China Approves Endoscopy Device from Mauna Kea

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PARIS—Mauna Kea Technologies, which develops optical biopsy products, announced today that one of its products, Cellvizio, has received State Food and Drug Administration (SFDA) approval in China, one of the fastest growing, largest medical-device markets in the world. Mauna Kea also announced that it has entered into a strategic partnership with FUJIFILM (China) Investment Co., Ltd., a subsidiary of FUJIFILM Corporation. The partners will work together to develop the Cellvizio market throughout China in various indications.

"We are pleased to add Cellvizio to our broad portfolio of endoscopic products that we offer physicians throughout China," said Koji Yokota, president of Fujifilm China. "Optical biopsies allow physicians to diagnose and treat their patients in real time and are a true differentiating factor in endoscopy. Cellvizio will complement and enhance our own proprietary suite of advanced endoscopic imaging devices and systems."

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

"Fujifilm is the ideal partner to help us penetrate the Chinese market and offer physicians across the most populous country in the world access to Cellvizio," said Sacha Loiseau, CEO of Mauna Kea Technologies. "Chinese endoscopists have been eagerly waiting for Cellvizio to be available in China. SFDA approval is a significant milestone for the company and strengthens our footprint around the globe, since Cellvizio is now available in more than 40 countries and used by hundreds of physicians."

Mauna Kea Technologies researches, develops and markets tools to visualize and detect cellular abnormalities during endoscopic procedures. Its flagship product, Cellvizio, a probe-based confocal laser endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI tract, biliary and pancreatic ducts and lungs.

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