Hospital Management

ABILITY Neurotech receives MREC approval for ALS BCI clinical trial

The clearance enables ABILITY Neurotech to move beyond intra-operative testing to long-term clinical investigation involving human participants.

ABILITY Neurotech has secured approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to initiate a chronic clinical trial of its fully implantable wireless brain-computer interface (BCI) in patients with amyotrophic lateral sclerosis (ALS).

The study will mark the company’s first chronic implantation in humans and will be conducted at University Medical Center Utrecht (UMC Utrecht), a European centre specialising in BCI research.

Approval was granted under the Investigational Medical Device Dossier (IMDD) procedure, allowing ABILITY Neurotech to move from intra-operative testing to a long-term clinical study involving human participants. The company says this is the first time its implantable platform will be used chronically in humans.

The clearance follows a review of preclinical evidence on biocompatibility, safety, and risk management, as well as confirmation of alignment with the European Medical Device Regulation.

The trial will run under the INTRECOM consortium, which includes UMC Utrecht, the Technical University of Graz (Austria), ABILITY Neurotech, and CorTec.

It will involve implanting the company’s BCI device in patients with ALS and will primarily evaluate performance in restoring communication and speech for use at home.

ABILITY Neurotech CEO Rotem Kopel said: “Receiving approval for our first chronic implantation study is a defining moment for both ABILITY and for the broader BCI field.

“The industry has long focused on proving neural interfaces can work in controlled environments. This study moves the field significantly in the direction of delivering a practical and scalable system that patients can use independently in everyday life.

“It validates our belief that the future of BCI lies in the fully implantable, data-rich, patient-centric platform engineered by ABILITY for long-term real-world use.”

ABILITY Neurotech’s platform features a sub-scalp, battery-free implant that uses a 50 megabits per second (Mbps) transcutaneous infrared optical link to stream high-resolution neural data.

The device aims to interpret a patient’s neural activity and convert it into digital actions such as autonomous text generation and real-time communication.

The company also plans a follow-up study at the Medical and Technical Universities of Graz in Austria, as well as a separate short-term study at the Technical University of Munich in Germany.