Strategic Alliance Between Esun Medical and Huaxin Medical Accelerates Global Commercialization of Innovative Disposable Endoscopes

On August 18, the strategic cooperation signing ceremony between EziSurg Medical Co., Ltd. (hereinafter referred to as “ESM”) and Hunan Huaxin Medical Device Co., Ltd. (hereinafter referred to as “Huaxin Medical”) was successfully completed.Both parties plan to establish a long-term strategic partnership for the global product development, commercial promotion, and marketing of single-use endoscope products.。

ESM is the market leader in minimally invasive surgical instruments., specializing in the R&D and industrialization of high-end medical devices for minimally invasive surgery, has currently establishedThree Major Product Platforms: Surgical Anastomosis Platform, Surgical Energy Platform, and Optical Imaging Platform, with a portfolio of innovative products including endoscopic staplers, ultrasonic scalpels, and single-use endoscopes, covering minimally invasive surgical procedures in the digestive, respiratory, and urinary systems.

AsNational-Level “Specialized, Refined, Differential, and Innovative” Little Giant Enterprises and Brand Cultivation Demonstration UnitsESM has achieved remarkable success in technological innovation, quality manufacturing, and brand marketing. It has made substantial contributions to the localization of high-end medical devices and import substitution, as well as to the promotion and widespread adoption of minimally invasive oncology techniques in China. For several consecutive years, ESM has maintained its leading position among domestic companies in the field of minimally invasive oncologic surgery. The company’s innovatively developed products, including endoscopic staplers and ultrasonic scalpels, have been adopted by more than 1,000 hospitals in China, with over 40% being Grade A tertiary hospitals. Its overseas business now reaches more than 70 countries and regions worldwide.

andHuaxin Medical: An Innovation Leader in the Field of Disposable Endoscopes, as one of the few companies globally with concurrent R&D capabilities for both rigid and flexible endoscopes, Huaxin Medical boasts profound technological accumulation.434 Patents Applied for Domestically and Internationally, with 50 valid invention patents approved. The company's product pipeline spans multiple specialties, including pulmonology, gastroenterology, urology, and otolaryngology. Products such as single-use bronchoscopes, ureterorenoscopes, and cystoscopes have obtained domestic registration certificates; notably, the single-use bronchoscope has also secured overseas certifications, including FDA approval and CE marking, enabling market entry into developed countries such as those in Europe, the United States, and Japan, along with rapid market adoption. Currently, Huaxin Medical's business operations cover more than 160 countries and regions worldwide.

The former boasts strong brand equity, channel resources, and platform-based commercial development capabilities, while the latter possesses profound expertise in technological innovation and mass production of single-use endoscopes. Their collaboration represents a strategic alliance between two industry leaders. Together, they will accelerate the clinical adoption and widespread use of their series of innovative single-use endoscope products in the Chinese market, thereby eliminating infection risks associated with reusable instruments, helping physicians improve diagnostic and treatment efficiency, and enhancing patient experience. Meanwhile, leveraging ESM’s mature global marketing network, they will expedite the global market penetration of these single-use endoscope product lines.

Minimally invasive surgery has rapidly developed in China due to its advantages, including minimal trauma, short operative time, and fast recovery. According to Frost & Sullivan, the volume of minimally invasive surgical procedures in China reached 15.7 million in 2021. Substantial clinical demand has driven the expansion of the minimally invasive surgical device market, which reached a size of RMB 22.893 billion in 2021 (excluding endoscopes). Currently, the field of minimally invasive surgical devices in China remains dominated by imports, particularly in the two major markets valued at over RMB 10 billion each—endoscopes and ultrasonic scalpels—where the localization rate awaits improvement.

