VIVOS INC 10-K

ITEM 1. BUSINESS. Vivos Inc. (the “ Company ,” “ we ,” “ us ,” “ our ”) is a radiation oncology medical device company engaged in the development of its yttrium-90 (“ Y-90 ”) based precision radionuclide therapy device, RadioGel™, for the treatment of non-resectable tumors, now trademarked as Precision Radionuclide Therapy TM . A prominent team of radiochemists, scientists, and engineers, collaborating with strategic partners, including national laboratories, universities, and private corporations, lead the Company’s development efforts. The Company’s overall vision is to globally empower physicians, medical researchers, and patients by providing them with new isotope technologies that offer safe and effective treatments for cancer. In 2013, the United States Food and Drug Administration (“ FDA ”) issued the determination that RadioGel™ is a device for human therapy for non-resectable cancers in humans. This should result in a faster path than a drug for final approval. In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or most solid tumors in animals. We expect the result of such classification and label review will be that no additional regulatory approvals are necessary for the use of IsoPet ® for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations. Based on the FDA’s recommendation, RadioGel TM is being marketed as “IsoPet ® ” for use by veterinarians to avoid any confusion between animal and human therapy. The Company already has trademark protection for the “IsoPet ® ” name. IsoPet ® and RadioGel TM are used synonymously throughout this document. The only distinction between IsoPet ® and RadioGel TM is the FDA’s recommendation that we use “IsoPet ® ” for veterinarian usage, and reserve “RadioGel TM” for human therapy. Historically, the Company’s primary focus was on the development and marketing of Isopet ® for animal therapy, through the Company’s IsoPet ® Solutions division. Over the last four years much effort has been directed to completing the testing require to obtain FDA approval for an Investigational Device Exemption and to obtain approval for clinical trials in India. The Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement of university veterinarian hospital to develop the detailed therapy procedures to treat animal tumors and ultimately use of the technology in private clinics. In January 2025 the Company restructured and aligned its internal resources and focused effort to align with animal therapy, human therapy, and recently other applications of its patented technologies. The Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet ® /RadioGel TM testing and therapy. Washington State University treated five cats for feline sarcoma and served to develop the procedures which are incorporated in our label. They concluded that the product was safe and effective in killing cancer cells. Colorado State University demonstrated the CT and PET-CT imaging of IsoPet ® . The University of Missouri conducted an animal study to treat canine sarcoma. Johns Hopkins University completed a study on VX2 Tumors in Rabbits. Every study confirmed that the Y-90 stayed at the injection site with insignificant distribution outside that boundary. 3 Commencing in July 2019, the Company recognized its first commercial sale of IsoPet®. A veterinarian from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face. The cat had previously received external beam therapy, but now the tumor was growing rapidly. He was given a high dose of 400Gy with heavy therapy at the margins. The Company anticipates that any near-term profits, if any, will be derived from direct sales of RadioGel™ (under the name IsoPet ® ) and related services, and from certifying veterinary clinics to administer IsoPet Therapy. Until recently the Company certified clinics at its own expense, but the demand has increased to the point that starting in 2025 the Company billed its first clinic for the certification process. The plan is to incorporate the data assembled from our work with Isopet ® in animal therapy to support the Company’s efforts in the development of our RadioGel™ device candidate, including obtaining approval from the FDA to market and sell RadioGel™ as a Class II medical device. RadioGel™ is an injectable particle-gel for Precision Radionuclide Therapy radiation treatment of cancerous tumors in people and animals. RadioGel™ is comprised of a hydrogel, or a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor. In the gel are small, less than two microns, Y-90 phosphate particles. Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local radiation dose. The radiation is beta, consisting of high-speed electrons. These electrons only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue. Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members. Since Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days. In 2021 the Company modified its Indication for Use from skin cancer to cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy). Papillary thyroid carcinoma belongs to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection. The Company’s Medical Advisory Board felt that demonstrating efficacy in clinical trials with this new indication provided a more efficient pathway to regulatory clearance. In December 2023, the Food and Drug Administration granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. This gave the company access to the “sprint” rapid review process for IDE comments. For the last several months the company has been taking advantage of that program to resoled detailed FDA questions on a variety of topics. In early 2025 the Company began actively pursuing human clinical trials in India. This involved successful step-by-step implementation of several requirements, including location of a respected lead investigator at a respected hospital; regulatory approvals (securing clearances from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, and the Company was issued the Clinical Trial Registry-India (CTRI) number required for publishing results); logistical coordination (acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel ® , and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product); protocol development (finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission discussions); operational readiness (re-validated RadioGel ® manufacturing at IsoTherapeutics to ensure compliance with Quality Management System standards and FDA sterility and validation recommendations); administrative preparations (signed agreements with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region); and training and certification (conducted comprehensive certification training for the treatment team). Failure on any step would have terminated the effort. In December 2024 the Company conducted an important offset strategic meeting to ensure that its entire key internal and external team was alighted to its strategic plans. Attendees included all our current internal team members, our senior health physics volunteer, the members of the Medical Advisory Board and the Veterinary Medicine Advisory Board, lead Investigator for the proposed Mayo Clinic clinical trial, lead investigator for the clinical trial in India, and our patent attorney. The primary objective was to re-assess our business direction, to select the next target series of indications for Use, to ensure that we have developed the optimum precision Radionuclide Therapy TM approach for each cancer type, including the isotope, the delivery technique, and the dose, and to ensure that our current and future patents protect these directions. It also discussed the domestic and internation plans. 4 The Company decided to explore the viability of harvesting its technology for other business opportunities as a separate “division.” The Company is working with Akina, on these initiatives. The current efforts are on the Peltier Chiller technology and the hydrogel. To prevent the Company from being distracted from its primary focus of treating cancer, if viable, Akina would probably also be the principal distributor. Alternatively, each business sector can be spun off as separate business activities to an interested party. Controlled Laboratory Chilling - As Akina explained, it is easy to purchase many laboratory devices to control heating, but there are limited or no options for controlled cooling, which is a common laboratory requirement usually involving ice baths. The Company is now testing a prototype universal laboratory cooling device. Hydrogel – the Company spent years on refining the development of its hydrogel, in which gelation initiates just above room temperature and is completed as it warms to body temperature. It is currently investing in quantifying and controlling the hydrogel resorption characteristics. There has been sufficient spontaneous interest in this component to warrant a serious business case assessment. The Company just trademarked the name Precision Gel TM and, in addition to its current hydrogel patent, has filed a new provisional patent in January 2025 to cover retention, transport, and release of a broad range of agents. These agents include radioactive and non-radioactive materials, solid particles, including nano-particles, large molecules, small molecules, including liquids, cells, and viruses. A MOU has been drafted to interface with potential clients including licensing and exclusive material contracting. Initial meetings are scheduled in the first quarter of 2025 with potential clients to assess the business viability. Intellectual Property Our original license agreement with Battelle National Laboratory (the “ Battelle License ”) reached its end of life in 2022. We have expanded our proprietary knowledge, as well as our trademark and patent protection, in anticipation of the Battelle License reaching the end of its term during the past several years. Our trademark protection, which usually is extended to 17 countries, has been expanding continuously as summarized below: We own applications/registrations for the following and should mark as noted below: ○ ISOPET® ○ RADIOGEL® ○ ALPHA-GEL TM ○ BETA-GEL TM ○ GAMMA-GEL TM ○ PRECISION RADIONUCLIDE THERAPY TM ○ PRECISIONGEL TM Similarly, we have systematically filed provisional and utility patents that cover our key components, hydrogel and the yttrium phosphate particles, and our injection system in the US office and more than ten others covering approximately 63 counties. In January 2025 we filed an additional provisional patent on the control, transport, and delivery of PrecisionGel. IsoPet Regional Clinics Vista Veterinary Hospital (“ Vista ”) was selected as the pilot private clinic to initiate commercial sales of IsoPet ® . It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country. Vista is in the Tri-Cities Washington area was convenient for interactions with key personnel of the Company. Vista has done well in several audits by the Washington State Department of Health. The Company worked closely with the Washington State Department of Health to refine and improve the radioactive material license by adding several detailed procedures, which will benefit future regional clinics. In addition, a second veterinarian has been certified. 