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Vivos Inc. (OTCQB: RDGL) is a biotechnology company specializing in the development of advanced brachytherapy devices and medical isotopes for both diagnostic and therapeutic applications. The company's core innovation, the patented Yttrium-90 RadioGel™, represents a significant advancement in localized cancer treatment. Brachytherapy, a form of radiation therapy, involves the precise placement of radioactive isotopes directly within or adjacent to cancerous tumors, enabling targeted destruction of malignant cells while minimizing damage to surrounding healthy tissues.
Core Technology and Product Focus
At the heart of Vivos' product portfolio is the Yttrium-90 RadioGel™, a proprietary brachytherapy device designed for the treatment of various cancers. This innovative technology leverages the unique properties of Yttrium-90, a beta-emitting isotope, to deliver highly localized radiation therapy. Unlike traditional brachytherapy methods, RadioGel™ offers enhanced safety and precision, making it particularly suitable for treating complex or hard-to-reach tumors. The company is also exploring related products in the Yttrium-90 brachytherapy category, further expanding its potential applications in both human and veterinary oncology.
Market Position and Industry Context
Vivos operates within the highly specialized radiopharmaceutical and medical device industries, which are integral to modern oncology care. The global brachytherapy market, valued at over $1 billion annually, presents significant opportunities for growth, particularly in the United States, which accounts for approximately half of the market. By focusing on innovative, targeted therapies, Vivos positions itself as a key player in the shift towards precision medicine, addressing the growing demand for safer and more effective cancer treatments.
Business Model and Operational Strategy
Vivos employs a streamlined business model, outsourcing critical aspects of manufacturing, distribution, sales, and marketing to third-party partners. This approach allows the company to focus its resources on core competencies such as research, development, and regulatory compliance. Additionally, Vivos plans to establish licensing agreements for its products outside the United States, enabling global market penetration while maintaining operational efficiency. The company’s strategy reflects a commitment to scalability and adaptability in a competitive and highly regulated industry.
Regulatory and Competitive Landscape
As a late-stage development company, Vivos' success is closely tied to regulatory milestones, particularly FDA clearance for its Yttrium-90 RadioGel™ product. Regulatory approval not only validates the safety and efficacy of the technology but also serves as a critical gateway to commercialization. In terms of competition, Vivos faces challenges from established brachytherapy providers and alternative cancer treatment modalities. However, its unique technology and focus on innovation provide a strong competitive edge.
Veterinary Applications
In addition to human oncology, Vivos is exploring the veterinary market through its Isopet® brand. This initiative underscores the versatility of the Yttrium-90 RadioGel™ technology and its potential to address unmet needs in veterinary cancer care. By targeting this niche market, Vivos diversifies its revenue streams and broadens the impact of its innovative solutions.
Conclusion
Vivos Inc. stands out as a forward-thinking biotechnology company dedicated to advancing the field of brachytherapy. Through its patented Yttrium-90 RadioGel™ technology, the company addresses critical gaps in cancer treatment, offering targeted, effective, and minimally invasive solutions for both human and veterinary applications. With a strategic focus on innovation, regulatory compliance, and operational efficiency, Vivos is well-positioned to make a meaningful impact in the oncology and radiopharmaceutical industries.
Vivos Inc. (OTCQB: RDGL) has filed a provisional patent application for a new system supporting precision radionuclide therapy. This includes shipping containers, a shielded vial holder, a Peltier chiller, and syringe shields, designed to enhance treatment efficacy and safety for tumors ranging from small human lymph nodes to larger equine tumors. The equipment aims to address concerns from clinical trials regarding contamination and radiation safety, receiving positive feedback from therapists. The company plans to provide this technology for human clinical trials at Mayo Clinic.
Vivos Inc. (OTCQB: RDGL) announced on September 14, 2022, the filing of a patent application for its hydrogel component of IsoPet and RadioGel in the USA and internationally. This development follows the recent Notice of Allowance for a patent related to their yttrium phosphate microparticles. The optimized hydrogel aims to enhance gelation and resorption characteristics while meeting FDA standards. Vivos continues to focus on strong intellectual property protection as part of its strategy to advance injectable radionuclide therapies for treating tumors in both animals and humans.
