Vivani Medical Subsidiary Cortigent to Present Orion Clinical Study Results at The Eye and The Chip World Research Congress on Artificial Vision October 8-10

Rhea-AI Summary

Vivani Medical's subsidiary, Cortigent, to present 5-year clinical trial results for Orion Visual Cortical Prosthesis System at research congress, showing no device malfunctions and potential for meaningful visual perception for blind individuals. Study extended to six years for further assessment. Positive potential for future pivotal study and FDA approval.

Positive

• No device malfunctions reported after 5 years of implantation
• Potential for meaningful visual perception for blind individuals
• Study extended to six years for further assessment
• Positive potential for future pivotal study and FDA approval

Negative

• None.

EMERYVILLE, Calif.--(BUSINESS WIRE)-- 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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This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “potential”, “may,” “anticipate,” “estimate,” “would,” “could”, “should” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding our business, products under development, including the therapeutic potential thereof and the planned development therefor, technology and strategy. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of our products under development, including NPM-119; delays and changes in applicable laws, regulations and guidelines including potential delays in submitting required regulatory applications to the U.S. Food and Drug Administration (“FDA”); risks related to the initiation, enrollment and conduct of our planned clinical trials and the results therefrom; our history of losses and our ability to achieve or sustain profitability in the future; and the impact of COVID-19 on our business. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K, and any subsequent quarterly filings on Form 10-Q filed with the Securities and Exchange Commission. There may be additional risks that the Company considers immaterial, or which are unknown and new risks emerge from time to time. Any forward-looking statement made by us in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

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Company Contact:

Donald Dwyer

Chief Business Officer

info@vivani.com

(415) 506-8462

Investor Relations Contact:

Brigid Makes

Chief Financial Officer

investors@vivani.com

(415) 506-8462

Media Contact:

Sean Leous

ICR Westwicke

Sean.Leous@westwicke.com

(646) 866-4012

Source: Vivani Medical, Inc.