Breakthrough designation covers the use of direct cortical electrical stimulation to support motor recovery in people with chronic stroke-related impairments.
Freiburg, Germany–based CorTec designed its Brain Interchange to deliver fully implantable, closed-loop BCI to clinicians to investigate therapies. The company believes the closed-loop functionality enables new possibilities for individualized treatments.
Brain Interchange continuously records brain activity, instantly interprets signals and delivers targeted electrical stimulation in real time. It enhances neuroplasticity — the brain’s ability to reorganize neural networks.
The company says that patients with the BCI may benefit from neuroplasticity-inducing stimulation during rehabilitation. Regaining control of the upper limbs would enable more independence and quality of life for patients. The company believes its BCI could potentially accelerate and improve patient rehabilitation through the integration of engineering, neurophysiology, and machine learning.
CorTec currently has its BCI under evaluation in a clinical trial, announcing its latest implantation in February. It won FDA investigational device exemption (IDE) to conduct the trial for its closed-loop BCI platform in May 2024.
The company currently has Brain Interchange under evaluation for epilepsy. It intends to explore indications like paralysis and depression, with development ongoing for those areas.
In a news release, Dr. Frank Desiere, CEO of CorTec, said:
“Only a few BCI companies worldwide – including Neuralink, Synchron, or Blackrock Neurotech – have received Breakthrough Device Designation to date. 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 in Seattle as well as additional long-term data published in Nature Scientific Data1 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.”
