Switzerland-based Aleva Neurotherapeutics has secured CE mark for its directSTIM Deep Brain Stimulation (DBS) system.
The DBS system technology allows accurate steering of current towards the desired structural area, enhancing the effectiveness of DBS and reducing potential side effects.
Aleva Neurotherapeutics is said to be the only technology company to have secured CE mark for DBS system. It will commence direct sales via a post-market clinical follow-up study in selective European neurological clinics.
Aleva Neurotherapeutics CEO André Mercanzini 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.”
Furthermore, Aleva Neurotherapeutics has also raised $8m in a Serious E financing round, joined by the company’s existing, as well as undisclosed private, investors.
The company notes that it will now focus on securing entry into the US market entry.
Aleva Neurotherapeutics, a spin-off of the Swiss Federal Institute of Technology (EPFL) Microsystems Laboratory, has raised more than $50m so far.
The company raised $50m from institutional investors such as Forrestal Capital, Kinled Holding, BioMedPartners, BB Biotech Ventures, Kreaxi and Initiative Capital Romandie, as well as some private investors.