Jingwei Vision Sets a Benchmark for Domestic Cellular-Level Endoscopy with Multiple Nationally Unique Products – Highlights from CMEF 2024

Domestic endoscopes are breaking the import monopoly and ushering in an explosive growth phase.

According to bidding data statistics, in the first half of 2024, the market share of domestically produced endoscopes increased significantly, showing a trend of overtaking imported brands. The five major overseas giants—Olympus, Fujifilm, Karl Storz, Hoya, and Stryker—collectively accounted for approximately 60% of China's endoscope market, far below their previous share of 90%. Meanwhile, domestic companies have entered the top ten in sales rankings, collectively occupying about 15% of the market.

Not only are an increasing number of domestic manufacturers showcasing innovative solutions at the exhibition, but their product categories, quality, and innovativeness are also sufficient to meet clinical needs and achieve large-scale implementation. Meanwhile, a growing number of renowned experts and scholars are participating in the exhibition, engaging in discussions and exchanges on the clinical application and latest advancements of these products during the event. Furthermore, companies are gradually beginning to participate in projects such as the National Key R&D Program of the Ministry of Science and Technology, aiming to promote the adoption of domestically developed technologies, increase the market share of demonstration products, and export Chinese technologies and standards.

It is worth mentioning that domestic innovative enterprises are stillConfocal Laser Endomicroscopy, Disposable Endoscopes, and Endoscopic Ultrasound: Innovation and Upgrades in Emerging Markets Yield Significant AchievementsThis trend was clearly evident at the 2024 China International Medical Equipment Fair (CMEF) Autumn Edition.

This year,Viestar, a leading Chinese enterprise in the cellular-level endoscopy industry, showcased its full product lineup at CMEF., and the product has achieved significant application results, among which BIOPSEE^®Beixi^®Adopted by more than 300 leading hospitals in China. Furthermore, at this exhibition, the company unveiled two newly developed confocal probes and shared the latest progress of the Ministry of Science and Technology’s “14th Five-Year” National Key R&D Program—Demonstration Project for Confocal and Ultrasound Applications.

Confocal laser endomicroscopy (CLE), as a novel endoscopic technology capable of real-time, in vivo, cellular-level observation, offers micron-scale resolution and optical sectioning capabilities. By integrating advanced optical systems with proprietary algorithms, it achieves ultra-high resolution and an ultra-compact distal tip, delivering cellular morphology that is highly consistent with histopathological biopsy findings.

For diseases involving deep-seated and highly occult lesions in the biliary, urinary, and respiratory systems, characterized by complex tumor microenvironments and difficult tissue biopsy, confocal laser endomicroscopy (CLE) enables non-invasive optical biopsy and targeted precise biopsy. This reduces missed diagnoses, improves diagnostic rates, and effectively compensates for the limitations of conventional detection methods. Due to its significant potential in tumor diagnosis, CLE is widely recognized in the clinical community as the optimal technology for cellular-level observation and a core medical device for the precise diagnosis of early-stage cancer.

As the first company in China to obtain regulatory approval for a probe-based confocal laser endomicroscopy (pCLE) system, the only Chinese manufacturer with approval for an ultra-thin probe-based pCLE system, the only company worldwide achieving large-scale manufacturing of pCLE systems, and the owner of the world’s largest large-scale production center for pCLE systems, viestar is also the only enterprise in the confocal field to consecutively lead two national key R&D programs, the only participant in the Ministry of Science and Technology’s application demonstration project, and the only provider of an application demonstration product endorsed by the Ministry of Science and Technology. As such, viestar is a key player driving development in this field.

Viestar Showcases Beixi at CMEF^®Ultrafine Probe-Based Confocal Laser Endomicroscopy System, Beixi^®Probe-based Confocal Laser Endomicroscopy System for the Gastrointestinal Tract, and FUSION™Products such as the integrated confocal laser endomicroscopy system for the biliary tract, along with a range of complementary accessories including probes and components, were showcased on-site to share the latest R&D achievements in confocal laser endomicroscopy with industry professionals.

Among them,Beixi^®Ultrafine Probe-Based Confocal Laser Endomicroscopy SystemYesThe Only Domestic ProductConfocal imaging products with approved medical device registration certificates in the biliary, urinary, and respiratory fields. This product can be equipped with an ultra-slim probe with a diameter of <1.0mm. The cellular-level imaging can reach ultra-narrow lumens and hollow organs such as the biliary tract, pancreatic duct, respiratory tract, and urinary tract. It horizontally covers the full clinical scenarios of digestive, biliary, urinary, and respiratory applications, addressing the pain points in the diagnosis and treatment of diseases in the biliary, urinary, and respiratory fields.

BIOPSEE^®Beixi^®Probe-based Confocal Laser Endomicroscopy System for the Gastrointestinal TractAsThe Sole Demonstrator Product of the Ministry of Science and Technology’s Confocal Clinical Application Demonstration Project, it offers the advantages of non-invasive optical biopsy and targeted precision biopsy in disease diagnosis, reducing missed diagnoses, improving diagnostic rates, and aiding pathological diagnosis. In treatment, it enables precise delineation of surgical margins, resection of multiple lesions, and postoperative follow-up monitoring, thereby reducing the incidence of postoperative residual disease and recurrence.