5 The testing at the universities and at Vista have demonstrated that IsoPet ® is effective on killing cancer tissue near the injections. It is most effective in early cases before the cancer has begun to spread. Later stage cancers are more difficult to treat since the tendrils from the primary cancer site are not well defined or imaged and therefore can lead to recurrence. Johns Hopkins University Veterinary Clinical Trials Network (“ Johns Hopkins ”), is now an Isopet ® regional clinic. They have the required radioactive material license and have completed their training certification for Isopet ® . This important relationship will also help meet our objective of obtaining high quality data on a range of cancers that can be published in leading journals. These publications are the optimal way to increase awareness of Isopet ® , and to gain broader acceptance from the veterinarian/oncology community. Johns Hopkins just completed the VX2 Tumor therapy animal study in rabbits and is writing a report for publication. The study further demonstrated the safety of RadioGel ® , generating the activity decay curves that show that the hydrogel remains at the injection site. This study also: (1) demonstrated the validity of the Instructions for Use; (2) the validity of the Injection Guidance Table; and (3) provided a basis for refining the techniques for treating small human cancerous lymph nodes. RadioGel’s classification as a breakthrough device was positively influenced by the safety and effectiveness of many animal therapies. We expanded the number of IsoPet Certified clinic from 4 in 2023 to 13 by the end of 2024: ● Vista Veterinary Hospital – Kennewick, WA ● University of Missouri – Columbia, MO ● Johns Hopkins University – Baltimore, MD ● New England Equine Practice – Patterson, NY ● Myhre Equine Clinic, Rochester, NH ● University of Wisconsin School of Veterinary Medicine, Madison, W ● Brazos Valley Equine Hospital, Navasota, TX ● Indian Creek Veterinary Hospital, Fort Wayne, IN ● Hopkinton Animal Hospital - Hopkinton, N ● NorthStar VETS Veterinary Emergency Trauma & Specialty Center, Robbinsville, NJ ● Animal Emergency & Specialty Center of Knoxville, Knoxville, TN ● Sumner Veterinary Hospital, Sumner, WA ● The University of Illinois College of Veterinary Medicine, Urbana, IL We now treat feline, canine, equine, and exotic animals. We are targeting to open approximately ten more clinics in 2025. The Company worked closely with FX Masse to assist the clinics with licensing. They developed nine certification training modules for use in potential regional clinics. These modules are necessary to satisfy the radioactive material handling licenses. During 2024, the Company saw the development of three new websites to elevate the online presence and brand identity. These included a corporate website and dedicated sites for its two divisions, RadioGel ® and IsoPet ® , tailored to their unique audiences. Each site featured user-friendly designs, informative content, and engaging blogs to educate visitors and build industry authority. Marketing Materials were created that effectively communicated our innovative cancer treatment Precision Radionuclide Therapy™. Our team managed a booth at six conferences. LeeAnna Binder toured the country discussing IsoPet therapy with several clinics in a specially modified IsoPet van. To amplify visibility, our marketing team managed and maintained an active presence on social media platforms, including Facebook, Instagram, X, and LinkedIn, with consistent, engaging posts to connect with our target audience. This comprehensive approach enhanced brand recognition, drove traffic to our websites, and supported business growth. In 2024, IsoPet Division transitioned from data collection to commercialization, utilizing our extensive data to refine our offerings. By collaborating closely with certified clinics, we have recalibrated our pricing to make our services more affordable for pet patients. As we enter 2025, with plans to expand our clinic network across strategic US regions, we are excited about enhancing pet care nationwide. With increasing patient volumes, we are also aligning with our production team to establish a more defined ordering schedule. This strategy will help synchronize patient bookings with product availability, ultimately reducing production costs and making IsoPet’s solutions even more accessible. 