MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies: new publication confirms important role of needle-based endomicroscopy for the characterization of pancreatic cysts

Transparency directive : regulatory news

21/10/2015 18:00

PRESS RELEASE

NEW PUBLICATION CONFIRMS IMPORTANT ROLE OF NEEDLE-BASED ENDOMICROSCOPY FOR THE
                    CHARACTERIZATION OF PANCREATIC CYSTS

   Retrospective analysis of CONTACT-1 population establishes robust imaging
              criteria to classify pancreatic cystic lesions

Paris, October 21, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263,
PEA-PME eligible), inventor of Cellvizio(r), the multidisciplinary confocal
laser endomicroscopy platform, today announced that the peer-reviewed journal
Surgical Endoscopy has released a new article highlighting the advantages of
needle-based confocal laser endomicroscopy (nCLE) for characterization of
different types of pancreatic cysts.

The group of endoscopists-investigators of CONTACT-1 study and their
pathologists have retrospectively defined new criteria to classify malignant and
pseudocysts for the first time and confirmed the  characteristics of the benign
serous cysts published earlier this year. This retrospective analysis included
33 patients followed 1-year and focused on the diagnosis of solitary pancreatic
cystic lesions using nCLE. Independent endoscopists have validated these
criteria with  a  substantial  intra-observer  agreement (kappa = 0.72).

Those results show a strong sensitivity and specificity for the 3 categories of
cysts (respectively 69% and 100% for serous cystadenomas, 91% and 95% for
mucinous cysts and 43% and 100% for pseudocysts).

According to the authors: "The development of nCLE techniques for the diagnosis
of pancreatic cysts, and in particular the high specificity observed in our
current dataset, can have important implications for patient management. In
cases where surgery is necessary (i.e., for cysts with malignant potential,
primarily MCN), it should be to achieve this with the shortest delay."

Doctor Bertrand Napoleon, Hospital Jean Mermoz, Lyon, France underlines the
importance of identifying benign cysts with such a level of confidence: "If the
cyst is considered without malignant potential (i.e.,  serous cysts), obtaining
a specific diagnosis at an early stage is key; it could avoid
unnecessary/repeated investigations inducing additional costs and delay, and
unnecessary surgery, associated with high morbidity and mortality".

"These additional results from our pilot study CONTACT-1 confirm the potential
benefits of Cellvizio in the management of patients with pancreatic cystic
lesions by rapidly and accurately identifying the nature of the lesions avoiding
commonly observed inappropriate treatments for numerous patients each year.
Mauna Kea Technologies remains on track to complete enrollment in its
200-patient sponsored-study CONTACT 2 by the end of the year. We look forward to
providing an update on our progress with this important trial in the near
future." said Sacha Loiseau, founder and CEO of Mauna Kea Technologies.

Publication reference: Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme
D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L,
Monges G, Poizat F, Giovannini M. In vivo characterization of pancreatic cystic
lesions by needle-based confocal laser endomicroscopy (nCLE): proposition of a
comprehensive nCLE classification confirmed by an external retrospective
evaluation. Surg Endosc. 2015 Oct 1.

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on protecting
patients' lives while enabling physicians and surgeons to make better decisions
thanks to direct visualization at the cellular level. The Company's flagship
product, Cellvizio, has received clearance to sell a wide range of applications
in more than 40 countries, including the United States, Europe, Japan, China,
Canada, Brazil and Mexico.

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 | Strategic 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 Technologies: new publication confirms important role of needle-based endomicroscopy for the characterization of pancreatic cysts

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