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

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EMERYVILLE, Calif.--(BUSINESS WIRE)-- 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.

“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.”

The 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 is an established metric of visual function.

Four subjects also participated in the “Functional Low-Vision Observer Rated Assessment” (FLORA) at three years post-implantation. This involved an independent specialist spending time at the patients’ homes to observe various activities of daily living such as navigating a sidewalk or sorting laundry. All four subjects who completed the FLORA evaluation had positive or mildly positive results with Orion turned on versus turned off, indicating that the system was providing real-life benefits. Three subjects have had the devices removed (explanted) for various reasons unrelated to device safety or reliability. Cortigent anticipates extending the EFS by one year to allow further observation of the long-term safety, reliability, and visual function provided by the Orion System. The Orion System is an investigational device that will require successful completion of one or more large-scale pivotal clinical trial(s) and subsequent U.S. Food and Drug Administration (FDA) approval for commercialization.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani Medical develops miniaturized, subdermal biopharmaceutical implants designed to deliver drug molecules steadily at the intended dose over extended periods of time, with the goal of improving patient adherence and potentially improving tolerability to their medication. Vivani’s lead program, NPM-119, is a miniature, 6-month GLP-1 implant under investigation for the treatment of patients with Type 2 diabetes and/or obesity. NPM-119 can provide patients the opportunity to realize the full potential benefit of their medication while avoiding the hassles associated with the daily or weekly administration of oral and injectable products. 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 and poor tolerability are main reasons why Type 2 diabetes and/or obesity treatments face challenges in achieving optimal real-world effectiveness.

Vivani represents the August 2022 merger of Second Sight Medical Products, Inc., and Nano Precision Medical, Inc. NPM-119 (GLP-1 implant) remains the top priority for the combined company and an Investigational New Drug application remains on track for filing with the U.S. Food and Drug Administration (FDA) in mid-2023 to support initiation of a Phase 2 clinical study called Liberate-1. 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 Cortigent, Inc.

Cortigent Inc., a subsidiary of Vivani Medical, Inc., was formed to continue the business of Second Sight Medical Products, a pioneer in developing targeted neurostimulation systems to help patients recover critical body functions including profound blindness and the recovery of arm and hand function in patients who are partially paralyzed due to stroke. Cortigent has publicly filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) relating to a proposed initial public offering of its common stock. Cortigent intends to list its common stock on the Nasdaq Capital Market under the ticker symbol “CRGT.” A registration statement relating to the proposed offering has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

Cautionary Statement Regarding Forward-Looking Statements

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.

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

Source: Vivani Medical, Inc.

Released July 11, 2023