Richard Wolf blue-light cystoscopy Phase III clinical trial meets its primary endpoint

Richard Wolf announced today (August 11, 2023) that the Phase III clinical trial of blue-light cystoscopy for the diagnosis and surgery of bladder cancer has met its primary endpoint.

The study is a prospective, within-patient controlled, multicenter Phase III clinical study comparing the bladder cancer detection rate of Hexvix® combined with blue-light cystoscopy versus white-light cystoscopy. The primary endpoint was the proportion of patients in whom Hexvix® with blue-light cystoscopy detected one or more additional bladder cancer lesions (stages Ta, T1 and CIS) compared with white-light cystoscopy. The principal investigator was Prof. Li Hanzhong of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. A total of 158 patients were enrolled, and the completed statistical analysis shows that the study was successfully completed and met its primary endpoint.

David Tian, Manager Greater China at Richard Wolf, said: "The clinical data for System blue blue-light cystoscopy further confirm its outstanding clinical performance. We sincerely thank all investigators and participants for their dedication and effort in this study. It shows that blue-light cystoscopy combined with Hexvix® effectively increases the detection rate of NMIBC, and a higher detection rate allows more complete resection, reducing tumor recurrence. We will now do everything we can to advance the next steps so that bladder cancer patients in China can benefit as soon as possible."

About PDD blue-light cystoscopy

In the treatment of bladder tumors, early detection is a crucial factor. Richard Wolf has therefore been developing photodynamic diagnosis (PDD) for more than 20 years and has recently launched a new LED-based photodynamic diagnosis product, the System blue PDD system. Used with Hexvix®, the System blue blue-light cystoscope significantly increases the detection rate in the diagnosis of bladder cancer and improves the safety of surgery. With Hexvix, bladder tumor tissue fluoresces red, in clear contrast to normal tissue, which appears blue. The System blue components are perfectly matched to the photosensitizer, significantly enhancing tumor fluorescence contrast and therefore the detection rate. The higher-contrast images make it easier to distinguish malignant from healthy tissue and give brighter, more natural images of the examined area, so that all tumors can be completely resected with a high degree of certainty.

About Richard Wolf

Richard Wolf is a medium-sized medical technology company with more than 1,500 employees, 18 subsidiaries and 130 representations abroad. The company develops, manufactures and distributes a wide range of products for endoscopy and extracorporeal shockwave therapy in human medicine, as well as OR integration systems.