SOURCE: Mauna Kea

July 26, 2011 11:30 ET

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

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--(Marketwire - Jul 26, 2011) - Mauna Kea Technologies (EURONEXT PARIS: MKEA), the leader in the endomicroscopy market, announced today that leading journals have recently-published four clinical studies and one pre-clinical 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, appear 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 pre-cancerous 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®, 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

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