Neuracle Completes IPO Tutoring, Races to Become China's First BCI Company Listed on STAR Market with World's First Approved Invasive Brain-Computer Interface

On June 9, the official website of the China Securities Regulatory Commission (CSRC) disclosed that Neuracle Technology (Shanghai) Co., Ltd. and its sponsor, CITIC Securities, had jointly submitted to the Shanghai Bureau of the CSRC a report on the completion of IPO tutoring. The four-month tutoring period has officially concluded, leaving this brain-computer interface (BCI) leader, founded in 2011, with only one final step before knocking on the door of the STAR Market. Almost simultaneously, Neuracle achieved its most significant milestone in commercialization: on March 13, 2026, the National Medical Products Administration (NMPA) issued a registration certificate for its "Implantable Brain-Computer Interface Hand Motor Function Compensation System" (NEO System), thereby granting the world's first invasive BCI medical device the "pass" for clinical application.

NEO System: A Coin-Sized "Neural Translator"

The newly approved NEO system is not a single device, but a comprehensive medical-engineering solution encompassing implants, EEG electrode kits, EEG decoding software, pneumatic gloves, and accompanying surgical toolkits. Its technical approach differs from traditional invasive methods by adopting an epidural minimally invasive implantation strategy—where only a micro-groove is milled into the skull to affix a coin-sized device onto the outer surface of the dura mater, without direct contact with brain tissue. This ensures high-quality neural signal acquisition while significantly reducing surgical trauma and the risk of biological rejection. The system achieves power supply and communication via near-field wireless technology, eliminating the need for implanted batteries in patients.

This product is precisely targeted at quadriplegic patients with stable C2–C6 cervical spinal cord injury, aged 18 to 60 years. By acquiring and decoding motor intentions from the brain in real time, the NEO system drives an external pneumatic glove to assist patients in performing daily activities such as grasping and holding a cup, thereby achieving effective compensation for hand motor function.

"China Speed" in Clinical Trials and Review

From the first implantation to market approval, Neuracle has pioneered a highly benchmark-setting path for clinical translation:

October 2023: The NEO system completed its first human implantation at Xuanwu Hospital of Capital Medical University, and was subsequently rapidly expanded to top-tier neuroscience centers—including Beijing Tiantan Hospital, Huashan Hospital Affiliated to Fudan University, and Jiangsu Province People’s Hospital—to conduct feasibility studies.

August 2024: The product has officially entered the National Medical Products Administration’s Special Review Channel for Innovative Medical Devices, receiving prioritized pre-review resources.

Second Half of 2025: Clinical progress has been comprehensively accelerated, with a total of 32 NEO implantations performed in patients with cervical spinal cord injury across 11 hospitals nationwide within 78 days. Postoperative follow-up showed that the cumulative safe implantation duration for subjects approached 5,000 days, with no device-related adverse events observed, and the primary clinical endpoint was achieved in 100% of cases.

March 13, 2026: Officially approved for market launch, marking the completion of the leap from laboratory to clinical application for the world’s first invasive brain-computer interface medical device.

Accelerated Capitalization and Competition in the Sector

As the commercialization vehicle for the Neural Engineering Laboratory at Tsinghua University’s Department of Biomedical Engineering, Neuracle has transformed over the past decade from a supplier of research equipment into an enterprise producing clinical-grade medical devices. Its shareholder roster includes prominent institutions such as Sequoia China, Baidu Ventures (BV), Kaifeng Venture Capital, and the Changzhou Government Investment Fund, establishing a robust capital moat.

Currently, China’s brain-computer interface (BCI) industry is entering an intensive window for capitalization validation. In addition to Neuracle’s push for a listing on the STAR Market, Hangzhou BrainCo Technology Co., Ltd. (BrainCo) also submitted a confidential IPO application to the Hong Kong Stock Exchange earlier this year. The competition between these two leading enterprises for the title of “the first BCI stock” is becoming increasingly fierce. By being the first to establish a complete closed-loop chain spanning “clinical validation–regulatory approval–capital markets,” Neuracle has not only provided the most robust technological narrative for its prospectus but also set a key benchmark for valuation anchoring and commercial evolution in the secondary market for China’s BCI sector.

Reference:http://www.neuracle.cn

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