Non-surgical device to remove skin lesions gets European thumbs up

Over-the-counter medical device is designed to offer an alternative to invasive and expensive skin lesion removal

BL-5010 is an over-the-counter medical device from BioLineRx is designed to offer an alternative to invasive and expensive skin lesion removal. These include cryotherapy, laser treatment and surgery. The device has received CE Mark approval in Europe.

Because the treatment is non-invasive, it poses minimal infection risk and eliminates the need for anaesthesia or bandaging. The product has completed clinical studies for the removal of seborrheic keratosis and other skin lesions with excellent efficacy and cosmetic results, and has received confirmation in Europe as a Class 2a medical device. The product will be commercially launched by Omega Pharma this year.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated: "We are very pleased with the CE mark approval for BL-5010, which is the final step necessary before the product’s launch as an OTC treatment in Europe, expected over the next few months. In particular, we would like to thank Omega Pharma for their efficient and professional development of this novel product, and hope this regulatory approval will also expedite the potential expansion of the product to other markets as well as to additional indications.”