China's Beinao-1 brain-computer interface enters registered trials

The Beinao-1 intelligent brain-computer interface (BCI) system has moved into registered clinical trials, after nearly 30 human implants were completed in the earlier investigator-initiated trial phase.

Jointly developed by the Chinese Institute for Brain Research in Beijing and NeucyberNeurotech (Beijing), Co Ltd, the semi-invasive system uses a flexible, ultra-thin electrode matrix with 128 channels (meaning 128 listening points). It is placed outside the brain's protective membrane — a safer position that avoids direct contact with brain tissue — and has achieved the world's highest signal throughput for a wireless, fully implanted, semi-invasive BCI system, according to the institute.

The institute said the device is designed to restore motor and speech functions for patients with spinal cord injuries or amyotrophic lateral sclerosis, or those who have experienced a stroke.

To date, the first implanted patient has lived with the device for over a year. Across all patients, the system has accumulated more than 65,000 hours of safe operation. The BCI enables fine motor decoding for paralyzed patients and speech decoding for those who are unable to speak. It comes with a vocabulary of nearly 100 commonly used Chinese words.

The team aims to complete all patient enrollment by 2026 and apply for a medical device registration certificate in 2027.

Meanwhile, Beinao-2 (The NeuCyber Array BCI System), a high-performance invasive intelligent brain-computer interface (BCI) system, has completed the development of its 512-channel, fully implantable wireless device. The system has now entered animal trials, with clinical verification expected to begin later this year.