TuPai Medical Files IPO Prospectus to Advance Import Substitution in Mid-to-High-End Ophthalmic Devices with Proprietary Swept-Source OCT System

Optical Coherence Tomography (OCT) is a high-resolution, non-contact, and non-invasive bio-tissue imaging technology that enables physicians to obtain cross-sectional retinal images non-invasively. Since its introduction into ophthalmic clinical practice in the early 1990s, OCT has undergone three generations of technological evolution: time-domain OCT, spectral-domain OCT, and swept-source OCT. Currently, the mid-to-high-end market for ophthalmic OCT in China is entirely monopolized by imported products from companies such as Zeiss and Heidelberg (Germany), Topcon (Japan), and Optovue (United States). Domestic products exhibit significant gaps in performance parameters compared to their imported counterparts.

As the latest generation of OCT technology, swept-source OCT (SS-OCT) offers faster scanning speeds and deeper imaging depth. However, due to the high R&D costs and technical challenges associated with ophthalmic SS-OCT, spectral-domain OCT (SD-OCT) still dominates the Chinese ophthalmic medical market. Currently, only Zeiss from Germany and Topcon from Japan have obtained regulatory approval for ophthalmic SS-OCT devices and achieved mass production globally, with Topcon being the sole company to have secured regulatory approval and realized sales in China. It is reported that in 2018, approximately 1,500–2,000 ophthalmic OCT units were sold in China, among which nearly 100 were Topcon’s ophthalmic SS-OCT models. Wang Yingqi, co-founder of TowardPi Imaging, believes that SS-OCT represents the future technological trend in the field of ophthalmic healthcare.

TowardPi Imaging is a R&D-focused enterprise specializing in ophthalmic swept-source OCT, recently contacted by 36Kr. According to Wang Yingqi, the company’s first ophthalmic OCT retinal diagnostic system—the ultra-high-speed swept-source OCT models Sigma-1000/2000—has been fully developed. It supports OCT angiography (OCTA) for retinal blood flow imaging, and is equipped with a high-precision fundus auxiliary positioning system and a powerful image analysis system. The product is expected to obtain regulatory approval and be officially launched this September.

Wang Yingqi introduced that the achievement of the aforementioned performance parameters lies in the company's overcoming of difficulties in the following three areas:

Development of Swept-Source OCT Systems: As the latest generation of OCT technology, swept-source OCT presents significant challenges in design, assembly, and debugging, requiring a thorough understanding of system theory.

Independent R&D of Core Underlying Components: Swept-source OCT consists of numerous core optoelectronic components, which currently have a very low localization rate in China. Through collaboration with Tsinghua University, TowardPi has overcome many technical and process challenges in this field, achieving independent design and development for the majority of these components. This has effectively reduced the bill of materials cost for the complete system and enhanced supply chain stability.

Imaging System: Currently, China lags behind overall in the field of optical imaging. Fundus imaging requires that the spatial optical system of the product matches the optical structure of the eyeball very well, posing high demands on optical design. The TowardPi imaging team has developed a proprietary solution in this area.

Wang Yingqi revealed that the company has initially established an R&D production line and reached collaborations with multiple enterprises in China’s optoelectronic manufacturing industry. He further stated that ophthalmic OCT products incorporate a series of platform technologies, which can be applied across various optical medical devices. Therefore, TowardPi will expand its portfolio to include more optical medical devices in the future, thereby driving the development of the upstream industry.

However, penetrating medical channels after product development remains a challenge. Wang Yingqi admitted that over the past two years, the company has focused on enhancing parameters and refining the product to improve overall user experience. Through academic collaborations with renowned hospitals such as Tsinghua Changgung Hospital and Peking Union Medical College Hospital via Tsinghua University’s academic platform, TowardPi has leveraged physician feedback to enhance product usability. After more than two years of market research and feedback, TowardPi has formulated its own market operation strategy and established an expert-level advisory team for market operations.

From a market perspective, China currently has nearly 140 million patients with fundus diseases. The ophthalmic healthcare market exceeds RMB 100 billion, with the medical device segment accounting for nearly RMB 10 billion. Within this niche, the OCT market recorded sales of only approximately RMB 1.5 billion in 2018, making it appear not particularly attractive. Wang Yingqi told 36Kr that due to the current monopoly of imported equipment and the lack of cost-effective products, OCT adoption remains low in primary care hospitals, leaving a large number of fundus disease patients unable to receive timely and effective OCT examinations. If product cost-effectiveness can be significantly improved to achieve comprehensive import substitution, demand will be rapidly unleashed.

He predicts that the OCT market will experience explosive growth over the next five years, driven by the widespread adoption of OCT devices in primary and secondary hospitals, as well as the rapid increase in the number of private ophthalmic hospitals, optometry centers, and health examination centers.

Finally, an introduction to the team: currently, there are more than 20 full-time employees, primarily consisting of a technical team, with all founding members being alumni of Tsinghua University. Professor Huo Li, the Chief Scientist, is currently teaching in the Department of Electronic Engineering at Tsinghua University and has twenty years of R&D experience in fields such as optical communication and optoelectronics. He has published nearly one hundred papers in OCT-related technologies; General Manager Wang Yingqi graduated from Tsinghua University's Department of Biology.MedicineThe Engineering Department possesses extensive experience in the system design and development of medical devices, as well as team management. Dr. Xing Yanfei, Technical Director, graduated from the Department of Electronic Engineering at Tsinghua University and has over ten years of R&D experience in the field of optoelectronics. Wang Xiao, Supervisor of Software Algorithms, also graduated from the Department of Electronic Engineering at Tsinghua University and has many years of R&D experience in image algorithms.

Some of the foundational technologies for this project originated from the commercialization of scientific and technological achievements by the Department of Electronic Engineering at Tsinghua University. The founding team was established in late 2016, and the company was officially incorporated in 2017. It has since completed two rounds of financing, totaling tens of millions of RMB.

Wang Yingqi revealed that the company would launch its Series A financing in April 2019, to be used for research and development, marketing promotion, and mass production.

Source: 36Kr Author: Dun Yuting