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New Clinical Studies Confirm Mauna Kea Technologies' Cellvizio(R) GI in Range of Procedures
Date:10/30/2007

at the cellular level without the need for taking biopsy samples," said Dr. Miehlke. "This reduces the potential for adverse events associated with biopsy procedures while providing rapid and accurate findings that can help to optimize patient care. Further evaluation of the Cellvizio(R) GI system with DBE is warranted in order to understand how to best apply this powerful imaging approach across a variety of known or suspected GI disorders."

Three other clinical studies describing positive preliminary results using Cellvizio(R) GI to diagnose GI Graft-versus-Host disease (GI-GVHD), biliary strictures and celiac sprue were presented in poster sessions. Sacha Loiseau, Ph.D. president and CEO of Mauna Kea Technologies, said, "These preliminary studies provide a solid foundation on which we will advance the evaluation of Cellvizio(R) GI in a growing range of gastroenterology procedures. We believe that these data demonstrate the importance of the Cellvizio(R) GI system as a novel, non-invasive imaging and analysis tool that has the potential to transform and improve the care and treatment of patients with known or suspected GI pathology."

Additional Clinical Data

Abstract PS-W-23 described preliminary results of a study evaluating Cellvizio(R) GI in diagnosing GI-GVHD, a frequent and often life-threatening complication of allogeneic hematopoetic stem cell transplant. To date, four procedures have been conducted in three patients. In all four procedures, Cellvizio(R) GI findings have been confirmed by histology, including three positive findings of GI-GVHD and one finding of normal villi architecture. These preliminary results are quite promising, especially given that the gold standard for diagnosing GI-GVHD is histology based on multiple biopsies. Moreover, the correlation between conventional endoscopy and histology in this disease is poor. Based on these promising findings, a prospective blinded study has been initiated to evaluate and define crit
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