GlobeNewsWire
27 Jul 2026, 14:49 UTC · 1h ago
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Vivos Inc. received FDA approval for its Feasibility Investigational Device Exemption (IDE) to begin first-in-human trials of RadioGel at the Mayo Clinic. — FDA clearance for first-in-human trials is a critical regulatory milestone that significantly reduces binary risk for a medical device company.
+0.80The FDA reduced the safety follow-up period for the clinical study from five years to 24 months. — A shorter follow-up window accelerates the timeline to pivotal trials and potential commercialization.
+0.40The company is expanding its animal therapy business (IsoPet), currently supporting 17 certified clinics with over 200 animals treated. — Demonstrated commercial traction and safety in the veterinary market provides a revenue stream to offset R&D costs.
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Human clinical trials in India were temporarily paused due to an internal audit at the study hospital, though the company claims the pause is unrelated to its product's results. — Regulatory or administrative pauses at clinical sites introduce uncertainty and potential delays in data collection.
-0.20Vivos expects to begin shipping IsoPet from its domestic facility in Richland, WA, by the end of the current quarter. — Operational readiness for shipping indicates a transition from development to active distribution.
+0.20Which stocks this story touches
The company received FDA approval for a feasibility study, reported positive clinical data in India, and is expanding its animal therapy business.
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