Regulatory Filings • Apr 20, 2015
Regulatory Filings
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PARIS, France – 20 April, 2015 – Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today it has received regulatory approval from COFEPRIS (Comisión Federal Para la Protección contra Riesgos Sanitarios), the Mexican health authority, for the commercialization of Cellvizio in a country that of 122 million people. Mauna Kea Technologies is now able to implement its marketing strategy with its partner, Endomédica, a company specialized in the fields of interventional endoscopy, gastroenterology, urology and surgery since 1986.
The Mexican medical device market is the second largest in Latin America after Brazil at 6.9 billion dollars. It is expected to grow by more than 13 % per year and is dominated by imports that have grown 6.9 % per year between 2008 and 2013 to reach 3.6 billion dollars1 .
"We are very pleased by this authorization that opens the dynamic Mexican market for Cellvizio, for which there is strong interest already, thanks to the global development of the technology", declared Fernando Amigo, General Manager of Endomédica, "We very much look forward to deploying our marketing and sales teams to address key specialists in biliary and pancreatic diseases, which are highly prevalent in our country."
Note (1): http://www.espicom.com/mexico-medical-device-market.html More information on Endomédica: http://www.endomedica.com
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 endoscopy procedures. The company's flagship product, Cellvizio®, a probe needle based Confocal Laser Endomicroscopy (pCLE/nCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large-scale, international, multicenter 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
France & Europe NewCap - Investor Relations & Financial Communication Florent Alba / Pierre Laurent Tél. : +33 (0)1 44 71 94 94 [email protected]
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