HuiChuang Medical Files IPO Prospectus: Empowering Brain Science with fNIRS Technology, Backed by RMB Hundreds of Millions in Three Rounds of Funding and Supporting Over 170 SCI Publications

The evolutionary history of the brain is much older than we imagined. Long before the appearance of the first animals on Earth, during the era of ancient oceans, single-celled organisms that floated and swam with the seawater already possessed the ability to sense and adapt to changes in their external environment.

850 million years later, the human brain has evolved into the most sophisticated, complex, and mysterious organ. Although the brain accounts for only 2% of the body's mass, 80% of it is blood, and its oxygen consumption accounts for 25% of the entire body.

How to unveil the mystery and observe our brain is the cornerstone of human research on the structure and function of the brain, as well as further effective diagnosis and treatment of brain diseases. However, the texture of the human brain is like soft silken tofu, surrounded by a hard skull and multiple layers of meninges. Therefore, how to "penetrate" these layers in a safer and more effective way to monitor the functional state of the brain is crucial.

In this regard, a painless, non-invasive, and portable non-intrusive brain function imaging technology is bringing new changes to the industry. This is functional near-infrared spectroscopy (fNIRS).

fNIRS is known as "functional MRI worn on the head." This technology is a new brain function imaging system that utilizes the differential absorption characteristics of oxygenated hemoglobin and deoxygenated hemoglobin in brain tissue for near-infrared light wavelengths between 600-900nm, enabling real-time, direct detection of cortical hemodynamic activity.

In terms of the global development of fNIRS, one company in China has taken the lead with globally advanced technological advantages and has repeatedly gained favor in the market and capital sectors, successfully completing three rounds of financing worth hundreds of millions. This is Danyang Huichuang Medical Equipment Co., Ltd. (hereinafter referred to as "Huichuang Medical").

Why Huichuang Medical Can Frequently Gain Capital Recognition? What Innovative Achievements Has the Company Made in the fNIRS Field? With Many Questions, VCBeat InterviewedWang Daifa, Founder, Chief Scientist, and Chairman of Huichuang Medical. A dialogue on the breakthrough development of fNIRS in China and the innovative applications of this technology in scientific research and medical fields.

 Wang Daifa, Founder, Chief Scientist, and Chairman of Huichuang Medical

"Writing research on the vast land of the motherland" is the corporate vision of Huichuang Medical and also the heartfelt insight of its founder, Wang Daifa.Although this may seem to have little to do with medical devices or Huichuang Medical, the two are in fact closely related and mutually beneficial.

First, the origin of "writing scientific research on the vast land of the motherland" is President Xi Jinping's earnest expectation for scientific and technological workers — "write papers on the vast land of the motherland." Huichuang Medical, established under the transformation of research results from Beihang University, is an innovative national high-tech enterprise. Wang Daifa himself is also a scientist and currently a professor at Beihang University, closely connected with "scientific research."

Wang Daifa graduated from Tsinghua University with both his bachelor's and doctoral degrees, and since his undergraduate studies, he has focused on near-infrared brain functional imaging research. After completing his doctorate, Wang Daifa joined Beihang University, and in 2016, under the support of Beihang University’s technology transfer policies, he founded Huichuang Medical to comprehensively advance the transformation of near-infrared brain imaging research achievements.

In 2019, Huichuang Medical independently developed and launched the world's first near-infrared brain function imaging product (NirScan) with over 100 channels, approved by NMPA for medical device certification; In 2021, Huichuang Medical achieved another milestone by launching NirSmart, the world’s first portable near-infrared brain function imaging device approved by NMPA for medical device certification, providing multidimensional and quantitative brain function imaging solutions for the diagnosis and treatment of brain diseases.

To this day, Wang Daifa has led his team in the near-infrared brain function imaging field for nearly two decades.And successfully embedded this innovative technology into real application scenarios, achieving demonstration applications in over a thousand hospitals, universities, and research institutes across China, continuously practicing the corporate vision of "writing research on the vast land of the motherland."

