Futong Huizhi Unveils World’s First Low-Cost, Millimeter-Precision Multi-Target TMS Solution Ahead of IPO

At the beginning of 2024, *The Lancet Neurology* published a study on neurological disorders. The study showed that in 2021, 3.4 billion people worldwide were living with neurological disorders, which are the leading cause of poor health and disability. With the deepening of the aging population process, this number is still growing rapidly.

Facing the heavy burden of mental illness, first disclosed in 1985Transcranial Magnetic Stimulation (TMS)By applying a time-varying magnetic field to the cerebral cortex, induced currents are generated to alter the action potentials of cortical neurons, influencing brain metabolism and neural electrical activity. It is painless and non-invasive, with wide applications in neuroscience, psychiatry, and rehabilitation medicine.

FUTONGHUIZHI's General Manager He Guohua pointed out that there are numerous patients with neurological disorders and psychiatric conditions such as stroke, Alzheimer's disease, and depression. Currently, many of these conditions lack effective drug treatments, and certain medications may bring side effects like addiction. Transcranial Magnetic Stimulators, as a mature device with over thirty years of clinical application history, have a large number of clinical cases and studies supporting their efficacy.

However, to achieve effective treatment, the treatment process requires precise positioning of the treatment target by skilled professionals or reliance on professional navigation equipment, which is difficult to effectively popularize in non-tertiary hospitals, limiting the widespread application of precise transcranial magnetic stimulation therapy.

In response to the above clinical pain points and market demands, FUTONGHUIZHI (Shanghai FUTONGHUIZHI Medical Technology Co., Ltd.) has independently developed a comprehensive precision treatment solution based on advanced algorithms and 3D printing technology. This solution can conveniently serve patients with brain diseases, providing them with high-quality, accessible, and low-cost precise transcranial magnetic stimulation therapy.

With the effectiveness of transcranial magnetic stimulation (TMS) technology being validated in clinical settings, its market demand is growing. However, existing TMS devices still have some limitations in clinical applications. The most prominent challenge in promoting and popularizing this technology is how to accurately locate the stimulation area to ensure treatment precision.

Navigated Transcranial Magnetic Stimulation (nTMS) achieves precise localization and regulation of specific brain regions by combining neuronavigation technology with a magnetic stimulator. "There is a huge gap between the market demand for precise positioning in current transcranial magnetic therapy and the domestic status quo in China. The main reason is that, at present, the cost of high-end navigation hardware and software equipment, whether produced in China or imported, is extremely expensive. Moreover, hospitals cannot charge for their use, which far exceeds the financial capacity of hospitals. Currently, only a few dozen medical institutions across China possess navigated transcranial magnetic stimulation devices," said He Guohua.

Therefore, He Guohua believes that if the existing logic continues to be used, even after ten more years, it will still be difficult for the popularity of navigated transcranial magnetic stimulation to see a significant increase in China. In order to solve this problem at a lower cost, FUTONGHUIZHI has designed a "world's first" precision positioning solution for transcranial magnetic stimulation.

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Traditional positioning methods rely on visual estimation and extensive experience for stimulation and positioning, which involves a certain degree of uncertainty. He Guohua explained,"Since the internal condition of the brain cannot be directly observed by the human eye, even a slight tilt or angular deviation of the treatment head on the scalp may, after being magnified through the layers of intracranial space, cause the treatment head to deviate from the target area, thereby affecting the treatment outcome."

Therefore, FUTONGHUIZHI has developed a personalized 3D printing device that can assist in precise positioning to address this situation, forming a comprehensive solution for precision treatment. On one hand, this innovative solution eliminates the purchase cost of high-end navigation software and hardware equipment, whether imported or domestically produced, lowers the technical threshold for operators, helps further explore the clinical application value and potential of precision positioning treatment technology, and promotes the widespread adoption of quality medical resources.

On the other hand, the magnetic therapy head holder based on 3D printing technology and advanced precision algorithms enables magnetic signals to penetrate the skull without loss through preset holes on the holder, precisely targeting specific areas of the brain. At the same time, due to the portability of the magnetic therapy head holder, FUTONGHUIZHI also hopes to expand the application scenarios of precise transcranial magnetic stimulation therapy from within medical institutions to home settings, benefiting more patients and truly achieving the goal of low cost and high efficiency.

Speaking of the original intention of starting a business, He Guohua said, "At the beginning of our venture, our company team focused on developing a precision positioning system based on 3D printing. This technology is not limited to being paired with transcranial magnetic stimulation technology. Our goal is to make this solution compatible with various neuromodulation devices, including transcranial magnetic stimulation, transcranial ultrasound, and transcranial laser, expanding the application scenarios of the solution."

