ABILITY Neurotech Receives IMDD Approval to Start Clinical Trial for Chronic Implantation of Brain-Computer Interface in ALS Patients

GENEVA, May 26, 2026 /PRNewswire/ -- ABILITY Neurotech, a clinical-stage brain-computer interface (BCI) company developing a neural data platform to restore communication, movement and independence for individuals with severe neurological impairment, today announced it has received Investigational Medical Device Dossier (IMDD) approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands to initiate the first chronic implantation study of the company's fully implantable wireless optical-link ECoG BCI in patients with amyotrophic lateral sclerosis (ALS).

The approval marks an important milestone, transitioning ABILITY from intra-operative testing into chronic clinical investigation and representing the first long-term use of the company's implantable platform in humans. This achievement recognizes the comprehensive preclinical, biocompatibility, safety, software, and risk-management data and its alignment with European Medical Device Regulation (MDR) requirements.

The study will be conducted at the leading European BCI center UMC Utrecht (University Medical Center Utrecht, Netherlands) under the auspices of the INTRECOM consortium, bringing together UMC Utrecht, the Technical University of Graz (Austria), ABILITY Neurotech, and CorTec. The study will involve implantation of ABILITY's BCI in ALS patients to evaluate its performance as a home-use system to restore communication and speech, as an initial goal toward the platform's broader intended use.

"Receiving approval for our first chronic implantation study is a defining moment for both ABILITY and for the broader BCI field," said Rotem Kopel, PhD, 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."

ABILITY's BCI platform provides an approach for long-term sub-scalp implantability and full, high-fidelity brain data capture. Combining uncompromising safety and patient-centric design, it ensures long-term viability and comfort. The system collects and transmits raw, high-resolution neural signals via a novel infrared optical link and 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.

Built on a 50 Mb/s transcutaneous optical link, ABILITY's platform streams raw, broadband neural data at a fidelity not previously achievable in a fully implantable, battery-free device. This bandwidth captures the full spectrum of cortical activity and establishes a neural data foundation engineered to support the next generation of AI-driven BCI applications.

"For patients with severe motor impairment, the loss of communication is devastating," said Mariska Vansteensel, PHD, UMC Utrecht (INTRECOM clinical lead). "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."

The chronic study at UMC Utrecht together with a planned follow-up study at the Medical and Technical Universities of Graz, will complement ABILITY's current parallel intra-operative evaluation program at the Technical University of Munich (Germany), creating a dual-track clinical strategy that combines acute signal characterization with chronic human device performance.

About ABILITY Neurotech
ABILITY Neurotech is a full-stack brain-computer interface (BCI) company developing a fully implantable wireless optical-link BCI system to restore autonomy for patients living with debilitating neurological conditions, including ALS, spinal cord injury, and stroke. The company is addressing the historical trade-offs of BCI systems enabling safe, long-term implantability with a patient-centric, minimally invasive platform technology. Following a "data-first" approach, ABILITY's technology preserves the full content of neural recordings by enabling continuous streaming of raw data. This positions ABILITY to deliver superior clinical outcomes, while building foundational models for the next-generation of neurotech AI applications.

Based in Geneva, ABILITY spun out of the Wyss Center for Bio and Neuroengineering with the early support of philanthropist Hansjörg Wyss. Leveraging a dual EU/US regulatory pathway, it is establishing Europe as a global leader in safe and scalable neurotechnology.

For more information and updates, follow ABILITY on LinkedIn or visit https://abilityneuro.com/.

Media Contact:
Danny Sudwarts
FINN Partners for ABILITY Neurotech
[email protected]

SOURCE ABILITY Neurotech