UroViu Announces IPO Filing: Pioneer in Portable Single-Use Endoscopy with Four FDA-Cleared Products Set for U.S. and China Expansion

“When others were still making laptops, we were already developing mobile platforms. And while others were working on mobile phones, we had already established a multifunctional platform (combining endoscopes with devices, and drugs with devices).”

Just as communication devices have become increasingly portable, medical devices are also trending toward lightweight and compact designs, and the evolution of endoscopes is no exception. The progression from traditional endoscopes to single-use endoscopes, and further to portable single-use endoscopes, represents not only a shift of endoscopes into the category of disposable consumables, but also a transformation of the main processing unit from bulky machines to compact, portable hosts and multifunctional platforms.

Currently, most endoscopy companies still equip their single-use endoscopes with large console units, whereas a company in the United States is already developing “handheld” devices.UroViu’s single-use endoscope features an integrated, portable design that keeps the target tissue, instruments, and endoscopic images within the operator’s direct line of sight during procedures.

Previously, during endoscopic procedures, physicians often had to manipulate the instrument while simultaneously viewing a separate monitor, mentally integrating these two streams of information to conduct examinations or treatments effectively. In contrast, UroViu’s “direct-view flexible endoscope” enables physicians to directly visualize lesions during manipulation, truly serving as an extension of the physician’s eyes.

UroViu Corporation Presents a New Solution in Single-Use Endoscopy Technology.

UroViu Corporation has obtained FDA clearance for four single-use endoscope products, including three models of single-use cystoscopes and one model of single-use hysteroscopes, all of which are commercially available in the United States.The company’s single-use endoscope features an integrated, portable design, and its compact console can simultaneously accommodate disposable hysteroscope and cystoscope shafts, enabling dual functionality in a single device.Hospitals need only purchase a single host system to enable multiple applications, which not only reduces procurement and management costs but also alleviates patient discomfort and optimizes the examination workflow.

According to Dr. Ouyang, founder of UroViu, in addition to serving a large number of clinics and outpatient facilities, UroViu’s portable single-use endoscopes can be deployed for hospital emergency and critical care at any time and anywhere, eliminating the need for bulky equipment and dedicated endoscopy rooms.

In the operating room, postoperative monitoring for ureteral injury is typically required after procedures such as hysterectomy. The need for physicians to switch endoscopic equipment prolongs both operating room occupancy and patient waiting times. This scenario is not limited to post-hysterectomy care; throughout various surgical interventions, physicians may need to employ endoscopic visualization either concurrently with or following treatment of a specific anatomical site.

Meanwhile,UroViu’s disposable endoscope offers a 140-degree field of view, enabling physicians to visualize a wider area without the need for repeated rotation and manipulation of the endoscope within the body.Currently, the widest field of view for disposable endoscopes on the market is 120 degrees. While certain traditional endoscopes can achieve a wider field of view, they require multiple glass lenses, resulting in high manufacturing costs. In contrast, UroViu Corporation has independently developed proprietary technology that achieves a 140-degree field of view using only two plastic lenses, thereby effectively controlling production costs.

Furthermore, UroViu has achieved the integration of endoscope and instruments; its single-use cystoscopes feature built-in working channels and even integrated instruments, thereby reducing the frequency of device exchanges by physicians and enabling more convenient operation.

The trend toward disposable endoscopes is now inevitable.

Traditional reusable endoscopes suffer from high acquisition costs, low turnover efficiency, and high maintenance expenses. In particular, the risk of cross-infection after repeated use cannot be overlooked, with frequent infection incidents involving traditional endoscopes reported globally in recent years. Endoscopes contain multiple small, long open channels that are difficult to clean and disinfect thoroughly, and many components of flexible endoscopes require high-level disinfection (HLD).

However, flexible endoscopes processed with high-level disinfection (HLD) continue to frequently cause cross-infection incidents. From January 2017 to February 2021, the FDA reported 450 endoscopy-associated infection cases in urology alone, while industry experts believe that many more infections have gone unreported. Meanwhile, repeated disinfection of traditional endoscopes compromises image quality and shortens equipment lifespan.

