Geneva, Switzerland-based Ability received Investigational Medical Device Dossier (IMDD) approval from the Medical Research Ethics Committee (MREC) NedMec in the Netherlands. It allows the company to evaluate its fully implantable, wireless optical-link BCI in patients with amyotrophic lateral sclerosis (ALS).
Ability says the approval allows it to transition from intraoperative testing into chronic clinical investigation. It marks the first long-term use of the implantable BCI in humans.
The Ability Neurotech BCI device features electrodes, the implant itself and a wearable external device. It offers a highly advanced capability to record, transmit, analyze, and stimulate the brain. The company seeks to restore fundamental functions and improve the quality of life for patients.
Initial access takes place through a small borehole, with electrodes sitting on the cortex (the surface of the brain). The invisible, battery-free implant is placed on the skill with the skin closed over the skull, thanks to its thin form factor. Ability’s wearable device docks by magnets to keep it in place and the data transfers through a laser-based system. The technology extracts the raw data of a brain recording, with the laser working with the external device to send a large capacity of high-speed data over multiple parameters.
With this data, the system can translate full neural intent directly into digital action. It enables autonomous text-generation, interaction with assistive technologies and real-time communication all from a patient’s thoughts.
Read more about Ability Neurotech’s plans for the future here.
Read more about the Ability Neurotech technology here.
The company plans to conduct its study at UMC Utrecht, a leading European BCI center, under the INTRECOM consortium. This brings together UMC Utrecht, the Medical and Technical University of Graz (Austria), Ability and CorTec, another BCI maker.
Ability expects the study to evaluate the BCI’s performance as an at-home system to restore communication and speech in ALS patients. It hopes to demonstrate the implant’s capabilities with eyes on broader uses.
The study at UMC Utrecht, together with a planned follow-up study at the Medical and Technical University of Graz, will complement the company’s current parallel intraoperative evaluation ongoing at the Technical University of Munich, it said. This creates a dual-track clinical strategy to combine signal characterization with chronic human device performance.
“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.”
