Company News: Aleva Neurotherapeutics Receives CE Mark for its directSTIM™ Deep Brain Stimulation System and Raises USD 8 Million Private Equity

Aleva Neurotherapeutics, a leading developer of implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, today announced that it has been awarded the CE Mark for its flagship product, the directSTIMTM Deep Brain Stimulation System.

Aleva’s revolutionary DBS system incorporates directional electrode technology and is designed to be more precise and efficient, with optimized stimulation that will potentially reduce side effects. At present, Aleva is the only emerging technology company to be awarded the CE-Mark for Deep Brain Stimulation. The Company will initiate direct sales through a post-market clinical follow-up study in select European neurological clinics.

The Company also announced it has raised USD 8 million in a first closing of a Series E financing round from existing and undisclosed new private investors. A limited additional amount of the round remains open to qualified investors. With its European market entry secured, the Company will now drive its efforts towards US market entry. The Company has been riding a wave of momentum driven by the uniqueness of its core technology and the major unmet needs in treating neurological disorders. Previously, the successful results of Aleva’s directSTN pilot study were published in Brain (DOI: 10.1093/brain/awu102) and strongly suggested the potential of directional stimulation in improving surgical outcomes. Earlier this year, Aleva announced the successful creation and funding of a joint venture with Dixi Medical SAS named Adept Neuro SA that aims to achieve regulatory approval for its core technology in the field of epilepsy surgery.

“The CE Mark is a significant milestone in Aleva´s development. Our Deep Brain Stimulation System incorporates first-in-class directional electrode technology with an easy-to-use patient programming interface that will enable functional neurosurgery teams to provide better outcomes for their patients. We have demonstrated that we can achieve and maintain technological leadership in our field, and we are now ready to expand our market in Europe while remaining focused on the US FDA regulatory process,” said André Mercanzini PhD, CEO of Aleva Neurotherapeutics.