Vivani Medical Receives Regulatory Approval for the Initiation of SLIM-1, a Phase 1 Clinical Trial of NPM-139 Semaglutide Implant in Obesity and Chronic Weight Management

About this update from Vivani Medical, Inc.

ALAMEDA, Calif., June 25, 2026 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that it has received approval from Bellberry, a human research ethics committee (HREC) in Australia to initiate SLIM-1™, a Phase 1 clinical trial of NPM-139, a semaglutide implant. Vivani CEO Adam Mendelsohn, Ph.D., stated, "HREC approval to initiate SLIM-1 in Australia marks an important moment for our Company, clearing the way for near-term, mid-2026, initiation. We are eager to conduct this Phase 1 clinical trial of NPM-139, a semaglutide implant, building on the success of the Phase 1 clinical trial with NPM-119 (exenatide implant) we conducted in Australia in 2025." Dr. Mendelsohn continued: "In parallel with the execution of SLIM-1, our team is preparing diligently for SLIM-2 which, pending successful results from SLIM-1, we anticipate will be a dose-ranging efficacy-oriented trial of NPM-139 with the aim of accelerating the development of NPM-139's clinical program. We believe that the market demand for a miniature, reversible GLP-1 implant technology will be strong, and we are fully committed to bringing this important technology to patients. We are grateful for the regulatory approval to initiate SLIM-1 and we look forward to providing further SLIM-1 updates as we proceed." About SLIM-1 SLIM-1 (Semaglutide ultra Long-acting IMplant in obesity) is a Phase 1 open label, randomized, active comparator-controlled clinical trial evaluating a low-dose NPM-139 (semaglutide NanoPortal implant) and Wegovy (0.25 mg/week) over a four-week duration in obese or overweight subjects (n=10 per group). The trial will primarily assess the safety, tolerability, and pharmacokinetics of NPM-139. Weight loss will be measured. 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 improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. 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. For more information, please visit: https://vivani.com.

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