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EYE ON CHINA
UroFlex now CE-marked; Chinese SFDA approval for Cellvizio
Mauna Kea Technology's UroFlex confocal miniprobe has received CE mark approval for use during cystoscopy procedures. UroFlex is believed to be the first optical biopsy probe designed for urological applications and allows the company to enter the EUR 1 billion European urology device market. The new probe allows physicians to obtain optical biopsies that may facilitate the diagnosis, surveillance and treatment of patients with bladder cancer. The CE mark extends Mauna Kea's Cellvizio portfolio beyond the gastrointestinal tract and lungs into the field of urology.

Clinical studies have demonstrated that optical biopsies with Cellvizio could help urologists determine if they have removed all cancerous cells during transurethral resection of the bladder tumour, the initial surgical procedure that a patient undergoes after the diagnosis of bladder cancer. Data also showed that optical biopsies can help physicians characterize lesions during long-term surveillance of bladder cancer patients.

In addition, Mauna Kea's Cellvizio has received SFDA approval in China, one of the fastest growing, largest medical device markets in the world. Concurrently, Mauna Kea has entered into a strategic partnership with Fujifilm Investment Co, a subsidiary of Fujifilm Holdings. The partners will work together to develop the Cellvizio market throughout China in various indications, such as gasteroenterology and pulmonology.

Fujifilm benefits from growth in its endoscopy market in China, and has established a strong distribution network all over the country. There are 800 advanced endoscopy centres in tertiary referral hospitals in China, which will constitute the primary target for Cellvizio.

Cellvizio is a probe-based confocal laser endomicroscopy system that provides high-resolution cellular views of tissue inside the body. Cellvizio has 510(k) clearance from the FDA and the European CE mark for use in the gastrointestinal tract, biliary and pancreatic ducts and lungs.

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