Vivos Inc. Achieves Two Major Operational Milestones: First IsoPet® Shipments from New U.S. Production Facility and Authorization from India’s Nuclear Regulatory Authority for International Manufacturing Center
Rhea-AI Summary
Vivos (OTCQB: RDGL) reported two major milestones: first IsoPet® shipments from its new in-house U.S. production facility at APEL in Richland, Washington, and authorization from India’s Atomic Energy Regulatory Board (AERB) to proceed with an international manufacturing center operated via its India-based partner.
According to Vivos, APEL now produces IsoPet® and RadioGel®, with an ISO Class 7 clean room being installed, while the India site will supply clinical and commercial programs across Asia, the Middle East, and Africa within a 7.5-hour air transit window for Yttrium-90 therapy.
Positive
- First in-house IsoPet® shipments from APEL U.S. facility
- AERB authorization for India international manufacturing center
- Dual-site production reduces single-site dependency and strengthens supply
- Over 17 U.S. IsoPet® clinics treating more than 200 animals
- India research study treated 12 patients with favorable safety and efficacy
- FDA IDE approval for first U.S. human RadioGel® feasibility study at Mayo Clinic
Negative
- None.
News Explained
India is authorized for a second facility, but APEL remains the only disclosed operating production site.
Vivos has commenced shipping IsoPet from APEL in Washington, making that facility an operating U.S. production site and removing reliance on third-party contract manufacturers for those shipments.
The release also says India’s AERB authorized Vivos to proceed with an India center operated through its partner; because that is authorization to proceed rather than evidence of shipments or a completed facility, the disclosed state is one operating site plus one authorized site.
Next milestones are the Mayo Clinic IRB submission for the FDA-approved first-in-human RadioGel study and the DCGI application for an India Phase 1 trial, with the release saying the latter follows resumption of HCG research.
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Kennewick, WA, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a medical device company pioneering Precision Radionuclide Therapy™ (PRnT) for the treatment of cancerous tumors, today announced two significant operational milestones: the commencement of IsoPet® shipments from its new in-house U.S. production facility, and the receipt of authorization from The Atomic Energy Regulatory Board (AERB) of India, India’s national nuclear safety regulator, equivalent to the U.S. Nuclear Regulatory Commission, to proceed with an international manufacturing center in India. Together, these milestones establish Vivos as a dual-site global production organization for the first time in the Company’s history.
MILESTONE 1: FIRST ISOPET® SHIPMENTS FROM APEL, RICHLAND, WA
Vivos has begun shipping IsoPet® from its Applied Process Engineering Laboratory (APEL) in Richland, Washington, to multiple certified animal clinics across the United States. APEL serves as the Company’s primary U.S. production site for both IsoPet® (animal therapy) and RadioGel® (human therapy) and will function as the center for ongoing process improvement and scale-up initiatives for both domestic and international supply.
Establishing in-house manufacturing required installation of specialized production equipment, operator certification, and updates to the Company’s Quality Management System to accommodate the new facility. Consistent with its commitment to product quality, Vivos did not authorize shipments until verification of sterility and all key safety parameters were independently confirmed. A state-of-the-art ISO Class 7 clean room is currently being installed as an additional layer of product protection and process control.
Bringing production under direct control at APEL eliminates reliance on third-party contract manufacturers, strengthens reliability of supply for the Company’s growing network of certified veterinary clinics, and enhances real-time quality oversight across every batch.
“Bringing IsoPet® production under our direct control at APEL is a meaningful operational milestone,” said Dr. Michael Korenko, CEO of Vivos Inc. “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. Ultimately, both production centers will support our objective of expanding Yttrium-90 Precision Radionuclide Therapy™ to additional countries and additional indications for use, so that this breakthrough cancer therapy can reach as many people and animals as possible.”
MILESTONE 2: INDIA AERB AUTHORIZATION FOR INTERNATIONAL MANUFACTURING CENTER
In parallel with the APEL launch, Vivos has received authorization from The Atomic Energy Regulatory Board (AERB) of India to proceed with an international manufacturing center in India. The AERB is India’s national nuclear safety regulatory authority, operating under a mandate equivalent to that of the U.S. Nuclear Regulatory Commission (NRC).
This authorization establishes the regulatory foundation for Vivos’ second production site, operated through Vivos’ India-based manufacturing partner, which will serve as the primary supply point for clinical and commercial programs across the Company’s priority international target markets in Asia, the Middle East, and Africa. The India manufacturing center will ship from New Delhi’s Indira Gandhi International Airport (DEL), placing the majority of target markets served by the India facility within a 7.5-hour air transit window, comfortably within the operational window for Yttrium-90 therapy.
The AERB authorization follows the Company’s receipt of FDA IDE approval in July 2026 for its first U.S. human clinical feasibility study at Mayo Clinic, and complements the ongoing research study at HCG Cancer Centre in India, which has treated 12 patients to date with consistently favorable safety and efficacy results.
“The AERB authorization is a significant achievement that validates our international manufacturing strategy,” said Brad Weeks, President of Vivos Inc. “With in-house production capability now established on two continents, we have the infrastructure to support both our clinical development programs and our long-term commercial objectives without dependence on any single production site or supply chain.”
PRODUCTION AND CLINICAL DEVELOPMENT STRATEGY
The two production sites, APEL in Washington State and the India facility in Vivos’ India-based manufacturing partner, are designed to operate as complementary, mutually redundant centers. The combination significantly expands geographic reach, reduces single-site dependency, and positions the Company to serve both its human therapy clinical programs (RadioGel®) and its growing commercial animal therapy program (IsoPet®) across a broad international footprint.
The Company’s current operational priorities include:
• Completing Mayo Clinic Institutional Review Board (IRB) submission to initiate the FDA-approved first-in-human feasibility study for RadioGel
• Preparing the RadioGel® India Phase 1 clinical trial application for submission to DCGI, following resumption of the ongoing research study at HCG Cancer Centre
• Expanding the U.S. IsoPet® certified clinic network, which now serves more than 17 clinics that have treated over 200 animals
• Advancing three peer-reviewed publications scheduled for submission in the coming months
• Initiating international precursor activities for RadioGel® clinical programs in priority target countries, and veterinary device registration processes for IsoPet® in international markets
About Vivos Inc.
Vivos Inc. is developing advanced Yttrium-90 Precision Radionuclide Therapy™ (PRnT) treatments for tumors in both animals (IsoPet®) and humans (RadioGel®). The Company holds FDA Breakthrough Device designation for RadioGel® and is focused on delivering safer, more targeted, and accessible cancer therapies through precise, localized delivery of radiation with a high therapeutic index. IsoPet® is FDA-authorized for commercial veterinary use in the United States.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of applicable securities laws. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied. Vivos Inc. undertakes no obligation to update forward-looking statements except as required by law.
Contact:
Mike Korenko, Sc.D. Brad Weeks
CEO, Vivos Inc. President, Vivos Inc.
mkorenko@radiogel.com brad.weeks@vivosinc.com
Follow Vivos Inc. on X: @VivosInc USA |www.VivosInc.com
