CorTec's brain-computer interface for stroke recovery has received FDA breakthrough device status, facilitating its clinical development.
CorTec has received breakthrough device status from the U.S. Food and Drug Administration (FDA) for its innovative brain-computer interface (BCI) system aimed at stroke rehabilitation.
This designation is reserved for pioneering medical technologies that address serious health conditions, enabling faster development and evaluation while maintaining safety standards.
The approval focuses on a system that utilizes direct electrical stimulation of the cerebral cortex to help restore motor functions in patients with chronic motor impairments following a stroke.
CorTec's device features a closed-loop system that integrates neural signal recording with adaptive stimulation. Currently, it is being tested in FDA-approved clinical trials at the University of Washington in Seattle.
"This marks the first clinical trial of a completely implantable wireless BCI system for stroke recovery in humans," according to the company.
Stroke is a leading cause of long-term disability among adults, with approximately 9 million cases of ischemic stroke globally each year. In the U.S. and Europe alone, around 1.7 million occurrences are reported annually, leading to significant mobility issues for over 80% of patients and permanent disability in about 50% of cases.
Currently, there are no approved implantable options for individuals with chronic stroke-related motor impairments who show no improvement from standard therapies. Frank Desiere, CEO of CorTec, highlighted that only a handful of BCI companies have received similar breakthrough designations, emphasizing the critical need for such advancements in stroke rehabilitation.
"This is a notable achievement for CorTec, showcasing the promise of our system to fulfill a critical demand in stroke recovery," Desiere stated.
The device has demonstrated signal stability for up to 500 days. Beyond stroke rehabilitation, CorTec is also exploring its potential applications for treating epilepsy, paralysis, and depression. In an example of its capabilities, BCI user Galen Buckwalter has been able to compose music using only his thoughts.
