SAN DIEGO, May 19, 2008 (PRIME NEWSWIRE) -- Mauna Kea Technologies, a leader in in vivo cellular imaging, today announced that leading international gastroenterologists presented data from four clinical studies on Cellvizio(r) GI at the Digestive Disease Week(r) (DDW) 2008 conference in San Diego. The reported data demonstrate Cellvizio GI's value in diagnosing colorectal cancer as well as other gastrointestinal diseases. A fundamentally new endoscopic imaging approach, Cellvizio could improve patient care by eliminating unnecessary biopsies and could further improve diagnostic rates across a broad range of diseases.
"This new evidence should lead to broader use of Cellvizio GI in the clinic as an essential tool for improving the diagnosis of a broad range of gastrointestinal diseases," said Sacha Loiseau, Ph.D., president and CEO of Mauna Kea Technologies. "The studies also highlight the technology's compatibility with other gastrointestinal diagnostic tools and its potential for improving the detection rate of gastrointestinal cancers."
Cellvizio and Colorectal Cancer
In a late-breaking oral presentation, Anna Buchner, M.D., Mayo Clinic, Jacksonville, Fl., U.S.A., discussed the results of a 26-patient study assessing Cellvizio GI's applicability for diagnosing benign and malignant lesions in colorectal polyps during colonoscopy screening. The trial found that the technology predicted the presence of premalignant, advanced colorectal lesions and malignant lesions with a high accuracy of 86.5% (CI 75.5-97.5%), sensitivity of 82.6% (CI 68.9-86.7%), and specificity of 92.9% (CI 70.3-99.6%).
Cellvizio and Ulcerative Colitis
A poster presentation (S1169) on an ongoing study of ulcerative colitis patients by Pr. Frank J van den Broek, Academic Medical Center, Amsterdam, Netherlands, concluded that Cellvizio makes it feasible to recognize histological features in vivo and may eliminate the need for random biopsies and unnecessary biopsies from lesions without tumors. Nine patients and a total of 57 colonic areas have so far been examined. After inspection with the Cellvizio GI, normal colonic tissue was found in 33 specimens; inflammation in 11 specimens; hyperplasia changes in 9; and intraepithelial tumors in 4.
Cellvizio and Barrett's Esophagus
A poster presentation (S1392) on a study by Heiko Pohl, M.D., VA Medical Center, White River Junction, VT, U.S.A, concluded that Cellvizio GI is highly effective at identifying which Barrett's esophagus patients do not have advanced growth of precancerous cells in their esophagus. The 38-patient study compared Cellvizio GI's ability to accurately diagnose the degree of pre-cancerous tissue in patients with Barrett's esophagus compared to histology results of biopsies taken from the same areas. Cellvizio evaluation by two independent examiners to detect advanced neoplasia was accurate in 88% to 93%, and showed a sensitivity and specificity between 75% and 80%, and 89% and 94%, respectively, translating at best into a low positive predictive value of 44.4% and a high negative predictive value of 98.8%.
A poster presentation (M1316) by Rami J. Badreddine, Mayo Clinic, U.S.A., described the results of a study of 62 patients with a history of Barrett's esophagus with high-grade dysplasia or early adenocarcinoma. Results showed that in patients with flat normal appearing mucosa, Cellvizio GI-guided EMR detected high-grade in a significantly higher number of patients compared to just surveillance biopsies (55% vs. 23%, p less than 0.03). The detection rate of high-grade dysplasia or cancer Cellvizio GI targeted EMR in flat normal appearing mucosa was similar to that found in nodular mucosa (55% vs. 61%, p less than 0.75).
Cellvizio is the first and only confocal microscopy system that is compatible with most endoscopes and allows physicians to view live tissue inside the body at the cellular level in dynamic, real-time images at 12 frames per second. Over 1,000 Cellvizio procedures have been completed to date. It has 510(k) clearance from the Food & Drug Administration and the European CE-Mark for use in the gastrointestinal and pulmonary tracts.
About Digestive Disease Week 2008
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) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. 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 leads the growing in vivo cellular imaging market enabling physicians to visualize, diagnose and treat pathologies that can not be seen using other imaging techniques. Mauna Kea Technologies' flagship Cellvizio system provides microscopic visualization of mucosal tissue and promises to improve clinical outcomes by increasing the diagnostic yield of existing endoscopic procedures. With over 1,000 Cellvizio procedures completed to date, Mauna Kea Technologies is currently focused on the gastroenterology and pulmonology markets. The company plans to expand into other markets in the future. The company also has a distribution agreement with Leica Microsystems to sell products for the Small Animal Imaging market in Europe, the U.S. and Japan. For more information about Mauna Kea Technologies: www.maunakeatech.com