NMPA Approves Four Innovative Directional Deep Brain Stimulation Devices by PINS Medical for Parkinson's Disease Treatment

May 28, 2024 20:59 CST Updated 20:59

Pins

Neuromodulation Product R&D, Production, and Sales

Source: Siyu MedTech; Editor: Qi Yuan

Reprint Requirements: Please indicate the source of the article at the beginning of the text, and it can be reprinted directly.

Audience Registration Open! First Global Medical Technology Conference

On May 28, 2024, NMPA approvedBeijing Pins Medical Co., Ltd.Implantable Deep Brain Stimulation Electrode Lead Kit, Dual-Channel Rechargeable Implantable Deep Brain Stimulation Pulse Generator Kit, Dual-Channel Implantable Deep Brain Stimulation Pulse Generator KitAndImplantable Deep Brain Stimulation Extension Lead KitRegistration applications for four innovative products.

Original text as follows:

"The above product isThe First Directional in ChinaDeep Brain Stimulation Products, when used in conjunction, can stimulate the subthalamic nucleus or globus pallidus internus and is used for cases where medications cannot effectively control certain symptoms.Advanced L-DOPA Responsive Parkinson's DiseasePatients undergo combination therapy. Compared with traditional electrodes, the aforementioned products can provide directional stimulation to specific functional subregions of the target nucleus.At the same time, in the case of slight electrode displacement, it can avoid the side effects of deep brain stimulation and reduce the risk of reoperation for electrode implantation.。”

# AboutDeep Brain Stimulation

"Brain Pacemaker" implantation, commonly known as Deep Brain Stimulation (DBS).

DBS is a technique that uses a pulse generator to stimulate certain nuclei deep in the brain, correcting abnormal brain electrical circuits to achieve therapeutic or improvement effects. As an intervention method that utilizes electrical energy to influence brain neural activity, it is currently the most widely accepted and important treatment. Related research is also exploring the use of DBS to treat other brain-related diseases, such as severe depression and Alzheimer's disease. (Further reading:A Comprehensive Guide to Brain Pacemakers）

In 1998, Deep Brain Stimulation (DBS) therapy entered China;

In 1999, DBS was registered in China for the treatment of Parkinson's disease and essential tremor.

In 2016, China approved DBS for the treatment of dystonia and refractory epilepsy.

▲History of DBS Development

Traditional DBSAfter the electrodes are implanted in the human brain, they send omnidirectional electrical pulses to the target points in the brain through the electrode contacts for stimulation. While improving the patient's motor symptoms, higher levels of stimulation can sometimes bring about certain side effects.

About a decade ago, the DBS market witnessed the entry of several emerging companies, namely St. Jude Medical (later acquired by Abbott), Boston Scientific, SceneRay, PINS, Neuropace, and Aleva Neurotherapeutics. Their arrival brought significant technological innovations to the market, including the application of segmented leads, enhanced precision in directional stimulation, significantly prolonged battery life, increased flexibility in setting stimulation parameters, and internet-based remote programming. These cutting-edge technologies injected new vitality into the development of the DBS market.

Recent developments include current directionality and electrode segmentation, expanded programming parameter space (particularly shorter pulse widths (10 microseconds) and frequencies up to 10,000 Hz), as well as advancements in MRI compatibility and neural recording capabilities.

Directional Deep Brain Stimulation System——An advanced system based on traditional DBS therapy, utilizing electrodes with more stimulation contacts (directional) and stimulation programs. It aims to identify more precise stimulation methods, reduce side effects caused by stimulation, and conserve energy consumption.

As of the date of publication, other approved deep brain stimulators and related accessories are listed in the table below:

# About Pins Medical

Beijing Pins Medical Co., Ltd. (hereinafter referred to as "Pins Medical") was founded in 2008, with its headquarters located in the Changping Park of Zhongguancun Science and Technology Park, Beijing. Pins Medical is a high-tech enterprise specializing in the research, production, and sales of a series of neuromodulation products, including brain pacemakers, vagus nerve stimulators, spinal cord stimulators, and sacral nerve stimulators. It is committed to providing advanced treatment options for patients with functional neurological disorders such as Parkinson's disease, epilepsy, pain, and urinary incontinence.

In 2023,Pins Medical Recognized as a National Enterprise Technology Center, Total Implantations Across Full Product Lines Exceed 30,000 Cases, Covering Nearly 600 Hospitals Across China

Pins Medical's Neuromodulation System (Brain Pacemaker) began its research and development in 2000, successfully conducted the first clinical trial in 2009, obtained the full series of brain pacemaker product registration certificates in 2014, and received CE certification in October 2016. By the end of 2023, Pins has over 450+ clinical cooperation centers in China, with more than 25,000 patients implanted nationwide.

Through collaboration with numerous clinical hospitals such as Tsinghua University, Beijing Tiantan Hospital, and Peking Union Medical College Hospital,Pins MedicalEstablished a "Production-Academic-Research-Medical" collaborative innovation model.Its series of brain pacemakers have been under development since 2000, led by Professor Li Luming's team from Tsinghua University. The first clinical trial was conducted in 2009, the full series of DBS product registration certificates were obtained in 2014, and CE certification was achieved in 2016.

Pins® 3.0T MRI-Compatible Brain Stimulator (G106/G106R Model), jointly developed by Pins Medical and Tsinghua University, features full independent intellectual property rights. It solves the worldwide medical safety issue of heat generation by DBS electrodes implanted in patients during MRI scans through anti-interference design, preventing thermal damage to surrounding tissues.

Pins® 3.0T MRI-Compatible Brain Stimulator (G106/G106R Type)In February 2019, it was included in the special review process for innovative medical devices in China, and in January 2022, it obtained the Class III medical device registration certificate issued by the National Medical Products Administration. It was featured in the National "13th Five-Year Plan" Science and Technology Innovation Achievements Exhibition and selected as one of "China's Important Medical Advances of 2022."

Pins® 3.0T MRI-Compatible Bluetooth Sensing Brain Stimulator (G106RS Model)Approved for marketing with the Class III medical device registration certificate obtained in March 2023,China's First Domestically Produced MRI-Compatible Bluetooth-Enabled Brain Pacemaker Fills the Gap in the Country。

▲ Pins Medical 3.0T MRI-Compatible Brain Pacemaker

On July 4, 2023, the new generation "Bluetooth-detectable, rechargeable, and remotely programmable 3.0T MRI-compatible brain pacemaker (Model 106RS)" completed its first clinical application post-market release at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital), marking another advancement in China's neuromodulation field.

As of the date of this report, the company's financing history is as follows: