Vivos Stock Price, News & Analysis

Vivos Inc (OTCQB: RDGL) has filed a provisional patent (No. 63/873,014) for a new electron beam (E-Beam) sterilization process for their hydrogel technology. The process, validated under ISO 11137, achieves a sterility assurance level of 10-6 - the highest standard for critical medical devices.

The new sterilization method offers significant advantages over their current filtration process, including improved reliability, cost-effectiveness, and enhanced scalability. This advancement benefits both their Radiogel® (human) and IsoPet® (animal) therapy product lines, positioning the company for broader market penetration and increased revenue opportunities.

Vivos Inc. (OTCQB: RDGL) announced that the FDA has declined approval of their Radiogel® Investigational Device Exemption (IDE) submission following the 30-day review period. The company plans to address the FDA's feedback and will have an initial call within 10 days, followed by a pre-sub meeting with the FDA review team to prepare for resubmission.

Despite this setback, Radiogel® maintains its FDA Breakthrough Device Designation and has demonstrated strong safety profile and therapeutic ratio. The company remains committed to pursuing US market approval for Radiogel®.

Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA for RadioGel®, their innovative hydrogel-based radioactive therapy designed for targeted tumor treatment. The submission represents a crucial advancement in their Precision Radionuclide TherapyTM (PRnT) program.

The IDE application was developed through extensive collaboration with the FDA under the Breakthrough Device sprint process, supported by comprehensive animal and human data. RadioGel® aims to deliver precise radiation to tumors while protecting surrounding healthy tissue, addressing an unmet medical need in cancer treatment.

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.