MAUNA KEA TECHNOLOGIES (EPA:MKEA) Mauna Kea Technologies announces CE mark for its novel near-infrared platform for endomicroscopic navigation during minimally invasive surgery
Transparency directive : regulatory news
22/07/2015 18:00
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PRESS RELEASE
MAUNA KEA TECHNOLOGIES ANNOUNCES CE MARK FOR ITS NOVEL NEAR- INFRARED PLATFORM
FOR ENDOMICROSCOPIC NAVIGATION DURING MINIMALLY INVASIVE SURGERY
* New regulatory approval covers broad use of novel Cellvizio 800 platform
PARIS, France - July 22, 2015 - Mauna Kea Technologies (Euronext: MKEA,
FR0010609263), inventor of Cellvizio(r), the multidisciplinary confocal laser
endomicroscopy platform, announced today CE mark for its Cellvizio 800
intra-operative platform which provides near-infrared endomicroscopic imaging
during minimally invasive surgical operations.
"This new regulatory step underlines our growing efforts and presence in the
surgical arena through an expanded and dedicated product line," Sacha Loiseau,
CEO and founder of Mauna Kea Technologies said. "With this novel endomicroscopy
platform now operating in the same setting and the same wavelength as widely
used macroscopic imaging surgical platforms, we are well positioned to take
fluorescence-guided surgery to the next level of precision and reliability."
Image-guided surgery with intra-operative macroscopic fluorescence systems
provides surgeons with immediate actionable information used to optimize
surgical treatments. The Cellvizio 800 platform is complementary to most
existing platforms such as the Pinpoint(r) or Firefly(r) systems.
This clearance also covers use of Cellvizio 800 in gastroenterology, pulmonary
and urinary indications. Cellvizio 800 (formerly Cellvizio 785) had already
obtained clearance from FDA in the US last year for GI endoscopy applications
only.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on protecting
patient lives by enabling physicians and surgeons to make better decisions
thanks to direct visualization at the cellular level. The company's flagship
product, Cellvizio(r) has received clearance for a broad range of applications
in more than 40 countries including the United-States, Europe, Japan, China,
Canada, Brazil and Mexico. For further information on Mauna Kea Technologies,
visit www.maunakeatech.com
Pinpoint and Firefly are registered trademarks of Novadaq Technologies Inc.
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