World News: 12:00 GMT Tuesday 3rd December 2019. [Vivos Inc. via Globe Newswire via SPi World News]
Richland WA, Dec. 03, 2019 (GLOBE NEWSWIRE) -- (OTCQB: RDGL) today announced that two dogs with different cancer types were treated using Vivos Inc.’s Isopet therapy on November 27 at our pilot clinic, Vista Veterinary Hospital in Kennewick, WA.
One dog with hemangiosarcoma and another dog with hemangiopericytoma were treated. Each patient had multiple tumors that were treated in a single session. Both patients were released on the same day in time for Thanksgiving. In addition to treating two new cancer types, we also demonstrated the ability to treat multiple tumors per pet in one treatment session. The single treatment session per pet remains an important differentiator of the Isopet therapy as compared to external beam therapy.
Further, we established a process that will allow for the treatment of more than one patient per day at Vista. The “Therapy Wednesday” approach allows us to reduce the cost per therapy and is well suited for Isopet on demand availability and single procedure per patient treatment protocol. Our mission is to provide pets, pet parents and veterinarians the industry standard for practitioner and patient friendly treatment of solid tumors. As the awareness of the safety and efficacy of Isopet increases, we intend to dedicate another weekday to Isopet therapy at our pilot clinic in the coming months. We are also very encouraged that the work being done at Vista will serve as the foundation for our regional clinic commercial development strategy.
Vivos Inc. has been reviewing Expression of Interest applications for Isopet therapy that have been submitted via our web page over the past several weeks. Many were highly metastasized advanced cancer patients or cancers that were not localized. In the near-term we continue to focus on potential patients that live within driving distance of our pilot clinic in Kennewick WA. The two recent patients were from Redmond WA and Vancouver British Columbia. We have just begun advertising in the Oregonian and the Seattle Times. The first pet parent scheduled in December will be driving in from Santa Clara California.
We also received numerous inquiries from Pet Parents in other geographic regions of the country that would require the additional time and expense of flying to the state of Washington. This validates the importance of our strategy to establish several regional clinics across the country.
As a complement to our commercial development strategy, we are committed to continuously generating new data that will be shared with the veterinary community to build their confidence. To this end we are currently designing a new clinical study to complement previous testing conducted at Washington State University and the University of Missouri.
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(R) 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(R) 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(R) 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(R) 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(R) to University animal hospitals and private veterinary clinic consortiums.
Isopet(R) 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.
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.
Vivos Inc. Michael K. Korenko, Sc.D.President & CEO
Globe Newswire: 12:00 GMT Tuesday 3rd December 2019
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