The procedure took place in an FDA-approved clinical trial involving stroke patients at Harborview Medical Center of UW Medicine. It follows the initial procedure in the study, which took place at the same Seattle center in July 2025. Co-principal investigators Dr. Jeffrey G. Ojemann and Dr. Steven C. Cramer performed both procedures.
Freiburg, Germany-based CorTec says the first procedure demonstrated encouraging neurological gains already. Its trial aims to collect initial safety data and evaluates whether direct cortical electrical stimulation can enhance upper-limb motor recovery in stroke patients.
The company won FDA investigational device exemption (IDE) to conduct the trial for its closed-loop BCI platform in May 2024.
CorTec designed its Brain Interchange system 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. CorTec’s study explores whether the system can help the brain relearn lost functions, accelerating and improving the rehabilitation of patients.
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 said that, on the back of two successful surgeries, it plans to enroll further participants and continue to gather data.
Commentary from CorTec officials and study investigators
Dr. Frank Desiere, CEO of CorTec, said:
“This second implantation is a milestone for our technology and the progress of our clinical program. More importantly, it brings us closer to realizing the potential of a new class of neurotherapeutic solutions that could meaningfully improve outcomes for patients with neurological conditions and lays the groundwork for the next phase of clinical and technology development.”
Dr. Ojemann, vice chair and professor of neurological surgery, University of Washington School of Medicine, said:
“We are very encouraged by the outcome of this second implantation and pleased with the participant’s steady recovery. The notable rehabilitation progress and meaningful neurological gains observed in our first study participant using CorTec’s BCI system has led us to this next phase. Each procedure helps us refine safe clinical practices for this emerging neurotechnology and explore its potential to improve outcomes for patients in the future.”
