China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that the market approval filing for its in-licensed Uro-G disposable hand-held electronic bladder endoscope catheter has been accepted for review by the National Medical Products Administration (NMPA). The company’s matching Uro-3500 electronic endoscope image processor is also awaiting regulatory decisions in China.
Uro-G: Product Features and Benefits
Compared to the rigid cystoscopes widely used in the market, the insertion tube of Uro-G is a flexible structure, which can significantly reduce patient pain and improve comfort. Uro-G offers a field angle of 120 degrees, an active angle of 210 degrees and 130 degrees up and down, and a rotation angle of 90 degrees clockwise/counterclockwise. These features facilitate flexible operation and provide a panoramic view of the bladder. Additionally, Uro-G has its own working channel, reducing the frequency of equipment changes by doctors. Its cutting-edge light source enhances the visualization effect during the microscopic examination process.
Uro-3500: Image Processing and Portability
The handheld Uro-3500 electronic endoscope image processor, used in conjunction with Uro-G, processes the collected images and sends them to its own display screen for imaging. This ensures that target tissues, instruments, and endoscope images are always within the doctor’s linear field of vision, facilitating smooth examinations. The integrated and portable design of Uro-3500 allows doctors to perform cystoscopy by hand, enhancing the flexibility of using Uro-G.
Regulatory and Market History
Uro-3500 and Uro-G, designed and developed by UroViu, were approved for marketing in the US in 2018 and 2021, respectively. Asieris struck a licensing deal with the US firm in May 2021, securing commercialization rights to UroViu’s disposable cystoscope system in China. In August 2022, Uro-G was used in conjunction with Uro-3500 in Bo’Ao, marking a significant step in the system’s market introduction.
Strategic Implications
The acceptance of the market approval filing for Uro-G by the NMPA is a strategic milestone for Asieris. It underscores the company’s commitment to advancing innovative medical devices in the field of urology and enhancing patient comfort and outcomes. By securing regulatory approval, Asieris aims to expand its product portfolio and contribute to the broader goal of improving urological care in China.-Fineline Info & Tech
