Study from The Ohio State University Published in World Journal of Gastroenterology
Paris, July 12, 2017 – Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced the publication of a new study in the World Journal of Gastroenterology, a peer-reviewed journal focused on the field of gastroenterology and hepatology. The study, titled “In vivo and ex vivo confocal endomicroscopy of pancreatic cystic lesions: A prospective study,” further supports the application of endoscopic ultrasound (EUS) guided needle-based CLE (nCLE) as an imaging biomarker in the diagnosis of pancreatic cysts.
The study was led by Somashekar Krishna, MBBS, MPH, and researchers from the Division of Gastroenterology, Hepatology and Nutrition at the Wexner Medical Center at The Ohio State University in Columbus, OH. The study concluded that in vivo nCLE patterns are reproducible in ex vivo pCLE for all major neoplastic pancreatic cysts.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “This new peer-reviewed study led by Dr. Krishna provides further validation of the application of Cellvizio needle-based CLE in the diagnosis of pancreatic cysts. There is a significant opportunity for clinicians to use optical biopsy with Cellvizio in the often-challenging task of diagnosing pancreatic cysts, allowing them to make faster diagnoses and better treatment decisions to achieve better outcomes for their patients.”
These results are part of a growing body of clinical evidence supporting the use of Cellvizio in diagnosing pancreatic cysts, which is a well-known medical challenge. The growing body of clinical evidence includes the following recent presentations and publications:
• At the Digestive Disease Week (DDW) 2017 conference in May 2017, Dr. Bertrand Napoleon of the Hospital Jean Mermoz in Lyon, France, made two presentations on the use of nCLE for the diagnosis of pancreatic lesions.
• In March, data from the National French Registry on Cellvizio procedures, for which 30% of cases were in the diagnosis of pancreatic cysts, showed that Cellvizio allowed real-time diagnosis and impacted immediate therapeutic decision in 80% of the patients.
• A peer-reviewed study from the Wexner Medical Center team published in the March 2017 edition of Gastrointestinal Endoscopy demonstrated 95% accuracy of Cellvizio for malignant pancreatic cysts and 98% for benign pancreatic cysts, both with near-perfect inter-observer agreement and intra-observer reliability.
• In October 2016, Dr. Napoleon presented results from the CONTACT clinical study on the characterization of pancreatic cysts using Cellvizio at the United European Gastroenterology Week (UEGW) 2016 meeting. The sub-group analysis presented at UEGW showed 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 achieved specificity above 95% for diagnosis of all pancreatic cystic lesions.
• Additionally, one-third of all study data on CLE, approx. 900 publications, is related to pancreatic cysts.
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
