• Cochlear for vision.
• Neuralink for sight restoration.
• A specialized Medtronic for artificial vision.

• Orion Visual Cortical Prosthesis System: An implanted cortical stimulation device intended to provide useful artificial vision to blind individuals.

Vivani Medical's major customers fall into the following categories:

• Hospitals and Medical Centers: These include large academic medical centers and specialized hospitals with departments focusing on neurosurgery, ophthalmology, or advanced rehabilitation. These facilities possess the necessary surgical expertise, infrastructure, and patient populations for the implantation and post-operative care of complex visual prosthetics.
• Surgical Centers: Specialized outpatient or inpatient surgical facilities that are equipped to perform intricate surgical procedures, such as those required for the implantation of the Orion Visual Cortical Prosthesis System.
• Government Healthcare Systems: In countries with nationalized healthcare, government-operated hospitals or national health services often serve as direct purchasers of medical devices, procuring them for use within their public healthcare networks.

1. Clinical Development and Regulatory Approval Risk: Vivani Medical's success is heavily reliant on the successful development and eventual regulatory approval of its pipeline of miniaturized, subdermal drug implants, such as NPM-115, NPM-119, and NPM-139, which are designed for chronic diseases like obesity and type 2 diabetes. The company's lead assets are currently in clinical-stage development. Failure to achieve favorable results in clinical trials, or an inability to navigate the complex regulatory approval processes, would pose a significant threat to its ability to commercialize these products and generate revenue. This risk is explicitly highlighted in analyses of the company's prospects.
2. Funding and Capital Needs: As a clinical-stage company with significant research and development expenses, Vivani Medical requires substantial capital to fund its ongoing programs. The company's cash and cash equivalents were $4.0 million as of September 30, 2025, a decrease from $19.7 million at the end of 2024. Vivani has recently raised capital through common stock offerings, indicating an ongoing dependence on external financing. The need for continuous fundraising and the potential for shareholder dilution are noted as significant financial risks.
3. Commercialization Challenges and Market Competition: Even with successful clinical trials and regulatory approvals, Vivani Medical's drug implants, particularly those targeting metabolic diseases with GLP-1, will enter a highly competitive market. Established pharmaceutical companies already offer widely used treatments for diabetes and weight management, such as Ozempic, Wegovy, and Trulicity. Vivani will face the challenge of differentiating its novel implantable drug delivery technology and gaining significant market acceptance against these entrenched competitors.

The primary clear emerging threat to Vivani Medical is the rapid advancement and increasing efficacy of alternative vision restoration therapies, particularly gene therapy and optogenetics. These technologies aim to restore natural biological vision or significantly improve existing vision by addressing the underlying cause of blindness at a genetic or cellular level, rather than relying on an implantable prosthetic device that delivers artificial vision. As these biological therapies move through clinical trials and gain regulatory approvals for a broader spectrum of blindness causes, they present a potentially superior, less invasive, and more natural solution, thereby threatening the market for complex surgical implants like Vivani Medical's Orion Visual Cortical Prosthesis System.

Vivani Medical (VANI) focuses on developing miniature, long-term, subdermal drug implants for metabolic diseases and also holds assets related to implantable visual prosthetics through its subsidiary, Cortigent, Inc..

The addressable markets for Vivani Medical's main products and services are as follows:

• GLP-1 Based Implants for Chronic Weight Management/Obesity and Type 2 Diabetes (e.g., NPM-115, NPM-119, NPM-139): The estimated global market for GLP-1 sales is projected to be over $60 billion for Obesity/Chronic Weight Management and over $60 billion for Type 2 Diabetes by 2030.

• Orion Visual Cortical Prosthesis System (through Cortigent, Inc.): The global bionic eye market, in which the Orion system competes as a cortical implant, is projected to reach approximately $524 million by 2032. Another estimate places the global bionic eye market at $372.4 million in 2024, growing to $826.7 million by 2030. Specifically, cortical implants accounted for approximately $93.1 million of the global market in 2024 and are projected to grow at the fastest CAGR through 2030. The bionic eyes market size in 2026 is estimated at $406.12 million, with cortical visual prostheses projected to expand at a 14.33% CAGR through 2031.

• Advancement and Commercialization of GLP-1 Drug Implants for Obesity and Type 2 Diabetes: Vivani Medical's lead drug implant candidates, NPM-115 (exenatide implant) and NPM-139 (semaglutide implant), are being developed for chronic weight management in obese or overweight individuals and type 2 diabetes. The company is prioritizing its obesity portfolio and is proceeding towards initiating LIBERATE-1, a First-in-Human study for NPM-115. These implants are designed to deliver smooth, consistent therapeutic levels of GLP-1 for six months or longer with a single administration, aiming to improve medication adherence and patient tolerability.
• Expansion of the NanoPortal™ Platform Technology to Other Chronic Diseases: The NanoPortal™ platform is highlighted for its broad potential application across a range of molecule types. This proprietary technology, which enables long-term, near constant-rate delivery of various medicines, presents a significant opportunity for Vivani Medical to expand its pipeline beyond GLP-1s into other chronic conditions.
• Addressing Medication Non-Adherence: A major challenge in treating chronic diseases is medication non-adherence. Vivani's miniaturized, subdermal drug implants are specifically designed to address this by providing long-term, consistent drug delivery, thereby offering an important alternative for patients and physicians. Successful adoption of this approach could significantly drive revenue growth.

Share Repurchases

Vivani Medical made no common stock repurchases in fiscal years 2021, 2022, 2023, or 2024.

Share Issuance

• Vivani Medical issued $11.6 million in common stock in 2021, $16,000 in 2022, $133,000 in 2023, and $15.9 million in 2024.
• The number of shares outstanding increased by 10.31% in one year.
• In January 2026, the company announced the pricing and closing of a common stock offering, raising $4.5 million to accelerate GLP-1 implant development.

Inbound Investments

• Upon the completion of its merger with Nano Precision Medical in September 2022, the company (then Second Sight Medical Products, Inc., which changed its name to Vivani Medical, Inc.) received approximately $55 million in cash.
• In July 2022, the company received $1.1 million from the National Institutes of Health (NIH) as part of a planned $6.4 million five-year grant for its Orion Trial, supporting research for its visual cortical prosthesis.

Capital Expenditures

• Capital expenditures totaled $572,000 in 2021, $338,000 in 2022, $887,000 in 2023, and $471,100 in 2024.
• In Q3 2025, Vivani Medical invested $823,000 in capital expenditures, focusing on funding long-term assets and infrastructure.