Richland WA, April 30, 2019 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCPINK: RDGL), provides an update on the progress towards commercialization of Y-90 IsoPet® for animal therapy.
This week we will be treating our last dog in the test series for soft tissue sarcoma therapy at the University of Missouri (“Missouri”). Missouri will write up the test report, which we will review and forward to the FDA. The primary purpose of the testing was to answer key FDA questions regarding the Radiogel™/ IsoPet® technology and to confirm our claims related to the safety and effectiveness in treating solid tumors. Following completion of the canine sarcoma study, we plan to expand our contract with Missouri to begin testing for treatment of equine sarcoids.
Dr. Mike Korenko, Vivos Inc. CEO stated, “I am encouraged by the outstanding preliminary results of the canine sarcoma treatments with Isopet®. All of the test subjects are alive and well and are showing objective evidence of tumor destruction. We will continue to track their progress based on their follow-up examinations. Dr. Charlie Maitz, the principal investigator at Missouri, did an excellent job demonstrating proficiency in administering IsoPet according to the procedures on our Label. The new state-of-the-art PET/CT equipment at Missouri provided objective evidence of IsoPet® near-uniform dose distribution via perfusion within the tumor. These results confirm precise delivery of a high dose of therapeutic radiation and address multiple questions the FDA has previously asked regarding the product.”
Pilot Clinic for Commercial Sale of Isopet®
We have been placing a high priority on obtaining the Radioactive Material License for our pilot clinic, Vista Veterinary Hospital. This process has taken longer than expected in part because Vista has not previously been licensed to handle any radiopharmaceutical material and because this is the first experience in the country that regulators have had with Isopet®. To address this, we agreed to additional oversight for the first few treatments to demonstrate safety of the procedures for handling and administering the product. This will help establish standard permit conditions for other clinics that to use IsoPet® in the future.
The Washington Department of Health conducted a pre-licensing inspection at Vista in the first week of April. They provided a list of actions that they wanted completed and decided to do a final inspection prior to issuing the license. Washington is an Agreement State, i.e. the State has been granted authority to implement US Nuclear Regulatory Commission regulations for medical uses of radioactive materials. When an Agreement State issues a license for a new product it sets a precedent for all other Agreement States. This will have a benefit when we begin expanding IsoPet® therapy to regional clinics across the country, since all but twelve states are agreement states.
Within this regulatory framework, we have decided to sell IsoPet® as part of a development effort wherein new users agree to provide data on the safety and efficiency of IsoPet administration procedures and report on the overall effectiveness of the therapy. This is consistent with the licensing practices of new products and guarantees that we harvest data which we will share with the FDA and other clinics.
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 recently 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
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
Michael K. Korenko, President & CEO