Regulatory Filings • Feb 25, 2016
Regulatory Filings
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PARIS, February 25,2016 /PRNewswire/ --
- New milestone into clinical evidence of needle-based endomicroscopy (nCLE) for the characterization of pancreatic cysts
- New Appraising Reviews published on nCLE
Mauna Kea Technologies (Euronext: MKEA, FR0010609263; OTCQX: MKEAY), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced that the enrollment phase in the clinical study CONTACT II has been completed on time with more than 200 patients.
"We are very pleased with this important milestone of our CONTACT studies. Six French sites with different experience-level with this unique technology have contributed to reach our sample population last month. The next steps will be to follow the patients post-procedure to validate on a longer term the diagnosis of each patient. We are looking forward to communicating soon our preliminary findings in upcoming scientific conferences", said Doctor Bertrand Napoleon, Hospital Jean Mermoz, Lyon, France.
Concomitantly, multiple general clinical reviews have been published on CLE in two peer-reviewed journals: the World Journal of Gastrointestinal Endoscopy and the Romanian Journal of Morphology and Embryology. In the first of these papers, Doctor Krishna, Ohio State University, Columbus, Ohio and Doctor Lee, MD Anderson Cancer Center, Houston, Texas, conclude after their appraisal of needle-based confocal laser endomicroscopy in the diagnosis of pancreatic cysts that "Endoscopic Ultrasound-guided nCLE appears to be a convincing minimally invasive process to diagnose and risk stratify pancreatic cystic lesions."
In addition, new evidence on the nCLE application to pancreatic cysts are still expected to strengthen the technology, as Dr Saftoiu, UMCP Craiova, Romania, concludes that "nCLE appears to be a new imaging technique that promises to improve EUS-FNA diagnostic accuracy."
"We are quite confident that the conclusions of this milestone trial will address key clinical questions and will continue to establish nCLE as a necessary step in the management of patients with pancreatic cysts, thus reducing significantly the amount of unnecessary repeat procedures and surgeries. In addition, health-economics studies based on these results and exemplifying the strong economic benefits for healthcare systems of wide-spread use of nCLE are pending publications. We look forward to the day when no patient with asymptomatic benign pancreatic cysts will undergo unnecessary surgery, as it is the case today for 40% of them", said Sacha Loiseau, Founder and CEO of Mauna Kea Technologies.
Publication references:
Appraisal of needle-based confocal laser endomicroscopy in the diagnosis of pancreatic cysts. Krishna SG, Lee JH. World J Gastroenterol. 2016 Jan 28; 22(4):1701-10
Needle-based confocal laser endomicroscopy in pancreatic cystic tumors assessment. Ştefănescu D, Pereira SP, Keane M, Săftoiu A. Rom J Morphol Embryol. 2015; 56(4):1263-8.
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 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
Mauna Kea Technologies
Investors relations US
Sebastien Cadet
Global Marketing Director
France and Europe
NewCap - Investor Relations | Strategic
Communication
Florent Alba/Pierre Laurent
Tel: +33 (0)1 44 71 94 94
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