Mauna Kea Technologies Announces Enrollment Completion of Two Multi-Center International...

Mauna Kea Technologies Announces Enrollment Completion of Two Multi-Center
International GI Endoscopy Clinical Trials With Cellvizio

PARIS, Oct. 19, 2009 (GLOBE NEWSWIRE) -- Mauna Kea Technologies announced today
completion of enrollment for two company-sponsored multi-center international
gastrointestinal (GI) endoscopy clinical trials using the Cellvizio(R)
probe-based confocal laser endomicroscopy (pCLE) system. The "DONT BIOPCE study"
and the "Cellvizio ERCP registry" were designed to evaluate if Cellvizio could
improve diagnostic outcomes and biopsy efficiency in patients with Barrett's
esophagus and those with suspected bile or pancreatic duct cancer, respectively.
Both studies were initiated at the end of 2008 with groups of dedicated, world
renowned clinical investigators from the United States of America (USA), France
and Germany.

"This is a significant achievement and a fantastic clinical milestone for the
company," said Sacha Loiseau, President, CEO and Founder of Mauna Kea
Technologies. "We would like to thank all the physicians, study coordinators and
staff involved in these clinical trials. We met the company's timeline in the
set-up and execution of both studies, and are confident that the data generated
will help us build the path for Cellvizio's wider adoption and routine use in GI
endoscopy."

The "DONT BIOPCE" study (Detection of Neoplastic Tissue in Barrett's Esophagus
with In vivO Probe-based Confocal Endomicroscopy) was a diagnostic, cross-over,
double-blind randomized efficacy study focused on evaluating the diagnostic
accuracy of Cellvizio for Barrett's esophagus surveillance. This study was led
by principal investigator Prof. Prateek Sharma, M.D., from the Veterans Affairs
Hospital in Kansas City, MO, and included four additional sites: two more in the
USA, Mayo Clinic in Jacksonville, FL and Columbia-Presbyterian Hospital in New
York, NY, as well as, Klinikum Rechts der Isar in Munich, Germany and University
Hospital in Nantes, France. Over 100 patients were enrolled in the study. Follow
up in this study continues and the study will be closed out by the end of 2009.

The "Cellvizio ERCP registry" was an observational prospective study in which
data were collected from patients routinely undergoing Endoscopic Retrograde
Cholangio-Pancreatography (ERCP) imaging and tissue sampling procedures for
diagnosing pancreatic and bile duct cancers. A follow up phase of the trial is
now underway. Six hospitals participated in this study: University of Colorado
Hospital in Aurora, CO, with principal investigator Prof. Yang Chen, M.D.;
Klinikum Rechts der Isar in Munich, Germany; Institut Paoli-Calmettes in
Marseille, France; Beth Israel Deaconess in Boston, MA; University of Pittsburgh
Medical Center in Pittsburgh, PA and Columbia-Presbyterian Hospital in New York,
NY. A total of 130 patients were enrolled in the study. This study will be
closed out once the follow-up is complete, which is anticipated to be no later
than September 2010.

Preliminary data from both studies will be presented at the Gastro 2009
conference to be held in London from November 21-25, 2009. The principal
investigator of each study will present interim results based on a subset of
these data. Additional results from the studies are expected by the end of the
year.

About Mauna Kea Technologies and Cellvizio

Mauna Kea Technologies believes that in continuously pushing the limits of
observation of life and by helping physicians design new medical references and
guidelines, it can improve patient care and reduce healthcare costs. Its
flagship product, Cellvizio(R), is the world's smallest and most flexible
microscope and the first system designed to provide live, real-time images of
internal human tissues at the cellular level during endoscopic procedures. This
new, advanced imaging technique helps physicians more effectively assess the
tissues of interest and differentiate normal versus abnormal tissues that may be
indicative of cancer, so patients potentially can be treated earlier and may
undergo fewer biopsies. Physicians and thought leaders at more than 60 top
medical institutions around the world have completed over 3,000 of these
procedures an have published more than 25 peer-reviewed papers on the technology
in leading medical journals. Cellvizio has premarket notification 510(k)
clearance from the United States Food and Drug Administration and the European
CE-Mark for use in the gastrointestinal and pulmonary tracts. For more
information visit www.maunakeatech.com.

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CONTACT: Lazar Partners
Media Contact:
Erich Sandoval
805-667-8402
esandoval@lazarpartners.com