Vivani Medical’s Cortigent to present Orion clinical study results

Vivani Medical wholly-owned subsidiary Cortigent will present the Early Feasibility Study results for the Orion(R) Visual Cortical Prosthesis System at The Eye & The Chip: 13th World Research Congress on Artificial Vision in Southfield, Michigan on October 8-10, 2023. Cortigent’s Principal Investigator for the National Institutes of Health – funded Orion EFS, Uday Patel Ph.D., will give a talk covering the abstract “Orion Visual Cortical Prosthesis System: 5-year Clinical Trial Results” that has been accepted by this preeminent research congress focused on recent advances in nanoelectronics and neurobiology to provide artificial vision. Five years after implantation of the Orion device on the surface of the visual cortex of the brain, the three subjects who are still participating in the study have not reported any device malfunctions and continue to be able to use their systems at home and in their communities. The Orion EFS has been extended to a six-year study to assess the long-term safety, reliability, and visual function provided by this novel medical device, and to allow exploration of novel techniques to further improve efficacy. The Orion system is being developed with the goal of providing artificial visual to people who are profoundly blind due to many common causes, comprising more than 82,000 Americans according to a company-sponsored report. The Orion System is an investigational device that will require successful completion of one or more pivotal clinical trial(s) and subsequent U.S. Food and Drug Administration approval for commercialization.