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又一国产脑神经刺激器获批,脑机接口产业的转折点?
思宇MedTech· 2025-08-17 00:10
Core Viewpoint - The rapid development of brain-computer interface (BCI) technology is leading a new wave of medical revolution, with significant investments and policy support driving the industry forward [1][3][15]. Investment and Financing - Neuralink, founded by Elon Musk, recently completed a $600 million financing round, setting a global record for the BCI sector [1]. - In February, Ladder Medical announced a 350 million yuan Series B financing, marking a record for public financing in China's implanted BCI industry [1]. Regulatory and Policy Support - The National Medical Insurance Administration released guidelines for pricing projects related to neurological medical services, establishing separate pricing standards for invasive and non-invasive BCI technologies [1]. - A series of national and local policies have been introduced to promote the innovation and development of the BCI industry, aiming for breakthroughs in key technologies by 2027 and establishing a competitive industrial ecosystem by 2030 [15][18][19][20][21][22]. Technological Advancements - Changzhou Ruishenan Medical's implanted deep brain stimulation (CNS) system has received approval from the National Medical Products Administration, becoming the third company in China to have a product approved in the invasive BCI field [1][2]. - The CNS system features innovative technologies such as 8-contact electrodes and automatic position sensing, enabling personalized treatment models [2][11]. Clinical Applications - Parkinson's disease, affecting over 10 million patients globally, is a key area for BCI applications, with deep brain stimulation (DBS) technology becoming crucial for mid-to-late stage patients [6]. - Clinical trial results for Ruishenan's system show significant improvements in patients' daily living abilities, with a 57.29% improvement rate in daily living ability and a 59.83% reduction in movement-related complications [6]. Market Potential - According to McKinsey, the global market potential for serious medical applications of BCI is estimated to be between $15 billion and $85 billion, while consumer medical applications could reach $25 billion to $60 billion [3]. Competitive Landscape - The domestic BCI industry is characterized by a diverse competitive landscape, with companies like Ladder Medical, Brain Tiger Technology, and BoRuiKang leading in invasive BCI technology, while non-invasive BCI applications are being explored by companies like Aoyi Technology and QiangNai Technology [8][10][12][13]. Challenges and Future Outlook - Despite the immense potential of BCI technology, challenges such as technical and ethical issues in invasive BCI, as well as the need for streamlined approval processes, remain significant barriers to rapid commercialization [14]. - The introduction of supportive policies and the establishment of a clear roadmap for the next five years are expected to facilitate the transition from laboratory exploration to large-scale application in the BCI industry [17].