Business
Vivani Medical Reports First Quarter Financial Results and Provides Business Update
EMERYVILLE, Calif.--(BUSINESS WIRE)-- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized,
About this update from Vivani Medical, Inc.
[{"type":"text","content":" EMERYVILLE, Calif.--(BUSINESS WIRE)--\nVivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, long-term drug implants, including lead product NPM-119 for the treatment of patients with type 2 diabetes and/or obesity, today reported financial results for the first quarter and provided a business update. NPM-119 is a preclinical stage, 6-month, GLP-1 implant using Vivani’s proprietary NanoPortal™ implant technology.\n\n\nVivani continues to advance the development of its emerging portfolio of innovative, highly differentiated drug implants leveraging its proprietary NanoPortal™ subdermal implant technology designed to guarantee medication adherence and improve patient outcomes in the treatment of chronic diseases.\n\n\nAdam Mendelsohn, Chief Executive Officer said, “Vivani remains on schedule with the planned submission of an Investigational New Drug (IND) application for NPM-119 (GLP-1 implant) and the subsequent initiation of the proposed first-in-human Phase 2 clinical study of NPM-119, 'LIBERATE-1, in mid-2023.” Dr. Mendelsohn further commented, “We believe that NPM-119 has the potential to significantly improve real-world outcomes for the approximately half of patients with type 2 diabetes who are non-adherent with their medication. We further believe that NPM-119 may also provide an improved gastrointestinal side-effect profile compared to other available GLP-1 treatment options because of NPM-119’s steady drug delivery profile.” The LIBERATE-1 trial will be the first clinical study of the company’s platform NanoPortal implant technology.\n\n\nFirst Quarter Business Highlights\n\n\nIn January 2023, Vivani successfully completed the IND-enabling, non-clinical toxicology, and biocompatibility studies to support the planned IND submission for NPM-119 (exenatide implant) under development for the treatment of patients with type 2 diabetes. By mid-2023, we plan to file an IND with the U.S. Food and Drug Administration (the “FDA”) and, if clearance is obtained, initiate LIBERATE-1. LIBERATE-1 is a randomized, 12-week investigation of the safety, tolerability, and full pharmacokinetic profile of NPM-119 (GLP-1) implant in patients with type 2 diabetes. LIBERATE-1 will enroll patients who have been on a GLP-1 therapy which will be discontinued prior to receiving either ...