VIVOS INC
For the period ended Jun 30, 2026. Filed Aug 12, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 12, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-023146
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-12.
0001493152-26-037380
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 169 previous paragraphs and 153 current paragraphs.
90 unchanged; 23 reworded; 31 added; 55 removed; 1 previous and 9 current paragraphs rearranged.
Tables are not compared: 21 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (31)
Current report
The Company’s IsoPet® Solutions division was established in May 2016 to focus on the veterinary oncology market. The Company has collaborated with multiple university veterinary hospitals and national laboratories on IsoPet®/RadioGel® testing and development, including Washington State University, Colorado State University, the University of Missouri, and Johns Hopkins University. These studies demonstrated that the Y-90 particles remain localized at the injection site with minimal distribution to surrounding tissues.
Current report
Commencing in July 2019, the Company recognized its first commercial sale of IsoPet®. Since that time, IsoPet® has been used to treat solid tumors and positive surgical margins in companion animals.
Current report
RadioGel® is an injectable yttrium-90 (Y-90) particle-gel designed for precision radionuclide therapy. It consists of a hydrogel that is liquid at room temperature and gels upon reaching body temperature after injection into a tumor. The hydrogel contains small Y-90 phosphate particles that become locked in place, delivering localized beta radiation to the target tissue while minimizing exposure to surrounding healthy tissue. The Y-90 isotope has a half-life of 2.7 days.
Current report
Proceeds raised from previous Regulation A+ Offerings have been used to fund these development efforts and proceeds from the March 2026 Regulation A+ Offering will be used to continue such development.
Current report
The continued deployment of Precision Radionuclide Therapy™ products and the Company’s worldwide regulatory approval efforts will require additional resources and personnel. The principal variables in the timing and amount of spending over the next 12 to 24 months will be the progress, enrollment, and results of the FDA-approved Early Feasibility IDE human feasibility study at Mayo Clinic in Jacksonville, FL, the transition to subsequent pivotal trials, ongoing and planned studies in India through Vivos Scientific India LLP, any additional FDA or international regulatory requirements, and broader clinical and manufacturing scale-up activities.
Current report
Thereafter, the principal variables affecting the Company’s spending and financing requirements will be the timing of regulatory approvals and the nature of arrangements with third parties for manufacturing, sales, distribution, and licensing, as well as the commercial success of the products in the United States and other markets. The Company intends to fund its future activities through a combination of strategic transactions, such as licensing and partnership agreements, and proceeds from Regulation A+ Offerings and the IsoPet® division.
Current report
Safety and efficacy data generated from IsoPet® treatments contributed positively to RadioGel® receiving Breakthrough Device Designation from the FDA and to support the Company’s FDA-approved Early Feasibility Investigational Device Exemption (IDE) for the first-in-human clinical study.
Current report
During 2025, the IsoPet®division achieved a 1,200% year-over-year increase in administered therapies, with more than 100 treatments performed and zero reportable serious adverse events. The Company launched a dedicated website for IsoPet®, staffed multiple industry conferences, and conducted nationwide outreach to support adoption. An abstract on tumor margin treatments using IsoPet® was accepted for presentation at the American College of Veterinary Surgeons (ACVS) conference. The Company is also utilizing data from multiple clinical studies for publication in peer-reviewed journals and will provide additional details as more information becomes available.
Current report
The Company continues to see increased patient adoption of IsoPet® therapy, which is driving higher treatment volumes, growing revenue, and expanded shipments. Shipments from the Company’s new in-house production facility in Richland, Washington are expected to commence in the near term. This increased scale is allowing the implementation of operational efficiencies and supporting progress toward narrowing the profitability gap in the Animal Therapy Division.
Current report
The Company received U.S. FDA approval of its Early Feasibility Investigational Device Exemption (IDE) in July 2026, enabling initiation of the first-in-human clinical feasibility study for RadioGel®at Mayo Clinic in Jacksonville, FL. Extensive work with regulatory consultants, integration of human clinical data from India, reformatted pre-clinical information, and strong veterinary safety outcomes from IsoPet® (over 100 therapies with zero reportable serious adverse events) strengthened the submission. This approval, building on the FDA’s Breakthrough Device Designation, positions the Company to advance human clinical trials. This version fully updates the outdated “resubmitted… remains in review” language to reflect the current approved status while maintaining a professional tone suitable for a 10-Q or corporate disclosure.
Current report
The Company’s Precision Radionuclide Therapy™ platform, including its RadioGel® device (marketed as IsoPet® for veterinary use), utilizes a proprietary injectable hydrogel containing Y-90 phosphate particles for localized treatment of solid tumors. Key attributes include:
Current report
RadioGel® is currently not approved for human use in the U.S. and is advancing through regulatory pathways, while IsoPet® is commercially available for veterinary oncology applications.
