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·The patient's 6-month compliance rate reached 80%, and 10-year long-term follow-up data showed a compliance rate of 69%. There were no significant adverse effects observed in cognitive, personality, memory, and life and work functions.

On December 15th, the China National Medical Products Administration issued a Class III product registration certificate for Jingyu Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as "Jingyu Medical") invasive brain computer interface therapy for drug addiction. This is the world's first approved invasive brain computer interface product for the treatment of addictive mental illnesses.

This product uses deep brain stimulation (DBS) technology, which involves drilling two small holes in the patient's skull to implant electrodes into specific neural nucleus regions of the brain. At the same time, a pulse generator about the size of a matchbox is implanted in the patient's chest, connected to brain electrodes through wires, providing continuous electrical stimulation to regulate the brain's reward and impulse control system that has been "hijacked" by drugs for a long time.


Schematic diagram of an invasive brain computer interface system for treating drug addiction, including implanted electrodes, pulse generators, and terminal devices. Image provided by Jingyu Medical

The person in charge of Jingyu Medical told Pengpai Technology that this product is mainly targeted at patients with refractory moderate to severe opioid addiction (fentanyl, methamphetamine, opium, etc.). After the product is launched, patients first need to seek evaluation from a psychiatrist, and then undergo surgical implantation by a functional neurosurgeon.

Drug addiction has long been listed by the World Health Organization as one of the major unresolved health problems for humanity. According to relevant data, there are approximately 300 million people worldwide who are troubled by drugs, with 50-60 million of them being opioid addicts. In 2019, approximately 600000 people worldwide died from drug-related issues. The efficacy of traditional treatment methods for this disease has always been very limited.

Ning Yihua, Chairman of Jingyu Medical, introduced at a previous press conference that addiction is not a moral defect, but a chronic disease caused by the brain being "kidnapped" by drugs, involving abnormalities in multiple neural circuits in the brain. Therefore, the product is designed with a dual target therapy approach that intervenes in addiction related neural circuit function by simultaneously regulating different neural nuclei.

In 2014, the company performed surgeries on 8 patients with severe heroin addiction. It is reported that 5 of the patients successfully quit drugs after surgery and have been followed up for 10 to 11 years without relapse.

In 2018, Jingyu Medical launched a larger scale clinical trial and the results were evaluated by an independent evaluation team. Ning Yihua said that the treatment showed good clinical effects, with the 6-month integrity rate of patients (the proportion of patients who did not relapse after the compulsory detoxification was lifted) reaching 80%, and the 10-year long-term follow-up data showed that the integrity rate was 69%. "No obvious adverse side effects" were found in the aspects of cognition, personality, memory, and life and work functions.

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