Leading U.S. Pulmonologists to Investigate Impact of Mauna Kea Technologies' Cellvizio on Lung Cancer Diagnosis

Leading U.S. Pulmonologists to Investigate Impact of Mauna Kea Technologies' 
Cellvizio on Lung Cancer Diagnosis 
Optical Biopsies of Lung Tissue Expected to Improve Accuracy of
Bronchoscopy Procedures, Reducing the Need to Repeat Invasive,
Expensive Diagnostic Tests for Lung Cancer 
PARIS -- (Marketwire) -- 03/21/13 --  Mauna Kea Technologies (NYSE
Euronext: MKEA), leader in the optical biopsy market and developer of
Cellvizio(R), the fastest way to see cancer, announced today that it
has launched a registry study to determine the impact of Cellvizio
optical biopsies on the diagnosis of lung cancer, the leading cause
of cancer death in the world. Previous studies have shown that
Cellvizio's real-time, cellular-level views of distal lung tissue
extend the reach and improve the diagnostic accuracy of bronchoscopy
procedures, reducing the need to repeat invasive, expensive
diagnostic tests. 
The registry will include 200 patients enrolled at up to ten leading
U.S. lung centers. 
"Data from the recently-published National Lung Screening Trial
(NLST) suggest that lung cancer screening with low-dose CT chest
scans in long-term smokers leads to early detection and improved
survival. However, the very high false positive rate associated with
CT scans often results in additional diagnostic procedures to
evaluate a lesion," said Sandhya Khurana, MD, Associate Professor of
Medicine, Pulmonary Diseases, and Critical Care at the University of
Rochester Medical Center (URMC). Dr. Khurana is one of the Principal
Investigators of the Cellvizio U.S. lung registry. "Our goal is to
accurately diagnose these lesions by using the least invasive, lowest
risk and highest-yield tests."  
According to the NLST, a study sponsored by the National Institutes
of Health and originally published in the New England Journal of
Medicine, 96.4 percent of CT scans generated false positives for lung
cancer. Based on a recent analysis of the data, 24 out of every 100
patients screened will have lesions and only one of the 24 will
eventually be diagnosed with lung cancer. Getting to a final
diagnosis can be quite taxing on patients because of the limitations
of traditional bronchoscopes and tissue biopsy techniques. Recent
studies have found that 31% of lung lesion biopsies need to be
repeated(i) due to radiologists and pathologists requesting
additional information. 
"Cellvizio offers a potential new way for pulmonologists to achieve
accurate real-time characterization of tissue as benign or malignant,
particularly in areas of the lung not directly accessible to the
bronchoscope," Dr. Khurana said. "Using a navigational bronchoscopy
system to guide physicians to the suspicious lesions could further
enhance diagnostic accuracy of optical biopsies and decrease the need
for additional invasive diagnostic procedures. We are excited to be a
part of this important trial."  
Dr. Khurana and Dr. Michael Nead, study co-investigator, enrolled the
first Cellvizio lung registry patient at URMC earlier this month. 
The U.S. lung registry study is a prospective observational study
which will aim to refine the criteria to differentiate healthy versus
diseased tissue in patients with discrete lung lesions. Once these
criteria have been refined, the diagnostic parameters and the
reproducibility of optical biopsies will be assessed. Investigators
will also use the registry to characterize acute lung rejection in
patients with transplanted lungs. The Food and Drug
Administration-cleared AlveoFlex(TM) probe is 1.4 mm in diameter and
works with a standard bronchoscope.  
Participating centers include the Mayo Clinic in Jacksonville, FL;
the University of Chicago Pritzker School of Medicine/University of
Chicago Medical Center; University of Michigan Medical
School/University of Michigan Medical Center; and Ohio State College
of Medicine/Wexner Medical Center. 
"Since receiving its CE mark and FDA clearance for probes used in
digestive and pulmonary tracts in 2005, the company has focused its
efforts on developing a strong foothold in the endoscopy market. The
U.S. lung registry, our first, large multi-center study in
pulmonology, will provide key performance data on the value of
Cellvizio to separate out benign nodules from malignant nodules,"
said Sacha Loiseau, PhD, Founder and CEO of Mauna Kea Technologies. 
To learn more, please visit
About Lung Cancer 
According to the American Cancer Society, an estimated 228,190 people
in the U.S. will be diagnosed with lung cancer in 2013 and that
159,480 men and women will die of the disease, making it the leading
cause of cancer death in the U.S.  
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 lungs. 
For more information on Mauna Kea Technologies, visit
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(i) Ricardi et al. (2008). Accuracy of CT-guided transthoracic needle
biopsy of lung lesions: Results of 612 consecutive procedures.
Journal of Clinical Oncology. Part I. Vol 25, No. 18S (June 20
Supplement), 2007: 18022 
United States
Erich Sandoval
Tel: +1 917 497 2867
Mauna Kea Technologies
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