Replies to post #112794 on Vivos Inc (RDGL)

[sharky]

RDGL Tuesday AH news: News: Vivos Inc. to Treat Advanced Canine Patient for Soft Tissue Sarcoma with IsoPet®
Richland, WA, Dec. 04, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL) a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in humans and animals, has agreed to supply IsoPet® to treat a dog with advanced cancer at the University of Missouri. The procedure is scheduled to take place on December 6, 2018. The animal has a large tumor that weighs approximately one-half pound, which is well outside the parameters of our study plan for treatment of canine sarcomas. In addition, the patient has a growth in one lung indicating the cancer may have metastasized.

The dog’s owner was passionate about obtaining the treatment. We ultimately agreed on humanitarian grounds that the potential benefits of treatment with IsoPet® would outweigh the risks, even though the patient is likely to eventually succumb to metastatic disease. It will be the largest tumor treated with IsoPet to date, and offers the opportunity to evaluate the practical aspects of treating large tumors and help determine the parameters of effectiveness of the therapy. Additionally, there is evidence that a dying tumor can stimulate an animal’s immune system to recognize and destroy the cancerous cells, providing some encouragement for an outside chance that the metastatic cancer cells could be attacked well outside the tumor boundary. Effectively then, this treatment is being provided both for the hopeful benefit of the dog, as well as research.

Dr. Mike Korenko, Vivos Inc CEO stated “We deliberated carefully prior to making this decision since losing an animal, as is likely the case here, can draw substantial scrutiny by the FDA. We are being careful to identify this case as being outside the study plan criteria. In the end, the humanitarian aspect was the overriding factor in making this determination. A secondary benefit is the potential to learn from this therapy. We are confident that IsoPet® will be effective in treating the primary tumor, but there are uncertainties on how the patient’s system will react to a large necrosis volume and whether a synergistic effect against the metastatic disease will in fact be observed.”

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® 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.

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 University of Missouri will begin in the near future.

The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device for skin cancer therapy in cats and dogs. The FDA also reviewed and approved the product labeling. 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.

The Company is also engaging the FDA for 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.

CONTACT:

Vivos Inc.
Michael K. Korenko, President & CEO
[e-mail]


$RDGL

[pennylandspirit]

Excellent post!!! DD is solid $$$$$&

[kayak_wench]

Cancer treatement, not cure.

With a half-life of 2.7 days treatment with Yi-90 is a logistical challenge. Each treatment will need to spawn the creation of the isotope and then it must be delivered very quickly to the treatment facility. You can't create it and let it sit on shelf like most products.

Its not an accident where they chose to have the vet trials done. Both universities have research reactors and I think they both produce the isotope. With a 2.7 day half life if it takes 3 days to transport the Yi-90 to the treatement site it will have lost much of the its effectiveness. I can only surmise that the private vet facility located near Vivos headquarters is going to leverage transportation capabilities arranged when Vivos (used to be ADMD) produced medical isotopes and sold (thus shipped) them to near-by hospitals from local air fields. Not every plane or company is cleared to transport radioactive material via air. So this will likely be a regional treatment capability that people will have to transport their pets to versus ever ending up in every neighborhood vet clinic. That is why they noted that the treatment range for their first private facility needs to be 250 miles. "It is expected that as the successful results of the therapies become known, pet owners from as far as Spokane, Seattle and Portland will seek to have their affected animals treated at the Vista Clinic. It is estimated that more than 9 million people live within 250 miles of Kennewick"

Also remember all the radiogel patents are licensed. Vivos did not invent the technology, they are licensing the technology on on my last read a yearly basis. They were gifted (for some reason) to bring this technology to market. If the company who owns the patents decides not to renew or to make it not exclusive then what? If a cash rich company comes in and shows the company that owns the patents they can roll out the technology more effectively and bring them more profit why wouldn't they drop Vivos or at the very least give a license to someone else.

That said its a good product and a reasonable risk, but its a risk. And again not a cancer cure nor a sure way to becoming rich. So investors should only invest what they can afford to completely lose.

If Vivos invented the technology and held patents I would be far more optimistic. But they don't.