Companies To Watch: Vivani Medical
By Ben Comer, Chief Editor, Life Science Leader
Overcoming adherence and tolerability issues in obesity and diabetes treatment.
Snapshot
Vivani’s subdermal implant NanoPortal device, a platform drug delivery technology, is designed to deliver a near-constant and minimally fluctuating dose of an active pharmaceutical drug for a duration of six months, and potentially one year. In Vivani’s first-in-human Phase 1 trial (LIBERATE-1), which began last December in Australia, the company is testing the device with exenatide, a GLP-1 inhibitor, for six months in overweight or obese patients.
The NanoPortal device is constructed with titanium oxide nanotubes that can be resized to fit different drug molecules and quantities, which are attached to a membrane connected to a reservoir containing the active drug. Adam Mendelsohn, Ph.D., Vivani’s cofounder and CEO, says the device aims to help patients overcome lapses in medication adherence; for GLP-1 drugs, missed doses can lead to gastrointestinal problems and other tolerability issues, or require patients to revert back to a lower starting dose, followed by an escalation period to get back up to the therapeutic dose target.
“There is so much opportunity right now with GLP-1 [drugs] across multiple therapeutic areas,” says Mendelsohn. Chronic weight management and Type 2 diabetes are the main indications, but opportunities in cardiovascular risk reduction, chronic kidney disease, Alzheimer’s disease and other areas are emerging. Vivani plans to ramp up development of a semaglutide NanoPortal program this year, as well.
What’s At Stake
Medication non-adherence is a significant problem across many therapeutics and disease areas. Studies have shown that close to half of patients don’t take medicines regularly as prescribed; as a result, they don’t get the expected drug benefits. Additionally, real-world adherence to medications is worse than adherence rates during clinical trials. “That’s true with the [GLP-1] injectables on the market, and it’s true with [Novo Nordisk’s] Rybelsus, the only oral GLP-1 on the market,” says Mendelsohn. Even with more convenient GLP-1 dosing regimens currently in development, non-adherence among some patients will persist, because the “human element hasn't changed, as far as all of the factors that contribute to people not taking their medicines.”
Exenatide, which has never been approved for a weight loss indication — or studied in a dose larger than 2mg — was first approved in 2005 with the brand name Byetta, for Type 2 diabetes patients. The first of the FDA approved GLP-1 drugs, exenatide is “actually the most potent one, more potent than semaglutide, dulaglutide, and tirzepatide,” says Mendelsohn. Exenatide’s short half-life, however, made it challenging to deliver effectively via injection, but exenatide’s “inherent capability [for weight loss], we think, is the same as semaglutide,” Mendelsohn says, citing Vivani’s preclinical research. “A short half-life isn't a problem when combined with an implant that's continuously replenishing the drug,” adds Mendelsohn.
Intarcia Therapeutics tried and failed to receive FDA approval for a six-month osmotic pump implant device delivering exenatide, due to “variability of the dose over time … intra-patient PK fluctuations leading ultimately — the FDA believed — to an acute kidney injury imbalance they saw in [Intarcia’s] study,” says Mendelsohn. “Our technology is designed with a passive, constant rate membrane that really avoids those fluctuations.”
Semaglutide is also being developed for use in the NanoPortal (NPM-139), behind exenatide (NPM-115) due to existing IP protections. Vivani aims to use FDA’s 505(b)(2) pathway for product approval, and to leverage existing safety data from both marketed products, using a PK bridge study to show comparable or better fluctuations. “Once a composition patent has expired, we think it’s pretty clear cut that we can take the drug substance, do a novel formulation to help make sure it’s adequately stable in our device, and that it works from a performance perspective with our membrane for release,” says Mendelsohn. NanoPortal development with semaglutide is timed with expected patent expiration for that drug, notes Mendelsohn.
Vivani plans to release topline LIBERATE-1 trial data in next couple of months, which will help inform the design of a dose-ranging LIBERATE-2 trial. The company is also working to further develop NPM-139, the semaglutide implant, as well as scaling up manufacturing readiness for a future registrational study of NPM-115 (exenatide), including “commercially representative manufacturing processes,” says Mendelsohn.
Vital Statistics
Employees: ~35
Headquarters: Alameda, California
Funding: Total assets approximately $35.5 million, with an additional $11.25 million in proceeds from equity financing agreements expected by March 2026.
Latest Updates:
May 2025: Announced the planned spin-off of Cortigent, a wholly-owned Vivani subsidiary developing a brain implant device to help patients recover critical body functions, in the third quarter of 2025.
April 2025: Expanded collaboration with Okava Pharmaceuticals to develop OKV-119, a long-acting NanoPortal/GLP-1 therapy for dogs and cats.
March 2025: Announced positive preclinical weight loss data for NPM-139 semaglutide implant and potential for once-yearly dosing.