MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES RECIEVES FDA CLEARANCE FOR NEXT GENERATION CELLVIZIO SYSTEM

Transparency directive : regulatory news

29/08/2011 17:45

Press release

MAUNA KEA TECHNOLOGIES RECIEVES FDA CLEARANCE FOR NEXT GENERATION CELLVIZIO
SYSTEM

The new Cellvizio(r) 100 Series is now available in the US;

The Cellvizio 100 Series includes significant improvements and new features

PARIS, August 29, 2011 - Mauna Kea Technologies (Nyse Euronext: MKEA), leader in
the endomicroscopy market, announced today that it has just obtained 510(k)
clearance (N° K111047) from the U.S. Food and Drug Administration (FDA) to
market the next generation endomicroscopy system for the GI and pulmonary
tracts, called the Cellvizio 100 Series. Launched in Europe after obtaining the
CE mark in April 2011, the Cellvizio 100 Series is now ready to be released in
the United States.

"We are proud to announce the market release of the Cellvizio 100 Series in the
USA," said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "Based on
the feedback from our current user base, we have made significant improvements
to help physicians integrate Cellvizio into their endoscopy suites. These new
features greatly improve endomicroscopic image acquisition and interpretation.
As announced during our Initial Public Offering in July 2011, this market
release is a major milestone and achievement for us and demonstrates our
continued commitment to innovation in the endomicroscopy market."

Used mainly in gastroenterology applications, Cellvizio provides physicians with
real-time microscopic images of tissue inside the body. The images facilitate
the diagnosis and surveillance of patients, improving the detection of
pre-cancerous lesions and helping physicians make immediate treatment decisions
for their patients.

The Cellvizio 100 Series incorporates key upgrades including enhanced image
quality and a "Cine Review" feature that allows physicians to focus on a single
frame of clinical evidence for as long as
necessary. Other features include an improved user interface, faster start up
and shut down times, and data exchange allowing images to be exported to
patient's medical files with ease.

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company and leader in the
endomicroscopy market. The company researches, develops and markets innovative
tools to visualize and detect abnormalities in the gastro-intestinal and
pulmonary tracts. Its flagship product, Cellvizio(r), a probe-based Confocal
Laser Endomicroscopy (pCLE) system, provides physicians and researchers high
resolution cellular views of tissue inside the body. Large, international,
multi-center clinical trials have demonstrated Cellvizio's ability to help
physicians more accurately detect early forms of disease and make treatment
decisions immediately. Designed to improve patient outcomes and reduce costs
within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio
has 510(k) clearance from the U.S. Food and Drug Administration and the European
CE-Mark for use in the GI and pulmonary tracts.

For more information about Mauna Kea Technologies visit www.maunakeatech.com

Disclaimer
This press release and the information contained herein do not constitute an
offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe
to, shares in Mauna Kea Technologies ("the Company") in any country. This press
release contains forward-looking statements that relate to the Company's
objectives. Such forward-looking statements are based solely on the current
expectations and assumptions of the Company's management and involve risk and
uncertainties. Potential risks and uncertainties include, without limitation,
whether the Company will be successful in implementing its strategies, whether
there will be continued growth in the relevant market and demand for the
Company's products, new products or technological developments introduced by
competitors, and risks associated with managing growth. Unfavorable developments
in connection with these and other risks and uncertainties described, in
particular, in the Company's prospectus prepared in connection with its IPO and
on which the French Autorité des marches financiers ("AMF") granted its visa
number 11-236 on June 230, 2011, could cause the Company to fail to achieve the
objectives expressed by the forward-looking statements above.

Media Contacts:

U.S. Media
Lazar Partners Ltd.
Erich Sandoval
Tel: +1 917 497 2867
E-mail: esandoval@lazarpartners.com

Mauna Kea Technologies
Alexander Bryson
Marketing Communications and Brand Manager
Tel: +33 (0) 1 70 08 09 92
E-mail: alexander@maunakeatech.com

French/European Media
ALIZE RP
Caroline Carmagnol
+ 33 1 42 68 86 43 // + 33 6 64 18 99 59
caroline@alizerp.com
Anne -Sophie Cosquéric
+ 33 1 42 68 86 41
Anne-sophie@alizerp.com

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