Welcome to our dedicated page for Vivani Medical news (Ticker: VANI), a resource for investors and traders seeking the latest updates and insights on Vivani Medical stock.
Company Overview
Vivani Medical Inc is a preclinical-stage biopharmaceutical company that specializes in the development of miniaturized, subdermal implants. Leveraging its proprietary NanoPortal technology, the company is dedicated to delivering near-constant, long-term drug therapies for patients suffering from chronic diseases with significant unmet medical needs. With a strong focus on innovation and precision medicine, Vivani integrates the fields of biotechnology and medical device engineering to create advanced implantable systems.
Innovative NanoPortal Technology
The cornerstone of Vivani's technological approach is its proprietary NanoPortal platform, designed to enable consistent drug delivery over extended periods. This technology is engineered to ensure that active pharmaceutical ingredients are released at a near-constant rate, providing a fresh paradigm in patient treatment management. By miniaturizing the implantable devices, Vivani Medical addresses critical challenges in conventional drug therapies, simultaneously enhancing patient compliance and overall efficacy.
Business Divisions
Vivani Medical organizes its operations into two primary segments that clearly delineate its focus areas:
- Biopharm Division: Primarily engaged in the development of drug delivery implants. This division focuses on harnessing the capabilities of NanoPortal technology to meet critical therapeutic needs, especially for chronic diseases.
- Neuromodulation Division: Concentrates on devices that use implantable technologies to address neurological conditions. This segment pioneers advancements in neuromodulation, facilitating targeted therapies and improved treatment outcomes.
Therapeutic Applications
The company’s approach targets a range of chronic conditions where treatment continuity is key. The implant systems not only improve drug bioavailability but also offer a patient-centric solution that may potentially reduce the frequency of traditional dosing methods. This technology is designed to meet the demanding requirements of chronic disease management, making it relevant across multiple therapeutic areas.
Competitive Position and Market Context
Operating within the nexus of biotechnology and medical device innovation, Vivani Medical distinguishes itself through its integration of cutting-edge engineering and pharmaceutical science. Although it remains at a preclinical stage, the company’s dual-division strategy positions it uniquely to address both pharmacological and neuromodulation applications. In a competitive landscape marked by rapid technological advancements, Vivani emphasizes proprietary technology and a robust, research-intensive approach to differentiate its offerings. The strategic focus on long-term, controlled-release implantable systems demonstrates a commitment to addressing complex patient needs while maintaining a rigorous scientific foundation.
Research, Development, and Industry Expertise
The research and development efforts at Vivani Medical underline a deep expertise in device miniaturization and controlled drug release technologies. The company’s commitment to innovation is evident in its targeted approach towards conditions with high unmet therapeutic requirements. With an emphasis on precision engineering and advanced materials science, Vivani’s products are being designed to seamlessly integrate with patient lifestyles, enhancing adherence and overall treatment efficacy. This approach not only showcases technical proficiency but also reflects the company's broader commitment to advancing the field of biopharmaceutical delivery systems.
Technology Integration and Future Applications
Vivani Medical’s integrated technology platform is adaptable across diverse clinical settings. The versatility of the NanoPortal technology allows for its application in various drug delivery scenarios, from chronic diseases to specialized neuromodulation treatments. The company’s innovative framework serves as a template for future implantable therapies, underpinned by a sophisticated understanding of both drug kinetics and device physiology. Each technological enhancement is purposefully designed to meet strict regulatory and clinical standards, reinforcing Vivani’s commitment to safe and effective patient care.
Conclusion
In summary, Vivani Medical Inc stands out as a pioneering entity in the preclinical biopharmaceutical space. Its unique integration of NanoPortal technology with a two-division operational structure highlights a strategic emphasis on delivering long-term, consistent therapeutic solutions. By focusing on innovative implantable systems for chronic disease management and neuromodulation, Vivani Medical contributes a fresh perspective to the fields of biotechnology and medical device development. The company’s rigorous research and development process, combined with its targeted approach to unmet medical needs, underscores its role as a technically proficient and scientifically driven enterprise.
