Vivos Inc. Demonstrates Precision in Precision Radionuclide Therapy

Rhea-AI Summary

Vivos Inc. (OTCQB: RDGL) has reported new data demonstrating the high precision of its RadioGel® and IsoPet® radionuclide therapy technologies. The company's therapeutic solutions have shown exceptional results in both veterinary and human applications, achieving high therapeutic ratios that maximize tumor destruction while minimizing damage to surrounding healthy tissue.

Key clinical successes include successful treatment of Ocular Squamous Cell Carcinoma (OSCC) in horses with no damage to surrounding eye tissue, and effective treatment of cancerous lymph nodes near critical structures in human trials, with tumors becoming undetectable after 90 days. RadioGel® has received FDA Breakthrough Device designation, though it is not yet FDA-approved for commercial use in the United States.

Positive

• Received FDA Breakthrough Device designation for RadioGel®
• Successful treatment of eye tumors in horses with no damage to surrounding tissue
• Human trial showed complete tumor elimination after 90 days with no adverse effects
• Technology demonstrates ability to treat tumors near vital organs

Negative

• RadioGel® not yet FDA-approved for commercial use in United States

Kennewick, WA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) announced new data demonstrating the exceptional precision of its proprietary Precision Radionuclide Therapy (RadioGel^® for human therapies and IsoPet^® for veterinary applications)

Advancing Targeted Cancer Therapies

The therapeutic ratio is the amount of radiation delivered to a tumor compared to surrounding healthy tissue and is a critical measure of treatment precision. A high therapeutic ratio minimizes collateral damage while maximizing tumor destruction.

The high therapeutic ratio achieved in clinical studies with RadioGel^®, was a key factor in the technology receiving FDA Breakthrough Device designation. This ratio was initially validated through rigorous health physics calculations performed by internationally respected physicists.

Now, the company has supporting data from our animal health division and human trial data that confirms these calculations.

• Veterinary Success:

Dr. Ben Buchanan of Brazos Valley Equine Hospital in Navasota, Texas, successfully treated Ocular Squamous Cell Carcinoma (OSCC) in multiple horses. Treatments included injections directly into eyelid tumors and even onto the cornea, with no damage to surrounding eye tissue and no reported adverse effects.

• Human Clinical Data:

In the international human trial, cancerous lymph nodes near critical structures, including the trachea and carotid artery, were treated effectively. At 90 days post-treatment, these tumors were undetectable by imaging. No measurable damage or reported adverse effects were observed. Analysis of CT/PET scans confirmed no radiation uptake by surrounding critical structures or adjacent areas of the neck.

 A Unique Capability for Treating Challenging Tumors

“These demonstrations give us confidence that RadioGel^® and IsoPet^® have the potential to treat tumors located near vital organs, which is a capability that sets them apart and can significantly expand the size of the addressable market,” said Michael K. Korenko, Sc.D., President & CEO of Vivos Inc.

“Vivos will continue to expand and strengthen our data through domestic animal therapies and international human clinical trials.”

RadioGel^® is not FDA-approved for commercial use in the United States at this time. The human clinical data cited in this release comes from an international clinical trial conducted under U.S. regulatory standards.

About Vivos Inc.

Vivos Inc. is dedicated to advancing innovative, targeted cancer therapies through its patented radionuclide delivery platforms, RadioGel^® and IsoPet^®.

The company has trademarked the term Precision Radionuclide Therapy^™ to describe this targeted treatment approach.

To learn more, visit www.VivosInc.com.
Follow Vivos Inc. on X (Twitter):@VivosIncUSA

Media Contact:
Michael K. Korenko, Sc.D.
Email: MKorenko@RadioGel.com

Safe Harbor Statement 

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including terms such as “will,” “expects,” “plans,” “anticipates,” and “intends.” Actual results may differ materially due to risks and uncertainties, including challenges in executing business strategies, economic conditions, competitive pressures, regulatory changes, and delays in clinic certifications. For a detailed discussion of these risks, please refer to the company’s filings with the U.S. Securities and Exchange Commission.

FAQ

What is the therapeutic ratio achievement of Vivos Inc's (RDGL) RadioGel® technology?

RadioGel® demonstrated a high therapeutic ratio, delivering targeted radiation to tumors while minimizing damage to surrounding healthy tissue, which was key to receiving FDA Breakthrough Device designation.

What clinical results has Vivos (RDGL) achieved with its RadioGel® treatment in human trials?

In international human trials, RadioGel® successfully treated cancerous lymph nodes near critical structures like the trachea and carotid artery, with tumors becoming undetectable after 90 days and no reported adverse effects.

How effective is Vivos's IsoPet® treatment for veterinary applications?

IsoPet® successfully treated Ocular Squamous Cell Carcinoma (OSCC) in multiple horses at Brazos Valley Equine Hospital, with injections directly into eyelid tumors and cornea showing no damage to surrounding eye tissue.

What is the current FDA approval status of Vivos Inc's (RDGL) RadioGel® treatment?

While RadioGel® has received FDA Breakthrough Device designation, it is not yet FDA-approved for commercial use in the United States.

What makes Vivos's (RDGL) radionuclide therapy unique in cancer treatment?

The technology's high precision allows for treatment of tumors located near vital organs, with minimal risk to surrounding healthy tissue, offering a unique capability in targeting challenging tumor locations.