Vivos Stock Price, News & Analysis

Vivos Inc. (OTCQB: RDGL) has expanded its IsoPet® Precision Radionuclide TherapyTM to exotic animals, treating its first ferret with encouraging results. The company observed a significant reduction in tumor size after three weeks of treatment. This development addresses the cancer treatment options for small exotic animals, where traditional surgical tumor removal can be too invasive.

Dr. Korenko, President & CEO of Vivos Inc., highlighted the growing need for cancer treatments in pets and zoo animals beyond cats, dogs, and horses. The company has been actively participating in relevant conferences to promote IsoPet Precision Radionuclide Therapy as an innovative solution for treating solid cancerous tumors in all animals.

Vivos Inc. (OTCQB: RDGL) has provided an update on its IDE submission status for Radiogel®. The FDA has been reviewing the extensive material submitted within the 30-day statutory time limit. Due to time constraints, Vivos has converted the IDE submission (G240159) to a Pre-Sub filing (Q241925) with FDA consent. This strategic move allows for comprehensive addressing of FDA feedback and maintains open communication through quick review sessions.

The company expects to receive follow-up questions from the FDA this week to fully analyze the risk/benefit assessment of Radiogel®. Vivos is confident that 90-95% of required information has been provided and plans to resubmit the refined IDE application within 45 days. The company is collaborating with Mayo Clinic and aims to promptly submit a treatment plan to Mayo Clinic's Independent Review Board (IRB) after receiving FDA approval. The initial treatment target for Radiogel® will be solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

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.

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.