CLEVELAND--(BUSINESS WIRE)--Sept. 5, 2006--Imalux(TM) Corporation announced today that they have received approval from the Therapeutic Goods Administration (TGA) to market their Niris(TM) Imaging System in Australia and New Zealand. This achievement will allow market development and product introduction to commence with their exclusive distributor Device Technologies Australia.
TGA approval is the latest in a long line of accomplishments in the Australia market for Imalux and Device Technologies Australia, including presentation of the Niris Imaging System at the Urological Society of Australasia 2006 Annual Scientific Meeting and the recent completion of the inaugural service training.
Imalux developed, manufactures and markets the Niris Imaging System to assist physicians in their diagnosis, treatment, and therapeutic monitoring of diseases in multiple specialties, including urology, gastroenterology, gynecology, dermatology, dentistry, and ENT applications.
Device Technologies Australia has extensive experience in market development and new technology introduction with such companies as STERIS Corporation, Intuitive Surgical, and Boston Scientific. Their strong reputation and established relationships throughout the Australia and New Zealand market will greatly assist in the market acceptance of the Niris Imaging System.
Jerry C. Cirino, President and Chief Executive Officer of Imalux states, “receiving TGA approval is the result of our strong cooperation with our exclusive distributor Device Technologies and we look forward to developing the market and building upon this important milestone with future product shipments.”
About Imalux & the Niris Imaging System
Imalux Corporation, based in Cleveland, Ohio, is commercializing Optical Coherence Tomography (“OCT”) technology originally developed at the Institute of Applied Physics of the Russian Academy of Sciences, one of the main progenitors of OCT technology worldwide. The application of the proven OCT technology is on the verge of becoming the sixth major imaging modality.
The Company’s Niris(TM) 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 in a number of specialty areas and has been used with more than 3,000 patients worldwide at leading medical institutions including The Cleveland Clinic, The George Washington University Medical Center, Baylor College of Medicine/The Methodist Hospital, University Hospitals of Cleveland, Nizhny Novgorod Medical Academy and Regional Hospital, Nizhny Novgorod, Russia; Municipal Hospital, Chartres, France; State Hospital, Athens, Greece; University Clinic of Eppendorf, Hamburg, Germany; and Hospital Maternidad Nuestra Senora de la Altagracia, Santo Domingo, Dominican Republic.
The Niris Imaging System has received market clearance from the U.S. Food & Drug Administration. In addition, Imalux has been awarded ISO 13485-2003 accreditation, CE mark certification, and Therapeutic Goods Administration (TGA) approval for the Niris Imaging System.
Contact: Imalux Corporation Jon J. Snyder, 216-502-0755 jsnyder@imalux.com web: www.imalux.com
Source: Imalux Corporation