6 Our objectives are to open several more regional clinics over the next three years, and to participate in a minimum of four conferences annually to spread the word about IsoPet ® in the veterinarian community for treating tumors in small animals and horses. Our Veterinary Medicine Steering Board provides advice on obtaining new pet patients. FDA Regulatory Status- Recent Developments Human Therapy In November 2020 the Company submitted a request for a Breakthrough Device Designation. Ultimately, this was denied, but the FDA acknowledged, “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a precision radionuclide therapy device outside of the liver.” More importantly, the process resulted in a rapid review of our existing data and approach. It led to a redirection of our efforts on writing the Investigational Device Exemptions (“ IDEs ”) and saved the Company much time in the review of that future application. Based on advice from the FDA the Company scheduled a Pre-Submission meeting on November 30, 2021 to discuss a draft of an IDE for Early Feasibility Medical Device Clinical Studies, including certain First in Human (“ FIH ”) Studies. Using this process results in more rapid feedback to prepare the final IDE. The FDA was supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The Mayo Clinic physicians did an excellent job presenting the need for Radiogel ™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo Clinic protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations. In May of 2022 the Company held another pre-submission meeting with the FDA. They concurred with our dosimetry techniques and requested one more animal test to confirm that the Y-90 stays at the injection site. We participated in another pre-submission meeting to discuss this new animal test of VX-2 tumors in rabbits at Johns Hopkins. We have a meeting scheduled with the FDA in October to obtain their feedback on our new animal test plan. We held another pre-submission meeting with the FDA on October 17, 2022 to obtain detailed feedback on the proposed VX-2/Rabbit Animal Test Plan and to submit the Risk Management Report (“ RMR ”). The RMR analyzed all hypothetical scenarios and concluded that RadioGel is inherently safe. We participated in pre-submission meetings with the FDA on April 10, 2023, and September 29, 2023, to discuss the preliminary results of the VX2 tumor animal study and to obtain feedback on the genotoxicity protocol. After providing addition information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use. Since September 2024 the company has been engaged in the sprint process to discuss several FDA comments in detail. There will continue through February 2024, at which time we will re-submit the request for an IDE. In parallel, the Company is working with the Mayo Clinic’s principal investigators to improve the clinical trial protocol for their Institutional Review Board. The Medical Advisory Board (“ MAB ”) selected 18 applications for RadioGel™, each of which meet the criteria described above. This large number confirms the wide applicability of the device and defines the path for future business growth. The Company’s application establishes a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma. We anticipate that this initial application will facilitate each subsequent application for additional Indications for Use. After the second Indication for Use, our objective is to apply for a broad Indication for Use which we would target to obtain approval to treat all solid tumors 7 Radiogel™ Device Designation: In 2014, the Company submitted a presubmission (Q130140) to obtain FDA feedback about the proposed product. The FDA requested that the Company file a request for designation with the Office of Combination Products (RFD130051), which led to the determination that RadioGel™ is a device for human therapy for non-resectable cancers, which must be reviewed and ultimately regulated by the Center for Devices and Radiological Health (“ CDRH ”). The Company then submitted a 510(k) notice for RadioGel™ (K133368), which was found Not Substantially Equivalent due to the lack of a suitable predicate, and RadioGel™ was assigned to the Class III product code NAW (microspheres). Class III products or devices are generally the highest risk devices and are therefore subject to the highest level of regulatory review, control, and oversight. Class III products or devices must typically be approved by FDA before they are marketed. Class II devices represent lower risk products or devices than Class III and require fewer regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. In contrast, Class I products and devices are deemed to be lower risk than Class I or II, and are therefore subject to the least regulatory controls. A pre-submission meeting (Q140496) was held with the FDA on June 17, 2014, during which the FDA maintained that RadioGel™ should be considered a Class III device and therefore subject to pre-market approval. On December 29, 2014, the Company submitted a de novo petition for RadioGel™ (DEN140043). The de novo petition was denied by the FDA on June 1, 2015, with the FDA providing numerous comments and questions. On September 29, 2015, the Company submitted a follow-up pre-submission informational meeting request with the FDA (Q151569). This meeting took place on November 9, 2015, at which time the FDA indicated acceptance of the Company’s applied dosimetry methods and clarified the FDA’s outstanding questions regarding RadioGel™. Following the November 2015 pre-submission meeting, the Company prepared a new pre-submission package to obtain FDA feedback on the proposed testing methods, intended to address the concerns raised by the FDA staff and to address the suitability of RadioGel™ for de novo reclassification. This pre-submission package was presented to the FDA in a meeting on August 29, 2017. During the August 2017 meeting, the FDA clarified their position on the remaining pre-clinical testing needed for RadioGel™. Specifically, the FDA addressed proposed dosimetry calculating techniques, dosimetry distribution between injections, hydrogel viscoelastic properties, and the details of the Company’s proposed animal testing. Financing and Strategy The Company requires funding of approximately $3.5 million per year for Selling and General Administration costs and to fund its ongoing initiatives. Over the next 36 months, the Company believes it will cost approximately $10 million to: (1) conduct human clinical trials; (2) activate several regional clinics to administer IsoPet ® across the county; (3) create an alternate manufacturing center based on a template for future international manufacturing. The principal variables in the timing and amount of spending depends on the speed of FDA approval for clinical trials. The currently approved 1-A Reg A provided a basis for obtaining most of the required investment, assuming there are willing investors. The Company intends to reduce its funding requirement via generating income from sales in the animal sector. Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships to facilitate its global commercialization strategy. Based on the Company’s financial history since inception, the Company’s independent registered public accounting firm has expressed substantial doubt as to the Company’s ability to continue as a going concern. The Company has limited revenue, nominal cash, and has accumulated deficits since inception. If the Company cannot obtain sufficient additional capital, the Company will be required to delay the implementation of its business strategy and may not be able to continue operations. As of December 31, 2024, the Company has $2,212,548 cash on hand. There are currently commitments to vendors for products and services purchased. To continue the development of the Company’s products, the current level of cash may not be enough to cover the fixed and variable obligations of the Company. The company has been utilizing the previously authorized Reg A as the principal vehicle to obtain funding and intends to continue to bring in the funding necessary to support the projected activities through 2027. There is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price. 8 Product Features The Company’s RadioGel™ device has the following product features: ● Beta particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby normal tissues. In medical terms Y-90 beta emitter has a high efficacy rate; ● Benefitting from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there is a greatly reduced radiation risk to the doctor. A simple plastic tube around the syringe, gloves and safety glasses are all that is required. Other gamma emitting products require much more protection; ● A 2.7-day half-life means that only 5% of the radiation remains after ten days. This is in contrast to the industry-standard gamma irradiation product, which has a half-life of 17 days; ● The short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste; ● RadioGel™ can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue. This contrasts with the injection of metal seeds, which does considerable damage; and ● After about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle. The only remaining evidence of the treatment are phosphate particles so small in diameter that it requires a high-resolution microscope to find them. This contrasts with permanent presence of metal seeds. Steps from Production to Therapy Device Production During the next two years, the Company intends to continue to outsource material aspects of manufacturing and distribution. As future product volume increases, the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located facility. Production of the Hydrogel RadioGel ™ is manufactured with a proprietary process under ventilated sterile hood by following strict Good Management Practices (“ GMP ”) procedures. It is made in large batches that are frozen for up to three months. When the product is ready to ship, a small quantity of the gel is dissolved in a sterile saline solution. It is then passed through an ultra-fine filter to ensure sterility. Production of the Yttrium-90 Phosphate Particles The Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GMP procedures. They are then mixed into a phosphate-buffered saline solution. They can be produced in large batches for several shipments. The number of particles per shipment is determined by the dose prescribed by the doctor. Pre-Mixing – Ready to Use (“RTU”) The Company now pre-mixes the particle solution and the hydrogel and places the RTU IsoPet® in standard size vials. This innovation is cost effective and reduces the probability of any accidental spills or biological contamination at the therapy sites. It also simplified the certification training for new regional clinics. Shipment The vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols. At the User The quantities and activities are in the information on the product label. The specific injection technique described on the Instructions for Use. For small tumors, one centimeter in diameter or less, the cancer is treated with a single injection. For larger tumors, the cancer is treated with a series of small injections from the same syringe or multiple syringes. 