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Mars 2008

Cellvizio had a strong scienti- fic presence at the 2008 Di- gestive Disease Week (DDW) and American Thoracic Socie- ty (ATS) annual conferences. In this Cellvizio News, we reveal study highlights from the meetings.

DDW also marked the suc- cessful commercial debut of our new CholangioFlex mini- probe that enables the Cellvizio system to be used with ERCP to image pancreatic and biliary structures, which previously have been difficult to visualize.

This is exciting and useful in- formation, and we look for- ward to keeping you updated on additional advances with this innovative technology in future newsletters.

Sacha Loiseau

Sacha Loiseau PhD,
President, CEO and Founder


October 4-8, 2008 European Respiratory Society Annual Congress
Messe Berlin GmbH, Berlin, Germany
 
October 18-22, 2008 United European Gastroenterology Week
Austria Center Vienna
 
October 25-30, 2008 CHEST
Pennsylvania Convention Center, Philadelphia

New Study Shows Standard Ways to Interpret Cellvizio Lung Images Being Developed

Standard ways to interpret Cellvizio in vivo microscopic lung images are now being developed (Dr. David Ost, N.Y. University; 8 patients).
Physician reviewers
agreed on certain lung image characteristics ge- nerated by Cellvizio du- ring bronchoscopy and were able to differentiate between images of non- smokers and smokers.


"These are valuable findings because they suggest Cellvizio could be used to detect lung diseases that affect respiratory bronchioles," Dr. Ost said.


Welcome to a familiar face in GI.
Brian Tinkham joins us as Vice President of Marketing in the U.S

He comes from Boston Scientific, where he spent the last seven years in endoscopy sales and marketing, and brings a wealth of market savvy, clinical knowledge and strong physician relation- ships.

This in vivo cellular-level Cellvizio image obtained with a CholangioFlex miniprobe shows normal bile-duct epithelium characterized by reticular arrangement of dark-grey bands on a light-grey background.
Click here for the unique, real time Cellvizio video.

Image courtesy of PD. Dr. Alexander Meining, Klinikum rechts der Isar, Technical University of Munich

Cellvizio Proves its Value in Diagnosing Range of GI Diseases

Colorectal Polyps: A 98% negative predictive value

Using Cellvizio during colonoscopy allows GIs to immediately distinguish normal polyps from lesions with a high chance of turning cancerous (Dr. Michael Wallace and colleagues, Mayo Clinic, Jacksonville, Florida; 26 patients). Compared with histopathology, Cellvizio predicted the presence of premalignant, advanced colorectal lesions and malignant lesions with a high accuracy of 86.5% and had a negative predictive value of 98% for 5 mm pale polyps, the kind most likely to be hyperplastic

Ulcerative Colitis Surveillance: 97% specificity

Cellvizio may help eliminate unnecessary biopsies for many ulcerative colitis patients (Dr. Frank J van den Broek and colleagues at the Academic Medical Center in Amsterdam; 9 patients, 57 colonic areas). "Typically, their neoplasia is difficult to see during colonoscopy and random biopsies are needed," Dr. van den Broek said.
"Cellvizio potentially avoids this by showing histological features in vivo."

Barrett's Esophagus: 98.8% Negative Predictive Value

Cellvizio may aid in the detection of cancer in Barrett's esophagus patients and is highly effective at identifying which Barrett's patients do not have advanced growth of precancerous cells in their esophagus, with a negative predictive value of 98.8 percent (Drs. Heiko Pohl, VA Medical Center, White River Junction, Vermont, USA; Thomas Roesch, Charite University Hospitals, Germany; and Alexander Meining, Technical University of Munich, Germany; 38 patients).

A second Barrett's study found that Cellvizio guided endoscopic mucosal resec- tions significantly in- crease the detection rate of dysplasia in high risk Barrett's patients and appear to be especially useful in identifying difficult-to-find dysplasia in flat Barrett's mucosa (Dr. Rami J. Badreddine and colleagues, Mayo Clinic, Rochester, Minnesota; 62 patients).

Cholangiocarcinoma: Improves Detection

Cellvizio is a promising and reproducible imaging approach for detecting biliary duct cancer
(Dr. Alexander Meining, Technical University of Munich, Germany; 14 patients). It predicted biliary tract cancer with an accuracy of 91.7%, superior to the 76.9% accuracy rate of histopathological analysis of biopsies, and Cellvizio had a negative predictive value of 88% vs. a typical 50% for histopathological analysis.

"This new tool could be of utmost importance as cholangiocarcinoma is difficult to diagnose and one of the cancers with the poorest prognosis,"
said Dr. Meining.

Cellvizio's ERCP Benefits Demonstrated Live at Brussels Workshop

   

Cellvizio's power, speed and ease of use to help improve the detection and diagnosis of cholan- giocarcinoma were seen first hand by more than 800 GIs at the first ever live Cellvizio ERCP demonstration, performed June 16 by Dr. Marc Giovannini, Paoli-Calmettes Institute, Marseillle, France, and PD. Dr. Alexander Meining, Technical University of Munich, Germany, at the Annual Gastroenterology and Endotherapy Workshop in Brussels. During the procedure, Drs. Giovannini and Meining immediately were able to obtain relevant information to characterize normal vs abnormal mucosa in the bile duct.

In a separate lecture, Professor Horst Neuhaus, University of Dusseldorf, Germany, discussed Dr. Meining's Cellvizio ERCP study results from DDW, emphasizing its major advantages over standard ERCP histology or cholangioscopic examination in Negative Predictive Value (88% vs. 50 %) and sensitivity (83% vs. 56%).




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