The IDE allows the University of Washington School of Medicine (UW) to evaluate CorTec’s Brain Interchange implant system in a clinical study. It will investigate the novel stroke rehabilitation treatment that uses cortical stimulation to enhance plasticity within the brain.
CorTec designed its Brain Interchange system to deliver fully implantable, closed-loop BCI to clinicians to investigate therapies. CTO Dr. Martin Schuettler believes the closed-loop functionality enables new possibilities for individualized treatments, according to a news release.
“The system is capable of interchanging information between biology and technology, between brain and computer,” Schuettler said. “That’s why we call it CorTec Brain Interchange. With our system, we are providing the technological tools that are needed to develop new therapies and brain-computer interface applications.”
Teams at Washington and UCLA will conduct the first IDE study utilizing the CorTec system. The studies have NIH funding and aim to obtain initial first-in-human safety data. Additionally, investigators hope to look at the development of novel therapeutic rehabilitation approaches for upper limb impairment in stroke patients through direct cortical electrical stimulation delivered by Brain Interchange. They slated earmarked the third quarter of 2024 for enrollment and the first implant.
“We are very excited about the feedback from the FDA,” said CorTec CEO Dr. Oliver Baertl. “This was an important first step for CorTec to support clinical research in the fast growing neuromodulation and brain-computer interface space. We foresee many more studies with our device. The first in human use will be the next milestone for our technology and our company.”
