Richland WA, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos, Inc. key personnel attended the Veterinary Cancer Society annual meeting last week in Houston Texas which was attended by nearly 700 veterinary oncology professionals. Vivos was a bronze sponsor at this premier event and had a booth in the exhibit hall. Our team included Dave Swanberg, our Chief Technology Manager, Dr. Darrell Fisher, our Medical Physicist, and Dr. Allice Villalobos and Tariq Shah from our Veterinary Medicine Advisory Board.
Dr. Charles Maitz presented a summary of the results of our clinical study on canine sarcoma at the University of Missouri. That study demonstrated the safety of IsoPet® therapy for the patient, therapist, and pet parents, while delivering a very high dose of therapeutic radiation directly to the tumor with negligible dose to surrounding normal tissues.
The primary objective of the study was to evaluate safety and dose delivery. The PET-CT images showed good distribution of IsoPet® within the tumor. The additional data on clinical outcomes collected in this study confirm that IsoPet® is effective at killing tumor cells. In addition, based on the study results and as part of our ongoing work to further develop and refine the Isopet® therapy, we intend to put greater emphasis on treating the margins surrounding the primary tumor to further reduce the chance of recurrence. A detailed scientific article on this study and the results from the feline sarcoma study at Washington State University is expected to be published soon in the journal Cancer Biotherapy & Radiopharmaceuticals.
Overall, feedback and interest in IsoPet® was very positive. Veterinarians that we spoke with confirmed that IsoPet® is the only therapy that can deliver high single dose radiation to the tumor site with minimal impact to adjacent normal tissue. This contrasts with external beam therapy, that can only deliver a fraction of the prescribed dose and involves multiple treatments. In addition, external beam therapy requires substantial capital investment to be made by the treatment facility. Veterinarians were impressed that IsoPet® can be shipped on-demand and treatment can be delivered in a 15-minute, one-time procedure. The up-front capital and set-up costs are minimal, especially for facilities that already possess a radioactive material license.
We first introduced IsoPet® at last year’s conference. At that time, we had minimal data on a single dog that had been treated for sarcoma. This year we presented much more data and built on the momentum of experience gained over the year. We had significantly more interest from clinics across the country and internationally. These are promising contacts for establishing additional regional clinics in the future.
One theme we heard repeatedly is that veterinary professionals expect to see more data on new technologies. We are committed to complement our current commercial development strategy with additional clinical studies that will generate data to be reported in professional publications and at future conferences.
IsoPet® is an exciting new tool offering a solution that can extend the life of many beloved pets suffering from cancerous tumors.
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. 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 currently underway.
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, Sc.D.
President & CEO