Lechuang Yigu's Innovative Wireless-Powered Spinal Cord Stimulation System Receives Ethical Approval from China-Japan Friendship Hospital

Feb 18, 2025 13:33 CST Updated 13:33

Leadinno Medical Valley

Developer of Medical Devices and Consumables in the Field of Pain and Neuromodulation

On February 14, 2025, Leadinno Medical Valley (hereinafter referred to as "Leadinno Medical Valley"), independently developed by BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTDInnovative Wireless Power-Carrying Spinal Cord Stimulation System Successfully Passes Ethical Review by the Drug (Device) Clinical Trial Ethics Committee of China-Japan Friendship Hospital, Officially Entering the Registration Clinical Trial Phase.

Leadinno Medical Valley's Wireless Power-Carrying Spinal Cord Stimulation System is the first wireless implantable spinal cord stimulation (SCS) product in China. The company has successfully established the first wireless implantable neurostimulation technology platform in China, featuring self-developed dedicated implant chips, high-performance RF power-carrying communication systems, and other technical advantages. It aims to provide safe, convenient, and cost-effective treatment solutions for patients with nerve injuries, chronic intractable pain, and other neurological disorders. Compared with traditional SCS products, Leadinno Medical Valley's products have four core advantages:

Note: Image source: Leadinno Medical Valley

The animal trials for this product have been successfully completed at BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD.From the design of animal experimental protocols, the approval of animal ethics, the operation of animal experiments, postoperative care of laboratory animals, analysis of pathological results, to the writing of preclinical evaluation reports, all are implemented by the professional technical team of BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD in accordance with standardized SOP procedures, ensuring the standardization of the experimental process, the authenticity of experimental data, and the reliability of experimental results. Moving forward, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD will also actively cooperate with clients in conducting clinical medical training to accelerate the speed of clinical promotion after product certification and market launch.

The information in this article is sourced from: Leadinno Medical Valley, all data and statements are subject to the official release by Leadinno Medical Valley.If there is any infringement, please leave a message, and we will delete it immediately!

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Tonghe LItai

BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD, located in Zhongguancun Medical Device Park, operates in a 7,500-square-meter facility. It is the only large-animal experimental technology service platform in China with a barrier-level environment, primarily using pigs. The platform has been named the "Medical Device Collaborative Innovation and Common Service Technology Platform" by the Beijing Municipal Science & Technology Commission.

Since its establishment, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD has been committed to building a strongly connected technology service platform centered on experts, deepening the platform's professional service capabilities, creating an ecosystem for experts, enterprises, and research institutions, and playing the role of an incubator for scientific research projects.

As a comprehensive service platform for preclinical animal testing of barrier-level medical devices in China, Tonghe Litai adheres to strict SOP procedures to serve each innovative medical device product. From experimental design to implementation, every step is strictly controlled to ensure the standardization of the experimental process, the authenticity of the data, and the reliability of the results. Since its establishment, BEIJING TONGHELITAI BIOTECHNOLOGY CO., LTD has issued more than 600 preclinical evaluation reports for medical devices that meet NMPA registration requirements.

BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD always adheres to the principle of being customer demand-oriented. According to customer needs, it can fully assist enterprises in different stages such as early incubation research, biocompatibility evaluation, preclinical evaluation, clinical trials, and registration of their products. It aims to address potential issues and deficiencies by providing reasonable suggestions and optimization plans, thereby saving costs and time for obtaining product certification as soon as possible. After the product certification is obtained, BEIJING TONGHELITAI BIOTECHNOLOGY CO.,LTD will also provide clinical promotion training through various channels, offering full-service support to help the product quickly gain clinical application.

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