MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies announces CE mark for use of Cellvizio in minimally invasive surgery

Transparency directive : regulatory news

18/05/2015 17:45

Press release

MAUNA KEA TECHNOLOGIES ANNOUNCES CE MARK FOR USE OF CELLVIZIO(r) IN MINIMALLY
INVASIVE SURGERY

* Broad scope of EU regulatory approval supports broader integration of
Cellvizio technology in many surgical and interventional image guided platforms
in oncology

PARIS, France - 18 May, 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
minimally invasive laparoscopic surgical indications. This regulatory milestone
positions Cellvizio for useful imaging support in a wide range of oncologic
surgical procedures, many of which have already been investigated successfully
in several clinical studies throughout Europe.

Cellvizio brings real-time visualization of tissue at the microscopic level,
representing a major advance in image-guided surgery. In this setting, the
Celioflex Cellvizio probe can be delivered laparoscopically through a trocar and
manipulated in the surgical field with standard laparoscopic hand-held
instruments. Usage of the Cellvizio probe with robotic instruments will be
accessible in the near future. Access to real-time visualization of tissue may
provide a range of benefits to surgeons and patients such as improved frozen
section sampling, more accurate tumor margin detection and improved surgical
planning. In addition, Cellvizio is compatible and synergistic with macroscopic
optical fluorescent imaging systems currently used in a range of surgical
applications.

Dr Silvana Perretta, from IRCAD-EITS, University of Strasbourg, France said,
"Cellvizio is able to provide important digital information in real time while
overcoming the physical barrier of the OR. The ability to bring this new level
of knowledge and precision into the surgical field is a significant advantage as
the global focus on evidenced-based medicine continues to expand."

Sacha Loiseau, CEO and founder of Mauna Kea Technologies said, "While we view
this achievement as an important regulatory milestone for the company, it is
also the next step in our ongoing effort to position this technology to
transform how surgery is performed in the years ahead. Based on a rapidly
growing body of clinical evidence, Cellvizio is the ideal technology for
integration into many surgical and interventional imageguided platforms. Based
on versatility and ease-of-use, we feel confident that adoption and use of this
landmark technology will continue to expand rapidly in the EU and around the
world."

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 & Financial Communication
Florent Alba / Pierre Laurent
Tél. : +33 (0)1 44 71 94 94
maunakea@newcap.fr

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