The company received its Washington State Radioactive Materials License for IsoPet manufacturing in June 2026, enabling compliant in-house production at its Richland facility. In February 2025, the first five human patients demonstrated the safety of RadioGel Precision Radionuclide Therapy, with confirmation via PET imaging that the Y-90 remained at the point of injection and no adverse events reported.
Cyborg Score Rationale
Vivos demonstrates promising clinical progress with positive early-stage human trial results and critical regulatory milestones (June 2026 manufacturing license). However, the company faces execution challenges: an FDA IDE submission was declined in August 2025, requiring resubmission efforts. The business model is pre-revenue or early-stage, with market cap under $65M, creating significant development and commercialization risks.
Top Insights
30-day PET imaging of a treated patient revealed over 80% reduction in tumor size and metastatic activity, with preservation of voice function.
In-house manufacturing at the Applied Process Engineering Laboratory in Richland enables domestic production scaling for IsoPet.
The company collaborates with contract manufacturer IsoTherapeutics (acquired by Telix in 2025) and is evaluating additional manufacturing partners in India and other regions.
Vivos engaged a top regulatory expert in brachytherapy devices with prior FDA experience and proven track record of successful IDE approvals for Class III implantable radiation devices.
Named Competitors
External-Beam Radiation Therapy — Standard radiation oncology treatment delivery
Brachytherapy Platforms — Radiopharmaceutical and brachytherapy products
Theragenics Implants — Permanent brachytherapy implant systems
Veterinary Oncology Services — Traditional veterinary cancer treatment providers
Recent Developments
(June 2026) Received Washington State Radioactive Materials License for IsoPet manufacturing at Richland facility
(August 2025) FDA declined RadioGel IDE submission; company pivoting to resubmission with enhanced regulatory strategy
(February 2025) Reported positive initial human clinical trial results: first five patients demonstrated safety with no adverse events and early efficacy signals