Chinese BCI Firms Race to the Forefront of Global Brain-Computer Interface Innovation

(Source:China MedicineReport)

Source: China Pharmaceutical News

□ Our Staff Reporter Jiang Hongyu

On the morning of February 5, Beijing was hit by biting cold winds, but the R&D laboratory of NEUCYBER (Beijing Xinzhide Neural Technology Co., Ltd.) presented a scene of intense activity. Several researchers were gathered around a computer, attentively discussing the test results of the hardware performance of "BeiNao II," their self-developed brain-computer interface system.

"It can be seen that the sensor can still maintain the integrity and accuracy of the signal in a complex environment," said a researcher happily.

NEUCYBER is a brain-computer interface industrialization company established in 2023. In less than two years, the company has developed "Beijing Brain No. 1," the world's first 128-channel, wireless, fully implantable semi-invasive brain-computer interface system, and is exploring its application for functional substitution and rehabilitation in patients with motor/speech dysfunction caused by spinal cord injuries and strokes.

It is reported that last year, "BCIFlex One" obtained the product type inspection report, initiated a prospective clinical trial, and completed six clinical implants. Currently, NEUCYBER is actively preparing for the launch of a large-scale registration clinical trial and plans to complete patient enrollment this year.

"In the development of the invasive brain-computer interface system 'Brain Two', the thousand-channel wired version has enabled monkeys to control computer cursors with their brains, and the 512-channel wireless fully-implanted version will enter the large animal testing phase soon," said Li Yuan, Business Development Director of NEUCYBER, with great confidence.

Beijing Bciflex Medical Technology Co., Ltd. (hereinafter referred to as BCIFlex), located 21 kilometers away from NEUCYBER, is also in the midst of vigorous research and development in the brain-computer interface field.

Electrodes are crucial components of brain-computer interface systems. According to reports, BCIFlex's research team recently achieved a significant technological breakthrough by successfully developing a stretchable high-throughput flexible electrode that combines high-throughput signal acquisition with biomechanical compliance, effectively solving the industry-wide problem of traditional linear flexible electrodes being prone to displacement and dislodgement. The related findings were published on February 5 in the international academic journal *Nature Electronics*. Additionally, the team developed a high-throughput wireless invasive brain-computer interface system based on the stretchable flexible electrode. This system significantly enhances the long-term stability and decoding accuracy of signals, laying a technical foundation for the scaled application of invasive brain-computer interface products.

Song Qi, founder and CEO of BCIFlex, introduced that the company has completed the first clinical implantation of its over-a-hundred-channel invasive brain-computer interface product, preliminarily verifying the product's safety and effectiveness. It plans to launch large-scale registered clinical trials this year, which will accelerate the product's market entry.

Currently, no invasive brain-computer interface medical device has been approved for marketing worldwide. In this world-class race, how are Beijing's R&D enterprises competing?

The respondents unanimously expressed that, with the intensive breakthroughs in underlying technologies and the strong synergy formed by multi-party collaboration, "Beijing Innovation" is accelerating its pace.

Beijing Possesses先天 Resources for the Development and Industrialization of Brain-Computer Interface Technology. The Beijing Institute of Brain Science and类脑 Research, the Chinese Academy of Sciences, Tsinghua University, and other research institutions and universities continuously tackle core technologies. Collaborating with enterprises, they utilize abundant clinical resources to accelerate the transition of brain-computer interface products from "laboratories" to "clinics."

While possessing a "foundation" advantage, policy tailwinds continue to stimulate innovation vitality. In January last year, multiple departments in Beijing jointly released the "Action Plan for Accelerating the Innovative Development of Brain-Computer Interface in Beijing (2025-2030)," which explicitly proposed to drive the full-chain acceleration breakthrough in brain-computer interface scientific and technological innovation and industrial cultivation. The plan aims to create a globally influential and competitive source of BCI technological innovation, a leader in scenario application, and a hub for industrial development.

Notably, throughout the accelerated breakthroughs in the development of brain-computer interface products, the presence of pharmaceutical regulatory authorities has always been evident.

"Brain-computer interface medical devices are an entirely new product. Companies need guidance from drug regulatory authorities to meet clinical and regulatory requirements. During the R&D process, Beijing's drug regulatory department communicated with us almost every week," said Li Yuan. "We focus on technology, and they are well-versed in regulations. Through collaboration, we are jointly seeking answers regarding the safety boundaries of the product."

Taking the Beijing Center for Medical Device Review and Inspection as an example, the center provides on-site guidance for related enterprises regarding questions on registration submission, contract manufacturing, and quality management system construction. It incorporates eligible brain-computer interface products into project-based management, offering services such as "early intervention, one product one policy, full-process guidance, and research-review coordination."

Running enterprises have also gained the favor of capital. It is reported that BCIFlex has recently completed a 300 million yuan A+ round of financing, which will accelerate the large-scale clinical trials and iteration of products, as well as speed up the clinical application of the products.

During the visit, the reporter found that the interviewed enterprises were full of expectations for the upcoming Year of the Horse. They were well aware that what they were igniting was the hope for countless patients to regain a "new life"; and what they were participating in was a technological race concerning the future.