PhotoCure - Hexvix® imaging one step closer to commercialisation
Oslo, Norway, 25 September 2003
PhotoCure is pleased to announce that it has received the first regulatory assessment of the marketing approval application for Hexvix® submitted to the Swedish Medical Products Agency (MPA) in December 2002. The feedback is overall very positive, with only a few issues that need to be resolved before a final approval can be granted.
Hexvix® imaging is an innovative and effective method for detection of bladder cancer. Bladder cancer is the sixth most common malignant disease worldwide. Approximately 5 million cystoscopies (visual bladder inspections) are performed in Europe and North America every year, in order to diagnose or rule out bladder cancer. Hexvix® imaging is developed as an adjunct to existing diagnostic methods, aiming to provide more accurate and earlier detection of bladder cancer, a crucial factor for the prognosis of the patient.Vidar Hansson, President and CEO of PhotoCure, comments: "We are very pleased with this initial assessment of Hexvix®, which arrived earlier than expected. The positive feedback from both urologists and now the Swedish regulatory agency on the clinical results gained with Hexvix®, reassures us that Hexvix® has a promising commercial potential."