BeiNao No.1 Nears Market Approval with Expected Launch in 2027 Following Successful Multicenter Clinical Trials

Source: Beijing Youth Daily

"BeiNao No.1," the intelligent brain-computer system jointly developed by the Beijing Institute of Brain Science and Neurotechnology and NEUCYBER, has now entered the multi-center registration clinical trial phase in China and is expected to be approved for marketing as early as 2027. "BeiNao No.2," which focuses on invasive technology, has completed the development of a 512-channel prototype and is expected to initiate clinical verification within 2026… Reporters from the Beijing Youth Daily learned yesterday from Changping District, where the Beijing Institute of Brain Science and Neurotechnology is located, that in order to further support the development of the brain-computer interface industry, the district recently officially released the "Several Measures to Support the Development of Brain Science and Brain-Computer Interface Industry in Changping District." With eight initiatives across three dimensions—technological innovation, enterprise clusters, and ecosystem construction—the policy aims to provide an "accelerator" for the entire industrial chain of brain-computer interfaces.

"NEUCYBER One" Enters Large-Scale Clinical Validation Phase

A 29-year-old patient paralyzed in the lower limbs due to a car accident, with complete loss of leg mobility and severe muscle atrophy, regained significant function after receiving a coin-sized flexible electrode device called "Beinao No.1." Just five months later, this patient, who had been paralyzed for six years, was able to independently turn over, move their legs, and kick. With the help of non-powered support devices and a walker, they could walk continuously for hundreds of meters and even regained voluntary control over bladder and bowel functions… This is not a scene from science fiction but a real clinical miracle achieved by China's self-developed "Beinao No.1" intelligent brain-computer system.

On April 13, Beijing Tiantan Hospital completed the public live broadcast of the "North Brain No. 1" implant surgery, marking a key milestone in the industrialization of China's high-end brain-computer interface technology. This signifies the transition from single-center exploration to large-scale multi-center clinical validation. Luo Minmin, Director of the Beijing Institute of Brain Science and Intelligence Technology and Chief Scientist of NEUCYBER, told reporters from the Beijing Youth Daily that "North Brain No. 1" uses semi-invasive methods for collecting brain signals, achieving breakthroughs in safety, stability, and effectiveness. The implanted 128-channel microsystem represents the highest signal flux globally for wireless full implantation in the human brain achieved by semi-invasive brain-computer interfaces.

So far, "NEUCYBER One" has completed 10 human implants, with the longest implant time exceeding one year, and a total accumulated safe working duration of 45,000 hours in humans; the system performance is stable. "Almost every patient can achieve good cursor control, and four-direction cursor control is the foundation of free movement, which also demonstrates the performance of 'NEUCYBER One'," said Luo Minmin.

"NEUCYBER Brain Device 2.0" Expected to Initiate Clinical Validation Within the Year

Unlike Musk's Neuralink, which primarily focuses on invasive brain-computer interface technology, the Beijing Brain Institute and NEUCYBER team are advancing both semi-invasive and invasive technological routes: "Beijing Brain No. 1" emphasizes safety and rapid implementation, while "Beijing Brain No. 2" aims for higher performance breakthroughs. "We hope to quickly serve patients with 'Beijing Brain No. 1,' a product with enhanced safety, while using 'Beijing Brain No. 2' to explore higher performance limits and meet more clinical needs," said Luo Minmin.

Reporters from Beijing Youth Daily learned that "NEUCYBER Brain II" adopts an invasive design, with electrodes that can be precisely implanted into brain tissue to record the electrical activity of individual neurons. It has currently completed the development of a 512-channel wireless fully-implanted product, with an information transmission rate of up to 7.18 bit/s. Its core performance rivals international top levels. The product has entered the large-animal implantation testing phase and is expected to officially commence clinical validation within 2026. In the future, it will achieve more refined brain function decoding and neural modulation.

According to the clinical advancement plan, "NEUCYBER One" is led by Tiantan Hospital, Xuanwu Hospital, and Shanghai Huashan Hospital as joint lead units, conducting multi-center clinical trials across 15 medical institutions in China. All patient enrollment will be completed by 2026, followed by a six-month clinical observation period. Registration for review will be submitted in 2027, and upon successful approval, it will officially enter the market, benefiting a wide range of patients with motor function disorders.

City and District Levels Provide Genuine Support for the Development of Brain-Computer Industry

"The rapid progress of 'NEUCYBER One' and 'NEUCYBER Two' is inseparable from the unique brain-computer interface industry ecosystem in Beijing and Changping District, as well as the strong financial support from both municipal and district levels. 'During the financially tight years of 2022 and 2023, Beijing invested 400 million yuan to support our research and development. The park also provided comprehensive support in terms of research, technology, talent, and ideas, allowing us to focus on overcoming challenges,' said Luo Minmin."

Reporters from Beijing Youth Daily learned that the Changping District's Life Science Park, where the Beijing Institute of Brain Science and Brain-like Intelligence is located, gathers top research platforms, clinical resources, and industrial carriers. It aims to build a leading industrial cluster for brain-computer interface technology in China. Recently, Changping District officially released the "Several Measures to Support the Development of the Brain Science and Brain-Computer Interface Industry in Changping District," with eight integrated special policies to comprehensively promote high-quality development of the industry.

In terms of technological innovation breakthroughs, the new policy provides supporting space and funding for major R&D platforms, encourages the open sharing of scientific research facilities, offers R&D investment subsidies, and fully reduces early R&D costs for enterprises while accelerating the transformation of achievements. In terms of enterprise cluster development, it ensures industrial land through flexible transfer, rent-first-then-purchase, and rent-buy combinations, providing financial and proportional subsidies for major projects and fixed asset investments, creating a high-quality business environment that is "ready to move in and fully supported throughout." In terms of industrial ecosystem construction, it promotes innovative products entering hospitals, being included in medical insurance, and rapid application, improves the supply-demand connection of the industrial chain, leverages the policy advantages of the "two zones," supports hosting high-level industry events, and comprehensively enhances industrial agglomeration and core competitiveness.

Text/By reporter of this newspaper, Zhang Yueyang

Photography/Shi Xuehai

Editor: Wang Yue (EN103)