Vivos Ships First Batches from U.S. IsoPet Production Facility, Receives AERB Approval to Build International Manufacturing Center in India

KENNEWICK, Wash. — Vivos Inc. recently announced two operational milestones: its in-house production facility in Richland, Washington, has begun delivering IsoPet® products to certified veterinary clinics in the United States; simultaneously, the company has received authorization from India's Atomic Energy Regulatory Board (AERB) to establish an international manufacturing center in India. This means Vivos will have a two-site production footprint spanning the U.S. and India.

According to the company, the U.S. production facility, housed at the Applied Process Engineering Laboratory (APEL), will manufacture IsoPet® veterinary oncology products and RadioGel® human oncology products, and will serve as the center for subsequent process improvements and scaled-up production. To initiate in-house production, Vivos completed the installation of dedicated production equipment, operator certification, and updates to its quality management system. The company stated that products were only released for shipment after sterility and critical safety parameters passed independent verification. The facility is also currently installing an ISO Class 7 compliant cleanroom to further enhance product protection and process control.

Vivos stated that bringing IsoPet® production under direct management at APEL reduces reliance on third-party contract manufacturers, improves supply stability for its network of certified veterinary clinics, and strengthens real-time quality oversight of each production batch. Company CEO Michael Korenko said the two production centers in the U.S. and India will support the advancement of Yttrium-90 precision radionuclide therapy™ in more countries and indications.

Meanwhile, the authorization from India's Atomic Energy Regulatory Board establishes the regulatory foundation for Vivos' second production site. The facility, to be operated by Vivos' manufacturing partner in India, is planned to serve clinical and commercial programs in target markets across Asia, the Middle East, and Africa. The company said the center will ship via Indira Gandhi International Airport in New Delhi, with most target markets located within approximately 7.5 hours of air transport, consistent with the operational window requirements for Yttrium-90 therapy.

In clinical development, Vivos previously received U.S. Food and Drug Administration (FDA) IDE approval in July 2026 to conduct the first U.S. human feasibility study of RadioGel® at Mayo Clinic. The company also noted that its study at HCG Cancer Centre in India has treated 12 patients and continues to demonstrate consistently favorable safety and efficacy results.

Vivos said it will next advance the Mayo Clinic Institutional Review Board application to initiate the FDA-approved first-in-human feasibility study of RadioGel®; simultaneously, it is preparing to submit a Phase I clinical trial application for RadioGel® to the Central Drugs Standard Control Organisation of India once the HCG Cancer Centre study resumes. The company also plans to expand its U.S. IsoPet® certified clinic network and advance related peer-reviewed publications and international market registrations.