MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies announces CE mark for use of Cellvizio® during interventional radiology procedures

Transparency directive : regulatory news

09/06/2015 17:45

PRESS RELEASE

         MAUNA KEA TECHNOLOGIES ANNOUNCES CE MARK FOR USE OF CELLVIZIO(r)
                     DURING INTERVENTIONAL RADIOLOGY PROCEDURES

* Key regulatory and product development milestone on the company's application
                                     roadmap

* Expansion of the company's needle-base device platform (nCLE) with new AQ-Flex
  19 IR miniprobe

* Approval will facilitate ongoing clinical and product development including
  existing strategic collaborations

Paris, France - 9 June, 2015 - Mauna Kea Technologies (Euronext: MKEA,
FR0010609263), inventor of Cellvizio(r), the multidisciplinary confocal laser
endomicroscopy platform, announced today CE mark for the use of Cellvizio in
interventional radiology indications. This new regulatory milestone positions
Cellvizio as a unique adjunct to important therapeutic procedures that are in
great need for direct and real-time image-guidance.

"Interventional radiology is all about using our powerful non-invasive imaging
modalities to guide and deliver treatments locally, as an alternative to
surgical or systemic chemotherapy approaches. With the combination of Cellvizio
with our existing image-guided platforms, we could be reaching a new level of
precision and efficacy in our interventions." said Pr. Afshin Gangi, Chief of
Interventional Radiology at the Nouvel Hôpital Civil in Strasbourg, France.
"We have been very pleased with our initial experience over the past few months
and are excited about this regulatory approval which will enable a faster
development going forward."

Cellvizio brings real-time visualization of tissue at the microscopic level,
representing a major advance in image-guided interventions. In this setting,
the AQ-Flex 19 IR Cellvizio probe can be delivered through a standard
percutaneous needle and provide microscopic images of lesions within solid
organs such as the liver, kidney, or lung. Access to Cellvizio imaging during
the procedure may provide a wide range of benefits to patients such as
real-time assessment of needle-placement before focal therapeutic interventions
and evaluation of completeness of tumor ablation.

Sacha Loiseau, CEO and founder of Mauna Kea Technologies declared, "While this
approval is an important accomplishment for Cellvizio and a meaningful potential
commercial opportunity, we do not expect Mauna Kea to be the primary marketer of
AQ-Flex 19 IR as we believe that full integration of our proprietary technology
into an existing interventional radiology platform would lead to a more rapid
adoption of Cellvizio in this community."

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company dedicated to the
advent of optical biopsy. The company researches, develops, and markets
innovative tools to visualize and detect cellular abnormalities during
endoscopic procedures. 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 tract, biliary and pancreatic duct, lungs, and during
fine needle aspiration procedures. Cellvizio has also been cleared by SFDA in
China and MHLW in Japan for use in the GI, respiratory and urinary tract. For
more 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 & Financial Communication
Florent Alba / Pierre Laurent
Tél. : +33 (0)1 44 71 94 94
maunakea@newcap.fr

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MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies announces CE mark for use of Cellvizio® during interventional radiology procedures

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