FUSION™Findings™Integrated Biliary Confocal Laser Endomicroscopy SystemAsThe World's First Integrated Product Combining Confocal Technology with Electronic Endoscopy, integrates a cholangioscope with confocal laser endomicroscopy for the biliary tract, and is equipped with an ultra-micro biliary probe (probe diameter <1.0 mm) capable of micron-level resolution. This system enables cellular-level imaging of lesions under direct visualization of the biliary tract, allowing for immediate assessment of lesion characteristics, effective identification of precancerous biliary tract lesions, and significantly improved diagnostic efficacy of ERCP (Endoscopic Retrograde Cholangiopancreatography).

Although viestar has achieved numerous breakthroughs in this field, the journey has been far from easy.

From a technical perspective, the core components involved in confocal laser endomicroscopy are extremely minute, requiring machining precision at the micron level, which places them at the forefront of ultra-precision machining. Any minor defect can compromise imaging accuracy, preventing the device from achieving the desired performance. Furthermore, as a diagnostic device capable of high-resolution microscopic imaging, confocal laser endomicroscopy integrates multiple disciplines, including optics, ergonomics, modern electronics, mathematics, software development, and algorithms.

Subsequently, to achieve large-scale production, it is necessary to overcome all fundamental technical challenges and even independently design and manufacture the essential equipment used, thereby integrating the upstream supply chain. After surmounting these obstacles, further strategic deployment is required for establishing core market channel networks and training end-user physicians. It can be said that every step of confocal laser endomicroscopy, from technological translation to commercial implementation, is fraught with challenges.

For this very reason, China’s development of confocal laser endomicroscopy (CLE) technology has traversed a challenging 20-year journey: from theoretical exploration and the invention of CLE technology in 2002; to technical research and the development of the first engineering prototype in 2009; to product realization with the launch of China’s first CLE device in 2014; to manufacturing breakthroughs marked by the establishment of the world’s first CLE factory in 2016; and finally, to the gradual commercialization and clinical installation of CLE systems by 2022.

As early as 2014, viestar established close collaborations with clinical experts, industry teams, and scientists, adhering to independent “full-chain” research and development, ultimatelyPioneered the scaled manufacturing and commercialization of confocal laser endomicroscopy in China.

2017, viestar leads the National Key R&D Program project of the 13th Five-Year Plan, obtainedChina's First and Second Confocal Laser Endomicroscopy Registration Certificates, completedR&D, Manufacturing, and Industrialization of the First Set of Confocal Laser Endomicroscopy Systems. Meanwhile, the company has broken through manufacturing barriers and is conductingSupply Chain Construction。

By the end of 2021, after overcoming all fundamental technical challenges, viestar’s products achieved a qualitative leap and entered mass production.Annual production capacity reaches over 300 units of equipment and more than 10,000 probes.Viestar has thus become the world’s largest manufacturer of confocal laser endomicroscopy (CLE) systems. Building on this foundation, the company is able to deploy over 100 training units and offer a comprehensive product line designed for use in conjunction with gastrointestinal endoscopes, with no limit on the number of times the probes can be used. This not only facilitates the widespread adoption of confocal laser endomicroscopy but also reduces hospital operational costs, propelling China’s endoscopic technology into a new era of cell-level pathological “visual biopsy.”

In 2022, the project “Research and Development of Core Components for Fluorescence Confocal Microendoscopy” was once again designated as“Key Projects of the National Key R&D Program during the 14th Five-Year Plan Period”, with viestar continuing to serve as the lead organization. In 2023, viestar not only undertook“Demonstration Study on the Application of Combined Ultrasound and Confocal Endoscopy”project, and its independently developed Beixi^®Confocal Laser Endomicroscopy has also become"The Only Demonstrative Product" of the Ministry of Science and Technology's Confocal Clinical Application Demonstration Project。

Currently, viestar continues to further advance the development of confocal laser endomicroscopy (CLE) technology across China. As the lead institution for the “Application Demonstration Research Project on Ultrasound and Confocal Composite Endoscopy,” a key sub-project under the Ministry of Science and Technology’s National Key R&D Program during the 14th Five-Year Plan period focused on “Diagnostic and Therapeutic Equipment and Biomedical Materials,” viestar is promoting the standardized use and widespread adoption of domestically produced CLE technology, thereby helping to improve the early detection rate of cancer.

At this CMEF, viestar showcased the latest progress of the project.

Currently,As a participating entity, viestar has provided core equipment for the project.The team, comprising academicians, national committee chairs, and Changjiang Scholars, will collaborate with viestar to establish a demonstration and promotion system for confocal laser endomicroscopy through medical-engineering integration. This system is supported by the National Clinical Research Center and the National Quality Control Center for Gastroenterology.Covering over 600 multi-tier demonstration centersThis initiative will further elevate the overall standard of confocal laser endomicroscopy, drive disciplinary advancement, promote standardized operational practices, facilitate academic exchange, and ultimately accelerate the clinical implementation of this technology.

Endoscopes are products within the field of medical imaging. The technical barriers in this industry are primarily reflected in four key areas: integration of the upstream supply chain, staining technology, endoscope manufacturing, and training for end-user physicians. Currently, viestar has achieved breakthroughs in the research, development, and manufacturing of core technologies, and its complete systems demonstrate significant advantages in both performance and cost-effectiveness. Today, leveraging the National Key R&D Program, the companyEstablish a demonstration and promotion system for the application of confocal laser endomicroscopy to facilitate its clinical implementation.

Currently, the independently developed by viestarBIOPSEE^®Beixi^®Adopted by over 300 leading hospitals in China, with the core market channel network fully established, successfully achieving the commercialization of confocal laser endomicroscopy and confocal microscopy fiber optic probes. In the future, we will continue to expand our portfolio of single-use fiber-optic diagnostic and therapeutic products, while also exploring international markets for confocal technology.