Vivani Medical Inc (VANI) News & EventsVANINews & EventsVivani Medical Inc

Vivani Medical Completes Enrollment for NPM-139 Clinical Trial

Vivani Medical announced full enrollment and successful initial dosing of all participants in its SLIM-1 Phase 1 trial for NPM-139, a miniature, subdermal semaglutide implant being designed to provide six- to twelve-months of continuous drug delivery utilizing our proprietary NanoPortal technology. The trial of 20 GLP-1 naive participants in Australia includes low-doses of NPM-139 and Wegovy to assess safety, tolerability, and pharmacokinetics. Changes in weight will be measured.

Vivani Medical Signs Agreement with Novo Nordisk to Evaluate NPM-139

Vivani Medical (VANI) announced the signing of a new agreement with Novo Nordisk (NVO) to enable Novo Nordisk to evaluate NPM-139, the company's semaglutide drug implant. NPM-139, which utilizes Vivani's NanoPortal platform technology, is under development for chronic weight management. There are no exclusivity provisions for NPM-139, or Vivani's proprietary NanoPortal technology associated with this agreement. Separately, Vivani expects to initiate a Phase 1, randomized, first-in-human study evaluating the NPM-139 semaglutide implant, with Wegovy injections as an active comparator, in mid-2026. The study's objectives are to characterize the safety, pharmacokinetics, and tolerability of NPM-139 to support the initiation of a Phase 2 dose-ranging study pending successful results of the Phase 1 study.

Vivani Medical Enters Merger Agreement with ClearOne

Vivani Medical (VANI) announced that it has entered into a definitive agreement and plan of merger among its wholly owned subsidiary Cortigent, ClearOne (CLRO) and a wholly owned subsidiary of ClearOne, pursuant to which Cortigent will become a wholly owned subsidiary of ClearOne upon consummation. In connection with the transaction, ClearOne has agreed to file a registration statement on Form S-1 to raise a minimum of $10M and a maximum of $15M concurrently with the closing of the transaction. As consideration for all of the issued and outstanding shares of common stock of Cortigent, Vivani will receive 12,500,000 shares of common stock of ClearOne. It is anticipated that Vivani will own 59.4% to 67.5% of the outstanding equity in the combined company and the former shareholders of ClearOne will own 12.7% to 14.4% of the outstanding equity in the combined company. ClearOne will be renamed Cortigent Holdings and is expected to trade under Nasdaq ticker symbol (CRGT). Upon closing, the combined company will be majority-owned by Vivani and will operate independently under the oversight of the reconstituted board of directors. The transaction has been unanimously approved by the boards of directors of both Vivani and ClearOne and is expected to close in the third quarter of 2026, subject to customary closing conditions, including receipt of the required stockholder approvals, closing of the financing, meeting the minimum net cash requirements set forth in the agreement, and the continued listing of the combined company's common stock on Nasdaq.