Recent news coverage includes earnings call transcripts and market updates from unrelated companies, with no direct recent news on Vivos Inc. The company’s last notable public update was in early 2025 regarding clinical trial results and business developments.

• Vivos Inc. reported encouraging results in clinical trials of RadioGel for cancer treatment as of February 2025 [N7].
• The company has seen a 1,200% year-over-year increase in administered therapies in its IsoPet Animal Therapy Division from 2024 to 2025, indicating rapid growth in veterinary applications [S1].
• Vivos established Vivos Scientific India LLP in September 2025 to support manufacturing, clinical trials, and commercialization efforts in India [S1].
• The company is actively pursuing FDA Investigational Device Exemption submission with Breakthrough Device designation, addressing FDA feedback and incorporating new sterilization processes [S1].
• Plans are underway to establish domestic and international manufacturing facilities in 2026 to improve supply chain resilience and reduce costs [S1].

The company’s technology addresses a niche in oncology with a precision therapy that minimizes radiation exposure to healthy tissue. Rapid growth in veterinary applications and clinic certifications demonstrate market acceptance. The establishment of manufacturing facilities in the US and India could improve cost efficiency and global reach. The Breakthrough Device designation and ongoing regulatory engagement may facilitate eventual FDA approval for human therapy. Expansion into new isotopes and indications could broaden the addressable market. Strategic leadership hires and international subsidiaries support operational scaling and commercialization efforts.

The company faces regulatory challenges, including a rejected FDA IDE submission and the need to address detailed FDA concerns, which may delay human therapy commercialization. Financially, the company reported a net loss and very low revenue, indicating limited current profitability and scale. Dependence on a single production site has been a risk, though mitigated by planned facility diversification. Market adoption outside veterinary applications remains uncertain. The company’s success depends on clinical trial outcomes, regulatory approvals, and the ability to scale manufacturing and sales effectively.

Vivos Inc.'s moat is based on its proprietary yttrium-90 hydrogel technology for precision radionuclide therapy, which offers targeted cancer treatment with minimal collateral damage. The company benefits from FDA device classification that facilitates a faster regulatory pathway compared to drugs, and it has established clinical and veterinary collaborations that validate safety and efficacy. Its dual focus on human and veterinary oncology markets, combined with a growing certified clinic network and expanding manufacturing capabilities, supports competitive positioning. The Breakthrough Device designation and engagement with regulatory experts enhance its regulatory navigation. However, the moat is contingent on successful regulatory approvals, clinical adoption, and manufacturing scale-up.

• Regulatory Approval Risk: The FDA rejected the initial IDE submission citing deficiencies, requiring the company to address detailed concerns and resubmit, which may delay commercialization of human therapy.
• Financial Risk: The company reported a net loss of $830,189 for the quarter ended June 30, 2026, with minimal revenue, indicating ongoing operational losses and reliance on financing.
• Manufacturing and Supply Chain Risk: Vivos has historically relied on a single production site, posing supply chain vulnerabilities. While plans for domestic and international facilities are underway, operational readiness and regulatory licensing remain in progress.
• Market Adoption Risk: While veterinary therapy has shown rapid growth, broader adoption in human oncology depends on regulatory approvals, clinical trial success, and physician acceptance.

• Vivos Inc. is a radiation oncology medical device company developing yttrium-90 (Y-90) based precision radionuclide therapy devices, including RadioGel® for human cancer treatment and IsoPet® for veterinary use (solid tumors in animals).
• RadioGel® is classified by the FDA as a device for human therapy for non-resectable cancers, enabling a faster regulatory path than drugs. IsoPet® is classified as a veterinary medical device, which does not require premarket approval, allowing commercial distribution in the US for animal tumor treatment.
• The company sells PLGA-g-PEG polymers and PrecisionGel™, a hydrogel polymer platform for delivering pharmaceutical agents.
• Vivos has collaborated with multiple national laboratories and university veterinary hospitals for testing and therapy development, confirming safety and efficacy of the Y-90 therapy with minimal off-target radiation.
• Commercial sales of IsoPet® began in July 2019, with significant growth in 2025 including a 1,200% year-over-year increase in administered therapies and expansion of certified veterinary clinics.
• The company transitioned to volume pricing and began charging clinics for certification starting in 2025, aiming for breakeven in the Animal Therapy Division in 2026.
• RadioGel® is an injectable hydrogel containing Y-90 phosphate particles that gel at body temperature, delivering localized beta radiation to tumors with minimal exposure to surrounding tissue.
• In 2021, the indication for use was modified to include treatment of locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma in patients not candidates for surgery.
• Vivos established Vivos Scientific India LLP in September 2025 to support manufacturing, clinical trials, regulatory approvals, and commercialization in India for both human and animal therapies.
• The company is pursuing FDA Investigational Device Exemption (IDE) submission with a Breakthrough Device designation, engaging regulatory experts and addressing FDA feedback extensively.
• The FDA rejected the initial IDE in August 2025 citing deficiencies; Vivos responded with a pre-submission document incorporating an E-Beam sterilization process and additional clinical data.
• Plans include establishing two production facilities in 2026: a domestic site in Richland, Washington, and an international site in India to improve supply chain resilience and reduce costs.
• The company is exploring alternate isotopes (P-32, Lu-177, Ac-225) for future indications, with Y-90 currently effective for targeted cancers.
• Financial snapshot as of 2026-06-30 shows cash and equivalents of $3.27 million, current assets of $2.44 million, current liabilities of $49,973, resulting in a current ratio of 48.85 and cash ratio of 65.34, indicating strong liquidity.
• Net loss for the quarter ended 2026-06-30 was $830,189 with basic and diluted EPS of $0.
• Revenue reported for fiscal year 2024 was $4,995.
• The company has strengthened its leadership team in 2025 to support growth and operational efficiency.
• The company’s business model includes direct sales of RadioGel®/IsoPet® and related services, certification of veterinary clinics, and manufacturing expansion.
• The company’s strategic initiatives include clinical trials in India, regulatory submissions, manufacturing diversification, and expansion of therapy indications.