Regulatory News :

Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263) (Paris:MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, announced its sales results for the fourth quarter and full year 2012.

In ? millions

IFRS

   2012   2011   Variation %
Q1   1.611   0.631   +155%
Q2   1.907   1.189   +60%
Q3   2.069   1.111   +86%
Q4   3.222   2.085   +55%
2012 Total Sales   8.809   5.016   +76%

Sales reach a record ?3.222 million during the fourth quarter of 2012

Fourth quarter sales rose 55% to a record ?3.222 million, bringing full year sales to ?8.809 million, a 76% increase over 2011 levels.

Strong growth sales of Cellvizio systems and probes to hospitals, the company's key target market, drove the strong revenue gains for the fourth quarter. Clinical sales rose 45% to ?2.600 million from ?1.797 million in the same period during 2011, while preclinical sales to research laboratories more than doubled (+116%) to ?0.622 million from ?0.288 million. Sales to hospitals and clinics accounted for 81% fourth quarter sales, while preclinical sales contributed the remaining 19%.

Sales of Cellvizio systems rose 61% to ?2.435 million during the quarter, while sales of miniprobes (consumables) were up 43% to ?0.545 million. The sale of services increased 30% to ?0.242 million.

Geographically, 52% of sales came from EMEA (Europe, Middle East and Africa), while the Americas and APAC (Asia Pacific) contributed 27% and 21% of sales, respectively. The company attributes the higher contribution from the EMEA and APAC regions to positive momentum of economic activity in parts of Europe and Asia.

Sales of miniprobes double (+96%) during 2012 as sales of Cellvizio systems rise 82%

For the full year 2012, Mauna Kea Technologies reported that sales grew 76% to ?8.809 million, driven by a 69% increase in sales to hospitals to ?7.461 million. Preclinical sales for the year more than doubled (up 129%) to ?1.349 million.

Sales of Cellvizio systems during the year were up 82% to ?6.172 million, while sales of miniprobes gained 96% ?2.003 million over 2011 levels. The sale of services rose 4% to ?0.634 million.

Geographically, sales within the Americas region accounted for nearly half of sales (48%) during the year, while EMEA and APAC regions represented 36% and 15% of 2012 sales, respectively.

As of December 31, 2012, 283 Cellvizio systems have been installed worldwide, including 185 in hospitals and clinical care facilities and 98 in pre-clinical research facilities. In North America, 102 Cellvizio systems are in place, including 95 in the U.S., while 142 systems have been installed in the EMEA region, 38 in the APAC region and one in Latin America.

"The strong increase in 2012 sales of Cellvizio systems and miniprobes, as well as the fast-growing number of scientific publications and new U.S. reimbursement codes, indicate that the medical community is adopting optical biopsy as an emerging standard of care in gastroenterology," Sacha Loiseau, CEO of Mauna Kea Technologies said. "As planned, we have also significantly expanded our geographical footprint into some of the world's largest markets including China, Brazil, India, Russia, Turkey and Canada during the year. We also continue to work with key opinion leaders throughout the world to expand indications for optical biopsy and announced CE mark approval for Cellvizio in urological indications and important programs in surgery. Despite the continuing uncertainty in the economic climate, we believe we are poised to continue our strong sales growth momentum in 2013."

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®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multicenter 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 ducts and lungs.

For more information on Mauna Kea Technologies, visit www.maunakeatech.com

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