Current report
The Company is pursuing two current synergistic sectors, human medical (RadioGel®) and veterinary (IsoPet®), based on its Precision Radionuclide Therapy™ platform. It is also developing PrecisionGel™ as a potential third market, a proprietary hydrogel platform designed for controlled delivery and release of a broad range of therapeutic agents (radioactive and non-radioactive), including small molecules, large molecules, cells, and nanoparticles.
Current report
RadioGel® is fully developed and classified as a medical device. The Company has completed required pre-clinical biocompatibility testing, incorporated extensive FDA feedback, and received U.S. FDA approval of its Early Feasibility Investigational Device Exemption (IDE) in July 2026. This approval enables the first-in-human clinical feasibility study at Mayo Clinic in Jacksonville, FL. Clinical trials have begun in India, with data expected to support U.S. FDA approval of subsequent pivotal trials. Regulatory applications for additional patients in India are underway.
Current report
IsoPet® (the veterinary version of the Company’s yttrium-90 Precision Radionuclide Therapy platform) is commercially available in the U.S. as a medical device following the 2018 FDA Center for Veterinary Medicine classification.
Current report
The U.S. pet population exceeds 163 million dogs and cats, with cancer a leading cause of death in older animals (approximately 6 million canine diagnoses annually). IsoPet® therapies grew over 1,200% year-over-year in 2025, with more than 100 treatments administered across multiple species and zero reportable serious adverse events. As of June 30, 2026, 17 clinics are certified, with additional sites in process. The Company is implementing profitability initiatives including training fees, volume pricing, and production efficiencies while expanding awareness through outreach and case studies.
Current report
The Company sources key raw materials, including yttrium-90, for its RadioGel® and IsoPet® products. Following the 2024 acquisition of its prior contract manufacturer, the Company accelerated diversification efforts and transitioned to greater in-house production capabilities to reduce single-source dependency and strengthen supply chain resilience.
Current report
The Company is advancing two new production facilities targeted for 2026 operations: one domestic facility in Richland, Washington (where Vivos Inc. will serve as manufacturer of record) and one international facility in India. It will maintain continuity with existing production arrangements during the transition. Additional suppliers support the PrecisionGel™ hydrogel component to enhance scalability for both human and veterinary applications.
Current report
These steps help mitigate supply chain risks, meet growing IsoPet® demand, and support future commercialization.
Current report
Potential customers for the Company’s Precision Radionuclide Therapy™ (PRnT™) products, RadioGel® for human use and IsoPet® for veterinary use, include a wide range of institutions and clinicians.
Current report
Veterinary Market (IsoPet®)
Current report
The veterinary market includes certified veterinary clinics, university teaching hospitals, specialty centers, and private practices serving small animals (dogs and cats), equine patients, and exotic species. A key advantage of IsoPet® is that clinics can adopt this targeted radiation therapy without requiring an on-site oncologist or prior brachytherapy program, due to the localized nature of Y-90 beta radiation. IsoPet® is used for both primary solid tumor treatment and post-surgical margin treatment following tumor resection.
Current report
Adoption continues to accelerate nationwide. As of June 30, 2026, 17 certified clinics were operational, including several academic institutions and private specialty centers. Real-world experience now exceeds 200 treatments across multiple species, with zero reportable serious adverse events. This clinical data and growing inquiries from veterinarians and pet owners are driving broader awareness and demand.
Current report
The Company expects continued growth in both markets through clinical data, case study publications, conference presence, and marketing efforts. Veterinary sales are made directly to certified clinics, while the human strategy anticipates future institutional adoption and partnerships. Manufacturing diversification planned for 2026 will support scalability.
Current report
Human Market (RadioGel®)
Current report
For human applications, target customers include hospitals, cancer centers, interventional radiologists, and radiation oncologists focused on treating non-resectable or difficult-to-treat solid tumors. The therapy’s localized beta radiation delivery provides a precise, minimally invasive option that limits dose to surrounding healthy tissue.
Current report
Comparison of the Six months Ended June 30, 2026 and 2025
Current report
Non-Operating Income
Current report
Our net loss for the six months ended June 30, 2026 and 2025 was $(2,015,034) and $(1,480,209), respectively.
