Richland WA, Aug. 16, 2022 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to report that it just certified the New England Equine Practice in Patterson, NY to administer Precision Radionuclide IsoPet® therapy for treating solid tumors in horses.
IsoPet® is a next generation treatment option, providing a same day therapy, using relatively low activity to deliver a high therapeutic dose that stays at the injection site with no contamination in the urine or feces.
As we gain experience at our equine sites and gain the confidence of the regulators, we intend to expand their radioactive material handling license to allow the use of a mobile Isopet® therapy vehicle that can treat horses on their home farm. This is an important feature as horses should not be trailered more than eight hours or they can develop serious medical respiratory issues called “trailer fever” the following day.
Dr. Korenko stated, “We are in active discussions related to opening additional equine clinics and are excited about offering Isopet® as a game changing treatment option for treating solid tumors in horses.
We are also pleased to report that our first demonstration of Isopet® equine therapy at the University of Missouri regional clinic (Summer Solstice) remains cancer free after fifteen months.”
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90 based injectable Precision Radionuclide Therapy 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.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources 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.
RadioGel™ 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 family members.
The IsoPet® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
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.
Safe Harbor Statement
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Michael K. Korenko, Sc.D.
President & CEO