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Vivani Medical, Inc. Subsidiary Cortigent Reports 5-Year Early Feasibility Study Update for the Orion® Visual Cortical Prosthesis System
EMERYVILLE, Calif.--(BUSINESS WIRE)-- Vivani Medical, Inc. (NASDAQ: VANI), an innovative, near-clinical stage biopharmaceutical company that is developing
About this update from Vivani Medical, Inc.
[{"type":"text","content":" EMERYVILLE, Calif.--(BUSINESS WIRE)--\nVivani 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.\n\n\n“Reaching the five-year milestone reinforces the safety and reliability profile of Orion observed to date,” said Dr. Ausaf Bari, lead investigator at UCLA, “and considering the user benefits observed during the three-year patient evaluations, we believe this innovative medical device [if approved by regulatory authorities] has the potential to deliver meaningful visual perception to profoundly blind people.”\n\n\nThe Orion system is being developed with the goal of providing useful visual perception to people who are profoundly blind due to many common causes, comprising more than 82,000 Americans according to a company-sponsored report. Five of the initial six subjects participated in an efficacy evaluation at three years post-implantation. All five were reported to have performed significantly better with the Orion system turned on versus turned off for “Square Localization” which involved pointing to a lighted square on a computer screen, and “Direction of Motion” which involved identifying the direction of motion of a line traversing a computer screen. Two of the five subjects achieved measurable “Grating Visual Acuity,” which...