IMALUX RECEIVES FINAL FDA CLEARANCE TO MARKET NIRIS

Imalux, a medical device company and developer of the Niris Imaging System based on Optical Coherence Tomography (OCT) technology, has announced that the Niris System received market clearance from the FDA.

Imalux announced in March 2004 that it had received initial clearance from the FDA to market the Imalux OCT Imaging System. Since then, the company has received two additional FDA clearances, one for an accessory sheath for the Imaging System probe, designed to provide a microbial barrier and aid in positioning the probe. The second cleared the Niris Imaging System for commercialization.

Imalux will begin intensive, broad-based marketing and sales efforts for the system in the first quarter of 2005.