Mauna Kea Technologies Receives Regulatory Clearance for Cellvizio(R) 100 Series in Brazil
Latest Generation Version of World's Smallest Microscope Is Approved for Use in Brazil, South America's Largest Medical Device Market
(firmenpresse) - PARIS -- (Marketwire) -- 06/12/12 -- Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market, announced that ANVISA, the National Health Surveillance Agency in Brazil, has cleared the company to sell its Cellvizio® 100 Series endomicroscopic imaging system throughout the country, which represents South America's largest medical device market.
"Regulatory approval in the fast-growing Brazilian medical device market greatly extends the Cellvizio portfolio and offers gastroenterologists and pulmonologists additional options when choosing advanced imaging technologies for patients with suspected digestive and respiratory disease," said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "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."
The company has a distribution relationship in place and will launch the Cellvizio 100 Series in Brazil shortly.
Cellvizio provides physicians with real-time microscopic images of tissue inside the body during GI and pulmonology procedures. During 2011 alone, 50 peer-reviewed scientific articles were published on the technology, underscoring the value of adding cellular-level imaging to standard endoscopy procedures. These data show that the cellular level views that Cellvizio provides in real time help physicians make more informed assessments and treatment decisions for their patients suffering from conditions including Barrett's Esophagus, bilio-pancreatic strictures and colorectal lesions. Studies also show that having cellular-level information at the bedside also can help physicians more confidently rule out disease, allowing some patients to avoid unnecessary procedures and surgeries.
The Brazilian market accounts for approximately $5 billion in annual medical equipment sales and is expected to grow over 10% annually, according to the U.S. Department of Commerce (DOC) and International Trade Administration.
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 and pulmonary tracts.
For more information on Mauna Kea Technologies, visit
Erich Sandoval
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Tel: +33 (0) 1 70 08 09 92
Caroline Carmagnol
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Tel : +33 1 44 71 94 94
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Datum: 12.06.2012 - 00:00 Uhr
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