Current report
Operating Expenses
Removed paragraphs (55)
Previous report
In January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel® (now marketed as IsoPet® for veterinary use) should be classified as a medical device for animal therapy, initially specified for feline sarcomas and canine soft tissue sarcomas. Additionally, after legal review, the Company believes that this device classification from the FDA Center for Veterinary Medicine is not strictly limited to canine and feline sarcomas but may extend to a broader population of veterinary cancers, including all or most solid tumors in animals. As veterinary medical devices do not require premarket approval or notification (such as 510(k) or PMA) for commercial distribution in the United States, IsoPet® is authorized for marketing and commercial distribution following this classification, provided the product is safe, effective, properly labeled, and compliant with applicable laws and regulations. The FDA does not exercise premarket authority over veterinary devices, and manufacturers bear responsibility for ensuring ongoing compliance. This classification enables the commercial distribution of IsoPet® for treating solid tumors in animals.
Previous report
Based on the FDA’s recommendation, RadioGel® 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® are used synonymously throughout this document. The only distinction between IsoPet®and RadioGel® is the FDA’s recommendation that we use “IsoPet®” for veterinarian usage, and reserve “RadioGel®” 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.
Previous report
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 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 efforts to align with animal therapy, human therapy, and recently other applications of its patented technologies.
Previous report
The Company has worked with five different national laboratories or university veterinarian hospitals on IsoPet®/RadioGel™ 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.
Previous report
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.
Previous report
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 Company has transitioned to “Volume Pricing” to stimulate broader interest and adoption. With significant growth achieved in 2025—including a reported 1,200% year-over-year increase in administered therapies and expansion of the certified clinic network—the Animal Therapy Division (IsoPet®) is positioned to reach breakeven status in 2026, supported by ongoing profitability-focused initiatives, continued clinic expansion, and improved operational efficiency.
Previous report
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.
Previous report
On September 17, 2025, the Board of Directors of the Company approved the creation of Vivos Scientific India LLP (“VSIL”), a wholly owned separate legal entity in India. Vivos India was formally established in September 2025 (with incorporation completed and government approvals finalized shortly thereafter), expanding the Company’s strategic initiatives in the region. The primary objectives include establishing the Company’s first international manufacturing center for RadioGel® and IsoPet®, advancing expanded human therapy demonstrations and clinical trials (including ongoing patient treatments initiated in December 2024 and progress toward DCGI regulatory clearance for larger-scale trials), pursuing commercialization of therapies for both humans and animals in India, and generating additional human trial data to support the Company’s regulatory processes with the U.S. Food and Drug Administration (FDA), such as the planned Investigational Device Exemption (IDE) submission in early 2026. As of February 2026, discussions continue with experienced radiopharmaceutical contract manufacturers in India to support the establishment of this international production facility, with a target for operational status by the end of 2026 to reduce shipping costs, enhance logistical efficiency, and facilitate broader global access to the Company’s precision radionuclide therapies.
Previous report
These enhancements maintain the intended use while maximizing the submission’s clarity, completeness, and alignment with Agency expectations. These recommendations required substantial effort to incorporate into our next submission.
Previous report
Over time we intend to expand the indications for use to include all lymph nodes, lung cancer, childhood brain cancer, eyelid cancer, and finally all solid tumors. Our health physics experts reviewed the benefits of every available isotope, with respect to the target range of potential indication for use. This strategic group confirmed that our current isotope, Y-90 was effective for all the targeted indications for use. However, we also decided to explore P-32, Lu-177, and Ac-225.
Previous report
Recent successful therapies of equine ocular tumors without damaging the eye and human therapy on cancerous nodes directly on the trachea without damaging that organ, confirm the use of Y-90 and may impact the business case of development of alternate isotopes.
Previous report
Our trademarks include BetaGel and AlphaGel and our provisional patents cover the isotopes P-32, Lu-177, and Ac-225. Depending on the business case conclusions, over the next three years we intend to conduct laboratory testing and then animal and finally human studies in India.
Previous report
In the second quarter of 2025, we signed a contract with Akina, Inc to sell this polymer. It is now in their catalog. The Company has had recent sales to universities and pharmaceutical companies; we anticipate this will be a slow growing but solid market. The priority remains IDE approval.
Previous report
Duncan Chiller – Akina encouraged Vivos to leverage our Peltier Chiller technology to develop a general laboratory equipment device for non-water localized chilling. An elementary device demonstrated proof of concept. A prototype will be produced at APEL for testing at and eventual distribution by Akina.
Previous report
Clinical experience at universities and Vista demonstrates IsoPet®’s effectiveness in ablating cancer tissue near injection sites, performing best in early-stage tumors before metastasis. Later-stage cancers are more challenging due to poorly defined tendrils, increasing recurrence risk.
Previous report
Johns Hopkins University Veterinary Clinical Trials Network (Baltimore, MD) is now a certified IsoPet® regional clinic, holding the required radioactive material license and completing training. This partnership supports high-quality data collection across cancer types for publication in leading journals, boosting awareness and acceptance in the veterinary oncology community. Johns Hopkins recently completed a VX2 tumor study in rabbits, confirming IsoPet® (and by extension RadioGel®) safety, with hydrogel retention at the injection site, activity decay curves, validation of Instructions for Use and Injection Guidance Table, and insights for refining human lymph node treatments.
