U.S. FDA grants Aleva Neurotherapeutics approval for an Investigational Device Exemption (IDE) study on directSTIM™ Directional Deep Brain Stimulation System
Aleva is committed to start the PMA trial in the next quarters, in parallel with the post-market clinical follow-up study currently underway in select European neurological clinics. The US trial will include up to 15 US institutions with the recruitment of up to 136 US patients.
Lausanne, Switzerland, February, 2022 – Aleva Neurotherapeutics, a developer of innovative implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, today announced they have received a letter of approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) study. The approved protocol has been designed to collect safety and efficacy data to support submission for a future PMA application. The approval has been granted following an intensive exchange of information between Aleva and the FDA, whereby all safety tests and clinical data have been scrupulously investigated. This authorisation follows the grant of the CE-Mark in Europe, and the ongoing post-market clinical follow-up study in select European neurological clinics whose completion is expected in the next 30 months.
“This is a pivotal milestone for Aleva” commented Stefano Alfonsi, CEO of Aleva Neurotherapeutics “as we are fully committed to provide the benefits of our truly directional DBS system to US patients and the community of Neurologists and Neurosurgeons. The North American DBS market is definitely the largest in volume and turnover, and we are convinced that the innovation provided by directSTIM™ combined with our vision will make a dent in this space.”
Aleva’s revolutionary DBS system incorporates directional electrode technology that is designed to be more precise and efficient than currently available approaches, as targeted stimulation has the potential to improve therapeutic benefits while reducing side effects. Aleva is the only DBS company that provides 24 independent current sources in combination with the only lead that has 12 directional contacts. The result is higher flexibility during surgery and the ability to personalize therapy to the patient’s evolving needs. Aleva’s vision is to create a digital AI-powered ecosystem that integrates clinical data to generate insights that power the surgical and programming experience to achieve better lives for patients.
About Aleva Neurotherapeutics
Aleva Neurotherapeutics started as a spin-off of the Swiss Federal Institute of Technology in Lausanne, Switzerland, with the objective of improving existing Deep Brain Stimulation treatment for patients suffering from neurological disorders. Today, Aleva is a commercial stage company that following directSTIM™’s CE marking, has started its commercial journey by partnering with the leading neurological clinics in Europe, aiming to penetrate the most relevant worldwide markets in the near future. Aleva introduced the Directional mode of Deep Brain Stimulation to Neuromodulation treatments, and its clinically proven technology has set the industry standard for directional leads. Aleva’s expertise in Deep Brain Stimulation (DBS) technologies for neurological and psychiatric diseases is demonstrated by 13 patent families and 90 granted patents in this area.
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, traditional DBS systems use leads with electrodes that send out electrical current in all directions, which can result in unwanted side effects.
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Aleva Neurotherapeutics Alexandre Grassin CFO: investors@aleva-neuro.com
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