Welcome to our dedicated page for Vivos news (Ticker: RDGL), a resource for investors and traders seeking the latest updates and insights on Vivos stock.
Overview of Vivos Inc (RDGL)
Vivos Inc is an innovative clinical-stage medical technology company dedicated to advancing brachytherapy and radioisotope-based therapies within the oncology landscape. Focused on the design and development of radiation therapy solutions, the company leverages its patented Yttrium-90 radiogel technology to deliver precise, localized treatment for cancerous tumors. By integrating breakthrough research in medical isotopes and interventional radiotherapy, Vivos has positioned itself to create a new paradigm in the treatment of malignancies.
Core Business and Technological Innovation
The company is primarily engaged in the development of specialized brachytherapy devices that utilize internally delivered radiation to target tumors more effectively. Its leading product, based on Yttrium-90 radiogel, is designed to provide a highly localized dose of radiation, thereby maximizing treatment efficacy while minimizing collateral damage to surrounding tissues. The product concept is built on deep research in nuclear medicine and radiopharmaceuticals, ensuring that its approach is both scientifically robust and clinically relevant.
Business Model and Operational Strategy
Vivos Inc employs a strategic business model that involves collaboration and outsourcing to streamline its operations. By outsourcing key functions—including manufacturing, distribution, and marketing—within regulated markets such as the United States, the company is able to focus on its core competencies in research and clinical development. Additionally, it is evaluating licensing arrangements for international markets, a strategy that may enhance its global reach without overextending its internal resources. This operational strategy not only optimizes efficiency but also positions Vivos to adapt to diverse market conditions and regulatory environments.
Clinical Development and Market Position
Emphasizing clinical excellence, Vivos Inc has initiated pivotal trials that validate the safety and efficacy of its innovative treatments. The company’s approach to clinical validation—exemplified by recent trials abroad—demonstrates its commitment to rigorous testing protocols and adherence to regulatory standards. Each clinical milestone reinforces the underlying science of its brachytherapy solutions and contributes to a growing body of evidence supporting the therapeutic potential of its radioisotope applications.
Expertise and Industry Distinction
With a leadership team led by Dr. Michael K. Korenko, Sc.D., Vivos Inc benefits from a foundation of scientific expertise and extensive industry experience. This background not only drives the company’s R&D initiatives but also instills confidence in its approach to addressing complex oncological challenges. The utilization of targeted radiation therapy, combined with strategic outsourcing and planned regulatory filings, underscores the company’s commitment to bringing transformative treatment options to patients while maintaining rigorous operational standards.
Competitive Landscape and Value Proposition
Within a competitive market that features several entities developing interventional oncology treatments, Vivos Inc distinguishes itself through its focused application of brachytherapy and specialized radioisotope formulations. Its scientific rationale is rooted in delivering localized, high-intensity radiation directly to tumor sites, a method that promises improved precision over traditional approaches. The company’s efforts in clinical trial execution and its planned regulatory submissions further illustrate the methodical and disciplined approach it employs in navigating an evolving healthcare market.
Future Context and Investment Considerations
Vivos Inc represents an important statistical case study for innovation in cancer treatment, embodying a convergence of advanced radiotherapy technology with strategic operational execution. Its comprehensive approach across research, clinical development, and strategic collaborations ensures that it remains a subject of interest for market observers focused on technological advancements in oncology. While the company maintains a measured and cautious growth strategy, its contributions to the field of brachytherapy underscore the broader potential of targeted radiation therapies in modern medicine.
In summary, Vivos Inc is shaping a specialized niche in the treatment of cancer by continuing to develop cutting-edge brachytherapy devices and exploring new clinical applications for its proprietary radioisotope technologies. This multifaceted approach, combined with strategic partnerships and rigorous clinical validation, enables the company to enhance its market significance while contributing to improvements in cancer care practices.
Vivos Inc. (RDGL) reported positive initial results from its human clinical trial of RadioGel Precision Radionuclide Therapy™. The first five patients demonstrated the treatment's safety, with PET imaging confirming Y-90 remained at injection sites and no adverse events reported. A notable case showed over 80% reduction in tumor size and metastatic activity in a patient with a cancerous node near the trachea.
The company plans to expand the trial from 30 to 50 patients, pending Ethics Committee approval. A new deep-injection CT-guided precision device will be implemented to treat deeper-seated tumors. The initial 30-patient trial is expected to complete by June 30, with the expanded trial finishing by year-end. Results will be submitted to medical journals and shared with FDA to support RadioGel®'s IDE submission.
Vivos is working with IsoTherapeutics (now part of Telix) to increase production capacity for Isopet™ and RadioGel®, while exploring additional manufacturing partnerships globally.
Vivos Inc. (OTCQB: RDGL) reported significant growth in its IsoPet® Animal Cancer Division during 2024. Key achievements include expanding certified clinics from 8 to 13, with 5-10 more expected in 2025. The company launched a dedicated division in May 2024, introduced a new website, and implemented a nationwide marketing campaign.
Notable developments include treating their first exotic animal (a ferret), introducing 'Margin Therapy' for tumor treatment, and establishing the first clinic certified for exotic animal treatment at Sumner Veterinary Hospital. The company operates in the global veterinary oncology market, valued at $1.18 billion in 2023, with a projected CAGR of 11.3% from 2024 to 2030.
Vivos Inc. (OTCQB: RDGL) has launched its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. The trial has successfully treated five patients with cancerous lymph nodes in the neck, with imaging confirming precise treatment placement and patients recovering well without complications. The study has approval to expand to 30 patients targeting cancerous nodes throughout the body.
The trial aligns with Vivos' planned Mayo Clinic study protocol in the United States, and results will be shared with the FDA to support their Investigational Device Exemption submission. The company expects to complete the trial in the first half of 2025, with results to be published in a leading medical journal.
Vivos Inc. (OTCQB: RDGL) has certified a new clinic, NorthStar Vets - Veterinary Emergency & Trauma Specialty Center in Robbinsville, NJ, to offer IsoPet® Precision Radionuclide TherapyTM for cancer treatment in small animals. This 24/7/365 facility provides emergency, trauma, and critical care along with various veterinary specialty services.
Dr. Korenko, President & CEO of Vivos Inc., emphasized the importance of expanding the number of certified clinics for IsoPet Therapy. He noted that certification is a cost-effective alternative to large capital investments, requiring enthusiastic veterinarians and oncologists. Vivos assists these clinics in obtaining or amending their radioactive material licenses and provides certification training, including their proprietary Injection Guidance Table.
The company reports having several clinics in the pipeline for certification, indicating potential growth in the availability of IsoPet Therapy.
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.
FAQ
What is the current stock price of Vivos (RDGL)?
What is the market cap of Vivos (RDGL)?
What is the primary focus of Vivos Inc?
How does Vivos Inc differentiate its treatment approach?
What is the significance of the Yttrium-90 radiogel technology?
What operational strategies does Vivos Inc employ?
How does Vivos Inc approach clinical validation?
Who leads Vivos Inc and what expertise do they bring?
What competitive advantages does Vivos Inc offer in the oncology space?
How is Vivos Inc positioned within the global market?