The advent of single-use endoscopes has resolved long-standing pain points in the endoscopy industry, prompting a wave of companies to invest in their research and development.

Developing single-use endoscopes is no easy task. Although they are designed for single use, their performance must not lag behind that of traditional endoscopes. Manufacturers must strive to enhance image quality, product safety, and stability. Furthermore, the flexibility and maneuverability of the insertion tube must be carefully considered in the design of single-use flexible endoscopes.

Meanwhile, as disposable endoscopes are classified as consumables, cost control and mass production are also critical components. To meet hospital demands, companies must consistently supply quality-assured products, ideally offering end-to-end services that enable full control from raw materials to finished goods.

As a pioneer in single-use portable endoscopes, UroViu Medical has established the capability for large-scale, automated production of single-use endoscopes. Compared with similar products, the company’s single-use endoscopes require fewer materials and have reduced consumable components, enabling lower manufacturing costs.

Furthermore, the Company’s long-term strategic manufacturing partner is a well-known CDMO/CMO manufacturer of single-use endoscopes in the industry. It has served globally renowned endoscopy companies for many years and possesses nearly 30 years of experience in semiconductor imaging as well as nearly 20 years of experience in the manufacturing of single-use endoscopes.

It possesses various medical-grade process modules and large-scale production capabilities for disposable medical endoscopes. From wafer dicing to chip packaging, molded lenses, and plastic-glass hybrid optical system design, it vertically integrates technologies spanning optics, mechanics, and electronics, with a focus on achieving automated production of disposable endoscopes to ensure the safety, reliability, and mass production of UroViu’s medical products.

After years of entrepreneurship, Dr. Ouyang’s greatest insight is that “a sound strategic direction and an effective execution team are mutually reinforcing.” Identifying the right direction is paramount; this involves focusing on clinical needs, pinpointing clinical pain points from a clinical perspective, while ensuring the team possesses strong execution capabilities to translate good ideas into action.

After earning his master’s degree from the Institute of Semiconductors, Chinese Academy of Sciences, Dr. Ouyang pursued further studies in the United States and obtained a Ph.D. in Medical Imaging from the University of Chicago. He is a rare interdisciplinary talent with expertise in both semiconductors and healthcare. Following his doctoral graduation, he conducted clinical research at McGill University in Canada and the University of California, San Francisco (UCSF), before transitioning to the industry sector.

Prior to founding UroViu Medical, Dr. Ouyang founded EndoSee, which was subsequently acquired by the gynecology leader Cooper Surgical.As a serial entrepreneur, Dr. Ouyang possesses extensive background in the medical chip and endoscopy industries, along with comprehensive experience in product R&D, regulatory registration and market launch, and business management.Meanwhile, UroViu’s team also comprises multidisciplinary talent in medical imaging, clinical medicine, and chip technology, providing ample support for an innovative enterprise to continuously launch leading products and expand into the global market.

Building on its proprietary technologies, UroViu Corporation will expand from its current urology and gynecology focus into the respiratory, orthopedic, and prostate sectors, developing a broader range of single-use endoscopes and minimally invasive or non-invasive consumables, while also advancing integrated pharmaceutical-device and endoscope-device combination products.

Since this year, UroViu has gradually initiated commercialization in the United States and plans to enter the Chinese market by establishing a subsidiary, while simultaneously expanding its presence across major global markets. Given the differences in healthcare environments between China and the United States, UroViu, originally founded in the U.S., must adapt its marketing strategies to align with the distinct market conditions in China.

The United States boasts an advanced healthcare system with a high density of specialty clinics; urology, for instance, is primarily delivered through such clinics to facilitate accessible, local care. Moreover, the U.S. health insurance system demonstrates strong payment capacity. However, patients seeking endoscopic examinations at major U.S. hospitals may face appointment wait times of one month or even several months. Consequently, the extensive network of specialty clinics represents a key target market for UroViu’s single-use endoscopes.

