Vivos Inc. (USOTC:RDGL) has begun IsoPet shipments from its new U.S. production facility and received authorization from India’s Atomic Energy Regulatory Board to proceed with a second manufacturing center in India, establishing production capabilities on two continents.
The milestones expand Vivos’ manufacturing infrastructure as it develops RadioGel for human cancer treatment and grows commercial distribution of its IsoPet veterinary therapy, while reducing reliance on third-party manufacturing and a single production location.
Key Investor Takeaways
- Vivos Inc. (USOTC:RDGL) has started shipping IsoPet from its Applied Process Engineering Laboratory in Richland, Washington, to certified U.S. veterinary clinics.
- Moving U.S. production in-house eliminates reliance on third-party contract manufacturers and gives Vivos greater control over supply and quality oversight.
- India’s AERB has authorized the company to proceed with an international manufacturing center through its India-based manufacturing partner.
- The India facility is intended to support clinical and commercial programs across Asia, the Middle East and Africa.
- The manufacturing expansion follows FDA IDE approval in July 2026 for Vivos’ first U.S. human feasibility study of RadioGel at Mayo Clinic.
Why RDGL Stock Is in Focus
Vivos has moved its U.S. IsoPet manufacturing operation into commercial production at APEL, where the company has started supplying multiple certified veterinary clinics.
The Richland facility will serve as Vivos’ primary U.S. production site for both IsoPet, its animal therapy, and RadioGel, its human therapy. Establishing the operation required specialised production equipment, operator certification and changes to the company’s Quality Management System.
Vivos said shipments began only after independent verification of sterility and key safety parameters. An ISO Class 7 clean room is also being installed to provide additional process control and product protection.
Separately, the AERB authorization provides the regulatory foundation for a second production center in India. Operated through Vivos’ India-based manufacturing partner, the facility is intended to supply priority international markets.
Vivos said shipments from New Delhi’s Indira Gandhi International Airport would put most target markets served by the facility within a 7.5-hour air transit window, an important operational consideration for Yttrium-90 therapy.
Why This Matters for Investors
The two developments address manufacturing and supply-chain capacity at a time when Vivos is advancing both commercial veterinary operations and human clinical development.
Direct control of U.S. production could improve supply reliability and quality oversight while removing dependence on contract manufacturers. Adding an international facility may further reduce single-site risk and provide a more practical supply route into markets across Asia, the Middle East and Africa.
The timing also matters for RadioGel. Vivos received FDA IDE approval in July 2026 for its first U.S. human clinical feasibility study at Mayo Clinic and is working toward the Institutional Review Board submission required to initiate that study.
In India, an ongoing research study at HCG Cancer Centre has treated 12 patients to date, with Vivos reporting consistently favourable safety and efficacy results. The company is also preparing a RadioGel India Phase 1 clinical trial application for submission to the DCGI.
The manufacturing milestones therefore provide infrastructure that could support future clinical and commercial activity, but they do not remove the regulatory and clinical execution risks surrounding RadioGel. The announcement also does not provide revenue forecasts or quantify the financial impact of either production facility.
What to Watch Next
The Mayo Clinic IRB submission and subsequent initiation of the FDA-approved RadioGel feasibility study represent important upcoming clinical steps for Vivos.
Investors can also watch for submission of the planned RadioGel India Phase 1 application, progress at the new India manufacturing center and further expansion of IsoPet’s U.S. veterinary network, which currently includes more than 17 clinics that have treated over 200 animals.
Vivos is additionally pursuing international RadioGel clinical programs, veterinary registrations for IsoPet and three peer-reviewed publications expected to be submitted in the coming months. Progress across those initiatives could indicate whether the company’s newly expanded manufacturing infrastructure is translating into broader clinical and commercial activity.