Vivos Inc. develops isotope-based radiotherapeutic products for targeted cancer treatment and related therapeutic applications. News about RDGL centers on RadioGel® for human use, IsoPet® for veterinary applications, and the company’s Precision Radionuclide Therapy™ approach, which is designed to deliver localized beta radiation directly to tumor sites while limiting exposure to surrounding tissue.
Recurring developments include FDA IDE-related work for RadioGel®, international human therapy demonstrations, veterinary clinic certification and IsoPet adoption, intellectual-property protection for hydrogel and radiotherapy technology, manufacturing arrangements for yttrium-90 phosphate particles and sterile hydrogel doses, and strategic collaborations in companion-animal radiotherapeutics.
Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA, following amendments addressing previous FDA comments (Q211938/S001). This marks their first filing post the FDA Breakthrough Device Designation for their Radiogel™ Precision Radionuclide Therapy. The application includes studies on RadioGel® genotoxicity and retention at injection sites in VX2 tumors in rabbits. Dr. Korenko noted the readiness to address any comments from the FDA's twelve reviewers. Approval of this IDE will allow Vivos to seek clearance from the Mayo Clinic's Independent Review Board (IRB) to initiate human clinical trials targeting metastatic tumors in lymph nodes from papillary thyroid cancer.
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On January 11, 2023, Vivos Inc. (OTCQB: RDGL) announced the filing of a utility patent application for a range of particles used in precision radionuclide therapy, following a provisional patent from January 15, 2022. The application covers several countries, including Canada, the EU, Japan, and China. Dr. Mike Korenko emphasized the importance of precision radionuclide therapy in future cancer treatments, particularly through their IsoPet and RadioGel therapies, which deliver localized radiation to tumors, minimizing side effects compared to traditional therapies.
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.