Mauna Kea Technologies Announces New Study Shows Optical Biopsy is More Accurate Than Conventional Endoscopic Biopsy in

  Mauna Kea Technologies Announces New Study Shows Optical Biopsy is More
  Accurate Than Conventional Endoscopic Biopsy in Detecting Stomach Cancer

  New clinical study conducted in Korea demonstrates that Cellvizio® optical
  biopsies improve the standard of care for the diagnosis of stomach cancers

Business Wire

PARIS -- March 14, 2013

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA), leader in the
optical biopsy market and developer of Cellvizio®, the fastest way to see
cancer, reported a new study showing that a Cellvizio optical biopsy can
overcome the limitations of standard tissue biopsies in accurately diagnosing
cancerous stomach tumors. The study was completed at the Soonchunhyang
University Hospital Gastrointestinal Cancer Center in Seoul, Korea. The study
findings^1 were published online in the March Issue of Gastrointestinal
Endoscopy.

In Asia, stomach cancer is the second most prevalent kind of cancer and the
leading cause of cancer in men according to the World Health Organization. An
estimated 736,000 people die from stomach cancer each year, making it the
second largest cause of cancer death worldwide^2.

“Histological examination of gastric lesions via forceps biopsy is known to be
of limited^3 accuracy and does not fully portray the severity and extent of a
stomach lining lesion. Therefore, there is a risk for missing carcinomas,”
said Joo Young Cho, M.D., Ph.D., Director of the Korea NOTES Research Group
and Director of the Gastrointestinal Cancer Center at Soonchunhyang University
Hospital. “Cellvizio optical biopsies offer a way for gastroenterologists to
accurately characterize many more spots in the stomach and get a more
comprehensive view of the patient’s stomach tissue, in real time.”

Patients enrolled in the study underwent an optical biopsy prior to endoscopic
resection of the cancerous tissue in the stomach lining previously diagnosed
by endoscopic biopsy. The overall accuracy of the optical biopsy diagnosis was
compared with endoscopic resection.

54 lesions consisting of three benign lesions, 19 pre-cancerous lesions and 32
adenocarcinomas were imaged and resected. Optical biopsies were found to have
a higher overall rate of accuracy of diagnosis for cancerous lesions than
conventional biopsies. The overall accuracy for the diagnosis of cancerous
lesions in the stomach lining was 91.7% for optical biopsies and 85.2% for
conventional biopsies. The combined accuracy of conventional endoscopic
biopsies and optical biopsies was 98.1%.

The study also showed that optical biopsy findings are highly reproducible
between physicians, with excellent overall agreement amongst physician
observers for optical biopsies (kappa statistic k=0.824) as compared to the
conventional biopsy (k=0.617).

“These results confirm the value of Cellvizio for stomach cancer and show that
optical biopsy is a reliable method that provides a better diagnostic solution
than the current standard of care. This is a very exciting clinical
development for the Asian market, where stomach cancer is a highly pervasive
disease,” said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. “We
are continuing our efforts to expand and deepen our footprint in the Asian
market and expect important studies like this to help facilitate utilization
of optical biopsies across the world’s most populated continent.”

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

Disclaimer

This press release and the information contained herein do not constitute an
offer to sell or subscribe to, or a solicitation of an offer to buy or
subscribe to, shares in Mauna Kea Technologies ("the Company") in any country.
This press release contains forward-looking statements that relate to the
Company’s objectives. Such forward-looking statements are based solely on the
current expectations and assumptions of the Company’s management and involve
risk and uncertainties. Potential risks and uncertainties include, without
limitation, whether the Company will be successful in implementing its
strategies, whether there will be continued growth in the relevant market and
demand for the Company’s products, new products or technological developments
introduced by competitors, and risks associated with managing growth.
Unfavorable developments in connection with these and other risks and
uncertainties described, in particular, in the Company’s prospectus prepared
in connection with its IPO and on which the French Autorité des marches
financiers (“AMF”) granted its visa number 11-236 on June 230, 2011, could
cause the Company to fail to achieve the objectives expressed by the
forward-looking statements above.

^1 Hyun Bok, G et al. (2013) The accuracy of probe-based confocal
endomicroscopy versus conventional endoscopic biopsies for the diagnosis of
superficial gastric neoplasia. Gastrointestinal Endoscopy. Published online 08
March 2013.
^2 GLOBOCAN 2008 (IARC) Section of Cancer Information (22/1/2013)
^3 Park, JS. (2013) Early-stage gastric cancers represented as dysplasia in a
previous forceps biopsy: the importance of clinical management. Digestive
Liver Disease. 2013 Feb;45(2):170-5. doi: 10.1016/j.dld.2012.09.008.

Contact:

United States
Erich Sandoval, Tel: +1 917 497 2867
esandoval@lazarpartners.com
or
Mauna Kea Technologies
Alexander Bryson, Tel: +33 (0) 1 70 08 09 92
Marketing Communications and Brand
Manager
alexander@maunakeatech.com
or
France and Europe
NewCap.
Pierre Laurent / Florent Alba, Tel: +33(0)1 44 71 94 94
Investor Relations and Financial Communication
maunakea@newcap.fr
 
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