Mauna Kea Technologies

Regulatory Filings • Dec 8, 2015

Mauna Kea Technologies Receives New Regulatory Approval for Cellvizio 100s in China

PARIS, December 8, 2015 /PRNewswire/ --

MAUNA KEA TECHNOLOGIES receives new regulatory approval for Cellvizio 100s in China

• Green light for expanded use of Cellvizio in China into pancreatic and urologic applications with the clearance of associated miniprobes
• Growth acceleration of the company's business in China now possible in a market increasingly receptive to endomicroscopy

PARIS, December 8, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today it has obtained approval from China's Food and Drug Administration (CFDA) for its latest version of Cellvizio 100s and for associated miniprobes dedicated to applications in pancreatic diseases (needle-based Confocal Laser Endomicroscopy, nCLE) and urology. Cellvizio 100s brings the physicians' clinical value and benefits to a new level with additional features and significant improvements in ergonomics, performance, connectivity and ease-of-use.

Adding urology and pancreatic applications opens up the market to more usage from the existing installed base and to accelerated acquisition momentum from new physicians who have been waiting for Cellvizio 100s. Following this significant milestone in its expansion strategy, the company is revamping its marketing and sales strategy in China to maximize the commercial opportunities for these new applications.

"Following the success of nCLE in Europe and the USA, we expect strong demand for our technology in the short term, in a country where pancreatic cancer is the sixth leading cause of death from malignant diseases", says Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "The Chinese market has been increasingly receptive to our technology in gastrointestinal and pulmonary indications and we are looking forward to its adoption in urology which has a potential at least as important."

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on protecting patients' lives while enabling physicians and surgeons to make better decisions thanks to direct visualization at the cellular level. The Company's flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com

Mauna Kea Technologies               NewCap.
Investors relations US               Investor Relations Europe  
Sebastien Cadet                      Florent Alba 
Global Marketing Director and OEM    Tel: +33 (0) 1 44 71 94 94 
Leader                               maunakea@newcap.fr
sebastienc@maunakeatech.com

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