Richland WA, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), provides 2019 recap and outlines future objectives. Vivos’ CEO, Dr. Mike Korenko stated, “as we begin 2020, I think it is important to review our progress during past year and to provide some insight on our goals and expectations for 2020 and beyond.”
2019 Key Highlight Include:
- ISOPET® THERAPY
- Confirmed that the FDA device classification is applicable to all solid tumors in animals
- Completed the University of Missouri sarcoma cancer therapy study and reported the results at the annual Veterinary Cancer Society meeting and in a peer reviewed scientific journal article
- Obtained the Radioactive Material License and completed the certification training to open a pilot private clinic for IsoPet® therapy at Vista Veterinary Hospital which will serve as models for future regional clinics
- Completed the first commercial IsoPet® therapy, followed by four other therapies that demonstrated treatment of four specific cancer types, treating multiple tumors per animal and multiple patients per day
- Communicated the commercial availability of IsoPet® therapy to veterinarians across the USA to begin to build national awareness and launched our local advertising campaign with the Seattle Times and the Portland Oregonian
- IsoPet® was introduced to the European Veterinary community at the Eiffelvet meeting held in Paris France
- INTELLECTUAL PROPERTY PROTECTION
- Continued our emphasis on intellectual property protection by filing a new patent on our yttrium-90 phosphate particle processing
- PRODUCT COST REDUCTION
- Reduced the IsoPet® product cost by standardizing the production process, and negotiating reduced fees for the RadioGel license agreement, production labor expense, and Yttrium-90 material cost
- FINANCE/SEC REPORTING
- Uplisted to the OTCQB
- Filed all audited financials in a timely manner
- Reg A Filing cleared by the SEC
We are committed to pursuing our growth plan in 2020 and beyond.
These future initiatives include:
- Additional IsoPet® therapies at the Vista Veterinary pilot facility
- Bring on-line the first regional clinic for IsoPet® therapy
- Generate additional treatment data from clinical studies to enhance the marketing of IsoPet® to the veterinary community
- Expansion of our IP portfolio to foreign jurisdictions
- Completion of Isolated Production Center
- Complete the pre-clinical testing required by the FDA for the Investigational Device Exemption (IDE) to set the stage for human trials
- Execute formal collaboration and/or partnering agreements for Radiogel following receipt of the IDE
In closing stated Dr. Korenko, “Over the last three years we have made steady progress, which we have communicated through formal press releases and social media. We are committed to continuing to build on this progress. IsoPet® is only therapy that can deliver non-systemic single high dose radiation to the tumor site, with minimal impact to adjacent normal tissue. IsoPet® can be shipped on-demand and treatment can be delivered in a one-time procedure taking less than an hour. We are looking forward to additional IsoPet® therapies that will continue to demonstrate the safety and effectiveness of this leading next generation therapy.”
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. The 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 was completed in 2018 and the testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.
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