Secondly, "treating diseases" is the fundamental attribute of medical care, but with the wide variety of brain diseases and their complex causes, many treatment methods fail to address the specific conditions. Against the backdrop of an era where China's brain science research urgently needs breakthroughs,Huichuang Medical has successively undertaken three key national R&D projects and other top national scientific and technological projects, owning more than 30 intellectual property rights including national invention and PCT patents.

To continuously empower scientific research and innovation in the near-infrared field, Huichuang Medical has also established an academic research department consisting of more than 20 master's and doctoral students. It has formed close and in-depth cooperation with many top clinical hospitals and research institutions at home and abroad, accelerating the transformation of scientific research achievements.According to the introduction, the company has currently supported experts in various fields to publish a total of more than 170 SCI papers, and on average, a new paper is added every three to four days.

Finally, Huichuang Medical has always been in close communication with researchers, continuously absorbing cutting-edge knowledge. The company consistently adheres to efficient independent research and innovation, which has enabled it to break the monopoly of Japanese manufacturers in the fNIRS field. This provides innovative, intelligent, and professional dynamic imaging, intervention, and treatment solutions for brain diseases in China and even globally.

High-resolution non-invasive imaging of brain activity in its natural state has always been a global challenge. Currently, apart from fNIRS, conventional non-invasive technologies for measuring brain signals on the market also include functional magnetic resonance imaging (fMRI) and electroencephalography (EEG).

First, fMRI requires the subject to lie in the scanner for imaging, and the subject's breathing, heart rate, etc., can all affect the measurement results. As the scanning speed increases, the clarity of the images decreases. Moreover, while EEG can achieve portability and high temporal resolution, it is also susceptible to influences from the subject and the environment during detection. Additionally, the results lack spatial resolution, making it impossible to determine whether the electrical signals originate from the cortex or deeper regions of the brain.

Against this technical background, fNIRS devices, which are safe and non-invasive, easy to move, resistant to motion interference, resistant to electromagnetic interference, high in spatiotemporal resolution, and allow for long-term monitoring, have become the preferred technology for non-invasive measurement of brain signals.

As of now, Huichuang Medical has developed multiple fNIRS products revolving around fNIRS technology—from research to medical applications, from stationary to portable devices, and from hardware equipment to software systems… Among these, Huichuang Medical offers two series of products for the medical field: the stationary NirScan and the portable NirSmart.

In August 2023, Huichuang Medical released its latest floor-standing fNIRS device, the NirScan-9000. Compared to the previous generation NirScan-6000, which had over 100 channels, the new NirScan-9000 increases the number of optical pathways to up to 157 channels, providing more comprehensive detection. Additionally, this product enables dual-brain, multi-region synchronous imaging with full-brain coverage and is currently the highest-channel product to have obtained a Chinese medical device registration certificate.

NirScan

Another portable device, NirSmart, emphasizes mobility. This device can not only be worn in a backpack, adapting to more clinical scenarios, but also be combined with a trolley to become a mobile floor-standing unit, facilitating movement in scenarios such as wards and communities.

As a portable medical device, NirSmart also supports wireless free collection of brain signals through wearable hosts. In addition, although NirSmart is a portable device, it can reach up to 63 channels, simultaneously covering multiple brain regions such as the frontal, temporal, parietal, and occipital lobes, with signal quality comparable to floor-standing products.

Wearing NirSmart During Exercise

In terms of product commonalities, first, both NirScan and NirSmart have broken through the limitations of traditional paradigms in psychiatric departments, allowing for applications across multiple departments such as rehabilitation, pediatrics, and neurology, while continuously iterating new paradigms and usage scenarios. Second, both series of products support multimodal integration with EEG, TDCS, TMS, fMRI, and VR, enabling the products to provide more comprehensive information while becoming a powerful tool for timely efficacy evaluation in clinical settings.