China’s healthcare system exhibits an “inverted pyramid” structure. Most high-end medical talent and equipment are concentrated in tertiary hospitals located in major cities, prompting patients to seek care at these large facilities. This has resulted in difficulties in accessing medical services and long waiting times, while some common diseases cannot be diagnosed and treated locally or at an early stage. To address the imbalance in medical resource distribution, China must not only prioritize the training of physicians but also promote the widespread availability and user-friendliness of medical devices, such as common minimally invasive instruments like endoscopes.

China has a large patient population, yet the penetration rate of single-use endoscopes remains low, particularly in vast grassroots regions. Leveraging advantages such as ease of operation, improved patient comfort, and cost control, UroViu holds significant competitive edge in the domestic market. Meanwhile, the company has partnered with Asieris Pharmaceuticals, which is responsible for the regulatory registration and marketing of two single-use cystoscope products in China. Asieris Pharmaceuticals possesses extensive clinical resources in the urological and reproductive fields, aligning well with UroViu’s product strategy.

Minimally invasive surgery is an inevitable trend, and the development of endoscopes, which serve as the "eyes" for surgeons or robots in minimally invasive procedures, is crucial. According to Frost & Sullivan analysis, the market size of endoscopes in China reached RMB 25.4 billion in 2020, with a compound annual growth rate (CAGR) of approximately 14.2% from 2015 to 2020.

With the advantages of single-use endoscopes validated by both clinical practice and the market, companies riding this wave must not only seize the opportunity but also ensure a safe landing, with technology and team serving as their solid foundation. UroViu Corporation, firmly grounded while capitalizing on this trend, strives to lead portable single-use endoscopes into the global market.

Recently, UroViu Corporation has completed its Series A financing round, led by Hengxu Capital, with participation from its partner, Yuhong Pharmaceutical.

Hengxu Capital (AMAC Registration No.: P1070270) was established in 2019. As the private equity investment platform under Shanghai Automotive Industry Corporation (SAIC Motor), it leverages the overall strengths of SAIC Motor to strategically invest in emerging industries such as advanced manufacturing, cutting-edge technology, healthcare, and consumer goods. It aims to deliver sustained and stable returns to investors while contributing to the development of SAIC Motor’s innovative industrial chain and the enhancement of its mobility ecosystem.

Hengxu Capital currently manages assets exceeding RMB 20 billion, with investors including industry leaders, financial institutions, local governments, and state-owned enterprises. The firm has received numerous awards, such as “China’s Most Growth-Oriented Investment Institution in the Healthcare Industry (2019–2020)” and “Top 10 Emerging Investment Institutions of 2020.” It has invested in companies including AsiaPharm, Aier Medical, Gaocheng Biologics, Changyu Pharma, Yudao Biotech, Like Technology, NanoVision Imaging, Meili Weiye, and Demei Medical, supporting their growth into market leaders in their respective sectors.

Apollomics (Stock Code: 688176.SH), established in March 2010, is a global innovative pharmaceutical company focused on urogenital tumors and other major disease areas. Upholding its corporate mission of “improving human health and enabling life with greater dignity,” Apollomics remains committed to innovation-driven technology and products. The company has strategically developed a deep product pipeline centered on urogenital diseases, with its core investigational products targeting unmet global therapeutic needs in bladder cancer and cervical precancerous lesions. By actively building integrated diagnostic and therapeutic solutions, identifying and addressing unmet clinical needs, and cultivating a competitive portfolio spanning from disease diagnosis to treatment, Apollomics aims to benefit more patients in China and worldwide.

Reference: “In-Depth | Disposable Endoscopes: A Multi-Billion Blue Ocean Market—Who Will Prevail?” — Meibo Healthcare

“Over 10 Domestic Companies Establish Foothold in Disposable Endoscopy Sector: Can They Accelerate Import Substitution and Compete with Global Giants?” — VCBeat

《FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes》