NeuroXess Launches Pivotal Trial for China's First Subdural Cortical Implanted BCI System as Part of Class III Medical Device Registration

NeuroXess announced today that its self-developed “Implantable Brain-Computer Interface System for Compensatory Hand Motor Function” has officially initiated GCP (Good Clinical Practice) registration clinical trials at Huashan Hospital Affiliated to Fudan University. This marks the first subdural cortical surface implantable brain-computer interface product in China to enter the Phase III medical device registration clinical stage.

In China, there are currently over 3 million patients with spinal cord injury (SCI), with approximately 90,000 to 100,000 new cases annually. Patients with quadriplegia resulting from cervical SCI suffer severe impairment of motor function in both upper and lower limbs, rendering them completely dependent on others for daily living. For patients with complete SCI, traditional rehabilitation therapies offer virtually no potential for further neurological recovery. Brain-computer interface (BCI) technology represents the core technical pathway currently enabling functional reconstruction for these patients.

This registered clinical trial, with the team led by Professor Mao Ying from Huashan Hospital serving as the principal investigators, aims to evaluate the safety and efficacy of this brain-computer interface product for upper limb functional compensation in patients with quadriplegia caused by cervical spinal cord injury.

Professor Mao Ying’s team has extensive experience in clinical surgical standards for brain-computer interfaces (BCIs) and neural signal decoding. Previously, the team successfully completed the first clinical implantation of NeuroXess’s “Implantable Brain-Computer Interface System for Hand Motor Function Compensation.”

This registered clinical trial adopts a multicenter collaborative model, jointly conducted by a total of 15 Grade A tertiary hospitals across Shanghai, Jiangxi, Jiangsu, Zhejiang, Anhui, Hunan, Hubei, Guangdong, Fujian, Shandong, Shanxi, Liaoning, and other regions.

In terms of its technical approach, NeuroXess’s “Implantable Brain-Computer Interface System for Compensating Hand Motor Function” adopts a subdural implantation strategy, attaching flexible electrodes to the surface of the cerebral cortex without penetrating brain tissue. This design ensures precise acquisition of neural signals while maximizing brain safety. Its split-component design places high-heat-generating units—such as the battery, wireless data transmission module, and wireless charging unit—under the skin of the chest, thereby keeping heat sources away from the brain and effectively mitigating the risk of hyperthermia.

The surgery employs a mature deep brain stimulation paradigm, requiring no dedicatedRobotThe system's end-to-end latency is under 50 milliseconds, and the brain-controlled cursor decoding performance reaches 5.2 bits per second.

In terms of industrial layout, NeuroXess’s “Super Factory” in the Ganjiang New Area of Jiangxi Province covers a planned area of 14,300 square meters, with production scheduled to commence in the second half of 2026, enabling stable delivery of products at a scale of tens of thousands of units.

Original Title: NeuroXess Initiates Clinical Trials for Class III Medical Device Registration, Marking China’s First Subdural Cortical Implantable Brain-Computer Interface Product