From the Wires
Mauna Kea Technologies Reports First Cellvizio(R) System Sales in Japan and New Clinical Research on Digestive Cancers and Disorders
Two Leading Japanese Physicians Acquire Cellvizio Systems to Gain New Understanding of Stomach Cancer and Functional Gastrointestinal Diseases; Their Clinical Research Could Lead to New Clinical Data, Demonstrating That Cellvizio Can Help Speed Diagnosis
By: Marketwired .
Jan. 30, 2013 01:30 AM
PARIS -- (Marketwire) -- 01/30/13 -- Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, reported its first Cellvizio system sales in Japan, the world's second largest healthcare market.
Physicians at prestigious Schools of Medicine in Japan, including the Hirosaki University Graduate School of Medicine in Aomori, have acquired Cellvizio systems to gain new understanding of stomach, pancreatic and esophageal cancers, as well as common functional gastrointestinal and motility disorders such as irritable bowel syndrome (IBS), gastro-esophageal reflux disease (GERD) and chronic constipation. Stomach cancer is second most prevalent kind of cancer in Asia and the leading cause of cancer in men in the region, according to the World Health Organization. An estimated 736,000 people die from stomach cancer each year, making it the second leading cause of cancer death worldwide.(i)
"Japan is the world's second largest healthcare market and the most advanced endoscopy market. These two installations at leading Japanese institutions represent a significant milestone for the company," said Sacha Loiseau, PhD, CEO of Mauna Kea Technologies. "The clinical research that will come out of them will play an important role in the development of new clinical data showing that optical biopsies can help speed the diagnosis and treatment of digestive diseases that are particularly prevalent throughout Japan and the rest of Asia. We are currently in the process of filing for regulatory approval of Cellvizio in Japan which, once obtained, will allow us to significantly broaden our footprint in the Asia Pacific region where we already have 38 Cellvizio systems installed."
Cellvizio was recently used for the first time in Japan, in collaboration with German physicians, to directly view the enteric nervous system of the digestive tract during an endoscopic procedure. Their early findings, which open the door to using optical biopsies as a tool to improve how physicians diagnose and treat functional GI and motility disorders, were recently published online in the medical journal, Gastroenterology, the leading journal in the digestive field.(ii)
Kenichi Hakamada, Professor and Chairman of the Department of Gastroenterological Surgery at Hirosaki University Graduate School of Medicine, will use Cellvizio to visualize cellular structures of various digestive cancers.
Independent clinical studies utilizing optical biopsies with Cellvizio will be launched during the second quarter of 2013. Both physicians acquired their Cellvizio systems after obtaining a "Yakkan Shoumei" import certificate that allows physicians to import unapproved medical devices into the country. They will both participate in the International Conference of Cellvizio Users (ICCU) in April 2013 in Istanbul in order to share their findings with the optical biopsy community.
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) GLOBOCAN 2008 (IARC) Section of Cancer Information (22/1/2013)
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