Vivos Inc. (OTCQB: RDGL) Reports Second Quarter 2026 Progress and Corporate Update - Correction
Rhea-AI Summary
Vivos (OTCQB: RDGL) reported Q2 2026 progress centered on its Precision Radionuclide Therapy platform. On July 2, 2026, the FDA approved a Feasibility IDE, allowing a first-in-human RadioGel study at Mayo Clinic Jacksonville in non-resectable papillary thyroid carcinoma, initially enrolling five patients, with safety follow-up reduced from five years to 24 months.
According to Vivos, human trials in India have generated sufficient data for peer-reviewed publication, though treatments at Healthcare Global Enterprises Hospital are temporarily paused during an internal review unrelated to RadioGel. The company supports 17 U.S. IsoPet clinics that have treated 200+ animals, is ramping dual manufacturing in Washington and India, and is commercializing its PrecisionGel hydrogel for research use.
Positive
- FDA Feasibility IDE approval on July 2, 2026 for first-in-human RadioGel study
- Safety follow-up period reduced from five years to 24 months after FDA feedback
- 17 certified IsoPet clinics in the U.S. treating over 200 animals
- Domestic APEL facility targeting IsoPet shipments for veterinary use by quarter-end
- India manufacturing build-out via contracted radioactive pharmaceutical supplier and Vivos Scientific India LLP
- PrecisionGel research sales expected to generate moderate, gradually growing cash flow
Negative
- Human treatments at Healthcare Global Enterprises Hospital in India temporarily paused during internal review
- Resumption of India human therapies still contingent on DCGI approval expected by end of 2026
News Explained
Manufacturing expansion is advancing, but Indian clinical restart and Washington shipments remain future milestones rather than completed operations.
The update adds a concrete manufacturing commitment: Vivos has executed a contract with an Indian radioactive-pharmaceutical supplier and begun procuring equipment, while its Washington facility’s validation remains underway, so dual production is being built but is not yet fully operational.
The India arrangement is a committed supplier contract and equipment-procurement phase, whereas the Washington site is targeted to ship IsoPet by the end of this quarter; neither statement confirms that the Indian facility is producing or shipping.
At
The next operating checkpoints are Washington validation and the planned IsoPet shipment by quarter-end.
Resumption of human treatments in India remains tied to anticipated DCGI approval by the end of
Sources and calculations
- Vivos Second Quarter 2026 Progress and Corporate Update — Correction (2026-07-27)
- Vivos first-quarter 2026 fundamentals (2026-03-31)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $2,525,782 / ($429,861 / 90) = [object Object]
AI-generated analysis. How Rhea-AI works. Not financial advice.
Kennewick, WA, July 27, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a medical device company pioneering Precision Radionuclide Therapy™, is pleased to share this update on the meaningful advancements the company has made across our core initiatives. Our team remains focused on advancing Precision Radionuclide Therapy™ (PRnT), our proprietary yttrium-90-based injectable hydrogel technology, to deliver accessible treatments for cancerous tumors in both humans (RadioGel®) and animals (IsoPet®).
HUMAN CLINICAL TRIALS – UNITED STATES
On July 2, 2026, we received approval from the U.S. Food and Drug Administration (FDA) for our Feasibility Investigational Device Exemption (IDE) application. This clearance enables us to initiate our first-in-human feasibility study at Mayo Clinic in Jacksonville, Florida, targeting patients with non-resectable papillary thyroid carcinoma.
The study aligns with our Breakthrough Device Designation and will initially enroll five patients to evaluate safety and feasibility. Data from this trial will inform the design of subsequent pivotal studies. We appreciate the FDA’s constructive feedback. Following structured communications with the FDA, the agency reduced the safety follow-up period from five years to the standard 24 months. This a practical and positive outcome as we intend to undertake additional pivotal trials during this period.
We have been working closely with the Mayo Clinic in parallel with the IDE submission to ensure we submit to the Mayo Institutional Review Board (IRB) within their required process and as quickly as reasonably possible. We are now in the final stages of that submission.
HUMAN CLINICAL TRIALS IN INDIA
We made significant progress with our clinical work in India, which provided important supportive data for our FDA IDE approval. The Principal Investigator recently reported that we now have sufficient patient data, after meeting several clinical follow-up endpoints, to prepare and submit an article for publication in a peer-reviewed scientific journal, which we expect to happen in the near future. We are excited about the positive results we are seeing from this study.
