Aleva secures a CE mark and $8 million

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17.12.2019
Brain

Aleva Neurotherapeutics’ flagship product, the directSTIM Deep Brain Stimulation System for neurological indications such as Parkinson’s disease and essential tremor is now CE Mark certified. The company has also raised USD 8 million in the first closing of a Series E financing round.

Based in Lausanne, Aleva Neurotherapeutics an EPFL spinoff from the Microsystems Laboratory is the leading developer of implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor. Its directSTIM Deep Brain Stimulation System (DBS 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. It was designed to be more precise and efficient with optimized stimulation that will potentially reduce side effects.

The company has been awarded the CE Mark for its DBS System, making it the first and only emerging technology company to-date to receive the CE-Mark. Aleva will initiate direct sales through a post-market clinical follow-up study in select European neurological clinics.

"The CE Mark is a significant milestone in Aleva´s development. 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.

The first closing of a Series E round
Concurrently, Aleva announced that it has raised USD 8 million in the 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 so far raised over USD 50 million from renowned institutional investors, among them Forrestal Capital, Kinled Holding, BioMedPartners (through its BioMedInvest-II LP Fund), BB Biotech Ventures LP, Kreaxi and Initiative Capital Romandie, as well as from select private investors.

Notable achievements
Aleva 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.

(Press release/ran)

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