Vivos Inc.

Vivos Inc. (OTCQB: RDGL) is a medical device company on the forefront of changing the way cancer is treated with its patented Precision Radionuclide Therapy™.  Also known as PRnT™, the treatment uses a highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area and delivers therapeutic radiation from within the tumor. Vivos Inc. has developed a hydrogel yttrium-90 injectable device to treat tumors in animals (IsoPet® Division) and humans (RadioGel® Division).

Radionuclide therapy, also known as nuclear medicine therapy or radiopharmaceutical therapy, involves the use of radioactive substances to treat diseases, most commonly cancer. The therapy utilizes radionuclides, which are radioactive isotopes, attached to molecules that can specifically target cancer cells. This allows the radionuclides to deliver targeted radiation directly to the tumor or diseased area, minimizing damage to surrounding healthy tissue.

In this treatment, the radioactive isotopes emit radiation that damages the DNA of the targeted cells, leading to cell death or a significant reduction in the cell's ability to multiply. The most familiar forms of radionuclide therapy include treatments for thyroid cancer using iodine-131, pain relief from bone metastases with strontium-89 or samarium-153.   Peptide receptor radionuclide therapy (PRRT) used for treating neuroendocrine tumors using radiolabeled peptides. Vivos Inc. and their patented Precision Radionuclide Therapy™ uses Yttrium-90 to kill tumors and is revolutionizing the treatment of cancer.

Yttrium-90’s Role in Cancer Treatment

Yttrium-90 (Y-90) is a radioactive isotope commonly used in radionuclide therapy, particularly for cancer treatment. Y-90 emits beta radiation, which is effective for treating certain types of cancers because of its ability to deliver high doses of radiation to localized areas with minimal impact on surrounding healthy tissue. Here are some key applications of Yttrium-90 in cancer therapy:

• Radioembolization: Also known as selective internal radiation therapy (SIRT), it involves delivering Y-90 microspheres directly into the arteries feeding a tumor, typically in the liver. This is commonly used for treating hepatocellular carcinoma (primary liver cancer) and metastatic colorectal cancer in the liver when surgery is not an option.

• Radiosynovectomy: Y-90 is used to treat inflammation in the synovial joints (such as in rheumatoid arthritis) by injecting it directly into the joint. Although not a cancer treatment, it's worth mentioning for its therapeutic use in joint disease using radiation.

• Non-Hodgkin Lymphoma: Y-90 is conjugated to monoclonal antibodies that target specific cancer cells in some types of non-Hodgkin lymphoma. The antibodies deliver Y-90 directly to the cancer cells, where it can destroy them with localized radiation.

The use of Y-90 allows for high precision in targeting tumors, reducing the risk of side effects typically associated with external beam radiation, such as damaging healthy cells. The treatment planning involves sophisticated imaging techniques to ensure accurate delivery of the radioactive material.

Y-90 therapy has been shown to be effective in extending survival and improving the quality of life for patients with specific types of cancer, making it a valuable option in the oncological toolkit.

Radionuclide therapy has several advantages, including its ability to treat cells systematically throughout the body, which makes it particularly useful for conditions where cancer cells have spread to multiple locations. It is typically considered for use when other treatments have failed or as an adjunct to other therapies to enhance their effectiveness.

The Vivos Inc., Precision Radionuclide Therapy™ is a subset of the anticancer agents.  By direct injection into non metastatic tumors, the yttrium-90 delivers lethal radiation dose to the fast-growing cancer cells. 

The Radionuclide Market 

The market for radionuclide therapy is expected to experience steady growth in the coming years, driven by several factors:

• Rising Cancer Burden: The increasing prevalence of cancer globally creates a larger patient pool for this treatment approach.
• Targeted Therapy Advantages: Radionuclide therapy offers a targeted approach with potentially fewer side effects compared to traditional radiation therapy.
• Technological Advancements: Developments in radiopharmaceuticals and targeted isotopes are improving the effectiveness and specificity of the treatment.
• Focus on Minimally Invasive Procedures: Radionuclide therapy can be administered with minimal invasiveness, leading to faster recovery and potentially lower costs.

Market segments - The radionuclide therapy market can be segmented based on various factors, including:

• Type of Radionuclide: Different isotopes with varying properties are used for specific applications.
• Cancer Type: The market can be further segmented by the types of cancers treated with radionuclide therapy (e.g., prostate cancer, neuroendocrine tumors, etc.).
• Delivery Method: The market can be segmented based on how the radiopharmaceuticals are administered (e.g., oral, intravenous, injection).