Vivani Medical (NASDAQ: VANI) has announced its participation in a virtual fireside chat hosted by H.C. Wainwright & Company on April 24, 2025, at 10 a.m. Eastern Time. The presentation will feature CEO Adam Mendelsohn, Ph.D., and CMO Lisa Porter, M.D., who will discuss the company's LIBERATE-1 clinical trial.
The discussion will focus on NPM-115, Vivani's innovative miniature, twice-yearly GLP-1 (exenatide) implant being developed for chronic weight management. The company is currently conducting LIBERATE-1 as a first-in-human study, with topline data expected in mid-year 2025.
Vivani specializes in developing miniature, ultra long-acting drug implants, with a portfolio focusing on once or twice-yearly GLP-1 implants for both chronic weight management and type 2 diabetes treatment.
Vivani Medical (NASDAQ: VANI) and Okava Pharmaceuticals have expanded their collaboration to develop OKV-119, a long-acting GLP-1 therapy for dogs, targeting weight management, diabetes, and cardiometabolic conditions. The therapy utilizes Vivani's NanoPortal™ technology to deliver therapeutic molecules over extended periods from a single implant.
The collaboration, initially focused on cats since 2019, now addresses a critical need as over 50% of U.S. dogs are overweight or obese. OKV-119 aims to provide dosing every six months or longer, mimicking the physiological effects of fasting without disrupting feeding routines. Research indicates leaner dogs can live more than two years longer than heavier ones.
The expanded partnership maintains minimal costs and risks for Vivani while offering potential upside through future milestone payments and royalties. The financial terms of the agreement were not disclosed.
Vivani Medical (NASDAQ: VANI) reported its Q4 and full year 2024 results, highlighting significant progress in its drug implant programs. The company successfully completed enrollment in its LIBERATE-1™ first-in-human study of NPM-115 (exenatide implant), with top-line data expected in mid-2025.
Key developments include positive preclinical weight loss data for NPM-139 (semaglutide implant), showing comparable results to Ozempic®/Wegovy® injections with potential for once-yearly dosing. The company secured $8.25M in equity financing, extending operations into Q2 2026.
Financial highlights for 2024:
- Cash position: $19.7M as of December 31, 2024
- Net loss: $23.5M, improved from $25.7M in 2023
- R&D expenses: $15.7M, down 7% from 2023
- G&A expenses: $8.9M, decreased 11% from 2023
The company plans to spin off its Cortigent subsidiary, which develops brain implant devices, to focus on its drug implant pipeline for chronic diseases.
Vivani Medical (NASDAQ: VANI) has secured an $8.25 million private placement equity financing through the sale of 7,366,071 shares at $1.12 per share. The financing was arranged with an entity owned by Gregg Williams, the Company's board chairman.
The funding will extend the company's cash runway into Q2 2026 and accelerate the development of two key products:
- NPM-139: A once or twice-yearly GLP-1 (semaglutide) implant for chronic weight management
- NPM-115: A twice-yearly GLP-1 (exenatide) implant for chronic weight management
The private placement was priced 'at-the-market' under Nasdaq rules and will have multiple closing dates. The securities being sold have not been registered under the Securities Act of 1933.
Vivani Medical (NASDAQ: VANI) has announced promising preclinical data for NPM-139, its subdermal semaglutide implant for chronic weight management. The implant, utilizing their proprietary NanoPortal™ technology, demonstrated nearly 20% placebo-adjusted weight loss from a single administration in healthy rats over a 91-day treatment period.
The technology successfully delivers semaglutide (active ingredient in Ozempic®/Wegovy®) with potential for once or twice-yearly dosing. NPM-139 has shown therapeutic semaglutide exposure levels over six months in healthy rats, with in vitro stability measurements indicating potential for once-yearly administration.
