MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies receives regulatory approval for the AQ-FLEX 19 miniprobe in Japan

Transparency directive : regulatory news

06/07/2015 18:00

PRESS RELEASE

MAUNA KEA TECHNOLOGIES RECEIVES REGULATORY APPROVAL FOR THE AQ-FLEX 19 MINIPROBE
IN JAPAN

Approval provides significant support for broader adoption of Cellvizio's
needle-based confocal laser endomicroscopy solution in a leading global market
for endoscopy

PARIS, France - 6 July, 2015 - Mauna Kea Technologies (Euronext: MKEA,
FR0010609263), inventor of Cellvizio(r), the multidisciplinary confocal laser
endomicroscopy platform, announced today it has obtained approval from Japan's
Ministry of Health, Labor and Welfare (MHLW) for its unique needle-base Confocal
Laser Endomicroscopy solution, the AQ-Flex 19 miniprobe.

Used during endoscopy procedures, the Cellvizio AQ -Flex(tm) 19 miniprobe is
comprised of a fiber-optic microscope that is small enough to thread through a
needle. It provides real-time microscopic imaging of pancreatic cysts during
endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures, making
it possible to see the cyst wall down to a cellular level to help physicians
find and identify features of each type of cyst that can drive treatment
decisions.

"The use of needle-based Confocal Laser Endomicroscopy in pancreatic lesions has
been shown in a range of clinical studies to provide essential information that
can help doctors make more accurate and faster treatment decisions," said Pr.
Kenji Yamao, director of the Division of Gastroenterology, Aichi Cancer Center,
"The approval of this ground-breaking technology in Japan is a major advantage
for physicians and pancreatic surgeons who manage a growing number of patients
with these pathologies".

The AQ-Flex 19 Miniprobe was awarded a CE Mark in the EU in 2012 and was cleared
by the US Food and Drug Administration in 2013.

"Japan represents the second largest market for endoscopic equipment in the
world, with high demand for GI screening and interventional procedures due to an
aging population and other factors. We are seeing growing awareness and support
for Cellvizio from Key Opinion Leaders in Japan and throughout Asia, which
represents an important market for us in the years ahead," said Sacha Loiseau,
founder and CEO 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 needlebased Confocal Laser
Endomicroscopy (pCLE/nCLE) 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 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
Eric Cohen
Vice President Finance
Tél. : +33 (0)1 70 08 09 70
investor-vpf@maunakeatech.com

France & Europe
NewCap - Investor Relations
Florent Alba / Pierre Laurent
Tél. : +33 (0)1 44 71 94 94
maunakea@newcap.fr

United States
Berry & Company Public Relations
Bill Berry
Tel: +1 212 253 8881
bberry@berrypr.com

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MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies receives regulatory approval for the AQ-FLEX 19 miniprobe in Japan

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