Previous report
Animal therapy safety and efficacy data from IsoPet® contributed positively to RadioGel®’s Breakthrough Device designation.
Previous report
In 2024, three new dedicated websites were launched: the corporate site and separate ones for RadioGel® (human) and IsoPet® (veterinary), featuring user-friendly designs, educational content, and blogs to build authority. Marketing materials effectively highlight Precision Radionuclide Therapy™.
Previous report
During 2025, the IsoPet® division achieved a reported 1,200% year-over-year increase in administered therapies, with over 100 safe treatments (zero serious adverse events). The team staffed booths at six conferences, and LeeAnna Binder conducted nationwide outreach via a modified IsoPet® van. Active social media management on Facebook, Instagram, X, and LinkedIn drove engagement and website traffic.
Previous report
The division shifted from data collection to commercialization in 2024–2025, refining pricing for affordability, aligning production with patient bookings to reduce costs, and implementing volume pricing. Starting Q1 2026, profitability initiatives include billing clinics for certification and continued network expansion.
Previous report
Objectives include adding several more regional clinics in 2026 (with interested parties in the pipeline) and participating in at least four conferences annually to promote IsoPet® for small animal and equine tumors. The Veterinary Medicine Steering Board advises patient acquisition strategies. This nationwide growth supports the goal of breakeven in the Animal Therapy Division in 2026.
Previous report
Currently, the IDE is in preparation under this expert’s guidance. The Company is positioned to incorporate final FDA input and submit the complete IDE application in the near term (targeted by the end of the first quarter or in April 2026). This expert’s proven ability to present complex IDE data in a format that this specific review panel can easily digest and understand has strengthened the submission, alongside integration of newly available human clinical data, reformatted pre-clinical information, and leveraging veterinary outcomes from IsoPet® (over 100 therapies with zero reportable serious adverse events). The Company remains encouraged by the constructive ongoing dialogue with the FDA and is strongly positioned for IDE approval to advance human clinical trials.
Previous report
The Company’s RadioGel™ device has the following product features:
Previous report
Steps from Production to Therapy
Previous report
During 2025 the Company decided to expand its manufacturing capabilities and to target for on domestic and one international production center. Several candidates were assessed.
Previous report
Production of the Hydrogel
Previous report
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. An alternate process of E-Beam sterilization was developed and verified. Limited GDA recommended testing will be conducted next year to obtain FDA approval for human therapy.
Previous report
Production of the Yttrium-90 Phosphate Particles
Previous report
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.
Previous report
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.
Previous report
Shipment
Previous report
The vials are shipped inside the specially designed plastic shipping pigs via FedEx or UPS, all following the proper protocols.
Previous report
At the User
Previous report
The quantities and activities are in the information on the product label.
Previous report
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.
Previous report
The Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below.
Previous report
RadioGel™is currently fully developed, requiring only FDA approval before commercialization.
Previous report
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, and the Company is engaged in the detailed sprint revie process. It has recently utilized the pre-submission process and the expertise of a well-respected advisor.
Previous report
Clinical trials have initiated in India. It is anticipated that these data, when it is restructured and expanded, will help accelerate FDA approval in the USA. We have applied for the regulatory approval to complete the remaining designated patients.
Previous report
The United States is home to approximately 163.6 million pet dogs and cats (with recent 2025 estimates from the American Veterinary Medical Association (the “AVMA”) indicating about 87.3 million dogs and 76.3 million cats). Cancer remains a leading health concern for these pets: roughly half of dogs over age 10 and a significant portion of older cats develop cancer, which is the number one natural cause of death in senior dogs and cats, accounting for nearly 50% of pet deaths in many cases. The National Cancer Institute and veterinary sources estimate that about 6 million dogs are diagnosed with cancer each year (more than 16,000 per day), with similar high incidence in cats.
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Reworded paragraphs (23)
Previous wording
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 devices. This includes RadioGel® Precision Radionuclide Therapy™ (Human Division) for treating solid tumors and positive surgical margins in humans and IsoPet® (Animal Division) for treating solid tumors in animals. The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform for delivering active pharmaceutical ingredients and therapeutic agents. 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, veterinarians, and patients by providing them with new isotope technologies and advanced polymer solutions that offer safe and effective treatments for cancer in both humans and animals.
