Vivani Medical, Inc. is a preclinical stage biopharmaceutical company, which engages in the business of developing miniaturized, subdermal implants utilizing proprietary NanoPortal technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. It operates under the Biopharm Division and Neuromodulation Division segments. The company was founded by Adam Mendelsohn on May 22, 2003 and is headquartered in Alameda, CA.
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- Novo Nordisk has signed a non-exclusive agreement with Vivani Medical to evaluate NPM-139, a miniature semaglutide drug implant utilizing the NanoPortal platform technology for chronic weight management. - Vivani expects to initiate a Phase 1, randomized, first-in-human study in mid-2026 comparing the NPM-139 implant with Wegovy injections, assessing safety, pharmacokinetics, and tolerability. - The NanoPortal implant platform is designed to provide near-constant, controlled drug release over extended periods, potentially enabling once- or twice-yearly dosing for GLP-1 therapies. - The collaboration underscores growing interest in long-acting implantable drug delivery systems that could address medication non-adherence, which affects approximately 50% of patients on prescription therapies.
- Vivani Medical has entered a definitive merger agreement to combine its wholly owned subsidiary Cortigent with ClearOne, creating a new publicly traded entity focused on brain-computer interface devices. - The transaction will see ClearOne renamed Cortigent Holdings, trading under the ticker "CRGT," with Vivani retaining 59.4% to 67.5% ownership of the combined company. - Cortigent's lead program, the Orion cortical stimulation system for blindness, has FDA Breakthrough Device Designation and completed a six-year early feasibility study in 2025 with promising results. - The deal includes a concurrent financing of $10 million to $15 million to accelerate development of Orion and a stroke rehabilitation device, with closing expected in Q3 2026.
- Vivani Medical's NPM-139 semaglutide implant demonstrated sustained weight loss exceeding 20% for a full year in preclinical studies with single administration. - The company successfully completed its first-in-human LIBERATE-1 study using NanoPortal technology, showing positive safety and tolerability profiles. - Phase 1 clinical trials for NPM-139 are planned to begin in mid-2026 in Australia, with results expected by the end of 2026. - The company raised $41.5 million in gross proceeds and maintains sufficient cash to fund operations into mid-2027.
- Okava and Vivani Medical are developing OKV-119, a six-month implant delivering exenatide to treat obesity in cats and dogs, with commercial availability expected by 2028-2029. - The chip-sized device addresses a growing crisis where approximately 60% of pets in the US and 50% of dogs and 43% of cats in the UK are overweight or obese. - Early clinical trials in cats demonstrated the implant was well-tolerated and achieved at least 5% body weight reduction over 112 days, with trials now expanding to dogs. - Veterinary experts emphasize the implant should complement, not replace, proper diet and exercise management for long-term pet health outcomes.
- Vivani Medical has successfully administered its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial, marking a significant advancement in addressing medication adherence challenges in metabolic diseases. - The company achieved full enrollment of 24 subjects within just four weeks, demonstrating strong interest in this twice-yearly subdermal implant that could provide an alternative to daily oral and weekly injectable treatments. - NPM-115, Vivani's lead GLP-1 implant, has shown comparable preclinical weight loss to semaglutide (Ozempic/Wegovy) and aims to improve medication adherence, with top-line results expected by mid-2025.
- Vivani Medical plans to spin off its Cortigent neurostimulation division as an independent Nasdaq-listed company by Q3 2025, allowing each entity to focus on their distinct therapeutic areas. - Cortigent's technology includes the Orion® artificial vision system for blindness, which completed a 6-year clinical study in 2024 with promising results, and applications for stroke recovery. - Post-spinoff, Vivani will concentrate exclusively on developing its proprietary NanoPortal™ GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration.
- Vivani Medical is developing the NPM-115 implant, a 6-month duration GLP-1 drug delivery system for obesity treatment, potentially improving patient compliance. - Phase 1 LIBERATE-1 study in Australia will assess the safety and effectiveness of NPM-115, with preliminary results expected in mid-2025. - Maxim Group and H.C. Wainwright reiterated Buy ratings for Vivani Medical, citing its innovative approach and the growing GLP-1 market.
- Vivani Medical received approval to begin its first-in-human clinical trial in Australia for its subdermal GLP-1 implant, NPM-115, designed for obesity and overweight individuals. - The LIBERATE-1 trial will assess the safety, tolerability, and pharmacokinetics of the exenatide implant, utilizing Vivani's NanoPortal technology for extended drug delivery. - The trial includes a comparison against weekly semaglutide injections, aiming to demonstrate comparable efficacy to drugs like Ozempic and Wegovy with twice-yearly administration. - Vivani anticipates initiating the trial in late 2024, with initial data expected in 2025, potentially supporting regulatory submissions in the U.S. and other regions.
