Vivos Inc. ships first IsoPet batches from in-house US facility

Vivos Inc. (OTCQB: RDGL) has announced two manufacturing milestones it says establish the company as a dual-site global producer of its Yttrium-90 radionuclide therapies for the first time. The Kennewick, Washington-based company has shipped its first IsoPet batches from its in-house Applied Process Engineering Laboratory (APEL) in Richland, WA, and has received authorisation from India's Atomic Energy Regulatory Board (AERB) to proceed with an international manufacturing centre.

IsoPet is Vivos' FDA-authorised veterinary oncology product, which delivers localised Yttrium-90 radiation to solid tumours in animals. The company previously relied on third-party contract manufacturers; bringing production to APEL is intended to improve batch-level quality oversight and supply reliability. The facility has passed independent sterility and safety verification, and an ISO Class 7 clean room is under installation. Shipments are now reaching more than 17 certified veterinary clinics across the United States, which have collectively treated over 200 animals.

"Bringing IsoPet production under our direct control at APEL is a meaningful operational milestone," said Dr Michael Korenko, chief executive of Vivos. "It strengthens the reliability of supply for our growing network of veterinary clinics, enhances quality oversight, and positions us to efficiently support RadioGel clinical and commercial needs."

India authorisation and international strategy

The AERB approval provides the regulatory foundation for Vivos' second production site, to be operated through an unnamed India-based manufacturing partner. The India facility is intended to serve clinical and commercial programmes across Asia, the Middle East, and Africa. Vivos notes that the majority of its target markets in those regions fall within a 7.5-hour air transit window from New Delhi's Indira Gandhi International Airport, a logistical consideration given the roughly 64-hour half-life of Yttrium-90.

Brad Weeks, president of Vivos, said the dual-site structure removes dependence on any single supply chain, supporting both the company's human therapy clinical programmes and the growing veterinary business.

The AERB authorisation follows the company's receipt of an FDA Investigational Device Exemption for a first-in-human feasibility study of RadioGel at Mayo Clinic, announced in July 2026. An ongoing research study at HCG Cancer Centre in India has treated 12 patients, with the company reporting consistently favourable safety and efficacy results, though no data have been published or peer reviewed.

Market and regulatory context

Locoregional radiotherapy delivery is an active development space, with a number of academic spinouts and early-stage companies pursuing injectable or implantable isotope formulations as alternatives to external-beam radiation. Vivos holds FDA Breakthrough Device designation for RadioGel, which may accelerate interactions with the agency as it moves toward a formal US clinical trial. Completing the Mayo Clinic Institutional Review Board submission is cited as the immediate next step.

For IsoPet, the veterinary oncology market has grown steadily as pet owners and specialist clinics invest in cancer treatments that mirror human therapeutic approaches. Vivos' certified-clinic network remains relatively small, and expanding that network in parallel with manufacturing scale-up will be a key execution challenge. The company also has three peer-reviewed publications pending submission, which, if accepted, would provide the independent clinical data its human RadioGel programme will need to attract larger partners or investors.