At the same time, import substitution is accelerating. Driven by strong national policies promoting the localization of high-end medical devices, domestic companies are rapidly capturing market share and expanding their innovative products globally, supported by advancements in innovative products and comprehensive solution portfolios. For instance, ESM’s laparoscopic stapler was the first worldwide to increase the stapler’s articulation angle from 45° to 60°, outperforming similar products from international giants and achieving rapid market adoption. Meanwhile, Huaxin Medical’s single-use bronchoscope, featuring a smaller bending radius and a larger bending angle, has seen explosive order growth in overseas markets.

In the field of minimally invasive surgical instruments, surrounded by domestic and international giants,Disposable Endoscopes Become the Breakthrough for Domestic Innovative Enterprises to Achieve LeadershipChina’s endoscopy market started relatively late, and the reusable endoscope segment is characterized by a high degree of import monopoly and formidable patent barriers. Domestic enterprises still have a long way to go in terms of technological accumulation and market promotion. Meanwhile, reusable endoscopes carry certain risks of infection, involve high unit prices, and incur substantial costs for sterilization and maintenance within hospitals, resulting in a high threshold for their adoption at primary healthcare institutions. In contrast, single-use endoscopes offer ease of operation, eliminate infection risks, and entail low maintenance costs, leading to their rapid development in China in recent years.

The trend toward disposable endoscopes is gaining momentum, with industry giants such as Olympus and Boston Scientific actively expanding into the single-use endoscope market.According to Boston Scientific's projections, the global market size for single-use endoscopes will reach $2 billion in 2024.The global single-use endoscope market is highly concentrated, with Ambu and Boston Scientific accounting for more than three-quarters of the market (by 2020 sales revenue). In contrast, the competitive landscape of China’s single-use endoscope sector remains unsettled, leaving greater room for growth for domestic innovative enterprises.

2022 marked a "boom period" for the regulatory approval of single-use endoscopes in China, with over 40 domestically produced models receiving clearance from the National Medical Products Administration (NMPA), primarily focusing on urological endoscopes. Given the varying technical and design requirements for single-use endoscopes across different medical specialties, Chinese manufacturers are gradually expanding from urology into respiratory, gastroenterology, gynecology, and other departments. Companies that proactively establish a multi-specialty presence will build competitive moats based on first-mover advantage and technological expertise.

Meanwhile,Disposable Endoscopes: Pursuing High Integration and Cost-Effectiveness, to meet the needs of tiered diagnosis and treatment. Furthermore, as disposable endoscopes gain traction in primary care settings,Higher mass production demands, with market promotion also relying on the company's channel resources. As single-use endoscope products in China continue to receive regulatory approval, competition in this sector is intensifying, increasingly testing the comprehensive capabilities of domestic enterprises in technological innovation, mass production, and market channel development.

Furthermore, with the development of endoscopic surgery,Both clinical practitioners and the market show a greater preference for companies that offer single-use endoscope products along with compatible surgical instruments.From a clinical perspective, the use of compatible surgical instruments can reduce operational difficulty and risks, thereby facilitating the widespread adoption of endoscopic surgery. From a market perspective, under the frameworks of centralized procurement and Diagnosis-Related Group (DRG) payment systems, a more diverse product portfolio can mitigate corporate development risks, create synergies in marketing efforts, and expand the target market.

ESM and Huaxin Medical have partnered on the R&D and commercialization of innovative single-use endoscopes to drive their global expansion. This collaboration is not only an “innovative move” that aligns with the trend toward disposable endoscopic consumables, but also serves to further enhance both companies’ product portfolios and integrate their resources.

As a leading enterprise in the field of minimally invasive surgical instruments, ESM is committed to providing comprehensive solutions for minimally invasive surgical instruments worldwide. The company boasts strong independent R&D capabilities, with its technological innovation strategy focused on meeting clinical and health economics needs. It has filed nearly 270 patents domestically and internationally, including over 50 Chinese invention patents and more than 130 international patents in countries such as those in Europe, the United States, and Japan.

