Imalux Corporation announced that it has initiated a series of major European clinical trials to help identify the earliest signs of bladder cancer.
A prospective bladder cancer study in smokers, first of its kind, is being conducted under the direction of Prof. Georg Bartsch, Chairman of the Urology Department and Dr. Hannes Steiner of the University of Innsbruck, Austria. The Company's Niris Imaging System uses optical coherence tomography (OCT) and will add high resolution imaging to help in early detection of cancer. This bladder screening program is expected to enroll over 25,000 patients.
A study "Optical Coherence Tomography in Urology is being conducted at the University of Munich Hospital in Germany by Drs. Herbert Stepp, Reinhold Baumgartner and Alexander Karl. For this study, Niris will be used in combination with white light cystoscopy, fluorescence (photodynamic diagnosis) to differentiate between benign and malignant lesions.
At Austria's largest hospital, the Vienna General Hospital (AKH), a study "Evaluation of Bladder Cancer by Optical Coherence Tomography combined with Fluorescence and White Light Cystoscopy is being conducted by Drs. Jörg Schmidbauer and Michael Marberger of the Department of Urology. Both this study and the University of Munich study are planned to demonstrate that OCT can reduce the large number of false positives that result from the use of fluorescent cystoscopy.
Nancy J. Tresser, M.D. Vice President and Medical Director of Imalux states: "The incorporation of Niris into the University of Innsbruck's comprehensive and prospective bladder cancer screening program should further validate the utility of OCT in early cancer identification and help define its usefulness in the prevention of bladder tumor recurrence and progression.
About Imalux & the Niris Imaging System
Imalux Corporation, based in Cleveland, Ohio, developed, manufactures and markets the Niris Imaging System to assist physicians in their diagnosis, treatment, and therapeutic monitoring of disease in urology, gastroenterology, gynecology, dermatology, dentistry, and ENT. The application of the proven OCT technology is on the verge of becoming the sixth major imaging modality.
The Company's Niris Imaging System is a compact, point-of-care System that creates images utilizing harmless, near infrared light. Niris provides clinicians with real-time, high spatial resolution, two-dimensional, cross-sectional depth visualization of normal and abnormal tissue microstructures The spatial resolution of the System is on the order of 0.01 mm, surpassing conventional ultrasound imaging by an order of magnitude. Imalux OCT technology has been under evaluation with physicians at leading US medical institutions including The Cleveland Clinic, University Hospitals of Cleveland, Ohio State University, Baylor College of Medicine, MD Anderson, University of Southern California Johns Hopkins and the Weill Cornell Medical Center.
The Niris Imaging System has received market clearance from the U.S. Food & Drug Administration. In addition, Imalux has received ISO 13485:2003 certification and been awarded the CE Mark.