Multiple clinical trials at the Healthcare Global Enterprises Hospital (HGC) study hospital, including ours, were temporarily paused as part of a broader internal review and audit process undertaken by new HGC management. This pause was unrelated to RadioGel® or our clinical study results, which remain very favorable. The hospital’s Ethics Committee and Clinical Trials Registry (CTRI) approvals for this study remain in place. We anticipate receiving The Drugs Controller General of India (DCGI) approval for our Principal Investigator at HGC to resume human treatments under the FDA-aligned protocol by the end of 2026.
We are also in active discussions with our regulatory experts in India and DCGI regarding next steps. Following their guidance, we are preparing submissions for DCGI approval to conduct a formal Phase I/II clinical trial at HGC. In addition, we have identified two additional hospitals for the expansion of clinical trials, which will broaden our intended use.
We are working closely with our regulatory experts to leverage our clinical data from the RadioGel® trials in India to support a commercialization strategy.
ANIMAL THERAPY
Our animal therapy business continues to expand steadily. We now support 17 certified clinics across the U.S. that have treated more than 200 small animals and horses. These cases have consistently demonstrated the safety and effectiveness of IsoPet therapy.
We have recently signed agreements with two veterinary clinics in California and one in North Carolina, and we have a strong pipeline of additional clinics in the works.
We are prioritizing peer-reviewed publications, including studies on treating surgical margins of resected tumors and equine ocular tumors, in which we eliminated tumors on the eye without damaging that critical organ. We believe we offer the leading and often only practical therapeutic option for equine therapy. These publications will support strategic price adjustments to move toward break-even and help internally fund our human development programs.
MANUFACTURING & OPERATIONS
Domestic Facility - (Applied Process Engineering Laboratory – Richland, WA): The required validation activities are underway at APEL and nearing completion with strong emphasis on sterility and our robust Quality Management System. We are on target to ship IsoPet from this facility for veterinary use by the end of this quarter. We also expect to produce material at APEL to support the resumption of human therapies in India once their DCGI approval is granted. APEL will further serve as a key site to support additional international clinical trials. We are adding an ISO Class 7 clean room for enhanced protection and will also use the facility for ongoing process improvements.
International Facility – (India): We have executed a contract with a reputable supplier of radioactive pharmaceuticals to replicate our production capabilities at APEL and have begun procuring the necessary equipment. Our Vivos Scientific India LLP company positions us for efficient supply to India and neighboring markets while preparing for broader international commercialization.
FUTURE STRATEGIC OBJECTIVES
The recent FDA IDE approval has already opened doors for increased interest from other countries in expanding clinical trials. We will be conducting a strategic meeting in Q4 2026 with Key Opinion Leaders (KOLs) to gain consensus on the optimum path to expand RadioGel® and IsoPet® therapy internationally, initially produced from our two facilities. We are currently in high level discussions with investigators at leading institutions in several countries.
PRECISIONGEL™ OPPORTUNITY
Over the past several years, we have been optimizing the properties of our proprietary hydrogel. Its unique thermogelling characteristics allow it to remain liquid when mixed with our yttrium-90 phosphate particles, enabling hydrostatic pressure to perfuse the patented particles deep into the tumor, where it then gels upon exposure to body temperature. Akina Inc has recently submitted a paper for publication in a scientific journal sharing a portion of our data.
We are currently evaluating the release characteristics of our hydrogel with a variety of therapeutic agents. In addition to our patent protection, we are offering the polymer and sterile hydrogel for research sale and have received interest from universities and major pharmaceutical companies. We anticipate this effort will generate moderate cash flow while growing gradually. However, we remain firmly focused on our primary mission: advancing treatments for cancerous tumors.
Mike Korenko, ScD, CEO
“The recent FDA IDE approval marks a major milestone for Vivos. As we look to the future, we are well-positioned to advance RadioGel® and IsoPet® toward broader availability. With dual production capabilities coming online and growing international interest, we remain committed to disciplined execution and delivering innovative Precision Radionuclide Therapy™ solutions that improve outcomes for patients and animals alike.”
About Vivos Inc.
Vivos Inc. is developing advanced Yttrium-90 Precision Radionuclide Therapy™ (PRnT) treatments for tumors in both animals (IsoPet®) and humans (RadioGel®). The Company is committed to delivering safer, more effective, and accessible cancer therapies with a high therapeutic index (TI) through Precision Radionuclide Therapy™.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of applicable securities laws. Actual results may differ materially from those expressed or implied due to various risks and uncertainties.
Contact:
Mike Korenko, ScD Brad Weeks
CEO, Vivos Inc. President, Vivos Inc.
mkorenko@radiogel.com brad.weeks@vivosinc.com
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