For instance, the core product, the endoscopic stapler, adopts the technical principle of robotic flexible joints combined with a double-ligament structure.Globally pioneering the increase of stapler articulation angle to 60 degrees, significantly enhancing the operational convenience for surgeons in confined spaces and expanding the clinical indications for surgery. The product has filed seven invention patents in China and secured nearly 20 international patents. Among these, two core patents have successively received the First Prize of Shanghai Intellectual Property Innovation Award and the China Patent Excellence Award, and the product has been included in the Catalogue of Innovative Medical Devices by the Ministry of Science and Technology of China.

Meanwhile, ESM’s ultrasonic scalpel products are among the first domestically produced ultrasonic scalpels in China to pass registration clinical trials and gain approval for sealing 5mm blood vessels. The waveguide rod of the ultrasonic scalpel head features an innovative design for which a patent for invention has been applied, enabling better coordination of the vibration frequency and amplitude of the ultrasonic scalpel head, andPioneered the R&D and Registration of Reusable Ultrasonic Scalpel Tips in China, which is expected to significantly reduce surgical costs. Furthermore, when ESM entered the field of optical imaging, it chose to develop safer and more convenient single-use endoscopes,The self-developed disposable electronic cysto-pyeloscope system was approved in late 2022.。

After years of development, ESM has established a relatively comprehensive global channel network and marketing team, gained recognition from numerous world-leading key opinion leader (KOL) surgeons, and secured procurement orders from many renowned hospitals worldwide. This has built significant brand visibility, enabling the rapid commercialization and market launch of new products.

As an innovative leader in the global disposable endoscope market, Huaxin Medical offers products spanning multiple specialties, including pulmonology, gastroenterology, urology, and otolaryngology. The company boasts strong R&D capabilities,The founding team possesses 16 years of accumulated expertise in endoscopy technology and 10 years of R&D experience in single-use endoscopes., all of its disposable endoscope products are independently developed and committed to achieving global innovation, with over 200 patent applications filed in 2023 alone. Meanwhile, the company acquired MGB, a century-old German rigid endoscopy manufacturer, in 2021, further strengthening its R&D capabilities in rigid endoscopes.

Huaxin Medical's disposable electronic bronchoscope features a riveted articulation section design, enabling a bending angle of 210 degrees and a smaller bending radius. Additionally, the articulated section allows for one-click locking at any desired bending angle, ensuring precise positioning and minimizing tissue trauma. This product has reached an internationally leading level.Obtained over 60 certifications from China's NMPA, the U.S. FDA, the EU CE, as well as Japan and South Korea, and has entered into a partnership with Olympus, the global endoscopy giant, appointing it as the exclusive distributor for this product line in the United States.

Furthermore, Huaxin Medical boasts a 15,600-square-meter production workshop and R&D building. The company independently develops its manufacturing processes and equipment, such as the world’s first automated endoscope assembly machine developed through joint efforts, achieving high production efficiency and quality with controllable costs.The company can produce 1,200 disposable endoscopes per day, with an annual output of 400,000 units.。

The “strong alliance” between ESM and Huaxin Medical will provide a powerful boost to the development of both companies,This move not only broadens ESM’s footprint in the field of optical imaging and further enriches the company’s portfolio of minimally invasive surgical instrument solutions, but also accelerates the commercialization and global expansion of Huaxin Medical’s innovative single-use endoscope products., fully leverage the resource advantages of both parties to create a virtuous development ecosystem.

Meanwhile, at the clinical application level, the innovative technology for domestically produced single-use endoscopes, jointly advanced by both parties, will further refine instrument solutions for minimally invasive surgical procedures, thereby accelerating the decentralization and widespread adoption of such techniques. At the industry level, the strategic collaboration between a leading domestic enterprise and an innovation pioneer will strengthen their competitive advantages in the field of single-use endoscope technology, accelerate the localization of related product lines, and facilitate the reverse export of Chinese innovative technologies to overseas markets, particularly in developed countries.