Vivos Inc
Vivos Inc.(OTCQB: RDGL) Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet ® ) and in humans (RadioGel ™ ). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers. In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet ® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet ® to University animal hospitals and private veterinary clinics. IsoPet ® for treating animals uses the same technology as RadioGel ™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
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