At the same time, He Guohua also emphasized the popularity of medical technology. He believed that if a treatment method is only limited to the use of high-end equipment or carried out in large hospitals, the number of patients who can benefit will be very limited. Therefore, he advocated for the integration of research results through collaboration between medical and engineering fields, developing economical, effective, and multifunctional medical products so that more people can enjoy high-quality medical services.

Globally, transcranial magnetic stimulation (TMS) technology has been widely applied in clinical settings, with relatively mature techniques and substantial research supporting its efficacy and safety. Against this backdrop, the comprehensive precision treatment solution using TMS devices launched by FUTONGHUIZHI has a solid market foundation and the potential for rapid growth in the future. Moreover, the company is committed to becoming a leader in the field of precision brain rehabilitation therapy while actively exploring and expanding into emerging neuromodulation technologies such as transcranial ultrasound stimulation (TUS).

Transcranial ultrasound stimulation offers the advantages of high spatial resolution and deep stimulation depth, enabling precise targeting of the cerebral cortex and deep brain regions. As an emerging non-invasive neuromodulation treatment, although its clinical application is still in the exploratory stage, it has demonstrated significant potential and benefits.

In order to accelerate the implementation of domestically produced transcranial ultrasound stimulation devices, FUTONGHUIZHI is collaborating with Professor Guoyuan Yang's team from Shanghai Jiao Tong University and Professor Jiangang Chen's team from East China Normal University to jointly develop related transcranial ultrasound equipment. The team has successfully developed the first-generation prototype of the transcranial ultrasound stimulation device, which is currently mainly used for scientific research and animal experiments.

At the same time, the joint team is also actively developing a portable focused ultrasound device for human neural regulation. By 2025, the iterative prototype is expected to complete its development. After the completion of prototype development, FUTONGHUIZHI will quickly initiate registration-based clinical trials to bring the product to market.

In order to quickly verify the effectiveness and feasibility of this innovative solution for different indications, and to complete doctor and market education, FUTONGHUIZHI is actively collaborating with Class III hospitals to conduct clinical research.

For example, the company cooperated with Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine."Experimental Solution for Precision Treatment with Large Transcranial Magnetic Stimulator"; in cooperation with Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine"Portable Transcranial Magnetic Stimulator Precision Treatment Comprehensive Solution - Stroke Rehabilitation"; Cooperation with Shanghai Sixth People's Hospital "Portable Transcranial Magnetic Stimulator Precision Treatment Comprehensive Solution -- Cognitive Impairment (MCI)etc.

Among them, the clinical observation "Clinical Observation on Acupuncture Combined with Precise Target Transcranial Magnetic Stimulation in Treating Limb Motor Dysfunction During the Recovery Period of Ischemic Stroke" conducted by FUTONGHUIZHI in cooperation with Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine has completed randomized, controlled human clinical research, and the relevant research paper is currently being published.

The results of this clinical study showed that: Acupuncture combined with transcranial magnetic stimulation therapy can accurately locate the treatment target for patients with ischemic stroke, significantly improve the motor and living abilities of patients, and alleviate the depression of patients.

It is worth mentioning that, based on the innovative solution of precise auxiliary positioning, He Guohua compared it with invisible braces: "Although FUTONGHUIZHI's products are not in the same category as invisible braces, their processes are very similar. Both are based on patients' personalized data, diagnosed by doctors to determine treatment plans, then manufactured using 3D printing technology, and finally used under the guidance of doctors. Both have the characteristics of low cost, wide coverage, and lower costs with higher market penetration, showing great potential for domestic substitution and market promotion."

According to research data from Global Info Research, the size of China's neuromodulation market reached 1.97 billion yuan in 2022 and is expected to reach 3.63 billion yuan by 2029, with a compound annual growth rate (CAGR) of 9.53%. As the market continues to expand, FUTONGHUIZHI's magnetic treatment head positioner, used in conjunction with a magnetic stimulation device, will be more widely adopted in hospitals, communities, and households, enabling medical staff to conduct brain rehabilitation research and treatment more effectively and benefit more patients.

At the end of the interview, He Guohua said, "FUTONGHUIZHI's goal is to develop medical devices that are both technologically advanced and reasonably priced, achieving the dual objectives of cost reduction and technological innovation, creating a virtuous cycle."

As an innovator in precision-targeted therapy, FUTONGHUIZHI also hopes to continuously deepen clinical practice in the future, promoting clinical research and the transformation of scientific research achievements in precise positioning treatment for neuromodulation devices. The company aims to enhance the accessibility of high-quality medical technologies and strengthen clinical research capabilities through innovative medical technologies and products, contributing to the strategic goal of achieving health for all in China.