MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES: EDITORIAL HIGHLIGHTING ADVANTAGES OF NEEDLE-BASED ENDOMICROSCOPY FOR CHARACTERIZATION OF PANCREATIC CYSTS PUBLISHED IN ENDOSCOPY

Transparency directive : regulatory news

14/01/2015 18:00

PRESS RELEASE

      EDITORIAL HIGHLIGHTING ADVANTAGES OF NEEDLE-BASED ENDOMICROSCOPY FOR
           CHARACTERIZATION OF PANCREATIC CYSTS PUBLISHED IN ENDOSCOPY

* Editorial accompanies publication of CONTACT 1-study results showing that
needle-based confocal laser endomicroscopy with Cellvizio able to confirm benign
serous cystadenomas with 100%-specificity.

* Mauna Kea Technologies, inventor of Cellvizio, on track to complete enrollment
in 200-patient CONTACT 2 Study on use of nCLE in diagnosis of pancreatic cysts.

PARIS, January 14, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced that the peer-reviewed journal Endoscopy has published
an editorial in the print edition highlighting the advantages of needle-based
confocal laser endomicroscopy (nCLE) for characterization of pancreatic cysts.
The editorial accompanies publication of results of the CONTACT 1 prospective
multicenter study showing that optical  biopsy procedures performed with
Cellvizio were able to confirm the nature of benign pancreatic cysts in 100% of
patients where a superficial vascular network was observed.

"Using Cellvizio, doctors were able to confirm that pancreatic cysts are benign
based on observation of a superficial vascular network that is visible for the
first time ever by using our Cellvizio nCLE technology," said Sacha Loiseau, CEO
and founder of Mauna Kea Technologies, adding, "we are very pleased that the
journal Endoscopy chose to single out our landmark technology with an editorial.
The use of Cellvizio has the potential to significantly improve the ability to
confirm that cysts are benign and help thousands of patients avoid unnecessary
and often risky surgical interventions."

The editorial, authored by Marco J. Bruno, MD, PhD, Department of
Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The
Netherlands, highlights many key points supporting the use of nCLE in
characterization of pancreatic cysts. In terms of specificity and positive
predictive value, the author concludes that results using nCLE "match or
outweigh other available diagnostic modalities, including morphology (computed
tomography, magnetic resonance imaging - magnetic resonance
cholangiopancreatography, EUS), cyst fluid analysis, and EUS-guided pathology."
The paper also confirms that EUS-guided nCLE can be executed quickly and
provides instant results.

The editorial goes on to note that CLE could have applications beyond cyst
differentiation, including diagnosis of pancreatic ductal adenocarcinoma and
pancreatic intraepithelial neoplasia.

"The findings from the CONTACT 1 study provide strong additional evidence for
continuing clinical investigations involving Cellvizio in the diagnosis of
pancreatic cysts and in other applications. Mauna Kea Technologies remains on
track to complete enrollment in its sponsored-study CONTACT 2, a large-scale
trial that will assess the use of Cellvizio in 200 patients. We look forward to
providing an update on our progress with this important trial in the near
future," Sacha Loiseau added.

The CONTACT 1 study included 31 patients and focused on the diagnosis of
solitary pancreatic cystic lesions using nCLE. Among patients in the study, the
presence of a specific superficial vascular network shown to be typical and
highly characteristic of serous cystadenoma, a benign form of pancreatic cysts
was described. Using this sign, experts were able to differentiate the benign
form of pancreatic cysts with a sensitivity of 69% and a specificity of 100%.

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: EDITORIAL HIGHLIGHTING ADVANTAGES OF NEEDLE-BASED ENDOMICROSCOPY FOR CHARACTERIZATION OF PANCREATIC CYSTS PUBLISHED IN ENDOSCOPY

Transparency directive : regulatory news

MAUNA KEA TECHNOLOGIES's latest news

Other stories