Vivos Inc. Announces Significant Progress Toward FDA Investigational Device Exemption (IDE) Submission for RadioGel® Precision Radionuclide Therapy(TM)
MWN-AI** Summary
On February 10, 2026, Vivos Inc. (OTCQB: RDGL), a pioneering medical device company based in Kennewick, WA, announced significant advancements in its pursuit of FDA Investigational Device Exemption (IDE) approval for its innovative RadioGel® technology. RadioGel® is designed as a Precision Radionuclide Therapy™ (PRnT™), targeting solid tumors with localized beta radiation, which minimizes damage to surrounding healthy tissue. Over the years, Vivos has actively collaborated with the FDA, addressing feedback from more than 40 reviewers, a process further complicated by frequent personnel changes within the agency.
In a strategic move to strengthen its IDE submission, Vivos has enlisted a highly regarded regulatory expert with a solid track record in brachytherapy and combination radiotherapy devices, ensuring comprehensive guidance through the FDA's Center for Devices and Radiological Health. This expert's insights have enabled Vivos to refine its submission format and effectively address outstanding FDA concerns.
Additionally, Vivos plans to incorporate recently available clinical human data and reformat pre-clinical data, enhancing the submission's clarity and alignment with regulatory expectations. The company's robust veterinary clinical data from its IsoPet® platform also bolsters its evidence package, demonstrating successful treatment outcomes across 100 therapies without serious adverse events. This includes specialized applications in equine patients, showcasing the therapy's effectiveness and safety in challenging anatomical areas.
Vivos Inc. is committed to advancing RadioGel® toward human clinical trials in the U.S. with plans to submit the IDE by mid-2026. CEO Michael K. Korenko expressed optimism about the productive dialogue with the FDA, highlighting the company's preparedness to bring this innovative therapy to patients in need.
MWN-AI** Analysis
Vivos Inc. (OTCQB: RDGL) is making significant strides toward obtaining FDA Investigational Device Exemption (IDE) approval for its RadioGel® precision radionuclide therapy, a promising innovation in targeted cancer treatment. With its recent announcement, the company indicates robust progress that may enhance its market positioning, compelling potential investors to consider its stock.
The meticulous work Vivos has undertaken to address more than 40 FDA feedback comments demonstrates a commitment to regulatory compliance and efficacy. Engaging a top regulatory expert further bolsters investor confidence that the company is equipped to navigate the complex FDA landscape. This expert’s insights into successful IDE approvals for similar devices augment Vivos's submission strategy, suggesting a higher likelihood of a favorable outcome.
Vivos's emphasis on compiling comprehensive clinical and veterinary data as part of their submission process is particularly noteworthy. By leveraging existing outcomes from IsoPet®, the company provides tangible evidence regarding the safety and efficacy of RadioGel®, which not only enhances its therapeutic argument but also facilitates a broader understanding of its platform’s applications.
Furthermore, the informative data on equine ocular applications adds a unique layer to the potential market for RadioGel®; it highlights the versatility of their treatment method and opens avenues for veterinary markets alongside human applications. Targeting niches such as ocular squamous cell carcinoma further distinguishes Vivos in a competitive landscape.
As Vivos plans to submit its IDE by early April, investors should watch the stock closely. Success in gaining FDA approval could result in significant momentum for the company and its stock. However, potential investors should also remain cautious and aware of the inherent risks in clinical-stage biotech, reflected in the volatility usually associated with the sector. Given the favorable regulatory progress, Vivos Inc. may be worth considering for those looking for exposure in the innovative healthcare space.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Kennewick, WA, Feb. 10, 2026 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a medical device company pioneering Precision Radionuclide Therapy™ (PRnT™) with its innovative RadioGel® technology, today provided an update on its ongoing efforts to secure FDA Investigational Device Exemption (IDE) approval for human clinical trials of RadioGel® in advanced human therapy applications.
RadioGel® is a targeted radiation therapy designed to deliver precise, localized beta radiation to solid tumors via direct injection, minimizing exposure to surrounding healthy tissue and reducing systemic migration of the radiopharmaceutical agent.
Over the past several years, the Company has engaged extensively with the FDA, successfully addressing feedback from more than 40 individual reviewers—many comments stemming from frequent review team changes within the Agency. Vivos has provided comprehensive data and finalized the key technical parameters related to demonstrating precision delivery of RadioGel® to the treatment area and ensuring minimal exposure to non-target tissues.
In a key strategic move, Vivos has engaged one of the top regulatory experts in the field of brachytherapy and combination radiotherapy devices, with deep experience guiding such products through the FDA’s Center for Devices and Radiological Health (CDRH). This expert’s prior role at the FDA and proven track record of successful IDE approvals for Class III implantable radiation device, several reviewed by the same branch overseeing RadioGel®, have provided invaluable guidance.
With this expert’s analysis of FDA feedback patterns, the Company is bolstering its IDE submission by:
- Fully addressing all outstanding FDA concerns and adopting a submission format and structure proven effective by regulatory experts for similar devices.
- Incorporating additional information from clinical human data that has become available since the Company’s last IDE submission, further strengthening the evidence package.
- Reformatting and summarizing pre-clinical data in a manner that more directly and effectively addresses the remaining FDA concerns.
- Leveraging extensive veterinary clinical data from IsoPet® commercial use: Integrating comprehensive treatment outcomes from over 100 safely administered therapies across diverse tumor types and species, with zero reportable serious adverse events attributable to the product, to provide additional real-world safety and efficacy evidence supporting the Precision Radionuclide Therapy™ platform.
- Highlighting specialized equine ocular applications: Including detailed case data on successful treatments of ocular squamous cell carcinoma in horses (with injections near or into the cornea), showing no major side effects in adjacent critical structures, to further demonstrate the therapy's precision, minimal invasiveness, and favorable risk profile in challenging anatomical locations.
These enhancements maintain the intended use while maximizing the submission’s clarity, completeness, and alignment with Agency expectations. These recommendations required substantial effort to incorporate into our next submission.
Vivos remains fully committed to advancing RadioGel® toward human clinical trials in the United States and continues its strong collaborations for future indications for use. The Company has plans to submit the IDE by the end of the first quarter or in April.
“We are encouraged by the constructive dialogue with the FDA and the substantial progress we have made in fortifying our submission,” said Michael K. Korenko, CEO of Vivos Inc. “With guidance from one of the field’s leading regulatory experts, combined with our incorporation of newly available human clinical data and a refined presentation of pre-clinical information, we are strongly positioned to achieve IDE approval and bring this innovative therapy to patients in need.”
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
About Vivos Inc.
Vivos Inc. is a clinical-stage medical device company developing RadioGel®, a precision radiotherapy hydrogel for human and veterinary oncology applications. IsoPet® is commercially available for veterinary use in certified clinics nationwide.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated. These risks are detailed in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
FAQ**
What specific challenges does Vivos Inc. (RDGL) anticipate in securing FDA Investigational Device Exemption (IDE) approval for RadioGel®, and how might these impact their timeline for human clinical trials?
How does Vivos Inc. (RDGL) plan to leverage previously acquired human clinical data in their IDE submission to enhance the credibility of RadioGel®'s safety and efficacy profile?
What criteria were used by Vivos Inc. (RDGL) to select the regulatory expert for guiding their IDE submission, and how will this expertise influence the outcome of their application for RadioGel®?
In what ways could the successful development and approval of RadioGel® by Vivos Inc. (RDGL) potentially shape the future of precision radionuclide therapy in oncology treatments?
**MWN-AI FAQ is based on asking OpenAI questions about Vivos Inc (OTC: RDGL).
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