FDA Approves Vivos Inc.'s RadioGel® for First-in-Human Cancer Study
RDGL sits 35% above its 52-week low of $0.043.
Summary
Vivos Inc. has received FDA approval for an Investigational Device Exemption (IDE) for its RadioGel® product, enabling the start of a first-in-human clinical feasibility study in the U.S. for non-resectable papillary thyroid carcinoma. This significant regulatory milestone allows the company to advance its yttrium-90-based injectable hydrogel into human trials, with the initial study enrolling five patients at Mayo Clinic. This positive development follows the company's recent Q1 report, which detailed a widened net loss and ongoing financial challenges, providing a crucial validation of its core technology. The approval is a major de-risking event for the company's lead product and is essential for its long-term commercialization prospects.
At the time of this announcement, RDGL was trading at $0.06 on OTC in the Life Sciences sector, with a market capitalization of approximately $28.3M. The 52-week trading range was $0.04 to $0.15. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.