In addition to its medical-end products, Huichuang Medical, an innovative enterprise that incorporates "scientific research" into its corporate vision, has also developed a range of products catering to the needs of researchers. These products, available in various forms such as floor-standing, portable, and wearable, are designed for scientific research applications. Importantly, each product is equipped with built-in scientific research modules and pre-configured research templates, while also supporting customizable and flexible design, making research more accessible.

Huichuang Medical has established a mature ecosystem with both software and hardware capabilities.NirSpark, a one-stop near-infrared brain function imaging data analysis software independently developed by the company, is the first commercial fNIRS data processing software on the market that requires no programming.Users can utilize the visual interface to perform various customized analyses such as data preprocessing, hyperscanning, and brain functional connectivity analysis, greatly expanding the application scenarios of fNIRS in scientific research and clinical work.

NirSpark One-Stop Near-Infrared Brain Function Imaging Data Analysis Software

Moreover, Huichuang Medical has established intelligent clinical examination templates across all fields. The system comes with built-in paradigm templates for various disease solutions, capable of automatically calculating and analyzing parameters such as image-related features, enabling a "one-click generation" workflow.

In addition to imaging examination techniques,Huichuang Medical, which has been deeply engaged in near-infrared light technology, is also continuously expanding the application boundaries of this technology. The first challenge it faces is Alzheimer's disease (AD), often referred to as "the incurable cancer."

According to WHO statistics, more than 55 million people worldwide suffer from dementia, with Alzheimer's disease being the main type. The etiology of Alzheimer's disease is complex, and its pathogenesis remains unclear, which has long imposed a heavy burden on society and tens of millions of families.

In July 2023, Leqembi, jointly developed by companies from Japan and the United States, was officially approved. As the first new Alzheimer's drug to receive full approval from the U.S. FDA in 20 years, Leqembi's official annual price is as high as $26,500, equivalent to nearly 200,000 RMB.

Facing a significant gap in clinical demand, Huichuang Medical applied for one of the earliest principle patents in China for near-infrared light treatment of degenerative diseases as early as 2019. After more than three years of innovative research and development, Huichuang Medical's phototherapy AD product has now entered the special review process for national innovative medical devices and has completed scientific research clinical trials on dozens of patients, showing significantly better effects than existing drugs. Moreover, in addition to AD, Huichuang Medical has also simultaneously initiated scientific research on other degenerative and psychiatric brain disorders such as autism and depression, achieving promising therapeutic results at this stage.

After years of accumulation, Huichuang Medical has transformed its role in the industry from an "explorer" to a "navigator." VCBeat learned during an interview that,The company is the sole corporate drafter of the national mandatory standards for NIRS devices. Its chief scientist co-authored China's first clinical expert consensus on functional near-infrared spectroscopy (fNIRS) brain imaging, and the company’s annual sales volume of fNIRS devices ranks first among domestic brands in China.

Then, when talking about the overseas expansion wave of high-end medical devices produced in China, Wang Daifa said, "When companies and products become leading in China, going global becomes a natural progression."It is reported that Huichuang Medical has obtained EU CE certification for its products. Moreover, even without overseas marketing, the company successfully completed its first order outside of mainland China in 2023, thanks to the innovative advantages and good reputation of its technical products. This achievement is accelerating the global market entry of domestically produced fNIRS devices.

The "Golden Age" of scientists' entrepreneurship is approaching. Wang Daifa said with emotion,"After passing through Series B financing, I deeply feel the power of 'role models.' In this new era full of opportunities, as an innovative medical device company that originated from a university, Huichuang Medical's current achievements have also ignited the entrepreneurial passion of many scientists and their enthusiasm for transforming scientific research results. For a company, only by taking the lead and setting an example in applying research to the vast land of our country can we continuously create greater value for patients with brain functional diseases in China and even globally."