Yiweite Medical Files for IPO: Pioneering Intelligent Pressure-Controlled Endoscopic Lithotripsy System for Urolithiasis
Gannan Region, located in southern Jiangxi Province, features a typical subtropical monsoon humid climate. The warm and humid conditions, with concurrent rainfall and heat, have fostered the growth of Gannan navel oranges, a product protected by China’s National Geographical Indication. However, did you know that this same warm and humid climate is also a potential contributing factor to the high prevalence of urolithiasis in the Gannan region?
High temperatures and humidity significantly increase water loss through sweating and respiration. Inadequate fluid intake under these conditions leads to concentrated urine, thereby substantially raising the risk of stone formation. Climate can induce stone development either directly or indirectly. Southern Jiangxi is a region in China with a high incidence of urinary calculi.
In 2017, the National Medical Products Administration granted special approval for an innovative medical device: the “Intelligent Pressure-Controlled Endourological Lithotripsy Irrigation and Suction Stone Clearance System.” Two years later, the system completed product registration and was officially launched on the market. This innovative urological device originated from Ganzhou City, Jiangxi Province.
Meanwhile, this innovative medical device system is also a product of research translation stemming from frontline clinical practice and the integration of medicine and engineering. VCBeat previously interviewed Professor Song Leming of Nanfang Hospital Ganzhou Hospital, the lead developer of this innovative device. However, with the product now on the market, how is this innovative device being commercialized? What is the current progress in its promotion? In light of these questions, VCBeat has investigated the corporate entity behind this innovative device—Jiangxi YiWeiTe Technology Co., Ltd. (hereinafter referred to as “YiWeiTe”).
China is one of the three countries with the highest prevalence of urinary calculi worldwide. Urinary calculi are common and frequently occurring conditions in urology, encompassing kidney stones, ureteral stones, bladder stones, and urethral stones. These calculi generally cause obstruction of the kidneys, ureters, bladder, or urethra, and severe cases can lead to renal impairment or failure. Current treatment modalities primarily include extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL), and ureteroscopic lithotripsy.
With the trend toward minimally invasive surgery in recent years, minimally invasive procedures such as percutaneous nephrolithotomy and ureteroscopic lithotripsy have become the preferred approaches for stone management. However, in clinical practice, particularly in primary-care hospitals, complications such as renal injury, peri-renal organ damage, hemorrhage, and even sepsis may occur.
For example, although flexible ureteroscopic holmium laser lithotripsy is technically straightforward, it has consistently failed to adequately address the “two highs” in clinical practice: high temperature generated by holmium laser lithotripsy and high intrarenal pressure due to fluid irrigation. Failure to control these two factors not only compromises surgical efficiency but also directly jeopardizes patient safety.
How to safely and efficiently perform natural orifice stone extraction? How to avoid serious complications caused by the "two highs"? How can primary care physicians quickly master these techniques? Against this backdrop,Professor Song Leming, Chief Physician of the Department of Urology at Nanfang Hospital Ganzhou Hospital, drawing on nearly four decades of clinical experience and over a decade of focused research on minimally invasive treatment for urinary stones, begin to envision:Can accumulated experience in pressure control be transferred to medical devices, enabling computerized digital pressure monitoring and subsequent regulation of intrarenal fluid pressure?
In April 2013, Professor Song Leming, in collaboration with Professor Cheng Tiedong from Jiangxi University of Science and Technology, commenced research and development efforts. In January of the following year, they filed one national invention patent application and three utility model patent applications. Subsequently, to facilitate the clinical application of the technology, the research team successfully secured a major clinical research project grant from the Jiangxi Provincial Department of Science and Technology in 2015.
During this period, the National Medical Products Administration (NMPA) issued the Special Approval Procedures for Innovative Medical Devices in 2014. The introduction of this policy served as a timely boon, significantly encouraging research teams to establish their own enterprises to facilitate the commercialization of patented technological achievements.
In 2016, under the leadership of Professor Song Leming, YiWeiTe was jointly established by medical professionals, academic researchers, engineering researchers with corporate experience, and senior executives, taking its first entrepreneurial step by organizing the application for the National Special Approval Procedure for Innovative Medical Devices.Approximately one year later, YiWeiTe’s flagship product, the “Intelligent Pressure-Controlled Endourological Lithotripsy, Irrigation, and Suction System for Stone Clearance,” was approved to enter the National Special Examination and Approval Procedure for Innovative Medical Devices. Concurrently, the company began advancing multi-center clinical trials and establishing its production system.
