Singrel Medical Technologies Files IPO Prospectus Highlighting Innovative Urology Solutions

According to data from the "Chinese Guidelines for Diagnosis and Treatment of Urological Andrological Diseases," the prevalence of urinary stones in European and American countries is 1-20%, with an annual incidence of 100-400 per 100,000 people. In China, the overall prevalence of urinary stones is 1-5%, reaching as high as 5-10% in southern regions, with an annual incidence of 150-200 per 100,000 people. Among these patients, 25% require hospitalization, and approximately 800,000 individuals per year need surgical treatment during hospital stays. The latest survey indicates that 1 in 17 Chinese people has kidney stones.

Laser lithotripsy for kidney stones is currently a critically important clinical method for treating nephrolithiasis. This procedure alone may involve the use of various consumables, such as guidewires, ureteral access sheaths, single-use flexible ureteroscopes, stone retrieval baskets, ureteral stents, and dilation and drainage components. Beyond stone removal surgeries, other minimally invasive urological procedures also entail substantial demand for instruments and consumables. Due to the large market size and complex clinical needs, there remain numerous “unmet needs” in this field, attracting many companies to enter the market and drive innovation in technology, products, and solutions.Xingeyuis one of the typical enterprises among them.

Recently, VCBeat interviewedGuo Yun, General Manager of XingeyuandCo-founder Xue Jianxin, the two of you have introduced us to the overall situation of the urology market and Xin Ge Yu's product portfolio.

Xingeyu was established in 2021, dedicated to the research and development and industrialization of specialized medical devices for urology, with the vision of becoming a well-known supplier of urological instruments both domestically and internationally. Although it has been established for a relatively short period, the company has already obtained5th Place in the Enterprise Category of the “2021 Huishan District All-Industry Technology Innovation and Entrepreneurship Competition”; Supported by the “2021 Wuxi Science and Technology Development Fund” (Medical and Health Technology Breakthroughs). Currently,Shortlisted for the finals of the 2022 “Taihu Light” Innovation and Entrepreneurship Competition organized by the Wuxi Municipal Human Resources and Social Security Bureau.

Xingeyu has established a richly layered product portfolio centered on the real clinical needs of urology, includingCommonly Used Consumables in Various Urological Surgeries, such as guidewires (e.g., hydrophilic, zebra, and dual-color), ureteral stents (coated, temperature-controlled, and tumor-compression-resistant), coated flexible ureteroscope sheaths, percutaneous nephrolithotomy dilation kits, prostatic stents, stone retrieval baskets, etc. It also coversCore Innovative Medical Consumables,such as disposable flexible ureteroscopes with temperature monitoring functionality and disposable everting suturing devices. Meanwhile, Xingeyu also plans to establish a simulation training base for clinical medical staff operations and provide services to customersTechnical training and other services。

The company has submitted 13 products for testing and filed the corresponding review materials, with regulatory approval expected by the end of 2022; four innovative products have been successfully developed. The company has filed 16 patent applications, including one PCT application and seven invention patents, of which four have been granted; additionally, one software copyright registration has been applied for.

Its flagship product was developed based on clinical needs.Disposable Flexible Ureteroscope with Temperature Monitoring Functionand those developed based on surgical suturing technologyDisposable Eversion Suture Device。

Disposable ureteral catheters are commonly used for ureteroscopy and pyelography, as well as for obtaining pathological biopsies. They are also utilized in laser lithotripsy via flexible ureteroscopy, demonstrating extensive clinical application in urology.

Due to their high susceptibility to damage and the need for sterilization, reusable flexible ureteroscopes incur high clinical costs; consequently, single-use flexible ureteroscopes are gradually becoming the future trend in clinical practice.

However, during laser lithotripsy, the laser generates significant heat while fragmenting stones, causing a rapid rise in irrigation fluid temperature. This can lead to the “boiled kidney” phenomenon, resulting in irreversible injury or complications for the patient.

To address this clinical pain point, Xingeyu’s R&D team has innovatively launched a disposable flexible ureteroscope with temperature monitoring capabilities. This device enables real-time monitoring of the water temperature around the distal tip of the scope during surgery, with an accuracy of 0.1°C. When the water temperature becomes excessively high, the numerical display on the monitoring screen changes color or flashes continuously to alert the surgeon to pause, allow for cooling, and then resume the procedure.

Xingeyu Disposable Flexible Ureteroscope with Temperature Monitoring Function

When using the eversion suturing technique, the tissue edges are everted outward, resulting in a smooth luminal surface. This facilitates precise approximation of wound edges, minimizes impact on blood circulation at the wound margins, helps prevent tissue bleeding, and promotes better healing of the sutured tissue. Since no commercially available eversion suturing devices were previously available, surgeons had to rely on traditional suture-based techniques. However, these techniques not only have a steep learning curve and are time-consuming, but manual suturing is also prone to producing irregular wound edges, leading to scar formation during healing.

Unlike traditional invaginating staplers, Xingeyu’s disposable everting stapler innovatively simulates the surgical technique of sutured anastomosis, not onlySuitable for scenarios involving the esophagus and gastrointestinal tract, where inversion or eversion suturing can be performed, as well as for the urinary, vascular, and reproductive tracts, where only eversion suturing is applicable., while expanding the application scenarios of staplers, it helps physicians easily achieve tissue suturing.

