Clinical-stage brain-computer interface (BCI) company ABILITY Neurotech has received approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to initiate the first chronic implantation study of its fully implantable wireless optical-link electrocorticography (ECoG) BCI platform in patients with Amyotrophic Lateral Sclerosis (ALS).
The study will be conducted at University Medical Center Utrecht, one of Europe’s leading BCI research centers. It will initially evaluate the performance of ABILITY’s BCI as a home-use system to restore communication and speech in ALS patients.
Approval was granted under the Investigational Medical Device Dossier (IMDD) procedure, enabling ABILITY Neurotech to move beyond intra-operative testing into chronic clinical investigation. According to the company, this marks the first long-term use of its implantable platform in humans.
“Receiving approval for our first chronic implantation study is a defining moment for both ABILITY and for the broader BCI field,” said Rotem Kopel, CEO of ABILITY Neurotech.
“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 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,” he added.
The approval follows an extensive review of preclinical, biocompatibility, safety, software and risk-management data, confirming alignment with European Medical Device Regulation (MDR) requirements.
The trial will be carried out under the INTRECOM consortium, which includes UMC Utrecht, the Technical University of Graz (Austria), ABILITY Neurotech, and CorTec.
“For patients with severe motor impairment, the loss of communication is devastating,” said Mariska Vansteensel, UMC Utrecht (INTRECOM clinical lead), adding, “Implantable BCI’s represent an important step towards restoring a reliable means of interaction and independence for people who are otherwise locked inside their own bodies.”
ABILITY’s BCI platform is designed for long-term sub-scalp implantation and high-fidelity brain data capture. The system uses a novel infrared optical link to collect and transmit raw, high-resolution neural signals. It is designed to translate full neural intent directly into digital action, including enabling autonomous text-generation, interaction with assistive technologies, and real-time communication, all directly from a patient’s thoughts.
Powered by a 50 Mb/s transcutaneous optical link, the platform streams raw, broadband neural data at a fidelity the company says has not previously been achieved in a fully implantable battery-free system. This capability could provide a foundation for the next generation of AI-driven BCI applications.
The company also plans a follow-up study at the Medical and Technical Universities of Graz, while its intra-operative evaluation programme at the Technical University of Munich remains ongoing.