9 Principal Markets The Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below. Medical Sector RadioGel ™ is currently fully developed, requiring only FDA approval before commercialization. Building on the FDA’s ruling of RadioGel ™ as a device, the Company incorporated the FDA suggestions and has invested in the pre-clinical testing required for IDE submittal. This included two years of effort on biocompatibility testing. The last remaining animal test has been completed, and the Company is engaged in the detailed sprint revie process. Clinical trials have just initiated in India. It is anticipated that these data will help accelerate FDA approval in the USA. Veterinary Sector There are approximately 150 million pet dogs and cats in the United States. Nearly one-half of dogs and one-third of cats are diagnosed with cancer at some point in their lifetime. The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports that cancer is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each year. The American Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer. The National Cancer Institute reports that about six million dogs are diagnosed with cancer each year, translating to more than 16,000 a day. The Company’s IsoPet ® operating division focuses on the veterinary oncology market Richard Weller DVM, DACVIM, is now the Chairman of the Veterinary Medicine Advisory Board. In addition, John E. Hendrich, PhD, DVM is a new member. Development of the product and application techniques and animal testing is allowed under FDA regulation. Commercial sales of RadioGel TM for animals requires confirmation by the FDA Center for Veterinary Medicine (“ CVM ”). In January 2018, the Center for Veterinary Medicine Product Classification Group, the entity within the CVM that is responsible for determining the classification of a product, ruled that RadioGel TM should be classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas. Additionally, after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including all or most all solid tumors in animals. We expect the result of such classification and label approval will be that no additional regulatory approvals are necessary for the use of RadioGel TM for the treatment of solid tumors in animals. The FDA does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations. The Company currently intends to utilize university veterinary hospitals for therapy development, given that veterinary hospitals offer superior and plentiful veterinarians and students, many animal patients, radioactive material handling licenses, and are respected by private veterinary centers and hospitals. Competitors The Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition. The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes. Several companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions that our products target. We cannot predict with accuracy the timing or impact of the introduction of potentially competitive products or their possible effect on our sales. Certain potentially competitive products to our products may be in various stages of development. Also, there may be many ongoing studies with currently marketed products and other developmental products, which may yield new data that could adversely impact the use of our products in their current and potential future Indications for Use. The introduction of competitive products could significantly reduce our sales, which, in turn would adversely impact our financial and operating results. 10 There are a wide variety of cancer treatments approved and marketed in the U.S. and globally. General categories of treatment include surgery, chemotherapy, radiation therapy and immunotherapy. These products have a diverse set of success rates and side effects. The Company’s Radiogel™ precision radionuclide therapy product would generally compete with brachytherapy devices currently marketed in the U.S. and globally. The traditional iodine-125 (“ I-125 ”) and palladium-103 (“ Pd-103 ”) technologies are well entrenched with powerful market players. The industry-standard I-125-based therapy was developed by Oncura, which is a unit of General Electric Healthcare. Additionally, C.R. Bard, a major industry player competes in the I-125 marketplace. These market competitors are also involved in the distribution of Pd-103 based products. Cs-131 brachytherapy products are marketed by GT MedTech. Several Y-90 therapies have been FDA approved including SIR-Spheres by Sirtex, TheraSphere by Biocompatibles UK. Raw Materials The Company currently subcontracts the manufacturing of RadioGel TM at IsoTherapeutics. Eckert and Ziegler is the sole supplier of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel ™ . The Company obtains supplies, hardware, handling equipment and packaging from several different U.S. suppliers. Eckert and Ziegler previously provided Y-90 to the USA from Germany, but we now receive the material from their Massachusetts operations. In 2024 IsoTherapeutics was acquired by Telix. That has stimulated Vivos to accelerate its efforts to develop an additional manufacturing contractor. Our objective is to develop more than one alternative to manufacture our components by 2026. During 2021, the Company engaged Akina, Inc. as an alternate supplier of its hydrogel polymer component. We have now expanded to include SciPoly as another alternate polymer supplier. We are completing the actions to expand Akina’s role to be the supplier of sterilized hydrogel, PrecisionGel TM . Customers The Company anticipates that potential customers for our potential precision radionuclide therapy products likely would include those institutions and individuals that currently purchase brachytherapy products or other oncology treatment products. We anticipate that the veterinarian and medical communities will recognize the Precision Radionuclide Therapy TM as the best option for treating many solid tumors. Government Regulation