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Mauna Kea Technologies Reports New Data Demonstrating Cellvizio(R)'s Potential as a Tool for the Characterization of Pancreatic Cysts


5/23/2012 10:03:47 AM

PARIS--(Marketwire - May 23, 2012) - Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), the leader in the endomicroscopy market, today reported new data showing that utilizing Cellvizio, the world's smallest microscope, during needle-based procedures is safe and may help physicians more accurately differentiate benign and cancerous pancreatic cysts to determine with more certainty if the patient needs immediate surgery.

"Pancreatic cysts are abnormal pockets of fluid on or within the pancreas. While most of these lesions are benign, some pancreatic cysts need to be surgically removed because the risk of harboring or developing a malignancy is high," said Kenneth J. Chang, Professor and Chief, Division of Gastroenterology and Executive Director of the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine School of Medicine. "Needle-based Confocal Laser Endomicroscopy provides a real time view of the cells inside pancreatic cysts, which may provide physicians with additional information to help them decide if a patient needs surgery. If larger studies confirm these promising early results, we expect this to lead to a significant change in how physicians diagnose and rule out pancreatic cancer."

Used during endoscopy procedures, this new miniprobe known as the AQ-Flex™ 19 is comprised of a fiber-optic microscope that is small enough to thread through a needle with a diameter of 1mm.

Dr. Chang and his colleagues presented the results of the "Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound, Through-the-needle confocal laser Endomicroscopy and Cystoscopy Trial (DETECT)" (abstract L4575) at an American Society of Gastrointestinal Endoscopy (ASGE) Topic Forum at Digestive Disease Week® (DDW) 2012, which took place May 19 to 22 in San Diego.

The investigators identified key features seen in Cellvizio images that were taken from inside pancreatic cysts in 21 patients. The investigators then correlated the presence of structures to clinical results and concluded that nCLE procedures improve the sensitivity for the diagnosis of malignant cysts.

Separately, Irving Waxman, MD, Professor of Medicine and Surgery and Director of the Center for Endoscopic Research and Therapeutics at the University of Chicago School of Medicine, presented similar results from a 65-patient, multi-center study known as INSPECT (abstract Mo1204) during an American Gastroenterological Association (AGA) poster session earlier this week.

Investigators were able to identify 100% of the pancreatic cystic neoplasms in these patients.

"We are dedicated to developing and rigorously evaluating advanced endoscopic imaging tools that provide physicians with more real-time, cellular-level information than they've ever had before," said Sacha Loiseau, CEO and founder of Mauna Kea Technologies. "The AQ-Flex 19 miniprobe extends Cellvizio's clinical reach into a new type of organ for the first time and represents a significant milestone for the company."

Over 40 abstracts and presentations demonstrating the clinical utility of endomicroscopy as a tool to improve outcomes in digestive disease were featured at DDW 2012.

* The nCLE probe has received the European CE Mark and clearance in Israel. The company is working on getting 510(k) clearance in the U.S.

About Pancreatic Cancer
Pancreatic cancer is one of the rare cancers for which chemotherapy and radiotherapy have disappointing results. The best patient outcomes are achieved with surgery in which the surgeon must remove all the cancerous cells, including those in the primary tumor, as well as those hidden in the surrounding pancreatic tissue and lymph nodes. The American Cancer Society (ACS) estimates that approximately 43,920 people (22,090 men and 21,830 women) will be diagnosed with pancreatic cancer this year and about 37,390 people (18,850 men and 18,540 women) will die of the disease. Since 2004, rates of pancreatic cancer have continued to steadily increase by 1.5% each year, according to the ACS.

About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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 help detect abnormalities in the gastro-intestinal and pulmonary tracts. 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, 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, go to www.maunakeatech.com


United States
Lazar Partners Ltd.
Erich Sandoval
Tel: +1 917 497 2867
esandoval@lazarpartners.com

Mauna Kea Technologies
Alexander Bryson
Marketing Communications and Brand
Manager
Tel: +33 (0) 1 70 08 09 92
alexander@maunakeatech.com

France et Europe
ALIZE RP
Caroline Carmagnol
Tel: +33 (0)1 42 68 86 43 / +33 (0)6 64 18 99 59
caroline@alizerp.com
Anne-Sophie Cosqueric
Tel: +33 (0)1 42 68 86 41
anne-sophie@alizerp.com

NewCap.
Investor Relations and Financial Communication
Pierre Laurent / Florent Alba
Tel: +33(0)1 44 71 94 94
maunakea@newcap.fr



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