MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES ANNOUNCES POSITIVE RESULTS FROM FOCUS PIVOTAL CLINICAL TRIAL ON USE OF CONFOCAL LASER ENDOMICROSCOPY IN BILIARY CANCER DETECTION

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27/01/2015 17:45

PRESS RELEASE

MAUNA KEA TECHNOLOGIES ANNOUNCES POSITIVE RESULTS FROM FOCUS PIVOTAL CLINICAL
  TRIAL ON USE OF CONFOCAL LASER ENDOMICROSCOPY IN BILIARY CANCER DETECTION

     Results published in peer-reviewed journal Gastrointestinal Endoscopy
   accompanied by editorial noting that the study "pushes the boundaries of
               diagnosis in indeterminate biliary strictures"

    Study results support the use of endomicroscopy with Cellvizio for the
                evaluation of indeterminate biliary strictures

PARIS, January 27, 2015 - Mauna Kea Technologies (Euronext: MKEA, FR0010609263),
inventor of Cellvizio(r), the multidisciplinary confocal laser endomicroscopy
platform, today announced publication of the final results of the multi-center
international prospective FOCUS clinical trial assessing the use of probe-based
confocal laser endomicroscopy (pCLE) in the diagnosis of biliary cancer during
endoscopic retrograde cholangio-pancreatography (ERCP).

In the FOCUS study a total of 112 patients with indeterminate biliary strictures
were treated in six centers around the world. Results were published in the
peer-reviewed journal Gastrointestinal Endoscopy, the official journal of the
American Society of Gastrointestinal Endoscopy (ASGE).

Adam Slivka, M.D., Professor of Medicine and Associate Chief, Division of
Gastroenterology, Hepatology & Nutrition at University of Pittsburgh Medical
Center, and principal investigator of the FOCUS study, said: "This important
study prospectively and statistically confirms the superiority of pCLE-enhanced
ERCP over traditional ERCP. This provides strong support for pCLE to be added to
the armamentarium of therapeutic endoscopists when performing ERCP and
evaluating patients with indeterminate biliary strictures."

The FOCUS trial evaluated the diagnostic performance of pCLE with Cellvizio for
the characterization of biliary strictures and thus for the presence of biliary
cancer (cholangiocarcinoma). Results show a very significant improvement in the
sensitivity of detection of cholangiocarcinoma, from 56% for biopsies to 89% for
pCLE.

Among the 112 patients enrolled in this study, pCLE correctly diagnosed 88% of
patients (Accuracy: 88%, Sensitivity: 89%, Specificity: 88%, Positive Predictive
Value: 93%, Negative Predictive Value: 82%) when combined with ERCP.

Importantly, tissue sampling (traditional biopsies) was inconclusive for a
majority of patients (70 out of 112) while pCLE was inconclusive for only 16
patients, thus helping physicians to correctly identify the condition of 54 of
the patients in this indeterminate group. Within this group, pCLE helped
identify cancer earlier than traditional methods in 24 patients and correctly
ruled out cancer in 30 patients with benign strictures.

The information provided by Cellvizio enabled endoscopists to improve patient
care by avoiding unnecessary invasive and costly surgical procedures as well as
repeat diagnostic procedures. Studies have shown that up to 50 % of patients
with indeterminate traditional biopsies undergo invasive bilio-pancreatic
surgeries, reducing their long-term survival rates and creating significant
unnecessary costs for the healthcare systems.

Sacha Loiseau, CEO and Founder of Mauna Kea Technologies, added: "These landmark
clinical trial results provide strong additional validation of the benefits of
using Cellvizio when performing interventional procedures in the biliary tree.
With the Cellvizio technology, physicians are much more likely to get a
confirmed diagnosis the first time, avoiding repeat procedures, delays and costs
in providing appropriate treatment to patients suffering from bilio-pancreatic
lesions such as pancreatic cysts and biliary strictures. With these additional
results and recommendations, endomicroscopy with Cellvizio is rapidly becoming a
must-have for interventional endoscopists performing these procedures."

A video of Dr Slivka discussing the FOCUS results is available on the GIE
journal website: http://www.giejournal.org/content/video_interviews

About biliary strictures and cholangiocarcinoma

Biliary strictures is a condition affecting more than 50,000 people in the
United States every year and can be linked to cholangiocarcinoma, an aggressive
form of cancer. Although uncommon, this form of biliary cancer is devastating
and notoriously difficult to diagnose using standard of care involving
multimodality imaging exams and tissue sampling. Procedures involving tissue
sampling in the area can create severe complications and have a low diagnostic
sensitivity (<50%) for the detection of cholangiocarcinoma. As a result, many
patients must undergo multiple procedures before reaching a definitive
diagnosis, often resulting in inappropriate or delayed intervention.

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                                 Westwicke Partners
Europe - Investor Relations            US - Investor Relations
Florent Alba                           Mark Klausner
Tel: +33 (0) 1 44 71 94 94             Tel : +1 (443) 213-0500
maunakea@newcap.fr                     maunakea@westwicke.com

Berry & Company Public Relations
US - Public Relations
Bill Berry
Tel: +1 212 253 8881
bberry@berrypr.com

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