Vivani's Tiny Implant Enters the Weight Loss Drug Race

ALAMEDA, CA – May 13, 2026 – In a market dominated by weekly injections, Vivani Medical is betting that a tiny, subdermal implant could represent the next frontier in the blockbuster weight-loss drug category. The clinical-stage biopharmaceutical company announced today that it is on track to begin a Phase 1 human trial of its six-month semaglutide implant, NPM-139, by mid-2026.

The trial, dubbed SLIM-1, marks a pivotal moment for Vivani and its proprietary NanoPortal™ technology. It aims to deliver the same active ingredient found in Novo Nordisk's wildly popular drugs Ozempic and Wegovy, but via a matchstick-sized implant designed to provide steady medication for half a year. This approach directly targets what is becoming the Achilles' heel of the GLP-1 revolution: patient adherence.

The Adherence Crisis in Weight Management

The meteoric rise of GLP-1 agonists has transformed the treatment of obesity and type 2 diabetes, but their real-world effectiveness is being undermined by a simple problem: many patients stop taking them. While clinical trials boast near-perfect adherence, recent studies paint a starkly different picture. One 2024 analysis found that only about 32% of patients prescribed a GLP-1 for weight loss were still taking it after one year.

This drop-off is driven by a host of factors, including "injection fatigue," needle anxiety, inconvenient dosing schedules, and gastrointestinal side effects that can be exacerbated by the peak-and-trough drug levels associated with weekly shots. Even daily oral options, while avoiding needles, come with their own adherence challenges and absorption issues.

Vivani believes its technology offers a compelling solution. "Challenges associated with medication adherence have emerged as a clear and undeniable barrier to the full realization of health outcomes otherwise possible with GLP-1 therapies," said Vivani CEO Adam Mendelsohn, Ph.D., in a statement. "Our NanoPortal™ technology is uniquely designed to solve for these challenges."

The company's NPM-139 implant is inserted in a quick outpatient procedure and is engineered to release semaglutide at a near-constant rate. This steady delivery could not only guarantee compliance for six months at a time but also potentially improve tolerability by smoothing out the drug concentration spikes that often trigger nausea and other side effects. While the implant provides long-term delivery, Mendelsohn noted it still allows for patients to stop drug exposure on a timeline similar to the current weekly injectables, suggesting a mechanism for removal if needed.

Navigating a Crowded and Innovative Field

Vivani is entering an intensely competitive arena. The GLP-1 market, projected to surpass $100 billion in the coming years, is currently a duopoly of Novo Nordisk and Eli Lilly. These pharmaceutical giants are not standing still; they are aggressively innovating with next-generation therapies.

Eli Lilly has already found massive success with its dual-agonist tirzepatide (Zepbound) and is advancing retatrutide, a triple-agonist, through late-stage trials that promises even greater weight loss. Novo Nordisk is developing its own combination therapies, like CagriSema, and a new oral and injectable molecule, amycretin, which targets both GLP-1 and amylin receptors and showed impressive early results. Other players, from Amgen to smaller biotechs, are also racing to develop their own novel oral pills and improved injectables.

In this context, Vivani’s strategy is not to invent a new molecule but to perfect its delivery. By focusing on a long-acting implant, the company is carving out a unique niche centered on convenience and adherence. If the SLIM-1 trial is successful, a six-month, "set-it-and-forget-it" option could be highly attractive to patients and payers frustrated by the high discontinuation rates and associated costs of current treatments. The company is already developing a next-generation version of the implant designed to hold larger doses of semaglutide, in line with the high-dose Wegovy formulation for obesity.

A Sharpened Focus and Solid Financial Footing

To support its ambitious clinical program, Vivani reported a strong financial position. The company holds approximately $28 million in cash, cash equivalents, and capital commitments, which it states will fund its operating plan through the first half of 2027. This runway is critical as it covers the anticipated timeline for initiating the SLIM-1 trial this year and receiving top-line results by year-end.

The company's financial stability is bolstered by a recent series of financing activities that raised $30.2 million in gross proceeds over the last twelve months. While the company posted a net loss of $6.8 million for the first quarter of 2026, slightly up from $6.3 million in the prior year, the spending reflects a focused increase in research and development as it pushes NPM-139 into the clinic.

Further sharpening its focus on biopharmaceutical implants, Vivani is also moving to separate its legacy neuromodulation business. Its wholly-owned subsidiary, Cortigent, which develops brain implants to restore functions like sight and movement, recently amended its Form S-1 registration statement with the SEC. Vivani is considering multiple paths, including an IPO or a spin-off, to establish Cortigent as an independent, publicly-traded company. This strategic maneuver would allow Vivani to concentrate fully on its promising GLP-1 pipeline while enabling Cortigent to attract dedicated capital and unlock its distinct value for shareholders.

The Long Road Through Clinical Trials

The initiation of the SLIM-1 trial in Australia is a crucial first step, but the path to market for a novel drug-device combination product is long and complex. Following the Phase 1 study, which will primarily assess safety and pharmacokinetics at a low dose, Vivani plans to meet with the U.S. Food and Drug Administration (FDA) before filing an Investigational New Drug (IND) application.

Pending positive results and regulatory clearance, Vivani aims to launch a larger Phase 2 dose-ranging study in 2027. Regulators in both Australia and the U.S. will closely scrutinize the implant's long-term safety, biocompatibility, and the consistency of its drug-release profile. Proving that the device is not only effective but also safe to remain in the body for extended periods and can be reliably removed if necessary will be paramount. The company's prior experience with its first-in-human LIBERATE-1 trial in 2025, which tested a different implant, provides a foundation for navigating this rigorous process. With top-line results from SLIM-1 expected by the end of the year, the medical and investment communities will be watching closely to see if this tiny implant can make a big impact.