PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Euronext:MKEA, OTCQX:MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced positive results from the CONTACT clinical study on the characterization of pancreatic cysts using Cellvizio confocal laser endomicroscopy were presented at the United European Gastroenterology Week (UEGW) 2016 meeting, which took place October 15-19 in Vienna, Austria. Dr. Bertrand Napoleon of the Hospital Jean Mermoz in Lyon, France presented today the first results from the CONTACT Study in an oral presentation titled “Needle based confocal endomicroscopy (nCLE) for the diagnosis of solitary pancreatic cysts. A prospective multi-center study.”
The CONTACT study enrolled 217 patients at 5 hospitals and clinics in France. These results presented by Dr. Napoleon validate and improve previously published performance of nCLE (CONTACT I Pilot Study, DETECT, INSPECT) in diagnosing pancreatic cystic lesions. In this sub-group of 78 patients with a confirmed diagnosis via surgery or histological assessment, Cellvizio optical biopsy provided 95% sensitivity and 100% test specificity for diagnosis of serous cyst adenomas (benign cystic lesions that require no surgery or surveillance). The results also demonstrate 95% sensitivity for high potential degenerating lesions (mucinous lesions, neuroendocrine tumors), with 100% specificity for certain types of tumors. Overall, Cellvizio achieves specificity above 95% for diagnosis of all pancreatic cystic lesions.
Dr. Napoleon, said, “Given the clinical results already published, the use of needle-based endomicroscopy should be considered for inclusion in the guidelines of pancreatic cyst diagnosis. This patient subset from the CONTACT study confirms the excellent results from the CONTACT I pilot study, as well as several other trials conducted in the USA. The ability of nCLE to provide precise and specific identification of benign and malignant tumors is a significant breakthrough that will save patients from unnecessary procedures and allow practitioners to make highly informed treatment decisions.”
“The characterization of pancreatic cysts remains a well-known medical challenge around the world. The very positive results presented today confirm the value of our technology in the field of pancreatic cancer prevention and will help the growing number of sites utilizing Cellvizio make better decisions for their patients who present with pancreatic lesions”, said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies. “These very positive results, which come on the heels of the American Society of General Surgeons’ endorsement of Cellvizio for Barrett’s Esophagus and Gastroesophageal Reflux Disease (GERD), further highlight the value and utility of Cellvizio.”
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico.
For more information on Mauna Kea Technologies, visit www.maunakeatech.com
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