On August 27, 2026, Apollomics (688176.SH) officially announced that its self‑developed portable disposable flexible blue‑light cystoscope (APLD‑2304) has successfully obtained CE certification under the EU Medical Device Regulation (MDR), together with the ISO 13485:2016 Quality Management System certificate. This marks the first approval of an in‑house‑developed product by Apollomics for the EU market. It signifies that the product fully complies with the latest EU market‑access requirements and has formally obtained the access permit for clinical application across Europe.
Apollomics Uro‑G Disposable Blue‑Light Cystoscope
As the world’s‑first portable, single‑use flexible blue‑light cystoscope, the APLD‑2304 is not a standalone diagnostic‑therapeutic device. Instead, it is designed to be used in combination with Hexvix®, Apollomics’ in‑house‑developed blue‑light imaging agent (hexaminolevulinate hydrochloride for instillation), forming a complete drug‑device combination solution for bladder cancer diagnosis.
Clinically, the core technical principle behind Apollomics’ portable single‑use flexible blue‑light cystoscope works as follows: after the imaging agent is instilled into the human body, its active ingredient is highly selectively absorbed by tumour cells. When illuminated by blue‑light emitted from the device, lesions fluoresce in bright red, creating a sharp visual contrast against normal‑tissue background. This enables previously hard‑to‑detect tiny or flat lesions to be visualized clearly.
It is understood that this product is equipped with photodynamic‑diagnosis functions and is specially designed for examination and imaging procedures in urology. Featuring a flexible shaft design, it is fully compatible with clinical operative pathways via natural orifices. Meanwhile, its core characteristics‑portability, sterility and single‑use‑reduce the risk of cross‑infection at the source, greatly improve operational convenience for clinicians, and further alleviate patient discomfort during examination.
From the perspective of real‑world clinical needs in Europe, bladder cancer remains a highly prevalent disease in the field of urology. There are 165,000 new‑onset cases annually within the European Union alone, while the total number of new cases across the whole of Europe exceeds 224,000 each year. Given the extremely high recurrence rate of bladder cancer, patients require long‑term and frequent postoperative follow‑up examinations, which generates substantial sustained clinical demand.
Compared with conventional white‑light cystoscopes widely used in clinical practice across Europe and America, traditional white‑light cystoscopy has long suffered from notable technical limitations. Flat or tiny early‑stage lesions are likely to be missed, which directly results in a low detection rate of early‑stage lesions and persistently‑high recurrence rates among patients.
conventional white‑light cystoscope
The launch of APLD‑2304 precisely targets this long‑standing clinical gap. Leveraging proven blue‑light imaging technology, it can effectively identify tiny lesions and carcinoma in‑situ (CIS) that are difficult to detect under white‑light illumination. It is expected to fundamentally raise the early‑detection rate of bladder cancer and thereby reduce patients’ risk of postoperative recurrence.
More critically, its portable, single‑use design breaks the scenario restriction of conventional blue‑light diagnostic technology, which could only be performed in large‑scale operating rooms. It enables this advanced technology to be deployed in patient‑centered settings such as outpatient clinics and day‑surgery units, greatly expanding the coverage of high‑quality early‑diagnosis services for bladder cancer.
The EU CE‑MDR certification was formally issued by the EU Notified Body, BSI Group The Netherlands B.V. APLD‑2304 features fully‑independent intellectual property rights. Multiple patent applications have been filed in China and numerous overseas countries and regions, providing full protection for its core‑technology rights and interests.
