Vivani Medical, Inc. (NASDAQ: VANI), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, announced today that its wholly-owned subsidiary Cortigent, Inc., a company pioneering targeted neurostimulation technology to recover critical body functions, will present the Early Feasibility Study (EFS) results for the Orion^® 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 (UH3NS103442), 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.

“Based on the user benefits and safety profile we have seen to date,” said Dr. Patel, “we believe the Orion system could become a major advance in the quest to deliver meaningful visual perception to profoundly blind people. The knowledge gained through the EFS will help guide us as we pursue a pivotal study.”

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 (FDA) approval for commercialization.

About Cortigent, Inc.

Cortigent Inc., a subsidiary of Vivani Medical, Inc., was formed to continue the business of Second Sight Medical Products and is a pioneer in developing targeted neurostimulation systems to help patients recover critical body functions. Cortigent’s investigational devices include Orion, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. The company has developed, manufactured, and marketed an implantable visual prosthetic device, Argus II®, that delivered meaningful visual perception to persons affected by a rare form of blindness.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve tolerance to their medication. Vivani’s lead program NPM-119 is a miniaturized, 6-month GLP-1 implant under investigation for the treatment of patients with type 2 diabetes and is also under consideration for the treatment of obesity. NPM-119 is designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness. Vivani is also developing a portfolio of innovative, highly differentiated, new drug products leveraging its proprietary NanoPortal implant technology, which has potential application across a broad range of compounds including peptide therapeutics. For more information, please visit www.vivani.com.

About The Eye and The Chip

The Eye and The Chip is a research congress that seeks to marry the most recent advances in nanoelectronics and neurobiology – to provide artificial vision to many people who are now blind as a result of many eye conditions, diseases and injuries. Results from the congress will advance the day when many persons now blind recover some level of useful vision. At this collaborative event, the Detroit Institute of Ophthalmology brings together more than 30 authorities from various vision science and technology fields.

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