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PARIS

Regulatory News :

Mauna Kea Technologies (Paris:MKEA) (Euronext: MKEA, FR0010609263), inventor of Cellvizio^®, the multidisciplinary optical biopsy platform, announces a strong presence at the annual CCDD 2014 conference on digestive endoscopy held in Jinan, China, from October 10 to 12.

Mauna Kea Technologies was represented at the conference by its partner Fujifilm, with part of its stand given over entirely to endomicroscopy with Cellvizio.

Cellvizio garnered a great deal of attention during the conference, including the presentation of the results of eight studies, a live Cellvizio procedure, a private symposium on how to use Cellvizio led by Pr. Michael Wallace from the Mayo Clinic and Pr. Yan Qing Li of the Qilu hospital attended by a large number of physicians, who received a copy of the GI Confocal Endomicroscopy book, written entirely in Chinese by doctors from the Qilu hospital.

“Interest in endomicroscopy with Cellvizio is gaining momentum in China and all the requisite elements for its development there are now in place. We have a country manager and clinical head in place on the ground and a powerful distribution partner. Opinion leaders have rallied behind it, and we have set up a medical training unit in conjunction with the Qilu hospital. Nine clinical trials are currently underway in the targeted conditions, and the treatments are reimbursed locally in certain regions”, stated Sacha Loiseau, Founder and CEO of Mauna Kea Technologies. “We are confident about the development of the Chinese market, which is expected to accelerate once we gain regulatory approval for Cellvizio 100 and the AQ-Flex 19 probe in the characterization of pancreatic cysts”.

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About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company’s flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large-scale, international, multi-center clinical trials have demonstrated Cellvizio’s ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan. For further information on Mauna Kea Technologies, visit www.maunakeatech.com