MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES announces acceleration of installations and use of Cellvizio endomicroscopy platform in Japan

Transparency directive : regulatory news

11/03/2015 20:47

Press release

    MAUNA KEA TECHNOLOGIES ANNOUNCES ACCELERATION OF INSTALLATIONS AND USE OF
                   CELLVIZIO ENDOMICROSCOPY PLATFORM IN JAPAN

     Cellvizio is now available in ten leading hospitals involving multiple
                              specialties in Japan.

  Technology highlighted in first-ever Japanese live demonstration during the
               14th Yokohama International Endoscopy Conference.

PARIS, March 11, 2015-Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced several developments showing adoption and expanded use
of the Cellvizio technology platform in multiple diagnostic applications in
Japan.

Cellvizio received MHLW regulatory approval in Japan in April 2014 and is now
installed in ten leading hospitals throughout the country including the National
Cancer Center Hospital in Tokyo. In response to growing interest among
clinicians and researchers, the Japanese Gastroenterological Endoscopy Society
(JGES) also established a special interest group on confocal laser
endomicroscopy (CLE) to advance a range of key initiatives and learning
opportunities.

On March 7th, Dr. Ken Ohata, Director of Endoscopy at NTT Medical Center Tokyo,
performed the first-ever live procedure involving the use of Cellvizio in Japan
at the 14th Yokohama International Endoscopy Conference. Prof. Shinei Kudo,
Chairman of Digestive Disease Center, Showa University Northern Yokohama
Hospital, cofounder of the Magnifying Endoscopy Society in Japan and Course
Director of the conference, commented, "We had a very powerful demonstration of
endoscopic microscopy technologies at the 14th Yokohama Live. These technologies
are an increasingly important part of the future of endoscopy and I fully
support their continued development in Japan."

In addition, more than 25 leading physicians from Japan will take part in the
upcoming International Conference of Cellvizio Users (ICCU) to be held in
Lisbon on April 10th . Dr. Yutaka Saito, Chief of Endoscopy at National Cancer
Center Hospital, is the incoming chairman of the ICCU meeting.

"Diagnosis and treatment of digestive cancers remain a critical health issue in
Japan, and the ability to characterize these cancers faster and with improved
specificity could have a significant impact on patient care and outcomes," said
Dr. Saito. "We are very proud to be leading the clinical development of
confocal laser endomicroscopy in Japan where the attention to analysis at the
microscopic level has for many years been a primary focus and goal."

In addition to the Yokohama meeting, data and case studies related to use of
Cellvizio will be presented at 13 different medical congresses in Japan in
2015.

"Japanese physicians have been leading the development of endoscopy for decades.
We are very proud to see that Cellvizio is already available at many of the top
research and treatment centers in Japan and that it is receiving strong support
from many of the leaders in the endoscopy community," said Sacha Loiseau, CEO
and Founder of Mauna Kea Technologies. "We look forward to working with even
more leading physicians throughout Japan to brin g the clinical value of
Cellvizio to more hospitals and patients, and we are confident that more
important applications of our technology will be developed in this significant
market."

Optical biopsy with Cellvizio enables the visualization of tissues at the
cellular level during an endoscopic examination to determine the presence of
diseases and conditions such as cancer. The procedure combines CLE with
standard endoscopy and produces images with microscopic precision that can
provide physicians with real-time information to support faster and more
accurate diagnosis.

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(r), 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 more information on Mauna Kea Technologies, visit www.maunakeatech.com

Mauna Kea Technologies
Eric Cohen
Vice President Finance
Tel: +33 (0)1 70 08 09 70
investor-vpf@maunakeatech.com

France and Europe
NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent
Tel: +33 (0)1 44 71 94 94
maunakea@newcap.fr

United States
Berry & Company Public Relations
US - Public Relations
Bill Berry
Tel: +1 212 253 8881
bberry@berrypr~com

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MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES announces acceleration of installations and use of Cellvizio endomicroscopy platform in Japan

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