MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies announces publication of confirmation data on the value of endomicroscopy for the characterization of pancreatic cystic neoplasms

Transparency directive : regulatory news

25/03/2015 18:00

PRESS RELEASE

MAUNA KEA TECHNOLOGIES ANNOUNCES PUBLICATION OF CONFIRMATION DATA ON THE VALUE
OF ENDOMICROSCOPY FOR THE CHARACTERIZATION OF PANCREATIC CYSTIC NEOPLASMS

Investigator-Initiated DETECT Study shows benefits of using Cellvizio to safely
differentiate the nature of pancreas cysts with high specificity and accuracy

  Findings from research team at UC Irvine published in peer-reviewed journal
                            "Gastrointestinal Endoscopy"

PARIS, March 25, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced publication of a pilot monocentric study by Dr Y.
Nakai et al, University of California Irvine Medical Center, Orange, CA. The
study results show that needle-based confocal endomicroscopy (nCLE) procedures
safely performed with Cellvizio were successfully able to differentiate mucinous
from non-mucinous pancreatic cysts with a high degree of accuracy.  Results were
published recently in the peer-reviewed journal Gastrointestinal Endoscopy.

In an article entitled: "Diagnosis of pancreatic cysts: EUS-guided,
through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial:
DETECT study ", the research team led by Dr Kenneth J. Chang, at UC Irvine
report that the use of Cellvizio demonstrated 100% positive predictive value and
100% specificity in characterizing mucinous cysts thanks to the visualization of
papillary projections, also called papillae. Researchers were able to confirm
the classification of these cysts as mucinous (IPMN) by either surgery or
standard tests (e.g, EUS, CEA, cytology, amylase) in a high-certainty diagnosed
sub-population. Authors showed nCLE-accuracy data at a level of 89% using this
criteria in pancreatic cysts.

"With nCLE, we were able to confirm the mucinous nature of pancreatic cysts
based on observation of papillary projections or dark rings that are visible
only with the Cellvizio nCLE technology. We were one of the pioneer centers
using this advanced technology for this application in the U.S.," said Dr Chang,
Chief of Gastroenterology and Hepatology and Director of the Comprehensive
Digestive Disease Center at UC Irvine, adding, "The ability to rapidly confirm a
diagnosis using nCLE means that we may be able to offer better options for these
patients and reduce or eliminate the need for patients to advance to surgery
when they don't need it."

"The findings from the DETECT study reinforce the evidence gathered on the use
of nCLE in characterization of pancreatic cysts as shown by the recently
published clinical trials results INSPECT (Konda et al, 2013, Endoscopy) and
CONTACT1 (Napoléon et al, 2014, Endoscopy)." said Sacha Loiseau, Ph.D, CEO and
founder of Mauna Kea Technologies "We are very pleased that independent users
from leading medical research centers are continuing to add to the body of
clinical evidence demonstrating the  benefits of nCLE  for patients suffering
from pancreatic lesions. These patients need more precise answers and better
orientation to therapeutic options, and our Cellvizio nCLE technology is helping
physicians around the world to do just that."

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             France and Europe
Eric Cohen                         NewCap
Vice President Finance             Investor Relations & Financial
Communication
Tel: +33 (0)1 70 08 09 70          Florent Alba / Pierre Laurent
investor-vpf@maunakeatech.com      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 publication of confirmation data on the value of endomicroscopy for the characterization of pancreatic cystic neoplasms

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