BriCo MedTech Announces IPO Filing Following NMPA Approval of World’s First Minimally Invasive Epidural Brain-Computer Interface System

Recently, the National Medical Products Administration approved Neuracle Technology (Shanghai) Co., Ltd. (hereinafter referred to as Neuracle) for its implantImplantable Brain-Computer Interface Hand Motor Function Compensation SystemThe registration application of this innovative product marks another significant breakthrough for a domestically produced device in the blue ocean track.

Image Source: NMPA Official Website

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The World's First

Breakthrough of China-produced BCI

The product approved for marketing this time is a blockbuster product of Neuracle ——The World's First Minimally Invasive Brain-Computer Interface System Featuring Epidural Implantation and Wireless Transmission Design(hereinafter referred to as: NEO) is a semi-invasive brain-computer interface product that entered the special review channel for innovative medical devices in August 2024.

According to the NMPA, this product is suitable for individuals aged between 18 and 60 with C2 to C6 cervical spinal cord injury ratings of A to C who have been diagnosed for over a year. Their condition should have been stabilized for at least six months following standardized treatment, yet they are still unable to perform hand grasping, but retain partial upper arm function.Patients with Quadriplegia Due to Cervical Spinal Cord Injury。

Compared with non-invasive headbands and fully invasive chips that require deep insertion into brain tissue, the epidural implantation technique of NEO, a semi-invasive approach, offers greater safety and clinical feasibility. According to Neuracle, NEOAdopt wireless, minimally invasive technology, which is placed under the skull and outside the dura mater of the human head. This location not only avoids direct damage to brain tissue but also provides the conditions for collecting high-precision signals. Moreover, it does not require an implanted battery inside the body, significantly reducing risks such as immune reactions, long-term rejection, battery leakage, or frequent battery replacement.

According to the disclosure by the Wen Wei Po, this product had previously been involved in clinical trials at 11 well-known hospitals in China, including Huashan Hospital Affiliated with Fudan University and Xuanwu Hospital. A total of 32 implant surgeries were completed within 78 days. The clinical trial results showed no device-related adverse reactions post-surgery, and all patients successfully achieved home-based brain-controlled grasping assistance and rehabilitation training.Hand function improved significantly by 100%, a significant improvement in hand grip ability has led to an enhancement in the patient's quality of life.

Neuracle, founded in November 2011, is a high-tech enterprise focusing on the research, development, production, and sales of brain-computer interface system-related equipment. It is always committed to providing professional and complete solutions for innovative neuroscience research and clinical neurological disease diagnosis, treatment, and rehabilitation research.

According to the PharmCube medical device data query, Neuracle is currentlyNine products have been launched., andFour other products have entered the innovation channel.. In addition, NeuracleCompleted 5 rounds of financing, Multiple funds are mainly used for promoting product development, and the minimally invasive implantable brain-computer interface system entering clinical trials, etc.

Image Source: PharmCube Medical Device Data

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Global Layout

Science Fiction Becomes Reality

In recent years, the BCI track has been heating up. As companies in and outside China are vying to make their moves, the brain-computer interface industry is experiencing rapid growth, turning previous scientific fantasies into reality.

In the global market, taking the United States as an example,The ecosystem of its brain-computer interface industry presents a diversified state.Companies such as Precision, Neuralink, and Synchron are accelerating their efforts and speeding up research and development. Invasive brain-computer interfaces are mainly led by American companies among the global leaders.

By the end of 2025, Elon Musk announced that the brain-computer interface device developed by his neurotechnology company Neuralink would officially enter large-scale production in 2026; Neuralink's second product, Blindsight, received the Breakthrough Device Designation from the U.S. FDA in September 2024, etc. With a flourishing of developments, American companies...Mainly showing a trend of multiple technical routes running in parallel in the invasive field.。

Looking at the domestic market, the Chinese market has emerged.A Unique Pattern Emphasizing Both Invasive and Non-invasive ApproachesApart from Neuracle, BrainCo also focuses on the non-invasive track. Notably, both companies initiated their IPOs in February, aiming to become China's first brain-computer interface stock.

In addition, there are companies like Neuracle and Zhiran Medical focusing on the invasive brain-computer interface track. Among them, Zhiran Medical completed two rounds of financing within half a year, with a total amount as high as 600 million yuan. Moreover, this year, Zhiran Medical is expected to launch large-scale registration clinical trials for its ultra-hundred-channel invasive brain-computer interface product.

It is worth noting that,China's 15th Five-Year PlanListed brain-computer interface as one of the six future industries, and among the policies in various regions, Shanghai issued the {Brain-Computer Interface Future Industry Cultivation Action Plan(2025-2030)" clearly proposes to promote the completion of clinical trials for more than 5 invasive and semi-invasive products by 2027.

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Conclusion

Driven by trends such as the introduction of the "15th Five-Year Plan," the surge in clinical demands due to an aging society, and the continuous iteration of chips and AI algorithms, the brain-computer interface sector will remain highly active.

Reference Source:

1. Neuracle Official WeChat Information

2. Wenhui Recommended Reading | 100% Significant Recovery of Hand Function in 32 Subjects, China's First Implantable Brain-Computer Interface Product Races to Market - Wenhui Daily