The company's ongoing LIBERATE-1 clinical study for NPM-115 (exenatide implant) is progressing, with top-line data expected by mid-2025. This study will provide critical information for both NPM-115 and NPM-139 development, representing the first human application of NanoPortal technology.
Vivani Medical (NASDAQ: VANI), a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants, has announced its participation in the upcoming Emerging Growth Conference on March 27, 2025.
Company President and CEO Adam Mendelsohn, Ph.D. will deliver a 30-minute presentation starting at 2:20 pm Eastern Time. The interactive session will include a company overview and a potential Q&A segment, providing individual and institutional investors, advisors, and analysts the opportunity to engage directly with management.
Investors can submit questions in advance to Questions@EmergingGrowth.com. The presentation will be archived and available on EmergingGrowth.com and the Emerging Growth YouTube channel post-conference.
Vivani Medical (NASDAQ: VANI) has announced two significant milestones in its LIBERATE-1™ clinical trial: the successful first implant of its NPM-115 GLP-1 (exenatide) implant and full enrollment of 24 subjects within four weeks. The miniature, twice-yearly implant is being developed for chronic weight management.
The NPM-115 implant has shown comparable preclinical weight loss results to semaglutide injections (Ozempic®/Wegovy®). The first implant administration was well-tolerated, and top-line study results are expected in mid-2025.
The company's NanoPortal™ platform technology aims to address medication adherence challenges, as approximately 50% of patients regularly miss doses. The LIBERATE-1 study will explore NPM-115's pharmacokinetic profile, which has demonstrated consistent and minimally fluctuating drug release in preclinical studies. The implant could potentially be used for treating type 2 diabetes and other conditions where GLP-1 treatment shows clinical benefit.
Vivani Medical (NASDAQ: VANI) has announced plans to spin off its Cortigent neurostimulation business as an independent publicly-traded company. The spin-off, expected to complete by Q3 2025, aims to create two focused companies dedicated to their respective therapeutic areas.
Cortigent specializes in brain implant devices and is known for developing the Orion® artificial vision system and the FDA-authorized Argus® II Retinal Prosthesis System. The company recently completed a 6-year clinical study for Orion in 2024, showing promising safety and efficacy results. The technology is also being developed for recovery of arm and hand motion in stroke-related paralysis.
Post spin-off, Vivani will focus exclusively on developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration. The transaction is intended to be tax-free for U.S. federal income tax purposes, with Vivani stockholders receiving shares in the new company.
Vivani Medical (NASDAQ: VANI) has initiated its first-in-human clinical trial, LIBERATE-1™, testing a novel GLP-1 (exenatide) implant for obesity and overweight treatment at two Australian centers. The trial marks the first clinical application of their proprietary NanoPortal™ drug implant technology, designed to provide comparable efficacy to semaglutide with twice-yearly administration.
The randomized trial will evaluate safety, tolerability, and pharmacokinetics in participants who will first undergo 8 weeks of semaglutide titration before being randomized into three groups: exenatide implant (n=8), weekly exenatide injections (n=8), or weekly semaglutide injections (n=8) for 9 weeks. Top-line data is expected in mid-2025.
Vivani Medical (NASDAQ: VANI) announced its participation in the Innovation in Obesity Therapeutics Summit West Coast in San Diego from December 10-12, 2024. CEO Adam Mendelsohn will engage in two key sessions:
1. A panel discussion on 'The Obesity Race on the Manufacturing Floor' on December 11 at 2:40 PM PT, addressing supply chain challenges for GLP-1 drugs alongside executives from Regor Therapeutics and Biolexis Therapeutics.
2. A presentation at 4:20 PM PT focusing on the company's NanoPortal™ implant technology and their lead program NPM-119, a six-month GLP-1 (exenatide) implant for chronic weight management. The implants are designed for once or twice-yearly dosing to improve medication adherence and patient tolerability. Clinical data from the LIBERATE-1 study is expected in 2025.