Participating centers include the Mayo Clinic in Jacksonville, FL; the University of Chicago Pritzker School of Medicine/University of Chicago Medical Center; University of Michigan Medical School/University of Michigan Medical Center; and Ohio State College of Medicine/Wexner Medical Center.
"Since receiving its CE mark and FDA clearance for probes used in digestive and pulmonary tracts in 2005, the company has focused its efforts on developing a strong foothold in the endoscopy market. The U.S. lung registry, our first, large multi-center study in pulmonology, will provide key performance data on the value of Cellvizio to separate out benign nodules from malignant nodules," said Sacha Loiseau, PhD, Founder and CEO of Mauna Kea Technologies.
To learn more, please visit http://www.clinicaltrials.gov/ct2/show/NCT01793246.
About Lung Cancer
According to the American Cancer Society, an estimated 228,190 people in the U.S. will be diagnosed with lung cancer in 2013 and that 159,480 men and women will die of the disease, making it the leading cause of cancer death in the U.S.
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
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in Mauna Kea Technologies ("the Company") in any country. This press release contains forward-looking statements that relate to the Company's objectives. Such forward-looking statements are based solely on the current expectations and assumptions of the Company's management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company's products, new products or technological developments introduced by competitors, and risks associated with managing growth. Unfavorable developments in connection with these and other risks and uncertainties described, in particular, in the Company's prospectus prepared in connection with its IPO and on which the French Autorité des marches financiers ("AMF") granted its visa number 11-236 on June 20, 2011, could cause the Company to fail to achieve the objectives expressed by the forward-looking statements above.
(i) Ricardi et al. (2008). Accuracy of CT-guided transthoracic needle biopsy of lung lesions: Results of 612 consecutive procedures. Journal of Clinical Oncology. Part I. Vol 25, No. 18S (June 20 Supplement), 2007: 18022
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Mauna Kea Technologies
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Investor Relations and Financial Communication
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