Current wording
Vivos Inc. (the “Company,” “we,” “us,” or “our”) is a radiation oncology medical device company focused on the development of its yttrium-90 (“Y-90”) based precision radionuclide therapy devices. These include RadioGel® Precision Radionuclide Therapy™ for the treatment of solid tumors and positive surgical margins in humans, and IsoPet® for the treatment of solid tumors and positive surgical margins in animals. The Company also sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform designed for the delivery of active pharmaceutical ingredients and therapeutic agents.
Previous wording
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.
Current wording
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 January 2018, the FDA Center for Veterinary Medicine classified IsoPet® (formerly RadioGel®) as a medical device for veterinary use. As a result, veterinary medical devices do not require premarket approval or notification for commercial distribution in the United States, provided the product is safe, effective, properly labeled, and compliant with applicable regulations. The Company markets RadioGel® as IsoPet® for veterinary use to distinguish it from the human therapy product.
Previous wording
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.
Current wording
In 2021, the Company modified the proposed indication for use for RadioGel® to focus on solid tumors pathologically associated with locoregional and recurrent papillary thyroid carcinoma, including metastatic lymph nodes or extranodal disease, in patients who are not surgical candidates or who have declined surgery.
Previous wording
In the third quarter ended September 30, 2025, the Company strengthened its leadership team to support accelerating growth in both the U.S. and international markets by appointing Brad Allan Weeks as President (effective September 1, 2025) and David J. Swanberg as Chief Operating Officer (effective September 15, 2025). These appointments reflect the Company’s strategic response to rapid expansion, particularly in the IsoPet® Animal Therapy Division—which achieved a reported 1,200% year-over-year increase in administered therapies from 2024 to 2025—and ongoing advancements in RadioGel® human therapy development, including progress toward FDA Investigational Device Exemption (IDE) submission and the establishment of Vivos Scientific India LLP in September 2025. The new executive roles are designed to enhance operational efficiency, scale commercial activities, drive clinic certifications and therapy adoption, and position the Company for sustained growth and potential profitability in the Animal Therapy Division by 2026.
Current wording
In the third quarter ended September 30, 2025, the Company strengthened its leadership team with the appointment of Brad Allan Weeks as President (effective September 1, 2025) and David J. Swanberg as Chief Operating Officer (effective September 15, 2025).
Previous wording
Cumulative proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), ongoing IDE resubmission preparations (with strengthened submission planned by end of Q1 or April 2026), international human therapy data generation in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site discussions aligned with Vivos Scientific India LLP (VSIL)), leadership enhancements, intellectual property expansion (e.g., U.S. Patent No. 12,521,452 B2 issued January 13, 2026, and additional provisional filings), and substantial growth in the IsoPet® Animal Therapy Division (1,200% year-over-year increase in administered therapies from 2024 to 2025).
Current wording
Cumulative proceeds from these offerings have supported critical advancements, including Breakthrough Device designation (December 2023), U.S. FDA approval of the Early Feasibility Investigational Device Exemption (IDE) in July 2026, international human therapy data generation in India, manufacturing diversification (new domestic facility at APEL in Richland, WA, and international site through Vivos Scientific India LLP (VSIL)), leadership enhancements, intellectual property expansion (e.g., U.S. Patent No. 12,521,452 B2 issued January 13, 2026, and additional provisional filings), and substantial growth in the IsoPet® Animal Therapy Division (1,200% year-over-year increase in administered therapies from 2024 to 2025).
Previous wording
Upon successful qualification, the 2026 Regulation A+ Offering would provide expanded capacity for equity fundraising to further advance RadioGel® human therapy development (including IDE submission and potential approval for clinical trials), scale IsoPet® commercialization (targeting breakeven in the Animal Therapy Division in 2026), support VSIL initiatives for local manufacturing and clinical trials in India, mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness), and pursue broader global access to the Precision Radionuclide Therapy™ platform in both human and veterinary oncology. The Company continues to monitor cash needs closely and explore additional financing avenues as it progresses toward regulatory milestones and operational profitability.
Current wording
Upon successful qualification, the 2026 Regulation A+ Offering would provide expanded capacity for equity fundraising to further advance RadioGel® human therapy development (including initiation of the FDA-approved Early Feasibility IDE study at Mayo Clinic in Jacksonville, FL targeting non-resectable papillary thyroid carcinoma), scale IsoPet® commercialization (targeting breakeven in the Animal Therapy Division in 2026), support VSIL initiatives for local manufacturing and clinical trials in India, mitigate single-site production risks through multi-facility operations (targeted for 2026 readiness), and pursue broader global access to the Precision Radionuclide Therapy™ platform in both human and veterinary oncology. The Company continues to monitor cash needs closely and explore additional financing avenues as it progresses toward regulatory milestones and operational profitability.
