Mauna Kea Technologies and Fujifilm Announce Regulatory Approval for Cellvizio® in China for Gastroenterology and Pulmonology

Regulatory News:

Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced today that Cellvizio® has received State Food and Drug Administration (SFDA) approval in China, one of the fastest growing, largest medical device markets in the world. Concurrently, Mauna Kea Technologies 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.”

During 2012 to 2017, the Chinese medical device market is estimated to grow at a rate of approximately 20.2% per year, making it one of the fastest growing markets in the world.¹ The latest annual data up to December 2011 show that imports of medical devices have grown very strongly during the period, rising by 26.6% to reach more than € 6,5 billion.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company dedicated to the advent of optical biopsy. The company researches, develops and markets innovative 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. Large, international, multicenter clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, 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.

For more information on Mauna Kea Technologies, visit www.maunakeatech.com

About Fujifilm China

FUJIFILM (China) Investment Co., Ltd. is the regional headquarters of FUJIFILM Corporation in China, located in Shanghai. It has brought a wide range of advanced high-tech products to China, including digital cameras, imaging products, skincare products, graphic products, medical products, optical components and high-performance materials, etc. Its medical systems business is one of the priority business and it provides broad solutions for diagnostic imaging such as endoscope, CR/DR, PACS and Imager, and contributes to the improvement of medical diagnostics and quality of care for patients in China.

¹ The Medical Device Market:China. (2012) Espicom Medical Market Research Reports. Dec 6, 2012. http://www.espicom.com/china-medical-device-market