Vivos Inc. (OTCQB: RDGL) has certified the New England Equine Practice in Patterson, NY, to administer Precision Radionuclide IsoPet® therapy for solid tumors in horses. This innovative therapy allows for same-day treatment using low activity to deliver high doses localized at the injection site, minimizing contamination. The company is exploring expansion to mobile treatment options to prevent horse travel-related health issues. Additionally, a successful demonstration at the University of Missouri has shown effective long-term results, with the treated horse remaining cancer-free after fifteen months.
Vivos Inc. (OTCQB: RDGL) has expanded its intellectual property protection by filing a particle patent in over ten patent offices, covering 63 countries. A provisional patent (63-299,930) was also filed, enhancing protection for hydrogel and particle components. The company plans to file additional claims internationally via the PCT process and a new utility patent for hydrogel innovations by Q3. Dr. Korenko emphasized the aim to strengthen their intellectual property to enhance shareholder value and establish a leadership position in precision radionuclide therapy.
Vivos Inc. (OTCQB: RDGL) has streamlined the IsoPet® therapy process by consolidating treatments into a single production run, effectively lowering production and shipping costs. This initiative was demonstrated at Johns Hopkins University, where two cats were treated using this new approach. Dr. Korenko emphasized the company's commitment to reducing costs while maintaining treatment quality for pets. Vivos' IsoPet® and RadioGel™ technologies use localized radiation for treating tumors in animals and humans, respectively, highlighting their innovation in the veterinary oncology space.
Vivos Inc. (OTCQB: RDGL) has successfully filed a particle patent in multiple countries, including the USA, EU, Japan, and others, enhancing its intellectual property strategy. The company is set to file a new utility patent for its hydrogel component later this year. This move underpins Vivos's plans to establish exclusive licensing agreements globally. Vivos has developed innovative brachytherapy treatments using Yttrium-90 for tumors in animals and humans, with its products aiming to offer effective radiation therapy while minimizing side effects.
Vivos Inc. (OTCQB: RDGL) provided a recap of its 2021 progress and future objectives. The company highlighted advancements in its IsoPet® animal therapy, including successful treatments and the formation of new regional clinics. For human therapy, RadioGel™ is undergoing FDA processes, with an upgraded Quality Management System in place. Challenges from the COVID-19 pandemic have been addressed, significantly improving hydrogel production efficiency. Financially, the company reports a strong capital structure with no toxic debt.
Vivos Inc. (OTCQB: RDGL) recently met with the FDA to discuss the Investigational Device Exemption for its RadioGel™ treatment for recurrent thyroid cancer. The FDA provided beneficial guidance, suggesting a Q-Submission path for expedited review and offering insights on clinical testing protocols. Vivos's representatives from Mayo Clinic effectively communicated the medical necessity for RadioGel™. CEO Mike Korenko noted that this pivotal meeting could prevent a rejected IDE submittal, emphasizing the company's readiness to cover costs for final IDE submission.
Vivos Inc. (OTCQB: RDGL) has announced a partnership with the Johns Hopkins Veterinary Clinical Trials Network for the Isopet® initiative, aimed at conducting animal studies on specific cancers. This collaboration is expected to enhance data collection for publishing in leading journals, thereby increasing awareness and acceptance of Isopet® within the veterinary oncology community. The Isopet® technology, based on yttrium-90, targets tumor treatment in animals and parallels the human treatment method, Radiogel™. The company aims to expand its regional centers and establish a robust presence in the veterinary market.
Vivos Inc. (OTCQB: RDGL) has announced that Johns Hopkins University is now an Isopet® regional clinic, which will conduct new studies on various cancers. This collaboration aims to generate high-quality data for publication, enhancing awareness within the veterinary oncology community. The Isopet® device, based on Yttrium-90, is designed to treat animal tumors effectively and can drive revenue through sales to veterinary hospitals and clinics. The FDA confirmed Isopet® as a medical device in 2018, streamlining its market introduction.
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