From a product perspective,YiWeiTe's intelligent pressure-controlled stone clearance system consists of a medical irrigation and suction platform and a disposable ureteral pressure-measuring guiding sheath.. The former is an active device, while the latter is a dedicated consumable for exclusive use with the specific instrument. It is reported that, compared with similar products currently on the market, this system isThe only product currently capable of calculating the fluid capacity of the sheath and featuring intelligent pressure control functionality。
Specifically,The system is used in combination with an endoscope and lithotripsy equipment during ureteroscopic holmium laser lithotripsy.. It employs precise computer algorithms to digitally display and intelligently control intrarenal fluid pressure, while meeting the fluid flow requirements for holmium laser lithotripsy, thereby avoiding severe complications caused by high intracavitary pressure.
“Medical Irrigation and Suction Platform and Disposable Ureteral Pressure-Measuring Guiding Sheath” Product Image Source: YiWeiTe
Once the irrigation flow rate is achieved, intrapelvic pressure is fully managed by the device, allowing the surgeon to focus on continuous lithotripsy and stone extraction. Meanwhile,The patient was placed in the lateral decubitus position on the healthy side during surgery., under the influence of gravity on the stones, the fragmented particles from lithotripsy in the renal pelvis and calyces naturally dislodge and flow toward the renal pelvic outlet due to fluid pressure differentials, where they are automatically cleared via the suction sheath. This approach avoids the issues of stone fragment deposition and obscured vision associated with traditional supine lithotripsy, eliminating the need for stone basket extraction.
Over the two years since its market launch, domestic experts in the field of urolithiasis have widely adopted the product for clinical trials. Experts at all levels from provinces with a high prevalence of kidney stones have introduced the working principles and surgical outcomes of the YiWeiTe Intelligent Pressure Control System through lectures, academic conference discussions, and live surgical demonstrations.
As the first product in China’s urology field to receive special approval under the National Medical Products Administration’s (NMPA) Innovative Medical Device Special Examination Procedure, the YiWeiTe Intelligent Pressure-Controlled Stone Clearance System officially obtained its Class II Medical Device Registration Certificate and Manufacturing License from the NMPA in December 2019. It was commercially launched in March 2020, with the first unit installed at Yudu County People’s Hospital.
From the perspective of R&D philosophy, YiWeiTe has alwaysAdhere to Clinical Problem-Guided Innovative R&D of Medical Devices. From the team perspective, currently itsThe talent team structure is relatively sound., including professional and technical personnel in clinical medicine, electronics and automatic control, materials, computer science, and engineering design, as well as personnel in quality management, production management, and marketing.
After achieving technological breakthroughs, innovative products still face significant challenges in market promotion. The launch of the intelligent pressure-controlled stone clearance system coincided with the COVID-19 pandemic, further intensifying promotional difficulties. However, the team at Jiangxi YiWeiTe Technology Co., Ltd. leveraged the advantages of online dissemination—namely its rapid speed, strong timeliness, and freedom from spatial and temporal constraints—to conduct specialized academic activities through an integrated online-offline approach.
Online, YiWeiTe has launched branded programs such as the “YiWeiTe Surgical Live Broadcast Room” and the “YiWeiTe Theoretical Lecture Hall,” achieving strong participant engagement and significantly boosting brand dissemination. Offline, it has established academic product representatives in 26 provinces and set up clinical technical training bases to drive the nationwide promotion and application of innovative technologies.
Overall, leveraging the multi-channel capabilities of online and offline teams, the product achieved rapid market entry.The intelligent pressure-controlled stone clearance system has been installed in over 200 hospitals across China, with sales reaching the tens of millions.. From the perspective of translating scientific research achievements into practical applications, this system has fully demonstrated its value. However, for Jiangxi YiWeiTe Technology Co., Ltd., this is merely its first step.
Regarding future development, Jiangxi YiWeiTe Technology Co., Ltd. stated that the company is dedicated to technological innovation in urology, medical device R&D, and the promotion of clinical technologies.. In the short term, with the aim of rapidly promoting and applying the product technology in provinces with a high incidence of stone disease within five years, thereby increasing market share.
In the long run, building on its existing intelligent pressure-controlled lithotripsy system, the Company is gradually developing products such as disposable flexible ureteroscopes, rigid ureteroscopes, urological guidewires, and stents, so as to establish a complete suite of instruments for intelligent pressure-controlled endoscopic minimally invasive stone removal. In the future, YiWeiTe willStarting from a focused presence in urology, the company has gradually expanded into specialized fields such as choledochoscopy and hysteroscopy, with an emphasis on R&D of devices and promotion of minimally invasive technologies.。
In line with these objectives, Jiangxi YiWeiTe Technology Co., Ltd. is continuously increasing its investment in R&D and marketing. On one hand, the company is relentlessly developing new products; on the other, it is strengthening academic promotion for existing products, establishing a technical training system, enhancing physician and patient education, and initiating expansion into European markets.