FDA Grants Investigational Device Exemption for Early Feasibility Study on Stroke Rehabilitation Utilizing CorTec’s Closed-Loop Brain Interchan

Friday, May 24, 2024

CorTec just shared exciting news: the US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application from the University of Washington School of Medicine (UW) for their closed-loop Brain Interchange Implant System.

This system will be used in a clinical study to explore a novel stroke rehabilitation method involving cortical stimulation to enhance brain plasticity. With FDA approval granted for human use of the Brain Interchange System, CorTec is ready to support clinicians and research teams with its advanced implant technology for investigating new treatments for neurological conditions.

The Brain Interchange System, developed by CorTec, offers clinicians a fully implantable closed-loop Brain-Computer Interface (BCI) for therapy investigations, CorTec's Chief Technology Officer, emphasizes the system's closed-loop functionality, which enables highly personalized treatments. He explains, "Our system facilitates the exchange of information between biology and technology, between the brain and computer.

Hence, we term it CorTec Brain Interchange. Through our system, we provide the technological groundwork necessary for developing novel therapies and brain-computer interface applications."

With FDA clearance secured, CorTec is collaborating with partners in the USA to advance the development of innovative therapies. The first IDE study involving the Brain Interchange System will be conducted in partnership with prominent figures in the field, including Professor Jeffrey G. Ojemann from the University of Washington School of Medicine and Professor Steven C. Cramer from the University of California Los Angeles, along with their respective teams.

Supported by funding from the US National Institutes of Health (NIH), the consortium aims to gather initial safety data and explore new therapeutic approaches for upper limb impairment in stroke patients using direct cortical electrical stimulation delivered by the Brain Interchange System. Patient enrollment and the first implantation of the neural interfacing system are scheduled for the third quarter of 2024.

Assistant Professor at the University of Washington and co-investigator of the NIH-funded study, underscores the significance of FDA approval for the upcoming IDE study: "In the United States, studies involving devices with significant risks necessitate approval from both the FDA and institutional review boards before participant recruitment.

The FDA's review process for Investigational Device Exemptions involves thorough scrutiny of study protocols, hazard analyses, and manufacturer documents to ensure the device's suitability for the study. Obtaining FDA approval marks a critical milestone, signaling readiness to proceed with participant recruitment pending local institutional review board approval."

CEO of CorTec, expresses enthusiasm about the FDA's decision: "We are thrilled with the FDA's feedback! This marks an essential first step for CorTec in supporting clinical research in the rapidly expanding fields of neuromodulation and Brain-Computer Interface. We anticipate many more studies utilizing our device. The first human application will represent the next milestone for our technology and our company."


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