Mauna Kea Tech : ologies announces publication of consensus report based on clinical evidence on use of endomicroscopy in gastroenterology

 Consensus report based on opinions of 26 world-renowned gastroenterologists represents first set of clinical recommendations on use of pCLE in GI applications

PARIS, January 20, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced publication of the first consensus recommendations on the clinical use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications, by the peer-reviewed journal United European Gastroenterology. The recommendations were presented in an article entitled: "Use of probe-based confocal laser endomicroscopy (pCLE) in gastrointestinal applications: a consensus report based on clinical evidence", authored by 26 international experts in gastroenterology and confocal laser endomicroscopy.
This consensus report was developed in four steps using a modified Delphi process with consistent literature review for four clinical applications (Barrett's esophagus, biliary strictures, colorectal lesions, and inflammatory bowel disease), as well as for training and credentialing initiatives. Five group leaders, Dr. Ken Wang (Mayo Clinic), Dr. David Carr-Locke (Mount Sinai Beth Israel), Dr. Satish Singh (Boston University), Professor Helmut Neumann (University Hospital Erlangen), and Dr. Helga Bertani (Nuovo Ospedale Civile Modena), coordinated the development of the consensus recommendations on how and when pCLE should be used.
Among the consensus findings, the panel concluded that "probe-based confocal laser endomicroscopy is superior to white light endoscopy in identifying intestinal metaplasia" (agreement: 100%), or that "pCLE is more accurate than ERCP with brush cytology and/or forceps biopsy in determining malignant or benign strictures, using established criteria" (agreement: 87%).
Pr. Jean-Paul Galmiche, formerly chair of gastroenterology at University Hospital in Nantes, president of the French National Society for Gastroenterology, and V ice-President of the INSERM board, and corresponding author of this report, said, "Probe-based confocal laser endomicroscopy has taken a very important role in the evaluation of a growing number of gastrointestinal pathologies. In order to standardize its use around the world, it was necessary to start developing a first set of recommendations for some key indications of the technology. We believe that these evidence-based consensus positions provide strong additional support for expanded use of pCLE in GI applications. These statements could help with establishment of necessary guidelines and promise an improvement in the standardization of the pCLE practice ».
"This consensus report establishes important benchmarks for the standardization of the pCLE practice to support physicians in making clinical decisions." added Sacha Loiseau, founder and CEO of Mauna Kea Technologies "This outstanding work prefigures expanded adoption of the technology for a range of diseases that afflict a very significant number of patients worldwide."

To access the full list of consensus statements, follow this link: access the publication.

Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during sta ndard gastrointestinal and pulmonary endoscopy procedures. The company's flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large- scale, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan.

For further information on Mauna Kea Technologies, visit www.maunakeatech.com

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