NeuroXess Launches China's First Class III Medical Device Registration Clinical Trial for Subdural Cortical Implantable Brain-Computer Interface

NeuroXess, a Shanghai-based brain-computer interface company, announced Monday that its self-developed "Implantable Brain-Computer Interface Hand Motor Function Compensation System" has officially begun Good Clinical Practice registration clinical trials at Huashan Hospital, Fudan University. The product marks China's first subdural cortical surface implantable BCI device to enter Class III medical device registration clinical stage.

The clinical trial, led by Professor Mao Ying's team at Huashan Hospital, aims to evaluate the safety and efficacy of the BCI product for upper limb function compensation in patients with quadriplegia caused by cervical spinal cord injury. The trial adopts a multi-center collaboration model, involving 15 tertiary hospitals across Shanghai, Jiangxi, Jiangsu, Zhejiang, Anhui, Hunan, Hubei, Guangdong, Fujian, Shandong, Shanxi, and Liaoning provinces.

China currently has more than 3 million spinal cord injury patients, with approximately 90,000 to 100,000 new cases annually. Patients with cervical spinal cord injury suffer severe impairment of upper and lower limb motor function, becoming completely dependent on others for daily living. For those with complete injuries, traditional rehabilitation treatments offer virtually no possibility of further neurological recovery. Brain-computer interfaces represent the core technological pathway capable of enabling functional reconstruction for these patients.

Professor Mao Ying's team brings extensive experience in BCI clinical surgical protocols and neural signal decoding. The team previously completed the first clinical implantation of NeuroXess's implantable BCI hand motor function compensation system.

The NeuroXess system employs a subdural implantation approach, attaching flexible electrodes to the brain cortex surface without penetrating brain tissue. This design precisely captures neural signals while maximizing brain safety. Its split configuration places high-heat components—including the battery, wireless data transmission, and wireless charging units—under the chest skin, keeping heat sources away from the brain and effectively mitigating high-temperature risks.

The surgical procedure utilizes the established deep brain stimulation paradigm and does not require dedicated robotic equipment. The system achieves full-link latency below 50 milliseconds, with brain-controlled cursor decoding performance reaching 5.2 bits per second.

On the industrialization front, NeuroXess's "Super Factory" in Ganjiang New District, Jiangxi Province, spans a planned area of 14,300 square meters. The facility targets production launch in the second half of 2026, with capacity for stable delivery of 10,000-unit level products.