Aleva Neurotherapeutics, who develop implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, has been awarded the CE Mark for the directSTIM Deep Brain Stimulation System.
The system incorporates directional electrode technology and is designed to be more precise and efficient, with optimised 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 $8 million in a first closing of a Series E financing round from existing and 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.
André Mercanzini, CEO of Aleva Neurotherapeutics, said: "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.”
