Silan Medical Technologies Files IPO Prospectus: Pioneering IVD Innovator with 79 Patents, 2 Software Copyrights, and Three Core Diagnostic Platforms Based on Bioimpedance Technology
The in vitro diagnostics (IVD) industry is experiencing rapid growth. According to statistics from the Zhongcheng Medical Device Research Institute, as of August 20, 2020, there were 82 listed companies in China whose core business involved the production and R&D of medical devices, with IVD companies accounting for 37% of this total. Furthermore, publicly compiled data from First Capital Securities at the end of last year indicated that the domestic IVD market was in a phase of rapid expansion, with the market size for IVD services in China exceeding RMB 220 billion in 2018.
Silan Technology (Chengdu) Co., Ltd. (hereinafter referred to as “Silan Technology”) is an in vitro diagnostics (IVD) company centered on bioimpedance technology. The company has established a medical application platform for bioimpedance technology, integrated with artificial intelligence, and independently developed next-generation non-invasive medical imaging devices, as well as portable wearable devices for rapid human tissue identification and human function monitoring. Its solutions cover three major areas: early imaging screening for tumors, intelligent intraoperative pathological examination of tumors, and sleep apnea monitoring.
Dai Tao, founder of Silan Technology, earned his bachelor’s degree in Electrical Engineering from Zhejiang University and subsequently pursued a Ph.D. in Electrical Engineering at Carleton University in Canada. He previously served as a Research Scientist specializing in prostate cancer detection at Imagistx in the United States.
Dai Tao is dedicated to researching the application of bioimpedance in the medical field. He is one of the core algorithm developers for EIDORS, an open-source project for Electrical Impedance Tomography (EIT), and has a medical informatics algorithm library named after him.
In 2012, Dai Tao co-founded Silan Technology with his university classmates, aiming to bring back to China the experience and achievements he had accumulated over more than a decade abroad in the medical application of bioimpedance. As the beginning is always the hardest part, the first challenge facing Dai Tao was how to build an elite team. To this end, Dai Tao took on the role of a “headhunter,” continuously recruiting top talent and strengthening the company’s team from the preparatory phase in 2011 through 2013.
This hands-on approach to talent acquisition laid the groundwork for Silan Technology’s rapid growth. In 2016, the company’s product, the MScan 1.0B Breast Tissue Impedance Analyzer, became the first to obtain registration with the China Food and Drug Administration (CFDA). In the same year, the PSM100A Portable Sleep Apnea Monitor also received CFDA product registration.
Silan Technology Development History
Bioimpedance (also known as medical electrical impedance technology) originated in the late 19th and early 20th centuries. It is a detection technique that extracts biomedical information related to human physiological and pathological states by leveraging the electrical properties of biological tissues and organs, as well as their variations.
Centered on bioimpedance and leveraging the electrical property differences between tumor and normal tissues, Silan Technology pioneered the development of MScan1.0B, an intelligent intraoperative pathological detection device for breast tumors. Capitalizing on the diverse applications of bioimpedance technology in medicine, the company has also ventured into human functional monitoring, independently developing the portable sleep apnea monitors PSM100A and PSM100B.
Furthermore, the ZScan1.0A, an early breast cancer screening device based on Electrical Impedance Tomography (EIT) technology, further promotes the diversified development of Silan Technology.
Sylan Technology's Flagship Products
In breast tumor surgery, frozen section biopsy serves as a critical basis for the rapid intraoperative identification of breast lesions. Although relatively quick, the procedure typically requires 30 minutes; this waiting time is further prolonged when a larger volume of breast tissue needs to be examined. The resulting extension of surgical duration increases the adverse effects associated with anesthesia. Furthermore, this method demands exceptionally high technical proficiency from pathologists. Consequently, real-time differentiation of breast tumor tissue remains a significant challenge in regions with limited medical resources.
To address this challenge, Silan Technology independently developed MScan1.0B, filling a gap in China’s medical field. This system can be used during breast tumor surgery to determine tumor nature (benign or malignant) and assess surgical margins (positive or negative), enabling rapid and accurate multi-point evaluation of breast tissue lesions within one minute.
