MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies obtains regulatory approval for the commercialization of Cellvizio in Mexico

Transparency directive : regulatory news

20/04/2015 18:00

Press release

  MAUNA KEA TECHNOLOGIES OBTAINS REGULATORY APPROVAL FOR THE COMMERCIALIZATION
                            OF CELLVIZIO(r) IN MEXICO

. Mexico is the second largest medical device market in Latin America after
  Brazil
. The local distributor, Endomédica, is now able to deploy its marketing and
  sales resources

PARIS, France - 20 April, 2015 - Mauna Kea Technologies (Euronext: MKEA,
FR0010609263), inventor of Cellvizio(r), the multidisciplinary confocal laser
endomicroscopy platform, announced today it has received regulatory approval
from COFEPRIS (Comisión Federal Para la Protección contra Riesgos Sanitarios),
the Mexican health authority, for the commercialization of Cellvizio in a
country that of 122 million people. Mauna Kea Technologies is now able to
implement its marketing strategy with its partner, Endomédica, a company
specialized in the fields of interventional endoscopy, gastroenterology,
urology and surgery since 1986.

The Mexican medical device market is the second largest in Latin America after
Brazil at 6.9 billion dollars. It is expected to grow by more than 13 % per
year and is dominated by imports that have grown 6.9 % per year between 2008
and 2013 to reach 3.6 billion dollars(1).

"We are very pleased by this authorization that opens the dynamic Mexican
market for Cellvizio, for which there is strong interest already, thanks to the
global development of the technology", declared Fernando Amigo, General Manager
of Endomédica, "We very much look forward to deploying our marketing and sales
teams to address key specialists in biliary and pancreatic diseases, which are
highly prevalent in our country."

Note (1): http://www.espicom.com/mexico-medical-device-market.html More
information on Endomédica: http://www.endomedica.com

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 endoscopy procedures. The company's flagship product,
Cellvizio(r), a probe needle based Confocal Laser Endomicroscopy (pCLE/nCLE)
system, provides physicians and researchers with high-resolution cellular
imaging of internal tissues. Large-scale, international, multicenter 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 virtually any endoscope. 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 has 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                   France & Europe
Eric Cohen                               NewCap - Investor Relations &
Vice President Finance                   Financial Communication
Tél. : +33 (0)1 70 08 09 70              Florent Alba / Pierre Laurent
investor-vpf@maunakeatech.com          Tél. : +33 (0)1 44 71 94 94
                                         maunakea@newcap.fr

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MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies obtains regulatory approval for the commercialization of Cellvizio in Mexico

Transparency directive : regulatory news

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