Vivos Inc. certifies new clinic for IsoPet® precision radionuclide therapy

Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy^™ medical device to treat tumors in animals (IsoPet^®) and humans RadioGel^®. Using the company's proprietary hydrogel technology, PRnT^™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. 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 the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.

NorthStar Vets - Veterinary Emergency & Trauma Specialty Center in Robbinsville, NJ. provides 24/7/365 emergency, trauma, and critical care and a suite of veterinary specialty services for small animals. They have been approved and licensed to offer IsoPet Precision Radionuclide Therapy as a cancer treatment for small animals.

Dr. Korenko stated “An important objective is to expand the number of clinics that are certified for IsoPet Therapy. Generally, different clinics specialize in small animal or equine therapy. Certification is much lower cost than other alternatives that require large capital investments. It requires veterinarians and oncologists that are enthusiastic about the effectiveness of IsoPet. Vivos assists them with obtaining or amending their radioactive material license and provides the certification training that includes our proprietary Injection Guidance Table. We now have several clinics in the pipeline.”

The Company has 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 was required 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.