contributions anticipated next year [3] Group 3: Profit Forecast - Revenue projections for 2025-2027 are estimated at 6.618 billion, 7.363 billion, and 8.347 billion yuan, with year-over-year growth rates of 8.44%, 11.26%, and 13.35% respectively [4] - Net profit forecasts for the same period are 1.12 billion, 1.293 billion, and 1.546 billion yuan, with substantial growth rates of 353.48%, 15.43%, and 19.63% respectively [4] - The current price-to-earnings ratios are projected at 29, 25, and 21 times for the years 2025, 2026, and 2027 [4]

Financial Performance - The company aims for a revenue growth of approximately 10% in the upcoming year [2] - In Q3, the company achieved an operating cash flow of CNY 1.013 billion, with an expectation of reaching around CNY 14-15 billion for the entire year [2] - The cardiovascular interventional devices segment is preparing for centralized procurement, which may lead to a slight revenue contraction [2] Medical Aesthetics Business - The medical aesthetics segment has seen significant growth, with the "童颜针" (Youth Needle) generating around CNY 100 million in revenue since its launch in early August [3] - The company targets CNY 1 billion in revenue for the medical aesthetics segment next year, with specific sales goals of CNY 600 million for "童颜针" and CNY 200 million each for PDRN and Thermage [3] - The company has entered over 80% of large brand chain medical aesthetic institutions and around 1,500-2,000 small to medium-sized institutions [3][6] Innovative Drug Development - The company is advancing its innovative drug pipeline, focusing on dual-target or multi-target SiRNA drugs, with MWN109 entering Phase III clinical trials next year [4] - The oral MWN109 tablet is nearing completion of Phase I clinical trials, with plans for Phase II trials before the Spring Festival [4] - The company is also developing a biodegradable embolization device, which has shown promising clinical feedback [11] Market Strategy and Challenges - The company is actively managing distributor inventory levels to prepare for centralized procurement, aiming to maintain inventory at a 1-3 month level [9] - The medical aesthetics market is competitive, with the company facing pricing pressures from platforms like New Oxygen, but it plans to maintain its pricing strategy [10] - The company is exploring partnerships with local medical aesthetic institutions to enhance shareholder services and expand its market presence [4][6] Future Outlook - The company anticipates that the interventional cardiology segment's performance will stabilize post-centralized procurement, with minimal long-term impact expected [3] - The innovative medical devices segment, including brain-machine interfaces, is expected to contribute to revenue growth in the coming years [5] - The company is committed to developing high-barrier products in response to centralized procurement policies, ensuring sustainable growth [4]

Core Insights - Boston Scientific announced the acquisition of Nalu Medical for approximately $530 million, marking a significant move in the chronic pain treatment sector [2][3] - The acquisition is expected to enhance Boston Scientific's product line in pain management, integrating Nalu's innovative wireless peripheral nerve stimulation system [5][10] Group 1: Acquisition Details - The acquisition will complete Boston Scientific's strategic investment in Nalu, which began in 2017, and is expected to finalize in the first half of 2026 [3] - Nalu is projected to exceed $60 million in sales by 2025, with a growth rate of over 25% in 2026 [3] Group 2: Strategic Implications - This transaction represents a strategic shift from "central control" to "peripheral control," broadening Boston Scientific's coverage in pain management from deep to peripheral nerve solutions [5] - The acquisition positions Boston Scientific competitively against major players like Medtronic and Abbott in the neuromodulation market [5] Group 3: Nalu's Growth and Technology - Prior to the acquisition, Nalu secured $50 million in growth capital from Trinity Capital, indicating its readiness for commercialization and expansion [6] - Nalu's Neurostimulation System is a battery-free, miniaturized, wireless device that simplifies surgical procedures and reduces maintenance costs [8] Group 4: Clinical Efficacy - Clinical trials demonstrated that Nalu's system achieved over 50% pain relief in 87% and 79% of patients in two randomized controlled studies, with an average pain reduction of 64% [9] - The system's design enhances patient compliance and post-operative experience, making it a viable alternative to traditional pain management methods [9] Group 5: Market Context - Chronic pain affects over 1 billion people globally, with traditional treatments posing risks of dependency and abuse [10] - The market is currently dominated by Medtronic, Abbott, and Boston Scientific, which together hold about 80% market share, but Nalu's innovative approach offers a differentiated solution [10] Group 6: Future Outlook - The acquisition signals a shift in the neuromodulation market towards simpler, more accessible technologies that can be widely adopted in clinical settings [11][12] - The focus is moving from complex systems to lightweight, replicable technology models, indicating a potential turning point for peripheral nerve stimulation [11][12]