Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (NYSE Euronext: MKEA, FR0010609263), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that results from a total of 43 research studies involving the use of Cellvizio probe-based Confocal Laser Endomicroscopy (pCLE) were presented at Digestive Disease Week (DDW). The range of research data presented demonstrates Cellvizio’s utility across the digestive tract. Ten abstracts alone will highlight the role of needle-based confocal laser endomicroscopy (nCLE) for the characterization of pancreatic cysts, masses and lymph nodes. Newly compiled Smart Atlases, computer-aided software based image recognition, were presented showing applications of the technology in pancreatic cyst, biliary structure, and gastric lesion indications. For the first time, consensus statements on the use of optical biopsy for the management of Barrett’s esophagus patients and biliary strictures, as well as on the standardization of training programs in pCLE will be reported. DDW 2014 runs from May 3-6, 2014 in Chicago.
In addition to presentation of research results during DDW, Vani Konda (MD, University of Chicago Medical Center) has conducted a full-day hands-on course on Cellvizio with pathologist John Hart (MD, University of Chicago Medical Center) at the Center of Care and Discovery on the University of Chicago campus on Friday, May 2nd. The program will include observation of live cases and review of case series ranging from evaluation of Barrett’s Esophagus using Cellvizio to the use of needle-based optical biopsy (nCLE) in EUS-FNA to diagnose pancreatic cysts. Demonstrations of the Cellvizio system and image interpretation also took place at the American Society for Gastrointestinal Endoscopy (ASGE) Learning Center.
The schedule of Cellvizio optical biopsy presentations and events at DDW 2014 can be downloaded here.
About Digestive Disease Week® (DDW®)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 3rd–6th, 2014, at McCormick Place Exhibition Center, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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, 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 duct, lungs, and during fine needle aspiration procedures. Cellvizio has also been cleared by SFDA in China and MHLW in Japan for use in the GI, respiratory and urinary tract.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com
Contacts
Jen Ringler, Tel: +1 212 253 8881
jringler@berrypr.com
or
Mauna Kea Technologies
Eric Cohen, Tel: + 33 1 70 08 09 86
Vice President, Finance
investor-vpf@maunakeatech.com
or
France and Europe
NewCap.
Investor Relations and Financial Communication
Pierre Laurent / Florent Alba
Tel: +33(0)1 44 71 94 94
maunakea@newcap.fr
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