China's First Bidirectional High-Throughput Intracranial Deep Brain Electrode by Zhiran Medical Enters Regulatory Fast Track

Recently, the "Intracranial Deep Electrodes"Entered the special review process for innovative medical devices (also known as the 'Green Channel') at the Center for Medical Device Evaluation (CMDE) under the National Medical Products Administration (NMPA), and the public announcement has been completed. AsThe First in ChinaThe high-throughput deep intracranial flexible electrodes entering this "green channel" for approval, with their breakthrough innovations and significant clinical value, not only enable the realization of high-throughput invasive flexible brain-computer interfacesFrom "Read" to "Read-Write" Two-Way InteractionStrengthening the technical foundation and establishing a key milestone for the development of China's neuromodulation brain-computer interface industry.

Figure: CMDE Official Website Publicizes Review Results

For a long time, restricted by material properties and processing techniques, traditional deep brain electrodes have faced technical bottlenecks in key areas such as increasing the number of channels and reducing implantation damage, making it difficult to meet higher clinical demands like fine brain function mechanism research and precise neural modulation. Meanwhile, most new-generation flexible electrodes only possess the unidirectional function of "reading" neural signals, and products capable of bidirectional "read-write" functionality have rarely entered clinical use.

The high-throughput deep brain flexible electrodes developed by BCIFlex, on the other hand, have fundamentally overcome the aforementioned technical barriers.

The product is made of ultra-thin flexible material, only one-tenth the thickness of a hair.The volume is only 1/30 of a traditional electrode., which can minimize the proportion of the brain and reduce implantation damage. At the same time,The product has both high-throughput neural signal acquisition and stimulation functions., which can simultaneously acquire field potentials and single-neuron action potential signals, enabling cross-scale recording from neural population activities to individual cell levels, and deliver precise stimulation to the target tissue, thereby completing bidirectional read-write operations in the brain.

In configuration, the productAdopting a macro-micro electrode integrated design, a single electrode supports up to 50 channels (each channel contains 32 micro contacts)., significantly improving the coverage density and spatial resolution of signal acquisition in deep brain nuclei, providing a reliable tool for the precise mapping of brain networks.

Fig: BCIFlex Intracranial Deep Electrode Macro-Micro Contact Schematic

To enhance clinical usability, the R&D team fully integrated actual clinical needs into the product design, ensuring that the product is fully compatible with the hospital's existing surgical robots, lowering the threshold for clinical operations, and guaranteeing efficient surgical procedures.

Currently, the high-throughput deep brain flexible electrode has successfully passed registration inspection and third-party biocompatibility studies, with its safety and reliability fully validated. Starting from 2024, this product has been undergoing clinical research at several top hospitals in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine, Huashan Hospital affiliated with Fudan University, and the China-Japan Union Hospital of Jilin University.Enroll multiple patients and collect more than 20TB of neuronal action potential data from deep human brain regions., fully demonstrating the electrode's capability in efficiently acquiring neuronal signals. Based on high-quality neuro-electrophysiological signals, the clinical team was able to accurately identify epileptic foci, providing a reliable basis for individualized diagnosis and treatment of patients.

The clinical application value of BCIFlex's high-throughput deep-brain flexible electrodes has gained high recognition from experts in the field. Professor Chen Gao, Director of the Neurosurgery Department at Zhejiang University Second Affiliated Hospital, commented: The world's first clinical implantation of ultra-thin flexible deep electrodes marks a significant breakthrough in the brain-computer interface field. It not only signifies China's leading position in the global high-throughput brain-computer interface domain but also provides a new tool for precise diagnosis and treatment of brain diseases as well as neuroscience research, further advancing the development of neurosurgery in China to new heights.

From technological breakthroughs to clinical applications, BCIFlex has always been at the forefront of innovation in the brain-computer interface field. In the future, the company will take its entry into the special review process for innovative medical devices as a new starting point, accelerating the clinical research and registration of next-generation high-throughput brain-computer interface products based on flexible electrodes. By leveraging cutting-edge technology, it aims to enhance precision diagnosis and treatment of neurological disorders, allowing more patients to benefit from advancements in brain-computer interface technology.

About "Special Review Procedure for Innovative Medical Devices”

The Special Review Procedure for Innovative Medical Devices is a priority review channel established by the National Medical Products Administration (NMPA) to encourage medical device innovation. This procedure primarily targets innovative medical devices that are internationally advanced in technology, with product operating principles or mechanisms of action being the first of their kind in China, and for which preliminary research has been completed and prototypes have been finalized. Without lowering review standards or omitting statutory procedures, national regulatory authorities provide early intervention and on-site guidance, thereby accelerating the market entry of innovative medical devices and allowing innovative achievements to benefit patients more quickly.

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