Vivos Seeks FDA Approval to Start Human Trials for Breakthrough Cancer Therapy
Vivos Seeks FDA Approval to Start Human Trials for Breakthrough Cancer Therapy
Key Takeaways (TLDR)
Vivos' Radiogel™ therapy can offer a competitive advantage in treating solid metastatic tumors with a more potent and localized radiation treatment.
The Radiogel™ therapy involves injecting Yttrium-90 phosphate microparticles directly into the tumor for a more potent and localized radiation treatment compared to traditional therapies.
The Radiogel™ therapy is a promising development that can offer more effective treatment options for cancer sufferers, potentially improving patient outcomes and quality of life.
Vivos' Radiogel™ therapy represents a groundbreaking approach to cancer treatment by directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor.
Why it Matters
The submission of Vivos' IDE application to the FDA for human clinical trials of its RadioGel therapy could be a game-changer in cancer treatment. If approved, this innovative approach has the potential to offer more effective options to cancer patients, providing hope and a new treatment avenue for those with challenging cancer types.
Summary
Vivos, the maker of the Radiogel™ Precision Radionuclide Therapy, has submitted an application to the FDA to initiate human clinical trials for its groundbreaking cancer treatment. The RadioGel therapy, designed for patients unable or unwilling to undergo surgery, involves injecting a hydrogel containing Yttrium-90 phosphate microparticles directly into the tumor for a more localized and potent radiation treatment.
This marks Vivos’ first filing with the FDA since being granted Breakthrough Device Designation, and the IDE submission addressed 63 FDA comments received in previous correspondences. If approved, this treatment could offer hope and potentially more effective options to cancer patients worldwide.
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