MAUNA KEA TECHNOLOGIES ANNOUNCES IMPORTANT REGULATORY CLEARANCES IN TURKEY
PARIS--(BUSINESS WIRE)--Oct 1, 2012--Regulatory News: Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market and developer of Cellvizio® imaging, the fastest way to see cancer, announced that it has received clearance from the Turkish Ministry of Health to sell both its Cellvizio® 100 Series endomicroscopic imaging system and the new AQ Flex® 19 miniprobe throughout Turkey, which currently represents the largest medical device market in the Asia Minor and Southeastern European region.
“Turkish regulatory approval for our latest generation Cellvizio system and the world’s first endomicroscopy probe for use in solid tumors extends the Cellvizio portfolio in the largest medical device market in the region,” said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. “Gastroenterologists and pulmonologists throughout Turkey now have additional options when choosing advanced imaging technologies for patients with suspected digestive and respiratory diseases. This represents an important regulatory milestone for the company and demonstrates our ongoing commitment to broaden and deepen the market for cellular level, endoscopic imaging to help physicians around the world diagnose and treat their patients more effectively and efficiently.” In some regions of Turkey, upper gastrointestinal cancers are the main cause of morbidity and mortality among all cancer diagnoses. According to a study published in The Turkish Journal of Gastroenterology, of all cancer types, GI cancer has the highest prevalence in Eastern Turkey, with upper GI cancers being the most frequent and most fatal group with the highest endoscopic prevalence due to dietary and environmental factors.
The Turkish medical device market accounts for approximately $1.1 billion in annual medical equipment import and export sales and is expected to continue growing at an exponential rate, reaching $3.12 billion in 2015, according to Infomedix.
Mauna Kea Technologies has successfully secured Cordamed as the official distributor of Cellvizio in Turkey. Cordamed is located in Central Istanbul and extends its distribution network to throughout all of Turkey.
The company also announced that Istanbul has been designated as the site of the 5th International Conference of Cellvizio Users (ICCU 2013). ICCU 2013, which runs from April 6 to 7, 2013, will draw hundreds of the world’s top gastroenterologists, pulmonologists, urologists and surgeons who will share their knowledge and findings, develop up-to-date guidelines for endomicroscopy and discuss new indications.
About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. 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, 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 ducts and lungs.
For more information on Mauna Kea Technologies, visit www.maunakeatech.comCONTACT: United States Lazar Partners Ltd.
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