Previous wording
Following receipt of required regulatory approvals (including potential FDA IDE clearance for human trials) and necessary financing to support working capital and expansion, the Company plans to transition to greater operational control over key aspects of its supply chain. In the U.S., Vivos is establishing Company-managed production facilities (with Vivos as the manufacturer of record) to produce Y-90 particles, hydrogel mixtures, and patient doses, while continuing to leverage select contract manufacturing during the transition period through Q2 2026. This approach aims to enhance supply chain resilience, reduce dependencies, and accommodate growing demand in both RadioGel® (human) and IsoPet® (veterinary) applications. For international markets, the Company is pursuing direct commercialization pathways through subsidiaries such as Vivos Scientific India LLP (VSIL), including local manufacturing and regulatory advancement in India, while remaining open to strategic licensing arrangements, partnerships, or collaborations to accelerate global access and market penetration for its Precision Radionuclide Therapy™ platform.
Current wording
Following receipt of required regulatory approvals (including the FDA’s July 2026 IDE approval for human trials) and necessary financing to support working capital and expansion, the Company plans to transition to greater operational control over key aspects of its supply chain. In the U.S., Vivos is establishing Company-managed production facilities (with Vivos as the manufacturer of record) to produce Y-90 particles, hydrogel mixtures, and patient doses, while continuing to leverage select contract manufacturing during the transition period. This approach aims to enhance supply chain resilience, reduce dependencies, and accommodate growing demand in both RadioGel® (human) and IsoPet® (veterinary) applications. For international markets, the Company is pursuing direct commercialization pathways through subsidiaries such as Vivos Scientific India LLP (VSIL), including local manufacturing and regulatory advancement in India, while remaining open to strategic licensing arrangements, partnerships, or collaborations to accelerate global access and market penetration for its Precision Radionuclide Therapy™ platform.
Previous wording
As of March 31, 2026, the Company had $2,525,782 in 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 will be insufficient to cover the fixed and variable obligations of the Company.
Current wording
As of June 30, 2026, the Company had $2,336,022 in 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 will be insufficient to cover the fixed and variable obligations of the Company.
Previous wording
These allocations align with the Company’s priorities of achieving breakeven in the Animal Therapy Division in 2026, securing FDA IDE clearance (with resubmission targeted for end of Q1/April 2026), diversifying manufacturing (targeting operational facilities in 2026), and generating additional clinical data to support global commercialization of RadioGel® and IsoPet®. Actual use may vary based on regulatory timelines, funding levels, and strategic opportunities.
Current wording
These allocations align with the Company’s priorities of continuing to close the profitability gap in the Animal Therapy Division, advancing the now-approved U.S. IDE human feasibility study, diversifying manufacturing, and generating additional clinical data to support global commercialization of RadioGel® and IsoPet®. Actual use may vary based on regulatory timelines, funding levels, and strategic opportunities.
Previous wording
Research and development of the Company’s precision radionuclide therapy product line has been funded with proceeds from the sale of equity and debt securities, including from the Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain operating activities. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the FDA approval process to conduct human clinical trials; (ii) conduct Phase I, pilot, clinical trials; (iii) activate several regional clinics to administer IsoPet®across the U.S.; (iv) create an independent production center within the current production site to create a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States. The proceeds raised from the Regulation A+ Offerings were used to fund this development and will be used to continue such development efforts.
Current wording
Research and development of the Company’s Precision Radionuclide Therapy™ product line has been funded primarily with proceeds from the sale of equity and debt securities, including prior Regulation A+ Offerings. The Company requires additional funding of approximately $3.0 million annually to maintain its current level of operating activities. The Company continues to make progress with its IsoPet® animal therapy division, narrowing the profitability gap with the goal of eventually operating it as a self-sustaining, standalone business. Over the next 36 months, the Company believes it will require approximately $9.0 million in additional capital to: (i) fund the ongoing FDA-approved human clinical program and related activities; (ii) conduct the Early Feasibility study, subsequent pivotal trials, and other clinical activities; (iii) activate several regional clinics to administer IsoPet® across the United States; (iv) create an independent production center within the current production site to serve as a template for future international manufacturing; and (v) initiate regulatory approval processes outside of the United States.
Previous wording
The Company selected Vista Veterinary Hospital in Kennewick, Washington (Tri-Cities area), as the pilot private clinic for initiating commercial IsoPet® sales. This location facilitated close collaboration with Company personnel to refine processes, serving as a model before national expansion. Vista has successfully passed multiple audits by the Washington State Department of Health, with the Company working closely alongside the Department to enhance the radioactive material license by incorporating detailed procedures that benefit future clinics. A second veterinarian at Vista has also been certified.
