BL-5010, a novel over-the-counter medical device offering an alternative to invasive and expensive skin lesion removal treatments such as cryotherapy, laser treatment and surgery, has received CE Mark approval in Europe.

Because the BL-5010 treatment is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia or bandaging. The product has completed clinical studies for the removal of seborrheic keratosis and other skin lesions.

The device will be launched commercially by Omega Pharma, a partner of BioLineRx in Modi’in, Israel. BioLineRx licensed the product in December 2014 from Innovative Pharmaceutical Concepts.

“We in-licensed BL-5010 as a pre-clinical asset, completed all the necessary pre-clinical and clinical studies, successfully changed the development pathway in Europe from a drug to a device, developed a new and unique applicator for the product, and extended the product’s patent life by many years,” said Dr. Kinneret Savitsky, CEO of BioLineRx.

“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.”

Savitsky said she hopes the regulatory approval for BL-5010 will expedite the potential expansion of the product to other markets as well as to additional indications.

Meanwhile, BioLineRx’s therapeutic candidate BL-8040, a cancer therapy platform,  successfully completed a Phase 2 study for relapsed/refractory acute myeloid leukemia (AML) and recently went into a Phase 2b study as an AML consolidation treatment.