Richland WA, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced today that they filed a provisional patent application on the system equipment to support precision radionuclide therapy.
This includes the shipping containers, the shielded vial holder, the Peltier chiller, and the syringe shields. These device designs are integrated into our production standardization effort. They can be used for treating a range of tumor sizes from 0.5-gram human lymph nodes to half-pound equine tumors. This equipment was just tested at our recent equine therapy in NY.
SHIPPING CONTAINER
- Eliminated the can and the lead pig containers and designed the shielding of the new plastic container to improve the ease of unpackaging and to ensure that we can ship to White 1 label (UN2910) standards to reduce the Fed Ex shipping costs and logistics.
SHIELED VIAL HOLDER
- Incorporated stability in securing the vials while filing the syringes and maximized the vial holder wall thickness to further reduce the relatively low radiation.
PELTIER CHILLER
- Designed to chill the vial holders and the syringes with a plug-in system.
- Avoids the potential contamination from ice baths, which was a Mayo Clinic concern for human clinical trials.
- Contains an imbedded magnetic stirrer to keep the IsoPet solution particles in suspension.
- Each syringe port can be dedicated to a specific human lymph node, a specific VX-2 tumor in the animal testing, or as a staging center for treating larger animal tumors.
SYRINGE SHIELD
- Maximized the diameter of the syringe shield to reduce radiation while designing the finger position to maintain the optimum ergonomics.
- Received very positive feedback from the therapists about the ergonomics. This flexibility is important to ensure the accuracy in precision injections.
Dr. Mike Korenko stated “This development occurred over the entire year while incorporating practical experience and feedback from our therapists. We will make this equipment available to the Mayo Clinic for human clinical trials and to the therapists in all our current and future regional clinics.”
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 microparticles 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 is 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 was required 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
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.
CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
MKorenko@RadioGel.com
