Vivani Medical Subsidiary Cortigent Reports 5-Year Early Feasibility Study Update for the Orion Visual Cortical Prosthesis System

Vivani Medical, Inc. (NASDAQ:VANI), an innovative, near-clinical stage biopharmaceutical company that is developing novel, miniature, long-term therapeutic implants, announced today that its wholly-owned subsidiary Cortigent, Inc., a company pioneering neurostimulation to recover critical body function, has completed the fifth year of its Early Feasibility Study (EFS) of profoundly blind patients implanted with the Orion® Visual Cortical Prosthesis System. The National Institutes of Health – funded Orion EFS commenced in 2017 and enrolled six subjects at two universities, the University of California, Los Angeles (UCLA) and Baylor College of Medicine. Five years after implantation of the Orion device on the surface of the visual cortex area of the brain, the three subjects who are still participating in the study have reported no device malfunctions and continue to be able to use their systems at home and in their communities. In terms of safety, a single serious adverse event (SAE) was reported during initial testing in the first three months after implantation which resolved quickly and resulted in no permanent harm. No SAEs have been reported since then.