$RDGL - Animal Skin Cancer Treatment Classified as a Device by FDA
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Vivos Inc. announced today that it has received FDA confirmation that RadioGel, a brachytherapy tool, is classified as a device for therapy of feline sarcomas and canine soft tissue sarcomas. As per FDA recommendation, RadioGel will be marketed as IsoPet for use by veterinarians to avoid any confusion with the device used in humans.

According to a company press release, the device is comprised of highly insoluble yttrium-90 particles delivered by needle injection using a water-polymer composite for high-dose treatment of nonresectable solid tumors that cannot be treated by other means. The therapy is designed to deliver a high dose of radiation to tumor tissue, with adjacent normal tissue and organs receiving small-to-negligible radiation doses.

Vivos, which changed its name from Advanced Medical Isotope Corporation earlier this month, said it completed a feline sarcoma therapy series at Washington State University (WSU) in January. From these tests—which were designed to improve procedures and determine the optimum dose—it was determined that RadioGel was safe and effective in eliminating cancer cells.

“Obtaining this approval is an important step to set the stage for selling IsoPet to private clinics for animal therapy,” said Mike Korenko, PhD, CEO of Vivos. “By being labeled a device there are no other regulatory approvals necessary for treating skin cancer, the most common cancer in animals.”

With the FDA confirmation, the company has immediate plans to partner with leading veterinary colleges to treat animals diagnosed with cancer. In February, it plans to incorporate lessons learned from the feline study at WSU to recruit canine skin cancer patients. The dogs are scheduled to be treated at the University of Missouri. In April, the company plans to begin using IsoPet at the University of California, Davis, on dogs with prostate and liver cancers. From there, it plans to begin treatment of equine sarcoids at the University of Missouri.

Vivos said that by obtaining FDA approval in stages, it hopes to establish a faster path to commercializing the product in the veterinary sector. Ultimately, the company said it will use the data generated from its animal studies as part of the testing required by the FDA for treating skin cancer in humans.