Current wording
The Company selected Vista Veterinary Hospital in Kennewick, Washington, as the pilot private clinic for commercial IsoPet® sales. This location has served as a model for process refinement and regulatory compliance. Vista has successfully passed multiple audits by the Washington State Department of Health, and the Company continues to work with the Department to strengthen radioactive materials licensing procedures that can be applied to future clinics. A second veterinarian at Vista has also been certified.
Previous wording
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.
Current wording
After providing additional information to the FDA on December 18, 2023, the FDA classified us as a Breakthrough device to our proposed Indication for Use.
Previous wording
Pre-Mixing – Ready to Use (“RTU”)
Current wording
During 2025, the Company advanced plans to establish one domestic and one international production center to support expanded demand for IsoPet® and future RadioGel® requirements. Manufacturing is conducted under Good Manufacturing Practices (GMP). The proprietary hydrogel and Y-90 phosphate particles are produced in large batches. The Company has implemented a ready-to-use (RTU) pre-mixed formulation in standard vials, which improves cost efficiency, simplifies clinic handling and training, and reduces risks of spills or contamination. Shipments are made in specialized packaging via common carriers in compliance with applicable radioactive material transport regulations. The product is administered by direct intratumoral injection per Instructions for Use, with dosing and technique tailored to tumor size.
Previous wording
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.
Current wording
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 would adversely impact our financial and operating results.
Previous wording
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.
Current wording
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. Currently Beta-Glue is expanding its international studies. This product forms a bolus versus upon injection versus BetaGel TM (RadioGel®) that perfuses into the tumor prior to gelation.
Previous wording
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.
Current wording
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 an acting CFO and a 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.
Previous wording
In September 2025 the Company’s brought on a full-time President to assist the CEO in managing the Company which includes expansion both domestically and internationally.
Current wording
In September 2025 the Company brought on a full-time President to assist the CEO in managing the Company which includes expansion both domestically and internationally.
Previous wording
Revenue was $36,068 and $26,748 for the three months ended March 31, 2026 and 2025, respectively. All revenue recognized in the three months ended March 31, 2026 and 2025 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Current wording
Revenue was $36,400 and $15,000 for the three months ended June 30, 2026 and 2025, respectively. All revenue recognized in the three months ended June 30, 2026 and 2025 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Previous wording
Operating expense for the three months ended March 31, 2026 and 2025 was $537,474 and $854,449, respectively. The decrease in operating expense from 2025 to 2026 can be attributed to the decrease in professional fees ($588,268 for the three months ended March 31, 2025 versus $285,432 for the three months ended March 31, 2026) related to the fees incurred for the consultants engaged in 2026 versus 2025 and the decrease in the value of the vested RSUs; the increase in general and administrative expense ($52,203 for the three months ended March 31, 2025 versus $58,685 for the three months ended March 31, 2026); the decrease in research and development ($119,281 for the three months ended March 31, 2025 versus $37,923 for the three months ended March 31, 2026) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($94,697 for the three months ended March 31, 2025 versus $155,434 for the three months ended March 31, 2026) related to the CEOs employment contract and bonus, as well as the President’s payroll in 2026.
Current wording
Operating expenses for the three months ended June 30, 2026 and 2025 were $652,809 and $640,020, respectively. The increase in operating expense from 2025 to 2026 can be attributed to the increase in professional fees ($358,455 for the three months ended June 30, 2025 versus $361,465 for the three months ended June 30, 2026) related to the fees incurred for the consultants engaged in 2026 versus 2025 and the decrease in the value of the vested RSUs; the increase in general and administrative expense ($80,913 for the three months ended June 30, 2025 versus $82,278 for the three months ended June 30, 2026); the decrease in research and development ($107,965 for the three months ended June 30, 2025 versus $49,182 for the three months ended June 30, 2026) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($92,687 for the three months ended June 30, 2025 versus $159,884 for the three months ended June 30, 2026) related to the CEOs employment contract and bonus, as well as the President’s payroll in 2026.
Previous wording
Our net loss for the three months ended March 31, 2026 and 2025 was $(1,184,845) and $(834,696), respectively.
Current wording
Our net loss for the three months ended June 30, 2026 and 2025 was $(830,189) and $(645,513), respectively.
Previous wording
At March 31, 2026, the Company had working capital of $2,427,649, as compared to working capital of $1,533,177 at December 31, 2025. As of March 31, 2026, the Company did not have any commitments for capital expenditures.
Current wording
At June 30, 2026, the Company had working capital of $2,391,000, as compared to working capital of $1,533,177 at December 31, 2025. As of June 30, 2026, the Company did not have any commitments for capital expenditures, other than some minor equipment purchases for the APEL facility.
