Vivos Inc. (OTCQB: RDGL) Reports Second Quarter 2026 Progress and Corporate Update - Correction

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 ® ).

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.

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.

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.