The Company’s present and future intended activities in the development, manufacturing, and sale of cancer therapy products, including RadioGel ™ , are subject to extensive laws, regulations, regulatory approvals, and guidelines. Within the United States, the Company’s therapeutic radiological devices must comply with the U.S. Federal Food, Drug and Cosmetic Act, which is enforced by FDA. The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities. In the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy of these products. We are also subject to other federal and state laws and regulations, including the Occupational Safety and Health Act and the Environmental Protection Act. The Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture, safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising, and promotion of such products. Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of the government to approve or clear product approval applications, disqualification from sponsoring or conducting clinical investigations, preventing us from entering government supply contracts, withdrawal of previously approved applications, and criminal prosecution. In the United States, medical devices are classified into three different categories over which the FDA applies increasing levels of regulation: Class I, Class II, and Class III. Most Class I devices are exempt from premarket notification 510(k); most Class II devices require premarket notification 510(k); and most Class III devices require premarket approval. RadioGel ™ is currently classified as a Class III device. 11 Approval of new Class III medical devices is a lengthy procedure and can take several years and require the expenditure of significant resources. There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k) process, whereby a company can market certain Class II medical devices that can be shown to be substantially equivalent to other legally marketed devices. As a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current Good Manufacturing Practices, or cGMP. These regulations require that we and any of our contract manufacturers design, manufacture, and service products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage, design control, and service activities. Modifications or enhancements that could significantly affect the safety or effectiveness of a device or that constitute a major change to the intended use of the device require a new 510(k) premarket notification for any significant product modification. The Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be associated with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious injury if the malfunction were to recur. Labeling and promotional activities are regulated by the FDA and, in some circumstances, by the Federal Trade Commission. As a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal, state, and local levels. For example, our facility is licensed as a medical device manufacturing facility in the State of Washington and is subject to periodic state regulatory inspections. Our customers are also subject to a wide variety of laws and regulations that could affect the nature and scope of their relationships with us. In the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective. In Washington State, the Department of Health, by agreement with the federal Nuclear Regulatory Commission (“ NRC ”), regulates the possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and federal laws and regulations. RadioGel ™ constitutes both medical devices and radioactive sealed sources and are subject to these regulations. Moreover, our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and state agencies depending on the nature of the substance or waste material. We believe that we follow all federal and state regulations for this purpose. Environmental Regulation Our business does not require us to comply with any extraordinary environmental regulations. Our RadioGel ™ product is manufactured in an independently owned and operated facility. Any environmental effects or contamination event that could result would be from the shipping company during shipment and misuse by the treatment facility upon arrival. Human Capital Since 2017, the Company has followed the cost-effective model of having had one full-time employee, the CEO. The Company utilizes several independent contractors to assist with its operations. This includes key positions, such as acting CFO and Quality Assurance Manager. The Company does not have a collective bargaining agreement with any of its personnel and believes its relations with its personnel are good. This enables the Company to operate on very low overhead, for cost-effective utilization of its investment and to manage our work scope like projects. Available Information The Company prepares and files annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and certain other information with the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at http://www.sec.gov. Moreover, the Company maintains a website at http://www.RadioGel.com that contains important information about the Company, including biographies of key management personnel, as well as information about the Company’s business. This information is publicly available and is updated regularly. The content on any website referred to in this Offering Circular is not incorporated by reference into this Offering Circular, unless (and only to the extent) expressly so stated herein. 12