Vivani Medical NASDAQ: VANI said it is preparing to begin human testing of its semaglutide implant in August and highlighted a recently announced agreement with Novo Nordisk to evaluate the company’s implant technology.
Adam Mendelsohn, co-founder, CEO and director of Vivani Medical, said the past several months have been “some of the most exciting” in the company’s history, citing the Novo Nordisk agreement as a key recent development. Vivani is developing biopharmaceutical implants using its proprietary NanoPortal platform, designed to deliver drug molecules steadily over extended periods.
Company Positions Implant as GLP-1 Adherence Solution
Mendelsohn said Vivani is focused on the obesity and GLP-1 market, where drugs have enabled significant weight loss and potential long-term health benefits. He said Vivani’s implant approach is intended to provide “very infrequent administration,” potentially once or twice a year, while retaining the ability to stop treatment quickly through implant removal.
He contrasted the company’s approach with longer-acting injectables and gene-editing approaches, saying Vivani’s implant could offer convenience while addressing issues tied to missed doses and treatment discontinuation. Mendelsohn said the company expects the implant could improve real-world outcomes by “essentially guaranteeing adherence” and delivering stable drug levels over time.
Vivani’s lead GLP-1 program is NPM-139, a semaglutide implant. Semaglutide is the active ingredient in Ozempic and Wegovy. Mendelsohn said the company is developing the implant to deliver semaglutide for six or potentially 12 months.
Novo Nordisk to Evaluate Semaglutide Implant
Mendelsohn said Vivani recently announced an agreement with Novo Nordisk under which Novo Nordisk will evaluate Vivani’s semaglutide implant. He described the agreement as notable, saying that, to Vivani’s knowledge, it represents the first public indication of potential big pharma interest in an implant modality for GLP-1s.
“To our knowledge, we are the only company that's actively developing such a solution,” Mendelsohn said during the presentation.
He said Vivani has made “considerable progress” developing the semaglutide implant and is looking ahead to both its upcoming clinical trial results and Novo Nordisk’s evaluation.
SLIM-1 Trial Expected to Begin Dosing in August
Mendelsohn said Vivani is now projecting first dosing in its SLIM-1 clinical trial to occur in August. The company received regulatory approval to begin the study in June, he said.
The initial study is designed to assess translation from animal models to humans using a low dose. Mendelsohn said Vivani selected an implant dose intended to match the starting dose of the Wegovy titration sequence, approximately 0.25 milligrams per week for a four-week duration.
The study is expected to assess safety, tolerability and pharmacokinetics, while also measuring weight loss. Mendelsohn said the active control will be 0.25 milligrams per week Wegovy treatment.
If the initial study provides confidence, Vivani expects to move into a more efficacy-oriented dose-ranging study. In that planned study, patients would be titrated to a Wegovy maintenance dose before being randomized to three different doses of Vivani’s semaglutide implant, placebo or continued Wegovy treatment for up to approximately six months.
Company Cites Broader Platform Potential
Mendelsohn said Vivani has also begun work with next-generation incretin molecules, including retatrutide, Eli Lilly’s triple agonist drug. He said Vivani views its technology as a platform that could be applied to newer molecules as the GLP-1 and incretin market develops.
In addition to obesity, Mendelsohn said the company is exploring a semaglutide implant application for type 2 diabetes and continuing efforts to make the technology available for cats and dogs.
Vivani said it has cash runway into the second half of 2027. Mendelsohn said the company remains focused on improving adherence, tolerability and convenience in GLP-1 treatment through long-duration implant delivery.
About Vivani Medical (NASDAQ:VANI)
Vivani Medical Solutions, Inc NASDAQ: VANI is a medical technology company focused on the design, development and commercialization of advanced specimen retrieval and hemostasis products for minimally invasive diagnostic procedures. Its core mission is to enhance procedural safety and streamline clinical workflows for interventional radiologists and pathology laboratories.
The company's flagship offerings include the StopBleed Retrieval Device and StopBleed Pad, which integrate proprietary hemostatic materials to control bleeding at biopsy sites and preserve tissue integrity.
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