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

- Data from five studies presented at United European Gastroenterology Week

(UEGW) - - Non-invasive imaging system diagnoses histology and pathology of the

gastrointestinal tract safely and effectively -

PARIS, Oct. 30 /PRNewswire/ -- Mauna Kea Technologies (MKT), the leader in the field of in vivo cellular imaging, announced that leading European gastroenterologists presented five abstracts related to the company's Cellvizio(R) GI at the 15th United European Gastroenterology Week (UEGW). The reported data demonstrate the clinical utility of Cellvizio(R) GI during double-balloon enteroscopy (DBE) as well as in the diagnosis of a range of gastrointestinal (GI) disorders. The findings also provide insight into criteria for optimizing Cellvizio(R) GI performance. The UEGW meeting is taking place in Paris October 27th - 31st .

Cellvizio(R) GI is the first and only confocal endomicroscopy instrument that is compatible with all endoscopes and allows real-time, dynamic microscopic imaging of the entire GI tract at 12 frames per second. To date, more than 600 patients have undergone an endoscopic procedure with the Cellvizio(R) GI imaging system.

Cellvizio and Double-Balloon Enteroscopy

In an oral presentation (Abstract FP-337), Pr. Stephan Miehlke, University Hospital, Dresden, Germany, described the first use of the Cellvizio(R) GI system with DBE to evaluate the entire small bowel in 27 procedures in 16 patients. Cellvizio(R) obtained informative images in all procedures but one, yielding a technical success rate of 96%. There were no adverse events related to DBE or the use of Cellvizio(R). The Cellvizio(R) system was able to detect both normal and abnormal villi throughout the GI tract. All Cellvizio(R) GI results were confirmed by subsequent histology of biopsy samples.

"The ability to use Cellvizio(R) GI with DBE provides a powerful new approach to evaluate the entire small bowel 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 criteria for use of Cellvizio(R) GI in diagnosing GI-GVHD.

Promising results were reported in a study evaluating Cellvizio(R) GI in the differential diagnosis of indeterminate biliary strictures (Abstract PS-W- 24). Standard approaches to making this differential diagnosis have certain limitations, which may be overcome by Cellvizio(R) GI. In 7 patients, the Cellvizio(R) probe was introduced directly into the common bile duct. In a further 7 patients, the further miniaturized probe was introduced and placed to suspected lesions under visual control via a cholangioscope. The probe could be introduced in all patients, and imaging of the cellular structures of the bile duct epithelium was possible in all cases. In two patients in whom the probe was inserted directly, the probe could not be inserted far enough to reach the stenosis and corresponding histology samples were unable to be obtained in these cases. No side effects were observed. Cellvizio(R) GI revealed normal findings in benign cases. Biliary cancers showed features of thickened vessels with black cells in 5 of 6 cases of malignancy. Investigators conclude that Cellvizio(R) GI enables imaging of cellular details even in small ducts such as in the biliary system. The system has the potential to increase the diagnostic accuracy for further differentiation of strictures and stenosis, which is one of the most poorly diagnosed GI conditions and can lead to cancers with the poorest prognosis: cholangiocarcinoma or pancreatic cancer.

Another study evaluated the ability of Cellvizio(R) GI to evaluate pathologic features of small intestinal pathology (Abstract PS-M-08). The study examined 20 patients with known celiac sprue and well controlled disease. Biopsies were taken from areas evaluated with Cellvizio(R) GI to allow precise comparison with histology findings. A total of 80 GI sites were evaluated. Seven patients had pathological findings consistent with celiac disease, two of which were classified as Marsh III. Image quality was sufficient to allow evaluation of morphological characteristics in 93% of sites; resolution was sufficient in 91%. Epithelial width could be measured in 94% and villous width in 88%. Epithelial cell cytoplasm and basal cell layer regularity could only be assessed in 30% and 26%, respectively. Investigators conclude that Cellvizio(R) GI can identify histological details critical for the detection of hallmark features of intestinal pathology in celiac patients.

Physicians from Klinikum rechts der Isar in Munich, Germany presented results from a preclinical study that investigated the optimal timing for use of Cellvizio(R) GI imaging with intravenous fluorescein in a pig model in a poster (Abstract PS-W-22). Results demonstrate that fluorescein-enhanced imaging of the gastrointestinal tract with Cellvizio(R) delivers best contrast and image quality one to eight minutes after fluorescein injection, with best resolution after five minutes. The authors conclude that these data may facilitate development of standardized protocols for utilizing Cellvizio(R) GI in clinical practice. Standard protocols are expected to facilitate more widespread adoption and appropriate application of this innovative imaging technology.

About Mauna Kea Technologies:

Mauna Kea Technologies engages in the conception, development, fabrication and commercialization of novel high-speed minimally invasive imaging systems for in-vivo and in-situ microscopy. MKT's unique fiber-based microscopy platform, Cellvizio(R), is the world's smallest microscope with multifarious applications in research and medicine. MKT's products, developed at the crossroads of optics, mathematics, image processing, biology and medicine, currently address the markets of digestive endoscopy, bronchoscopy and small animal imaging. For more information, visit http://www.maunakeatech.com.

For further information:

Fern Lazar

Lazar Partners

212-867-1762

flazar@lazarpartners.com


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SOURCE Mauna Kea Technologies
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