MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLGIES, TWO NEW PUBLICATIONS FROM LEADING TEAM IN CHINA PRESENT DATA FROM LARGE CLINICAL TRIALS

Transparency directive : regulatory news

03/03/2015 18:03

Press release

TWO NEW PUBLICATIONS FROM LEADING TEAM IN CHINA PRESENT DATA FROM LARGE CLINICAL
   TRIALS HIGHLIGHTING ADVANTAGES OF CELLVIZIO IN DIAGNOSIS OF GASTRIC AND
                                ESOPHAGEAL CANCERS

Clinical trials at Qilu Hospital enrolled 356 and 240 patients respectively

Publications in peer reviewed journals Gastrointestinal Endoscopy and Journal of
    Clinical Gastroenterology highlight diagnostic value of confocal laser
endomicroscopy in treatment of highly-prevalent pathologies in China and across
                                      Asia

PARIS, March 3, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced that clinicians from leading center for endomicroscopy
in China have just published two new large prospective studies highlighting the
advantages of Cellvizio probe-based confocal laser endomicroscopy (pCLE) in the
diagnosis of esophageal and gastric cancers. Results of a study of more than 240
patients with gastric cancers were published in the Journal of Clinical
Gastroenterology while results of a second study on 356 patients with esophageal
squamous neoplasia (ESN) were published in the journal Gastrointestinal
Endoscopy.

In the first study, the team from Qilu Hospital at Shandong University in China
presented results of a prospective Phase 2 trial showing that the use of pCLE
significantly improves specificity of diagnosis in gastric cancer thanks to a
new classification of pCLE interpretation criteria. Clinicians were able to
diagnose with very high accuracy a variety of common gastric conditions, ranging
from atrophic gastritis to intestinal metaplasia and cancer. In particular,
physicians using pCLE diagnosed neoplasia with 89.89% sensitivity and 99.44%
specificity. In addition, the inter-observer agreement for the image
interpretation criteria developed for neoplasia was proven to be substantial,
further validating the use of this new classification.

"Gastric cancer is a significant health issue all around Asia-Pacific and
especially in China. Challenges with diagnosis often mean that patients are
unable to get an early and accurate diagnosis, putting them at risk." said
Professor Yan-Qing Li, MD, PhD, Director of the Department of Gastroenterology
and Vice-President of Shandong University Qilu Hospital "The ability of pCLE to
improve both speed and accuracy in early diagnosis represents a major advantage
in the treatment of gastric cancers in the years ahead."

In the second study, clinicians assessed the diagnostic value of pCLE in a
sub-group of 91 patients among a population of 356 patients with early stage
ESN. Within this population the use of pCLE was shown to support the diagnosis
of ESN with very high levels of sensitivity (95%), specificity (91%), positive
predictive value (87%) and negative predictive value (96%). Total accuracy was
92.3%. .

"These highly positive results indicate that pCLE can play an important role in
diagnosing and differentiating ESN. Rapid and accurate detection and
differentiation of ESN is essential to improve patient outcomes, and use of pCLE
with Cellvizio to support diagnosis can play a critical role in helping more
patients access appropriate care faster," added Prof. Yan-Qing Li.

"These landmark research studies in China represent a new level of confirmation
of the advantages of Cellvizio in the diagnosis of two types of cancer that are
especially prevalent in China and throughout Asia. These excellent results on
such large populations will support the wider adoption of Cellvizio and its
reimbursement in China. We are proud to see how the Qilu Hospital, already the
largest pCLE center in China and home of several clinical studies on pCLE, is
constantly exploring new indications for our technology." concludes Sacha
Loiseau, CEO and Founder of Mauna Kea Technologies.

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 5
10(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

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

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MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLGIES, TWO NEW PUBLICATIONS FROM LEADING TEAM IN CHINA PRESENT DATA FROM LARGE CLINICAL TRIALS

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