During use, no additional incisions are required in the organs, thereby avoiding iatrogenic trauma from secondary surgeries and reducing associated complications. It also effectively prevents postoperative anastomotic stenosis caused by hyperplasia within the scar cavity. Without altering the anatomical structure of the patient’s original tissues and organs, suturing and shaping can be achieved with a single staple firing, offering convenient operation and significantly simplifying surgical procedures. Furthermore, it eliminates the need for multiple uses of traditional staplers to achieve suturing, substantially lowering clinical costs and saving expenses for both patients and medical insurance systems.

This product is a patented product of Xingeyu Technology,One PCT patent application, six invention patent applications, and two utility model patents (granted).

Xingeyu Disposable Eversion Suture Device

Xingeyu’s keen grasp of clinical needs in urology and its bold innovation in medical devices are inextricably linked to the composition of its founding team.

Guo Yun, General Manager of Xingeyu

General Manager Guo Yun,A graduate of China Pharmaceutical University, she previously served for many years at a Grade III Class A hospital in Wuxi. In 2016, she founded Jiangsu Yunzhong Medical, a company specializing in surgical instruments, and has been operating it ever since. She possesses extensive experience in product integration and sales, and is well-versed in quality management systems, CE certification for medical products, and import/export procedures. Her years of independent operation of a medical device company have equipped her with mature and systematic management expertise, as well as substantial industry resources and comprehensive industry insights and judgment.

Xue Jianxin, Co-founder of Xingeyu

Dr. Xue Jianxin, Co-Founder and Chief Technology OfficerAttending Physician in Urology; Member of the Jiangsu Provincial Society for Immunology; Committee Member of the Micro-Invasive and Non-Invasive Medicine Branch of the Jiangsu Medical Doctor Association. Previously served as Principal Investigator for one National Natural Science Foundation of China project and two provincial/municipal-level research projects; participated in one additional National Natural Science Foundation project. Recipient of the Third Prize of the Jiangsu Provincial Medical Technology Award. Published 18 SCI-indexed papers as first or corresponding author; filed 29 PCT and domestic patent applications; served as associate editor for two books. Possesses extensive experience with the clinical use of medical devices by physicians, demonstrates high sensitivity to new products and emerging trends, and has successfully translated five patents into clinical applications.

Other core team members include a Marketing Manager who has served as a Regional Manager for multiple pharmaceutical companies and possesses extensive project management experience, as well as Mechanical and Automation Engineers holding more than 10 patents. Each member excels in their respective field, helping Xingeyu achieve steady and sustained growth from early-stage R&D to later-stage mass production.

Meanwhile, Xingeyu has also collaborated with numerous hospitals and universities to forge a pathThe Innovation Path of Integrating Industry, Academia, and Research。

In terms of clinical application, Xingeyu andCollaborations with Multiple Large Grade-A Tertiary Hospitals Inside and Outside the Province, conduct clinical trials of the product, improvement and optimization, etc.

In the field of basic materials research, Xingeyu collaborates withSchool of Chemistry and Materials Engineering, a Renowned University, collaborate on substrate material selection and modification, as well as exploration of coating materials and processes.

In terms of functional implementation and aesthetic design, Xingeyu has collaborated with the Medical Device Research Institute of a renowned university and the School of Microelectronics of another university to develop clinical-need-driven medical devices, jointly conducting R&D in mechanical structural functionality, intelligent control, and ergonomic design.

Xingeyu’s founding team holds great confidence and enthusiasm for the company’s development. In the early stages of its establishment, Xingeyu invested significantly to purchase a manufacturing facility spanning over 1,000 square meters in Huaqing Chuangzhi Park.

“I have the confidence to undertake this initiative,” said Guo Yun. “Since founding the company in 2016, we have been deeply committed to the field of surgical instruments. Despite the challenges posed by the pandemic and the widespread centralized procurement of medical consumables in China, we have maintained a surplus on our balance sheet. I hope our partners and customers at Xingeyu can see and feel our strength and determination. Meanwhile, this facility will serve as Xingeyu’s R&D innovation hub and training ground.”

Xingeyu Factory: Actual Photos

When Guo Yun and Xue Jianxin founded SingenYu, they charted out the company’s development planThree Three-Year Plans——

• In the first three years, we will advance product registration and patent applications, and initially establish a customer network. The company is currently in this phase and requires capital infusion to fuel its growth;

• In the second three-year period, advance product upgrades and iterations, build the brand, and expand the customer base;

• During the third three-year phase, commencing in 2027, we will deepen product development and refine our brand for greater market penetration, aiming to become a urological device and consumable supplier capable of competing on par with international giants. Simultaneously, we will advance minimally invasive surgical specialty products into more complex clinical areas and strive to expand into high-tech, high-value-added fields such as artificial intelligence, automated healthcare, and non-invasive medical technologies.

In product promotion, Xingeyu emphasizes the use ofAcademic-Driven Channels. In terms of profitability, it is also supported by multiple channels, not only canDirect sales of products, licensing of patented technologies, and OEM services for technologies such as coatings.

Currently, XingeyuSeeking a new round of financing,for investment in infrastructure construction, procurement of industrialization equipment, research and development, and market promotion.