Mauna Kea Technologies Announces New Study Shows Optical Biopsy Is More Accurate Than Conventional Endoscopic Biopsy in

Mauna Kea Technologies Announces New Study Shows Optical Biopsy Is More 
Accurate Than Conventional Endoscopic Biopsy in Detecting
Stomach Cancer 
New Clinical Study Conducted in Korea Demonstrates That Cellvizio(R)
Optical Biopsies Improve the Standard of Care for the Diagnosis of
Stomach Cancers 
PARIS -- (Marketwire) -- 03/14/13 --  Mauna Kea Technologies (NYSE
Euronext: MKEA), leader in the optical biopsy market and developer of
Cellvizio(R), the fastest way to see cancer, reported a new study
showing that a Cellvizio optical biopsy can overcome the limitations
of standard tissue biopsies in accurately diagnosing cancerous
stomach tumors. The study was completed at the Soonchunhyang
University Hospital Gastrointestinal Cancer Center in Seoul, Korea.
The study findings(i) were published online in the March Issue of
Gastrointestinal Endoscopy.  
In Asia, stomach cancer is the second most prevalent kind of cancer
and the leading cause of cancer in men according to the World Health
Organization. An estimated 736,000 people die from stomach cancer
each year, making it the second largest cause of cancer death
"Histological examination of gastric lesions via forceps biopsy is
known to be of limited(iii) accuracy and does not fully portray the
severity and extent of a stomach lining lesion. Therefore, there is a
risk for missing carcinomas," said Joo Young Cho, M.D., Ph.D.,
Director of the Korea NOTES Research Group and Director of the
Gastrointestinal Cancer Center at Soonchunhyang University Hospital.
"Cellvizio optical biopsies offer a way for gastroenterologists to
accurately characterize many more spots in the stomach and get a more
comprehensive view of the patient's stomach tissue, in real time."  
Patients enrolled in the study underwent an optical biopsy prior to
endoscopic resection of the cancerous tissue in the stomach lining
previously diagnosed by endoscopic biopsy. The overall accuracy of
the optical biopsy diagnosis was compared with endoscopic resection. 
54 lesions consisting of three benign lesions, 19 pre-cancerous
lesions and 32 adenocarcinomas were imaged and resected. Optical
biopsies were found to have a higher overall rate of accuracy of
diagnosis for cancerous lesions than conventional biopsies. The
overall accuracy for the diagnosis of cancerous lesions in the
stomach lining was 91.7% for optical biopsies and 85.2% for
conventional biopsies. The combined accuracy of conventional
endoscopic biopsies and optical biopsies was 98.1%. 
The study also showed that optical biopsy findings are highly
reproducible between physicians, with excellent overall agreement
amongst physician observers for optical biopsies (kappa statistic
k=0.824) as compared to the conventional biopsy (k=0.617).  
"These results confirm the value of Cellvizio for stomach cancer and
show that optical biopsy is a reliable method that provides a better
diagnostic solution than the current standard of care. This is a very
exciting clinical development for the Asian market, where stomach
cancer is a highly pervasive disease," said Sacha Loiseau, CEO and
Founder of Mauna Kea Technologies. "We are continuing our efforts to
expand and deepen our footprint in the Asian market and expect
important studies like this to help facilitate utilization of optical
biopsies across the world's most populated continent." 
About Mauna Kea Technologies
 Mauna Kea Technologies is a global
medical device company dedicated to the advent of optical biopsy. The
company researches, develops and markets innovative tools to
visualize and detect cellular abnormalities during endoscopic
procedures. Its flagship product, Cellvizio(R), a probe-based
Confocal Laser Endomicroscopy (pCLE) system, provides physicians and
researchers high-resolution cellular views of tissue inside the body.
Large, international, multicenter clinical trials have demonstrated
Cellvizio's ability to help physicians more accurately detect early
forms of disease and make treatment decisions immediately. Designed
to improve patient outcomes and reduce costs within a hospital,
Cellvizio can be used with almost any endoscope. Cellvizio has 510(k)
clearance from the U.S. Food and Drug Administration and the European
CE-Mark for use in the GI tract, biliary and pancreatic ducts and
For more information on Mauna Kea Technologies, visit  
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(i) Hyun Bok, G et al. (2013) The accuracy of probe-based confocal
endomicroscopy versus conventional endoscopic biopsies for the
diagnosis of superficial gastric neoplasia. Gastrointestinal
Endoscopy. Published online 08 March 2013. 
(ii) GLOBOCAN 2008 (IARC) Section of Cancer Information (22/1/2013) 
(iii) Park, JS. (2013) Early-stage gastric cancers represented as
dysplasia in a previous forceps biopsy: the importance of clinical
management. Digestive Liver Disease. 2013 Feb;45(2):170-5. doi:
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Tel: +33 (0) 1 70 08 09 92 
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