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.