BioLineRx Announces European Confirmation of Medical Device Regulatory Pathway for BL-5010, for Non-surgical Removal of Skin Lesions

BioLineRx

announced today that BL-5010, for the non-surgical removal of benign skin lesions, has received European confirmation from the British Standards Institution Notified Body in the UK, of the regulatory pathway classification as a medical device Class IIa. This considerably reduces the time and resources required for marketing authorization for the product in comparison to the drug approval process. BL-5010 is a novel formulation for the non-surgical removal of benign skin lesions. In December 2010, BL-5010 completed a Phase I/II clinical trial in which it demonstrated efficacy in complete removal of benign skin lesions and safety. Kinneret Savitsky, Ph.D., BioLineRx's CEO, stated, "Receiving confirmation of the medical device regulatory pathway, as opposed to the drug approval pathway, is a considerable achievement which significantly shortens the time needed to bring BL-5010 to market. Since announcing the promising results of the Phase I/II clinical trial in December 2010, we have invested considerable efforts in evaluating the appropriate regulatory and development path for this product and we are very pleased with the outcome of these efforts.”