MAUNA KEA TECHNOLOGIES (EPA:MKEA) MAUNA KEA TECHNOLOGIES ANNOUNCES FIVE NEW PUBLICATIONS SUPPORTING USE OF CELLVIZIO® IN THE GI TRACT AND IN NEW INDICATIONS INCLUDING UROLOGY, PULMONARY MEDICINE AND PANCREATIC CANCER
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Press release
MAUNA KEA TECHNOLOGIES ANNOUNCES FIVE NEW PUBLICATIONS SUPPORTING USE OF
CELLVIZIO(r) IN THE GI TRACT AND IN NEW INDICATIONS INCLUDING UROLOGY,
PULMONARY MEDICINE AND PANCREATIC CANCER
Probe-based Confocal Laser Endomicroscopy (pCLE) system has potential to speed
and direct treatment decisions by enabling real-time cancer detection and
disease characterization
PARIS, July 26, 2011 - Mauna Kea Technologies (NYSE EuroNext: MKEA), the leader
in the endomicroscopy market, announced today that leading journals have
recently-published four clinical studies and one preclinical paper supporting
the use of Cellvizio probe-based Confocal Laser Endomicroscopy (pCLE) as an
imaging tool to help physicians immediately confirm or rule out cancer or other
diseases throughout the body so they can make targeted, informed treatment
decisions in real time.
Final results of an international multicenter, prospective, randomized,
controlled study, "Real-time increased detection of neoplastic tissue in
Barrett's esophagus with probe-based confocal laser endomicroscopy," were
published in the Gastrointestinal Endoscopy (GIE) journal. The results confirm
Cellvizio's utility as a tool to help gastroenterologists more accurately
detect and rule out conditions leading to esophageal cancer compared to the
most widely used endoscopic imaging techniques alone.
"The Barrett's Esophagus study results demonstrate that probe-based
endomicroscopy (pCLE; Cellvizio) can make surveillance endoscopy procedures in
patients with Barrett's esophagus more efficient and lead to more informed,
real-time patient management decisions, including immediate treatment," said
lead investigator Prof. Prateek Sharma, M.D., Professor of Medicine, University
of Kansas School of Medicine, Kansas City, USA.
Barrett's esophagus is a condition that can develop in patients with advanced
gastroesophageal reflux disease (GERD) or "heartburn" and has to be monitored
carefully because it can lead to esophageal cancer. The other four clinical and
pre-clinical publications show the potential of the system as a real-time
diagnostic tool in newer indications including urology, pulmonary medicine and
pancreatic cancer (see details about other published studies below).
"The growing body of clinical data confirms that endomicroscopy with Cellvizio
helps gastroenterologists confirm and rule out digestive disease in real time
so they can make immediate, targeted treatment decisions for their patients,"
said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "We're
incredibly pleased to see similar trends within urology and pulmonary medicine,
as well as ground-breaking pre-clinical results in pancreatic cancer. Based on
the findings from these studies, we are working with leaders in each respective
specialty to determine the best path forward and the scope and design of future
clinical developments."
Details about other published studies
Urology
A study underscoring pCLE's potential as a tool to help urologists more
effectively and efficiently detect cancer within the urinary tract appears in
the July 2011 issue of Urology.
Urologists currently use white light cytoscopes to evaluate the urinary tract
and then take tissue samples from the patient and send them for pathological
analysis to determine if the patient has cancer. It can take up to a week to
receive the pathology results. Importantly, when white light cytoscopes are
used alone, it is very difficult for physicians to differentiate flat cancerous
tumors from benign inflammation or to see the borders of those cancerous
tumors, so cancer can be missed.
"In contrast, this study shows that pCLE provides real time, cellular-level
views of the lower urinary tract, enabling us to potentially differentiate
cancer from inflammation during the examination," said Joseph C. Liao, MD,
Assistant Professor, Urology, Stanford School of Medicine, and the senior
author of both urology papers. "Now that we have identified the key features of
malignant and benign urinary tract tissue in Cellvizio images, we expect wider
adoption of pCLE as a tool to expedite diagnosis of bladder cancer and other
urinary tract diseases."
In a separate study that appears in the June 2011 issue of the Journal of
Endourology, Dr. Liao and his colleagues evaluated which confocal miniprobe is
best suited for urinary tract imaging.
Pulmonary Medicine
The asthma study, which appears in the June 2011 issue of Respiratory Research,
Prof. Peter Kunst and colleagues from the Department of Pulmonology, Academic
Medical Center, Amsterdam conclude that pCLE might become a real-time imaging
tool to estimate the type and degree of airway remodeling in asthma patients.
Airway remodeling can occur if an asthma patient's airways remain swollen over
long periods of time and can cause structural changes in the lungs that may
lead to a loss of airway function over time.
Pancreatic Cancer
A separate pre-clinical study showing Cellvizio's potential as a tool to
improve early detection of pancreatic cancer, the most common and deadly form
of pancreatic cancer, appears in the June 14, 2011 edition of Proceedings of
the National Academy of Sciences of the United States of America. Pancreatic
cancer is associated with extremely high mortality, often resulting from late
diagnosis when the cancer has already advanced. Currently, methods to diagnose
early-stage pancreatic cancer are limited and not available inside the body.
Dieter Saur of Medizinische Klinik, Technische Universität München, in Munich,
Germany and his colleagues concluded that when translated to the clinic, pCLE
has the potential to improve detection of precancerous pancreatic tissue and
change how physicians manage patients who are at risk for pancreatic cancer.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company and leader in the
endomicroscopy market. The company researches, develops and markets innovative
tools to visualize and detect abnormalities in the gastro-intestinal and
pulmonary tracts. 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,
multi-center 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 and pulmonary tracts.
For more information about Mauna Kea Technologies visit www.maunakeatech.com
Next press release : mid-year results 2011: 31 August 2011
Contacts:
U.S. Media French/European Media
Lazar Partners Ltd. ALIZE RP
Erich Sandoval Caroline Carmagnol
Tel: +1 917 497 2867 + 33 1 42 68 86 43 // + 33 6 64 18 99 59
E-mail: esandoval@lazarpartners.com caroline@alizerp.com
Anne -Sophie Cosquéric
Mauna Kea Technologies + 33 1 42 68 86 41
Alexander Bryson Anne-sophie@alizerp.com
Marketing Communications and
Brand Manager
Tel: +33 (0) 1 70 08 09 92
E-mail: alexander@maunakeatech.com