CorTec announced today that the US Food and Drug Administration (FDA) has granted a Breakthrough Device designation for the company’s novel brain-computer interface (BCI) technology—the Brain Interchange system. This designation covers the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments.
“Only a few BCI companies worldwide—including Neuralink, Synchron and Blackrock Neurotech—have received Breakthrough Device designation to date,” said CorTec chief executive officer (CEO) Frank Desiere. “Achieving this designation is a defining milestone for CorTec and underscores the potential of our Brain Interchange system to address the significant unmet need in stroke rehabilitation. Together with promising initial results from our first-in-human study […] as well as additional long-term data published in Nature Scientific Data demonstrating signal stability over 500 days, this designation provides strong momentum as we advance toward larger clinical trials. We believe CorTec occupies a unique position in the global BCI landscape, combining a fully implantable, bidirectional closed-loop platform with a therapeutic approach focused on restoring motor function after stroke.”
CorTec details that its Brain Interchange system combines neural signal recording with adaptive stimulation in a closed-loop system. The platform is currently being evaluated in a US FDA-approved investigational device exemption (IDE) study at the University of Washington in Seattle, USA, marking “the first clinical investigation of a fully implantable, wireless BCI system for stroke rehabilitation in humans”, the company also claims.
In a press release, CorTec further states that its approach represents a “distinct direction” within the global BCI field—adding that, while a number of BCI systems have received Breakthrough Device designation but are restricted to enabling patient communication by controlling digital devices via thought, the Brain Interchange platform is being developed as a fully implantable, bidirectional device, enabling brain-based communication but also therapeutic neurostimulation that may allow the restoration of motor function after stroke. At present, no other BCI company worldwide holds a US FDA Breakthrough Device designation for this indication, the release notes.
“The Breakthrough Device designation enables more frequent and structured engagement with the US FDA as we advance our development programme,” commented Mara Assis, head of regulatory affairs and quality management at CorTec. “Our regulatory strategy has followed a stepwise approach, from prior device clearance to IDE approval and successful human implantations. This designation will help accelerate planning of clinical trials and support the next regulatory milestones.”
CorTec says it is continuing to advance the Brain Interchange system as a flexible, adaptive platform with potential applications across multiple neurological conditions; in addition to the ongoing stroke rehabilitation study, the company’s platform is also being evaluated for epilepsy, with further indications including paralysis and depression under development too.