In a multicenter, double-blind trial organized by the West China GCP Center in 2016, MScan technology demonstrated high concordance with pathological examination, achieving a sensitivity of 92.98%, a specificity of 94.62%, and an overall diagnostic accuracy exceeding 95%.
Traditional tumor differentiation methods often fail to clearly detect early functional changes in tumors, and their diagnostic outcomes rely heavily on clinicians’ experience, making them difficult to implement in regions with limited medical resources. Therefore, the development of portable detection instruments that are accurate, reliable, highly sensitive, and offer high tumor-to-background contrast represents a critical challenge that needs to be urgently addressed in early cancer screening.
In response, Silan Technology has independently developed the ZScan 1.0A Early Breast Cancer Screening System, which assists healthcare professionals in locating and identifying lesions within the breast, thereby facilitating the assessment of patients' health status and enabling the timely detection of pathological tissues or cancer risks.
ZScan1.0A is an early-stage tumor screening device that performs comparative analysis based on the bioimpedance distribution map of the patient’s breast and a library of impedance characteristics of pathological breast tissues. By injecting small, safe electrical currents or voltages into the human body and measuring surface potentials, ZScan1.0A reconstructs bioimpedance distribution images across specific internal cross-sections, thereby providing insights into the current status of physiological activities and internal tissue lesions.
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) has a prevalence of approximately 4% in China, although the actual rate may be higher. The condition is more common in men than in women, and its prevalence increases with age. Studies have shown that the mortality rate among patients with untreated severe OSA is 3.8 times higher than that of the general population. Data from 20 hospitals in China confirm that the prevalence of hypertension among Chinese OSA patients is 49.3%, while OSA accounts for 83% of cases in patients with resistant hypertension; treatment of OSA significantly reduces blood pressure in this patient subgroup. Furthermore, the risk of stroke in individuals with OSA is 4.33 times that of the normal population, and their mortality rate is 1.98 times higher.
Currently, polysomnography (PSG) is the gold standard for diagnosing obstructive sleep apnea-hypopnea syndrome (OSAHS); however, high diagnostic costs and scarce diagnostic resources prevent most patients from receiving timely and effective diagnosis and treatment.
Silan Technology’s independently developed PSM100 series of portable sleep apnea monitors leverages artificial intelligence-based pattern recognition, bioimpedance technology, and multi-signal fusion techniques to objectively correlate physiological parameters—including electrocardiogram (ECG), nasal airflow, blood oxygen saturation, thoracic and abdominal movements, snoring sounds, body position, and body movements—with sleep-disordered breathing and sleep staging, thereby automatically generating analytical results.
It is reported that Silan Technology, as an invited participant, will attend the 2nd West China Hospital Health Management Summit Forum to present and exchange academic insights on new technologies in health management. The company aims to enable hospital physical examination centers and private check-up institutions to deliver high-quality sleep health management services through its PSM100B system.
Centered on bioimpedance technology, the company has exclusively developed three in vitro diagnostic devices. To date, it has published 25 papers in internationally renowned journals and at scientific conferences, secured 79 patented technologies authorized by the China National Intellectual Property Administration (CNIPA), and obtained two software copyrights.
As the core innovation of Silan Technology, bioelectrical impedance analysis (BIA) not only features objectivity, real-time monitoring, non-invasiveness and safety, ease of use, and rich biological information, but also offers extensive clinical application potential, laying a solid foundation for Silan Technology’s subsequent research and development of products across multiple directions and fields.
Among these, Silan Technology is expanding the medical applications of its MScan technology for real-time differentiation of tumor tissues beyond breast cancer. The company is currently engaging in academic collaborations with authoritative medical institutions such as West China Hospital of Sichuan University and Chengdu Third People’s Hospital. These collaborations focus on the rapid intraoperative assessment of ex vivo tissues in gastric, colorectal, and cervical cancer surgeries, as well as the intraoperative identification of parathyroid glands and bioimpedance-assisted endoscopic identification of in vivo tissues, thereby extending its reach to multiple cancer types and diverse clinical applications.
2019 was a landmark year for Silan Technology, with its products adopted by nearly 400 hospitals across China, significantly alleviating the strain on medical resources. Meanwhile, the company entered into a deep strategic partnership with Sinopharm Medical Devices, the largest medical device distribution channel in China, propelling its development to a new level.