Market Research - While a single definitive market size for the global radionuclide therapy market might be elusive, some market research firms provide reports on related segments:

• Radioligand Therapy Market: This segment focuses on radiopharmaceuticals that use antibodies or peptides to target cancer cells. 
• Radionuclide Therapy Market: Considering the growth drivers and targeted therapy advantages, the radionuclide therapy market is expected to be a promising area within nuclear medicine.
• Reports suggest this market could reach USD 13 billion by 2030 according to Meditechinsights.com

The global radiation therapy market size was estimated at $7.47 billion in 2023 and is expected to reach $10.4 billion to $16.3 billion by 2033 at a CAGR of 8.58% from 2024 to 2033. Major companies like Pfizer (NYSE: PFE) are returning to their emphasis on cancer treatment after focusing on COVID-19 for the past few years. Other major pharmaceutical companies like AstraZeneca(NASDAQ: AZN) and Eli Lilly (NYSE: LLY) are also expanding their nuclear medicine capabilities with radiation to tackle cancer.  Big Pharma’s billions of dollars in investments in nuclear medicine highlight how cancer treatment is shifting to targeted approaches.

Vivos Inc. has made significant developments in both their human and animal divisions. The company has achieved milestones announcing that the FDA granted RadioGel® Precision Radionuclide Therapy™ the designation of a Breakthrough Device and will use this designation to accelerate clinical trial approvals. The IsoPet® division is treating animal cancer in horses, cats and dogs at eight clinics across the United States and is expanding quickly. Key regional clinics are the University of Missouri, Johns Hopkins Medicine, and the most recently certified University of Wisconsin for Equine cancer treatment. The RadioGel® Division is working closely with the Mayo Clinic for the initial indication for delivering therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer. 

Expansion into Veterinary Care with IsoPet®

Vivos Inc. has been expanding its reach in veterinary medicine with a yttrium-90 based Precision Radionuclide Therapy™ for treatment used for solid tumors in animals. The equine healthcare market is experiencing significant growth, driven by rising demand in various sectors including racing and sports, along with increased awareness and investment in equine health. In 2023, the global equine healthcare market size was estimated at approximately $1.5 billion and is projected to reach $2.5 billion by 2032, reflecting a compound annual growth rate (CAGR) of approximately 5.6%. North America is a dominant player in this market, largely because of a well-established equine industry.

In terms of veterinary oncology, which includes cancer treatment for horses among other animals, the market was valued at $923.5 million in 2023 and is anticipated to grow to $1.7 billion by 2032. This growth is attributed to the increasing incidence of cancer among animals, advancements in cancer diagnostics and treatment, and a greater focus on pet health. 

Vivos Inc. has been focusing efforts to certify additional clinics to offer IsoPet® treatment, enhancing access to advanced cancer treatments for cats, dogs and horses. There is also an opportunity to treat exotic animals and the company is in discussion with several interested parties to open a broader market for IsoPet®. 

Clinical Trials with RadioGel®

Dr. Mike Korenko, CEO, stated, “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel® is intrinsically safe and our animal therapy data verified its effectiveness. We are currently working closely with Mayo Clinic for our initial indication for use of Radiogel® for delivering therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease. The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.”

Cancer On the Rise

In 2023, it's estimated that around 43,720 cases of thyroid cancer will be diagnosed in the United States, with about 2,120 fatalities expected from the disease. Thyroid cancer is notably more prevalent among women than men and tends to be diagnosed at a younger age compared to most other adult cancers, with the average age of diagnosis at 51 years. The incidence of thyroid cancer has been increasing, which may in part be because of advancements in diagnostic technologies that can now detect smaller cancers that might not have been found in the past. It's important for ongoing research and patient support to adapt to these trends to optimize treatment strategies and improve outcomes. 

According to the latest data from the International Agency for Research on Cancer (IARC), there were approximately 20 million new cancer cases and 9.7 million cancer deaths globally in 2022. Lung and breast cancers are the most prevalent worldwide, with lung cancer also being the leading cause of cancer death overall and in men. For women, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death. The projections suggest a surge to 35 million cancer cases by 2050, mainly because of population growth and aging, if current incidence rates remain unchanged. 

Vivos Inc. - The  Leader in Precision Radionuclide Therapy™

Vivos Inc.'s strategic endeavors in medical and veterinary oncology are indeed pushing the boundaries of healthcare innovation. Holding nearly 30 patents including Precision Radionuclide Therapy™ and trademark protection for IsoPet®, RadioGel®, Alpha-Gel™, Beta-Gel™ and Gamma-Gel™ just to name a few, Vivos Inc. is securing its place as the leader in radionuclide therapy. 

Vivos Inc.'s recent achievement of OTCQB certification is a significant development, underscoring the company's dedication to transparency and regulatory compliance. On March 22, 2024, CEO Dr. Michael Korenko led the company to secure its registration under Section 12(g) of the Exchange Act. This certification is more than procedural; it reflects Vivos Inc.'s strategic foresight and proactive approach in maintaining high governance standards, ultimately benefiting investors and partners by providing clear insights into the company's operations and financial health. 

With critical FDA designations for its groundbreaking treatments and achieving milestones like OTCQB certification, Vivos Inc. is demonstrating its commitment to innovating the treatment of cancer and saving lives worldwide. 

Currently RadioGel® is not approved for human therapy.