Vivos (USOTC:RDGL) reported second-quarter 2026 progress across its Precision Radionuclide Therapy™ programs, highlighting FDA approval to begin its first U.S. human clinical study, continued advancement of international trials, and growth in its veterinary cancer treatment business.
Key Investor Takeaways
- Vivos (USOTC:RDGL) received FDA approval for a Feasibility Investigational Device Exemption (IDE) to begin its first U.S. human trial of RadioGel®.
- The initial Mayo Clinic study will evaluate RadioGel® in patients with non-resectable papillary thyroid carcinoma.
- IsoPet® continues expanding, with 17 certified veterinary clinics treating more than 200 animals.
- The company expects its U.S. manufacturing facility to begin shipping IsoPet® products by the end of the current quarter.
- Vivos is advancing commercialization efforts in India while pursuing additional international clinical opportunities.
Why RDGL Stock Is In Focus
Vivos announced several operational and regulatory milestones centered on its Precision Radionuclide Therapy™ platform for human and veterinary oncology.
The company’s most significant development was FDA approval of its Feasibility IDE application, allowing Vivos to launch its first U.S. human clinical study at Mayo Clinic in Jacksonville, Florida. The initial feasibility trial will enroll five patients with non-resectable papillary thyroid carcinoma to evaluate the safety and feasibility of RadioGel®. Vivos also noted that, following discussions with the FDA, the required safety follow-up period was reduced from five years to 24 months.
Internationally, the company reported continued progress in India, where patient data from ongoing clinical work is expected to support a peer-reviewed publication. While treatments at the participating hospital remain temporarily paused because of an internal review by hospital management, Vivos said the interruption is unrelated to RadioGel® or study results and expects approval to resume treatments under the FDA-aligned protocol by the end of 2026.
Beyond human clinical development, Vivos said its IsoPet® veterinary therapy is now available through 17 certified U.S. clinics, which have treated more than 200 small animals and horses. The company also signed agreements with three additional veterinary clinics.
Why This Matters For Investors
The FDA IDE approval represents an important regulatory milestone because it allows Vivos to begin its first human clinical trial in the United States, moving the RadioGel® program into a new stage of development. Early safety and feasibility data from the Mayo Clinic study could help shape future pivotal trials.
At the same time, Vivos continues building commercial infrastructure alongside clinical development. The company expects its Applied Process Engineering Laboratory facility in Washington to begin supplying IsoPet® products for veterinary use by the end of the current quarter while also supporting future human studies and international expansion.
The veterinary business may provide an incremental source of revenue as the company continues investing in human clinical programs. Vivos also disclosed that it is evaluating broader applications for its proprietary PrecisionGel™ hydrogel technology and has received research interest from universities and pharmaceutical companies, although management characterized this as a secondary opportunity relative to its oncology programs.
What to Watch Next
Investors will likely monitor:
- Institutional Review Board approval and enrollment of the Mayo Clinic feasibility study.
- Resumption of human treatments in India and progress toward a formal Phase I/II trial.
- Commercial shipments from the U.S. manufacturing facility.
- Continued expansion of the IsoPet® veterinary network and treatment volumes.
- Updates on peer-reviewed publications, international clinical expansion, and PrecisionGel™ commercialization initiatives.