Richland WA, June 18, 2019 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCPINK: RDGL), Vista Veterinary Hospital obtained their license to administer IsoPet® for animal therapy from the state of Washington.
This license is an important step in our IsoPet® commercialization plan. The next step for Vista is to complete certification training by performing an IsoPet® injection procedure using surrogate tissue. This will demonstrate Vista’s ability to properly administer the product and safely handle the material. In addition, Vista is also required to complete three patient administrations in order to reach full authorized user status.
Vivos is implementing a program where new IsoPet® users agree to provide data from follow-up examinations of their patients on the overall efficacy of the therapy. This is a best practice for a new product on the market that ensures data will be collected for publication in the technical literature and at technical conferences. The data will also benefit Vivos’ efforts to gather information on safety and effectiveness of IsoPet® from animal studies and support an eventual IDE submission required for a pre-market review for human therapy.
We anticipate the Vista pilot clinic will be ready to begin enrolling patients in the near future and we will have additional announcements once all necessary preparations are complete.
We continue to receive expressions of interest in IsoPet® therapy from pet owners across the country and plan to establish a web portal with information for prospective patients/pet owners and veterinarians.
Dr. Mike Korenko stated “Obtaining the initial license at a private clinic was a long process, but we now have a valuable model that is repeatable and scalable for our next phase of selecting regional clinics in other NRC Agreement states. We used a very disciplined approach that is necessary when the health and safety of animals and therapists are of paramount importance.”
About Vivos Inc. (OTC: RDGL)
Vivos Inc. is a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals. It has developed an Yttrium-90 based brachytherapy injectable 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 formulation. 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.
IsoPet® is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to the family.
The IsoPet® Solutions division is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on canine soft tissue sarcomas at the University of Missouri is near completion.
The Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a 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. FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet® to University animal hospitals and private veterinary clinic consortiums.
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.
The Company is also engaging the FDA for premarket clearance to market RadioGel™ for the treatment of advanced basal and squamous cell skin cancers in humans.
Safe Harbor Statement
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Michael K. Korenko, President & CEO