Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation
(Richland WA December 20, 2023) Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.
Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness. We are currently working closely with Mayo Clinic for our initial indication for use of Radiogel for delivering “therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease.” The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.
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