SOURCE: Mauna Kea

May 09, 2011 15:04 ET

Real-Time Cellular-Level Visualization With Cellvizio Significantly More Accurate at Detecting Bilio-Pancreatic Cancer Than Tissue Sampling Method

Final Results of Multi-Center, Longitudinal Registry Study of Probe-Based Confocal Laser Endomicroscopy (pCLE) Announced in a Presidential Plenary Session at Digestive Disease Week 2011

CHICAGO, IL--(Marketwire - May 9, 2011) - Mauna Kea Technologies, leader in the endomicroscopy market, announced that new data show direct, cellular-level visualization of the lining of the bile or pancreatic ducts with its Cellvizio pCLE system and CholangioFlex™ miniprobe significantly improves bilio-pancreatic cancer detection rates in patients with previously indeterminate bilio-pancreatic strictures.

Adam Slivka, MD, PhD, Associate Chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh Medical Center (UPMC), presented (Abstract #721) these findings -- the final results of the company's prospective, multicenter, international, longitudinal registry study -- during the Presidential Plenary Session of the American Society of Gastrointestinal Endoscopy at Digestive Disease Week (DDW) 2011, which is taking place here through May 10. The study results were also relayed during DDW in two other oral communications delivered by Dr. Slivka and Pr. Alexander Meining, MD, PhD, from Munich, Germany.

"Our preliminary experience with pCLE in patients with indeterminate bile duct strictures is promising. We were able to detect more bile duct cancers at the index procedure compared to conventional tissue sampling methods," said Dr. Slivka. "In our study pCLE detected, in real time, over 90% of the cancers at the index procedure where standard pathology missed over half of them. Early and more accurate diagnosis and treatment of bile duct cancers should improve patient outcomes. We welcome pCLE into our diagnostic armamentarium."

Overall, 102 patients with indeterminate strictures who were scheduled for Endoscopic Retrograde Cholangio-Pancreatography (ERCP), the standard procedure used to diagnose disease inside the bile and pancreatic ducts, were enrolled into the study at five international hospitals. Patients were followed until the physicians were able to confirm malignancy through histopathology or for a year if repeat tissue sampling led to benign results; 89 of the patients finished follow-up and were evaluable for the final analysis.

Participating physicians could choose whether to deliver the CholangioFlex™ confocal miniprobe™ through a cholangioscope or a catheter. Both cholangioscopic and catheter approaches provided significant improvement in sensitivity over histopathology. There was no statistical difference between the two delivery methods in terms of accuracy.

Sensitivity, the ability to accurately predict disease, of pCLE was 98% while sensitivity of tissue sampling was 45%.

"We have dedicated ourselves to working with the medical community to develop robust clinical evidence that supports use of pCLE and Cellvizio in diseases like cholangiocarcinoma where there's a significant unmet medical need for improved tissue characterization so patients can receive the accurate diagnosis and treatment more quickly and effectively," said Sacha Loiseau, President, CEO and Founder of Mauna Kea Technologies. "We would like to thank all of the physicians who participated in this important study, most notably the study's original primary investigator, Prof. Yang Chen. He worked tirelessly through his life to improve biliary cancer detection rates and I hope he would be proud of the results that Dr. Slivka and Pr. Meining presented earlier today."

The study has been accepted for publication by the Gastrointestinal Endoscopy Journal.

About Bile Duct Cancer (Cholangiocarcinoma)
Cholangiocarcinoma is a cancer of the bile ducts, which drain bile from the liver into the small intestine. The American Cancer Society (ACS) estimates that about 2,000 to 3,000 people in the U.S. develop bile duct cancer each year. Advanced bile duct cancer is associated with only a 2% five-year relative survival rate, according to the ACS. The prognosis improves when bile duct cancer is found earlier, however, current testing methods have been limited and obtaining an accurate diagnosis has been difficult to date.

About Pancreatic Cancer
Pancreatic cancer, or cancer of the pancreas, is a cancer of an organ found behind the stomach, whose job is to produce hormones, including insulin, and enzymes involved in the absorption of foods, especially fats. The National Cancer Institute at the National Institutes of Health estimated that there would be 43,140 new cases and 36,800 deaths from pancreatic cancer in 2010. Cancer of the pancreas is associated with a poor survival rate, even if found early, and is a leading cause of cancer death.

About DDW
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 7 - 10, 2011, at McCormick Place, Chicago, IL. 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 a leader in endomicroscopic innovation. The company researches, develops and markets innovative tools to visualize and 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.

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