--- title: "Stair Med's implantable BCI reaches China's regulatory fast lane" date: 2026-11-06 category: Brain–Computer Interface site: NeuroAI canonical: https://neuroai.site/a/na-stair-med-implantable-bci language: en --- # Stair Med's implantable BCI reaches China's regulatory fast lane > Shanghai's Stair Med (阶梯医疗) put a 256-channel implantable brain-computer interface into patients and into China's innovation review fast lane. A patient who lost the use of both arms imagines moving a cursor, and a screen responds. The signal travels from electrodes thinner than a hair, through a coin-sized implant, to a computer that reads intention as command. For a five-year-old Shanghai startup, that scene has already left the simulation. ## Key takeaways - Stair Med (阶梯医疗), founded in August 2021 by researchers Zhao Zhengtuo (赵郑拓) and Li Xue (李雪) from the Chinese Academy of Sciences, builds fully implantable brain-computer interfaces (脑机接口). - Its WRS01 system is a 256-channel minimally invasive implantable BCI aimed at restoring movement for high-level paralyzed patients. - In March 2025 the company ran China's first pre-registration prospective (FIM) trial of an invasive BCI at Huashan Hospital (华山医院), Fudan University. - WRS01 became the first invasive BCI product admitted to the NMPA (国家药监局) "innovation green channel" (创新医疗器械特别审查程序), carrying a "globally new" (全球新) designation. - As of late 2026 the company reports 42 long-term implants and has opened IPO counseling; cumulative funding reached about 26亿元 (≈ US$366M / HK$2.9B), with Alibaba and Tencent among backers. ## A young company, a hard problem Stair Med is often described as the Chinese invasive-BCI startup most comparable to Neuralink, because it chose the hardest route: placing electrodes directly in contact with brain tissue. The company was founded by a married pair of 1991-born researchers who returned from US doctoral and postdoctoral training to the CAS Center for Excellence in Brain Science and Intelligence Technology. - Zhao Zhengtuo (赵郑拓) leads neural-interface research; Li Xue (李雪) leads multimodal neural-interface work. - Both are listed as controlling shareholders in the IPO counseling filing. - The stated logic: invasive engineering, while harder, offers more deterministic performance once resources are committed. ## The device: coin-sized, hair-thin The hardware is deliberately small and soft. Public reporting and the company describe an implant about the size of a coin and electrodes far finer than conventional rigid arrays. - Implant body: roughly 26 mm in diameter and under 6 mm thick. - Ultra-flexible electrode: about one-hundredth to one-three-hundredth the diameter of a human hair. - Channel count: 256, for high-throughput neural recording. - Surgical access: a 3–5 mm skull micro-hole using mature minimally invasive neuro-navigation. According to Zhao Zhengtuo, "a brain-computer interface is not only an engineering problem; it also needs the foundational support of neuroscience." The softer electrode is meant to reduce tissue damage and the immune scarring that rigid implants can trigger. ## Clinical milestones The company's progress moved from animal work to human implantation within a few years, and China became the second country after Neuralink to enter invasive-BCI clinical trials. - March 25, 2025: first domestic pre-registration prospective (FIM) invasive BCI trial at Huashan Hospital (华山医院), with patients controlling cursors and games after weeks of training. - A matching study, "A Study on the Safety and Functionality of the Implantable Wireless Brain-Computer Interfaces for Motor Rehabilitation (STAIR)," is registered on ClinicalTrials.gov as NCT06944834, sponsored by Shanghai StairMed Technology, last updated April 2025, listed as not yet recruiting, with estimated enrollment of 5 and primary completion in April 2027. - Company-disclosed figures reported by financial media describe 42 long-term implants, cumulative in-body time above 5,000 days, and brain-control usage above 10,000 hours. ## From lab to listing Stair Med has become one of the most capitalized invasive-BCI ventures in China and started formal steps toward public markets. - IPO counseling began in late 2026 with Huatai United Securities as sponsor, per the CSRC (中国证监会) filing. - Cumulative financing reached about 26亿元 (≈ US$366M / HK$2.9B) by September 2026. - A March 2026 strategic round of 5亿元 was led by Alibaba, with Tencent and other existing backers following — reported as the first time both internet giants co-invested in an invasive BCI company. ## Beyond movement: stimulation The same ultra-flexible electrode and decoding platform is being extended from movement restoration toward treating neurological disease. This matters because it turns a single hardware investment into two medical markets. - The company also develops a closed-loop, ultra-low-damage deep-brain neurostimulation system. - It reported four clinical research implants of that stimulator and plans a 2027 trial with Parkinson's disease and epilepsy as indications. - If the stimulation track advances, the implant could both read intent and write signals back, a step toward two-way brain-computer interfaces. ## Honest limitations - Implant counts and "exceeds Neuralink" comparisons are company-disclosed figures reported by financial media, not independently audited clinical registries; we could not confirm 42 implants against a public database. - The "innovation green channel" (创新医疗器械特别审查程序) speeds review but is not market approval; WRS01 remains in the registration-clinical stage, not a cleared product. - Long-term safety of multi-year implants in a small cohort is preliminary; broader evidence and multi-center trials are pending. - This piece focuses on one firm; other Chinese invasive-BCI programs follow separate routes and timelines. ## What readers can do now - Monitor the NMPA innovation-channel public notice list and ClinicalTrials.gov (NCT06944834) for verified status rather than headlines. - For investment, distinguish a "globally new" (全球新) designation and IPO counseling from actual product approval and revenue. - Clinicians and patients should wait for peer-reviewed, multi-center outcomes before weighing invasive BCI as a treatment option. --- Published by NeuroAI (https://neuroai.site/) — https://neuroai.site/a/na-stair-med-implantable-bci Free to quote with attribution and a link to the original.