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

  Leading U.S. Pulmonogists 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

Business Wire

PARIS -- March 21, 2013

Regulatory News:

Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the optical biopsy
market and developer of Cellvizio®, 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

“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^1 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™ probe is 1.4 mm in diameter and works with a
standard bronchoscope.

Other 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

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

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®, 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 www.maunakeatech.com


This press release and the information contained herein do not constitute an
offer to sell or subscribe to, or a solicitation of an offer to buy or
subscribe to, shares in Mauna Kea Technologies ("the Company") in any country.
This press release contains forward-looking statements that relate to the
Company’s objectives. Such forward-looking statements are based solely on the
current expectations and assumptions of the Company’s management and involve
risk and uncertainties. Potential risks and uncertainties include, without
limitation, whether the Company will be successful in implementing its
strategies, whether there will be continued growth in the relevant market and
demand for the Company’s products, new products or technological developments
introduced by competitors, and risks associated with managing growth.
Unfavorable developments in connection with these and other risks and
uncertainties described, in particular, in the Company’s prospectus prepared
in connection with its IPO and on which the French Autorité des marches
financiers (“AMF”) granted its visa number 11-236 on June 230, 2011, could
cause the Company to fail to achieve the objectives expressed by the
forward-looking statements above.

^1 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, +1 917 497 2867
Mauna Kea Technologies
Eric Cohen, + 33 1 70 08 09 86
Vice President, Finance
France and Europe
Investor Relations and Financial Communication
Pierre Laurent / Florent Alba, +33(0)1 44 71 94 94
Press spacebar to pause and continue. Press esc to stop.