MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES ANNOUNCES PUBLICATION OF CONSENSUS REPORT BASED ON CLINICAL EVIDENCE ON USE OF CONFOCAL LASER ENDOMICROSCOPY IN GASTROENTEROLOGY

Transparency directive : regulatory news

20/01/2015 17:45

PRESS RELEASE

   MAUNA KEA TECHNOLOGIES ANNOUNCES PUBLICATION OF CONSENSUS REPORT BASED ON
CLINICAL EVIDENCE ON USE OF CONFOCAL LASER 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(r), 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 Vice-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.

About Mauna Kea Technologies

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 standard gastrointestinal and pulmonary endoscopy procedures. The
company's flagship product, Cellvizio(r), 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

NewCap
Europe - Investor Relations
Florent Alba
Tel.: +33 (0)1 44 71 94 94
maunakea@newcap.fr

Westwicke Partners
United States - Investor Relations
Mark Klausner
Tel.: +1 (443) 213-0500
maunakea@westwicke.com

MAUNA KEA TECHNOLOGIES's latest news

25/04/2024 20:50

MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES ANNOUNCES PUBLICATION OF CONSENSUS REPORT BASED ON CLINICAL EVIDENCE ON USE OF CONFOCAL LASER ENDOMICROSCOPY IN GASTROENTEROLOGY

Transparency directive : regulatory news

MAUNA KEA TECHNOLOGIES's latest news

Other stories