Company News: Aleva Neurotherapeutics Recruits First Patient into its PMCF Study with its directSTIM™ Directional Deep Brain Stimulation System
— First system implanted at University Hospital of Dresden / Prof. Sobottka
— Post-market clinical follow-up and revenue-generating study in the EU
— Targeting US FDA IDE approval in Q4, 2021
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 the successful implantation of a first patient with the directSTIMTM Directional Deep Brain Stimulation System.
The groundbreaking procedure was performed by Prof. Dr. Stephan Sobottka at the University Hospital of Dresden, Carl Gustav Carus, Clinic for Neurosurgery, Dresden, Germany, and is part of a larger study being conducted in Germany that will include up to 60 patients. The revenue-generating study aims to demonstrate improved outcomes with the technology of Aleva´s directSTIMTM Directional Deep Brain Stimulation system in the EU for Parkinson’s Disease and Essential Tremor. The study aims to use Aleva´s unique directional electrodes and confirm previous studies that were published in several journals, including a seminal study in Brain (DOI: 10.1093/brain/awu102) which introduced the directional method for the first time in patients. Final results are expected in the first half of 2022. Aleva is aiming to obtain IDE approval by the US FDA in Q4, 2021.
Aleva’s revolutionary DBS system incorporates a directional electrode technology that is designed to be more precise and efficient than currently available approaches, as optimized stimulation has the potential to reduce side effects. Aleva is the only DBS company that provides 24 independent current sources and the only DBS lead to have 12 directional electrodes, providing the surgical team with complete flexibility. In stark comparison to competitors, each directional electrode is rounded in shape, not rectangular, providing added safety and enhanced directional fields. These advantages are based on its proprietary microengineered leads using MEMS technology (microelectromechanical systems) developed and licensed from the Swiss Federal Institute of Technology, Lausanne (EPFL).
“The directSTIM system is simple and straightforward to use. We will be able to immediately determine the advantages of directional stimulation, and we look forward to completing the study with Aleva,” said Prof. Dr. Stephan Sobottka.
“As one of the originators of Directional Deep Brain Stimulation, Aleva has done a substantial amount to study this modality and its benefit to patients. We expect to quantitatively determine its specific advantages within the Aleva study,” said Prof. Andres Lozano, Department of Neurosurgery, University of Toronto, and longtime Senior Medical Advisor to Aleva.
“Enrolling a first patient in our PMCF study is a significant milestone in Aleva´s development. Our Deep Brain Stimulation System incorporates several technologies that will provide better outcomes for Parkinson’s patients,” said André Mercanzini PhD, CEO of Aleva Neurotherapeutics.
About Aleva Neurotherapeutics
Aleva Neurotherapeutics is a spin-off from the Swiss Federal Institute of Technology in Lausanne (EPFL) Microsystems Laboratory of Prof. Philippe Renaud. Aleva Neurotherapeutics has so far raised over USD 60 million from renowned institutional investors, among them Forrestal Capital, Kinled Holding, BioMedPartners (through its BioMedInvest-II LP Fund), BB Biotech Ventures III LP, Kreaxi and Initiative Capital Romandie, as well as from select private investors.
For more information, visit: www.aleva-neuro.com
About Deep Brain Stimulation
Deep brain stimulation (DBS) is approved worldwide for the treatment of Parkinson’s disease (PD), essential tremor, dystonia, obsessive-compulsive disorder (OCD), and epilepsy. It is also under investigation for the treatment of a number of other conditions, including major depression. DBS relies on the delivery of mild electrical pulses to specific areas in the brain via an implanted lead connected to a battery-powered pulse generator placed in the patient’s upper chest area. A physician is able to vary and control the stimulation delivered through the lead to the brain using an external, hand-held programmer. At present, DBS systems use leads with electrodes that send out electrical current in all directions, which can result in unwanted side effects.