Update April 23, 2025
An excerpt from April 15 Press Release
Regulatory Engagement and Market Entry Strategy
Building on the FDA “Breakthrough Device” status of Radiogel ® Precision Radionuclide Therapy™, Vivos is sharing preliminary India trial data directly with the FDA to support the company’s goal to submit an Investigational Device Exemption (IDE) within the next 90 days
While the company is encouraged by its regulatory progress, it also acknowledges the inherent unpredictability of the U.S. regulatory environment, particularly amid shifting priorities and evolving review protocols under the new FDA administration. As such, Vivos continues to pursue a multi-track global strategy to ensure momentum regardless of domestic regulatory timing. Importantly, the clinical and commercial potential for RadioGel ® outside the U.S. is significant, particularly in regions with streamlined regulatory pathways and increasing demand for innovative, minimally invasive cancer therapies.
Vivos views its expanding presence in India not only as a foundation for local commercialization, but also as a strategic hub for broader international adoption—especially in markets where the burden of solid tumors remains high and treatment innovation is urgently needed.
The Indian cancer treatment market presents a significant and growing opportunity for innovative therapies like RadioGel ® . In 2023, the market was valued at approximately USD 4.21 billion and is projected to reach USD 5.89 billion by 2030. Given the substantial size and growth of the Indian cancer treatment market, progress and adoption of RadioGel ® in international markets like India present a substantial opportunity to enhance long-term shareholder value.
By establishing a presence in these expanding markets, Vivos can diversify its revenue streams and accelerate the global recognition of Radiogel ® as a globally relevant oncology solution.
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