ABILITY Neurotech Receives Approval for Chronic Brain Implant Study in ALS Patients

ABILITY Neurotech announced in a press release that it has received Investigational Medical Device Dossier (IMDD) approval from the Medical Research Ethics Committee NedMec in the Netherlands to begin a chronic implantation clinical trial of its fully implantable wireless optical-link brain-computer interface in patients with amyotrophic lateral sclerosis.

The study will take place at UMC Utrecht, a leading European brain-computer interface center, under the INTRECOM consortium, which includes UMC Utrecht, the Technical University of Graz, ABILITY Neurotech, and CorTec. The trial will evaluate the system's use at home to restore communication and speech in ALS patients.

The approval marks ABILITY's transition from intra-operative testing to chronic clinical investigation and represents the first long-term human use of its implantable platform. The company's system captures high-fidelity brain data through a 50 Mb per second optical link designed for continuous transmission of raw neural signals.

A follow-up study is planned at the Medical and Technical Universities of Graz, complementing ABILITY's ongoing intra-operative evaluation program at the Technical University of Munich. Together, these studies form a dual-track clinical strategy to assess both acute and long-term device performance.