Sam Brusco, Associate Editor05.24.24
CorTec and the University of Washington (UW) School of Medicine have gained investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) for its closed-loop Brain Interchange Implant system.
The study will evaluate a novel stroke rehab treatment that uses cortical stimulation to enhance the brain’s plasticity. The company aims to offer a fully implantable, closed-loop brain-computer interface (BCI) for clinicians to investigate therapies. CorTec’s chief technology officer Dr. Martin Schuettler said the closed-loop functionality offers new potential for highly individualized treatments.
“The system is capable of interchanging information between biology and technology, between brain and computer,” Dr. Schuettler told the press. “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.”
The first IDE study of the Brain Interchange system will be conducted in partnership with principle investigator professor Jeffrey G. Ojemann from the University of Washington School of Medicine in Seattle as well as Prof. Steven C. Cramer from the University of California Los Angeles and their respective teams. The consortium hopes to gather initial first-in-human safety data and develop/evaluate novel therapeutic rehab approaches for upper limb impairment in stroke patients with direct cortical electrical stimulation delivered by the Brain Interchange System.
CorTec said patient enrollment and first implant of the neural interfacing system are scheduled for Q3 2024.
“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.”
The study will evaluate a novel stroke rehab treatment that uses cortical stimulation to enhance the brain’s plasticity. The company aims to offer a fully implantable, closed-loop brain-computer interface (BCI) for clinicians to investigate therapies. CorTec’s chief technology officer Dr. Martin Schuettler said the closed-loop functionality offers new potential for highly individualized treatments.
“The system is capable of interchanging information between biology and technology, between brain and computer,” Dr. Schuettler told the press. “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.”
The first IDE study of the Brain Interchange system will be conducted in partnership with principle investigator professor Jeffrey G. Ojemann from the University of Washington School of Medicine in Seattle as well as Prof. Steven C. Cramer from the University of California Los Angeles and their respective teams. The consortium hopes to gather initial first-in-human safety data and develop/evaluate novel therapeutic rehab approaches for upper limb impairment in stroke patients with direct cortical electrical stimulation delivered by the Brain Interchange System.
CorTec said patient enrollment and first implant of the neural interfacing system are scheduled for Q3 2024.
“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.”