Vivos Inc., a medical device company based in the Tri-Cities region of Washington State, is moving ahead with plans to manufacture its radionuclide cancer therapy technology in India after receiving authorization from India’s Atomic Energy Regulatory Board (AERB).
The authorization allows Vivos to proceed with an Indian manufacturing center operated through a local manufacturing partner. The facility is intended to supply Vivos products for clinical programs and, eventually, commercial markets in India and other parts of Asia, the Middle East and Africa.
Vivos is developing a localized cancer treatment based on Yttrium-90, a radioactive isotope. Its technology is being developed as RadioGel for human cancers and is already marketed in the United States as IsoPet for treating tumors in animals.
India is playing a role in both the manufacturing and clinical development of the technology.
Vivos has an ongoing research program at HCG Cancer Centre in India, where 12 patients have been treated to date, according to the company. It is also preparing an application to India’s Central Drugs Standard Control Organization for a Phase 1 clinical trial of RadioGel.
The AERB authorization adds a manufacturing component to that India relationship. Because the product incorporates radioactive material, production and transportation involve requirements that are different from those of conventional medical devices.
Vivos plans to use New Delhi’s Indira Gandhi International Airport as the principal export point for products manufactured in India. The location would provide relatively short air connections to many potential markets in Asia, the Middle East and Africa — an important consideration for a product using Yttrium-90, which has a limited radioactive half-life.
The Indian operation will complement Vivos’ recently established in-house manufacturing facility at the Applied Process Engineering Laboratory in Richland, Washington. The company has begun shipping IsoPet from the Richland facility to veterinary clinics in the United States after previously relying on contract manufacturing.
The two locations are intended to provide Vivos with separate production bases for the United States and international markets.
The India expansion comes as the company is also moving its human therapy program forward in the United States. In July 2026, Vivos received FDA approval of an Investigational Device Exemption for an initial human feasibility study of RadioGel at Mayo Clinic. The company is now working through the institutional review process required before that study can begin.
Vivos’ activities illustrate an increasingly important aspect of U.S.-India cooperation in medical technology: India can serve simultaneously as a clinical research location, manufacturing base and platform for reaching other international markets.
For smaller American medical technology companies in particular, establishing a wholly owned manufacturing and commercial infrastructure across multiple countries may not be practical. Vivos has instead chosen to work with an India-based manufacturing partner while maintaining its primary U.S. production operation in Washington State.
The company now has parallel initiatives underway in the two countries — manufacturing in Washington and India, a planned U.S. clinical study at Mayo Clinic, and continuing clinical development in India. How quickly RadioGel progresses will ultimately depend on the results of those studies and subsequent regulatory reviews, but India has clearly become an important part of Vivos’ international development strategy.
