PhotoCure ASA is a Norwegian pharmaceutical company that has developed Hexvix is developed for the detection of bladder cancer. This product is based on the same photodynamic technology, combining the drug known as a photosensitizer with a light source that activates the photosensitizer. It was founded in the year 1993 and listed on Oslo Stock Exchange. The company does develop and sell pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.

PhotoCure ASA has received a non-approvable letter from the United States Food and Drug Administration related to the Hexvix new drug application. PhotoCure will, together with its US regulatory advisors, initiate a discussion with FDA to better understand the additional requirements required to obtain approval for Hexvix from the agency. Hexvix has previously been approved for the detection of bladder cancer in patients with known or suspected bladder cancer in about 27 European countries.

Bladder cancer is the third most common malignant disease present worldwide, with approximately four million cystoscopies performed in the USA and Europe every year. Patients have a good prognosis if they are diagnosed early and treated adequately. Hexvix Imaging is a new, innovative, and effective diagnostic method that can be used for all types of bladder cancer and will be used as a supplement to current standard methods. It is in particular effective for carcinoma in situ, a highly malignant cancer that is difficult to see with standard white light cystoscopy. Hexvix gives a more accurate picture of diagnosis than current standard methods and will therefore provide health economic benefits.