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.
Vivos Inc. (OTCQB: RDGL) generates news centered on its development of radiotherapeutic devices and hydrogel-based technologies for oncology in both humans and animals. Company updates frequently highlight progress with its core platforms, RadioGel® for human use and IsoPet® for veterinary applications, which are designed to deliver targeted radiation directly to tumors while limiting exposure to healthy tissue.
Investors and observers following RDGL news will see detailed coverage of regulatory milestones for RadioGel, including Investigational Device Exemption (IDE) submissions to the U.S. Food and Drug Administration, FDA feedback, and the company’s use of pre-submission processes to refine its data on dosimetry, migration, and sterilization. Releases also describe international clinical activity, such as human trials conducted under U.S. regulatory standards and expansion efforts through Vivos Scientific India LLP.
Another major theme in Vivos news is the IsoPet animal therapy division. The company reports year-over-year growth in administered IsoPet therapies, case studies across dogs, cats, horses, and exotic animals, and certifications of new veterinary clinics, including equine and small animal hospitals. Updates often discuss clinical outcomes like equine ocular squamous cell carcinoma treatments without ocular damage, as well as subsidized case study programs intended to generate publishable data.
Additional RDGL coverage includes manufacturing and intellectual property developments, such as validation of an electron beam sterilization process under ISO 11137 and patent filings related to sterile thermogels and PrecisionGel agent-release characteristics. Vivos also issues news on strategic collaborations, notably with Exubrion Therapeutics, to coordinate clinic relationships and co-market IsoPet in equine oncology. For readers tracking the evolution of targeted radionuclide therapies and related medical devices, the Vivos Inc. news stream provides ongoing insight into clinical, regulatory, and operational progress.
Vivos Inc. (OTCQB: RDGL) has announced the certification of the University of Florida Veterinary Hospital to offer IsoPet® Precision Radionuclide Therapy™, a targeted cancer treatment for animals. This innovative therapy uses a proprietary radionuclide injection to treat solid tumors in pets, offering a minimally invasive alternative to traditional treatments.
The certification marks an expansion in Vivos' network of certified clinics, with the company providing comprehensive support through the licensing process and training to ensure safe and effective administration of IsoPet therapy. Additional veterinary hospitals are currently in the certification pipeline as part of the company's growth strategy.
Vivos Inc. (OTCQB: RDGL) reported record-breaking growth in its IsoPet® Animal Cancer Division for Q1 2025. The company's Precision Radionuclide Therapy™ treated 15 pets, marking a 150% year-over-year increase in treatment volume.
Key achievements include:
- Expansion to 14 certified clinics (8 small animal, 6 equine) with three new additions in Q1
- Breakthrough treatments in equine oncology, including four horses with ocular squamous cell carcinoma
- Biweekly production schedule of yttrium-90 hydrogel ensuring steady treatment supply
- Notable treatments at facilities like NorthStar Vets (NJ) and Brazos Equine Hospital (TX)
The company operates in the global veterinary oncology market, valued at $1.18 billion in 2023, with projected 11.3% CAGR through 2030. IsoPet® offers a non-invasive, single-session outpatient approach, positioning itself as a cost-competitive alternative to traditional radiation.
Vivos Inc. (OTCQB: RDGL) has reported significant progress in its India human clinical trial for RadioGel® Precision Radionuclide Therapy™, an FDA-designated Breakthrough Device for solid tumor treatment. The trial has successfully treated ten patients with cancerous nodes, demonstrating both safety and early efficacy signals.
Key highlights include:
- All patients met primary safety endpoints with precise Yttrium-90 isotope retention
- No adverse events or complications reported
- Successful treatment of high-risk tumors near trachea and carotid artery
- Trial approval expanded to treat up to 30 patients, with plans to request increase to 50 patients
The company plans to submit an IDE to FDA within 90 days and is establishing operations in India, including a corporate office and manufacturing facility. The Indian cancer treatment market, valued at USD 4.21 billion in 2023, is projected to reach USD 5.89 billion by 2030, representing a significant opportunity for RadioGel®.
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.
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