Second implantation at Harborview Medical Center in Seattle marks continued progress in the FDA-approved study informed by promising results from the first participant.
CorTec, a pioneer in active implantable medical technologies, has announced the “successful second implantation” of its proprietary Brain-Computer Interface (BCI) system, the Brain Interchange, in an FDA‑approved clinical trial involving stroke patients at Harborview Medical Center, a major site of UW Medicine.
The implantation follows encouraging neurological gains observed in the study’s first participant, whose rehabilitation progress has strengthened confidence in CorTec’s fully implantable platform for stroke recovery.
This represents another key milestone in the joint effort to evaluate CorTec’s fully implantable closed-loop BCI platform, developed and manufactured entirely in Germany, for therapeutic applications in neurological disorders.
This second procedure took place in early February at Harborview Medical Center (Seattle) under an FDA Investigational Device Exemption (IDE).
Led by Principal Investigator Jeffrey G. Ojemann, MD, from the University of Washington School of Medicine in Seattle and Co PI Professor Steven C. Cramer from the University of California, Los Angeles, the trial gathers initial safety data and evaluates whether direct cortical electrical stimulation can enhance upper-limb motor recovery in stroke patients.
The study is funded by the National Institutes of Health (NIH).
“The procedure went smoothly, and the participant is recovering as expected,” said Dr. Martin Schuettler, CTO of CorTec. “Having supported the implantation of our BCI system on site for a second time, it is inspiring to see how seamlessly our teams at CorTec and UW Medicine work together.
“This kind of clinical and technical research collaboration is essential to deliver these procedures safely. With each step, we gain important insights that strengthen our confidence in the future of this technology.”
Jeffrey G. Ojemann, MD, 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.”
With two successful surgeries completed at Harborview Medical Center, the study will enroll further participants and continue to gather neural and behavioral data. CorTec’s implantable closed-loop BCI platform is designed to continuously record and interpret neural activity with high fidelity and deliver targeted electrical stimulation in real time.
This novel approach enables highly precise and personalized neurotherapeutic interventions by enhancing neuroplasticity – the brain’s ability to reorganize neural networks – and explores whether lost functions can be relearned, potentially accelerating and improving patient rehabilitation through the integration of engineering, neurophysiology, and machine learning.
“This second implantation is a milestone for our technology and the progress of our clinical program,” said Dr. Frank Desiere, CEO of CorTec.
“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.”
CorTec will continue to share updates as the study progresses, and additional insights emerge.