Previous wording
Net cash used in operating activities for the three months ended March 31, 2026 and 2025, was $429,861 and $455,198, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, the loss on exchange of warrants as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the three months ended March 31, 2026 and 2025, there was no cash used in investing activities except for the purchases of fixed assets in 2026 of $151,205. Net cash provided by financing activities for the three months ended March 31, 2026 and 2025 was $1,548,323 and $1,507,750, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings and payments of lease obligations.
Current wording
Net cash used in operating activities for the six months ended June 30, 2026 and 2025, was $1,169,441 and $1,059,708, respectively. Cash used in operating activities was primarily related to the Company’s net loss from operations, stock-based compensation, the loss on exchange of warrants as well as the changes in accounts receivable, inventory, prepaid expense, and accounts payable. During the six months ended June 30, 2026 and 2025, there was no cash used in investing activities except for the purchases of fixed assets in 2026 of $245,744. Net cash provided by financing activities for the six months ended June 30, 2026 and 2025 was $2,192,682 and $1,507,750, respectively, consisting of proceeds from the sales of Common Stock and warrants as part of our Regulation A+ Offerings and payments of lease obligations.
Previous wording
The Company has generated material operating losses since inception. The Company had a net loss of $1,184,845 for the three months ended March 31, 2026 as compared to a net loss of $834,696 for the three months ended March 31, 2025. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Current wording
The Company has generated material operating losses since inception. The Company had a net loss of $2,015,034 for the six months ended June 30, 2026 as compared to a net loss of $1,480,209 for the six months ended June 30, 2025. The Company expects to continue to experience net operating losses for the foreseeable future. Historically, the Company has relied upon investor funds to maintain its operations and develop the Company’s business. The Company anticipates raising additional capital within the next twelve months for working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available on terms acceptable to the Company, if at all. If the Company is unable to obtain additional financing to meet its working capital requirements, it may have to curtail its business or cease all operations.
Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
The following table sets forth information from our statements of operations for the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
Revenue was $72,468 and $41,748 for the six months ended June 30, 2026 and 2025, respectively. All revenue recognized in the six months ended June 30, 2026 and 2025 relate to the procedures performed with respect to the IsoPet® therapies, sales of IsoPet®and freight.
Current report — wording carried from elsewhere
Operating expense for the six months ended June 30, 2026 and 2025, respectively consists of the following:
Current report — wording carried from elsewhere
Operating expenses for the six months ended June 30, 2026 and 2025 were $1,190,283 and $1,494,470, respectively. The decrease in operating expense from 2025 to 2026 can be attributed to the decrease in professional fees ($946,723 for the six months ended June 30, 2025 versus $646,897 for the six months ended June 30, 2026) related to the fees incurred for the consultants engaged in 2026 versus 2025 and decrease in value of RSUs vested; the increase in general and administrative expense ($133,117 for the six months ended June 30, 2025 versus $140,963 for the six months ended June 30, 2026); the decrease in research and development ($227,246 for the six months ended June 30, 2025 versus $87,105 for the six months ended June 30, 2026) as the Company continued to ramp up the development of their products in 2025 in India as well as the US including research studies as well as continuing the steps necessary to be accepted by the FDA, and an increase in payroll expense ($187,384 for the six months ended June 30, 2025 versus $315,318 for the six months ended June 30, 2026) related to the CEOs employment contract and bonus.
Current report — wording carried from elsewhere
Non-operating income (expense) for the six months ended June 30, 2026 and 2025 were as follows:
Current report — wording carried from elsewhere
Non-operating income (expense) for the six months ended June 30, 2026 and 2025 related to interest earned on the Company’s cash accounts, and in 2026, the loss on exchange of warrants.
Current report — wording carried from elsewhere
Revenues and Cost of Goods Sold
Current report — wording carried from elsewhere
Management does not anticipate that the Company will generate sufficient revenue to sustain operations until such time as the Company secures multiple revenue-generating arrangements with respect to RadioGel®and/or any of our other brachytherapy technologies.
Current report — wording carried from elsewhere
Commencing in 2025, the Company had started ordering Hydrogel to use in more than one treatment. This is anticipated to increase the number of treatments that can be handled in a particular clinic monthly. As a result, we have inventory built up that when used will increase our cost of goods sold over time.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The continued deployment of precision radionuclide therapy products and a worldwide regulatory approval effort will require additional resources and personnel. The principal variables in the timing and amount of spending for the precision radionuclide therapy products in the next 12 to 24 months will be the FDA’s classification of the Company’s precision radionuclide therapy products as Class II or Class III devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies. Thereafter, the principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’ success in the U.S. and elsewhere. The Company intends to fund its activities through strategic transactions such as licensing and partnership agreements or from proceeds raised from the Regulation A+ Offerings.