Vivos Inc. Submitted the Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Clinic
Vivos Inc. (OTCQB: RDGL) has submitted an Investigational Device Exemption (IDE) application to the FDA for RadioGel®, their innovative hydrogel-based radioactive therapy designed for targeted tumor treatment. The submission represents a crucial advancement in their Precision Radionuclide TherapyTM (PRnT) program.
The IDE application was developed through extensive collaboration with the FDA under the Breakthrough Device sprint process, supported by comprehensive animal and human data. RadioGel® aims to deliver precise radiation to tumors while protecting surrounding healthy tissue, addressing an unmet medical need in cancer treatment.
Vivos Inc. (OTCQB: RDGL) ha presentato una domanda di Esenzione per Dispositivo Sperimentale (IDE) alla FDA per RadioGel®, la loro innovativa terapia a base di idrogel radioattivo progettata per il trattamento mirato dei tumori. Questa presentazione rappresenta un passo fondamentale nel loro programma di Terapia di Radionuclidi di PrecisioneTM (PRnT).
La domanda IDE è stata sviluppata grazie a una stretta collaborazione con la FDA nell'ambito del processo sprint per Dispositivi Innovativi, supportata da dati completi su animali e esseri umani. RadioGel® mira a erogare radiazioni precise ai tumori proteggendo al contempo i tessuti sani circostanti, rispondendo a un bisogno medico insoddisfatto nel trattamento del cancro.
Vivos Inc. (OTCQB: RDGL) ha presentado una solicitud de Exención para Dispositivo en Investigación (IDE) a la FDA para RadioGel®, su innovadora terapia radiactiva basada en hidrogel diseñada para el tratamiento dirigido de tumores. Esta presentación representa un avance crucial en su programa de Terapia de Radionúclidos de PrecisiónTM (PRnT).
La solicitud IDE se desarrolló mediante una extensa colaboración con la FDA bajo el proceso acelerado para Dispositivos Innovadores, respaldada por datos completos en animales y humanos. RadioGel® busca administrar radiación precisa a los tumores mientras protege el tejido sano circundante, abordando una necesidad médica no satisfecha en el tratamiento del cáncer.
Vivos Inc. (OTCQB: RDGL)는 FDA에 혁신적인 하이드로겔 기반 방사선 치료제인 RadioGel®에 대한 임상시험용 의료기기 면제(IDE) 신청서를 제출했습니다. 이 제출은 그들의 정밀 방사성핵종 치료 프로그램(Precision Radionuclide TherapyTM, PRnT)에서 중요한 진전입니다.
IDE 신청서는 혁신 의료기기 신속처리 프로세스 하에 FDA와의 광범위한 협력을 통해 개발되었으며, 동물 및 인체에 대한 포괄적인 데이터를 바탕으로 합니다. RadioGel®은 주변 건강 조직을 보호하면서 종양에 정확한 방사선을 전달하여 암 치료 분야에서 충족되지 않은 의료적 필요를 해결하는 것을 목표로 합니다.
Vivos Inc. (OTCQB : RDGL) a soumis une demande d'Exemption pour Dispositif d'Investigation (IDE) à la FDA pour RadioGel®, leur thérapie innovante à base d'hydrogel radioactif conçue pour le traitement ciblé des tumeurs. Cette soumission marque une avancée majeure dans leur programme de Thérapie par Radionucléides de PrécisionTM (PRnT).
La demande IDE a été élaborée grâce à une collaboration étroite avec la FDA dans le cadre du processus accéléré pour dispositifs innovants, soutenue par des données complètes issues d'études animales et humaines. RadioGel® vise à délivrer une radiation précise aux tumeurs tout en protégeant les tissus sains environnants, répondant ainsi à un besoin médical non satisfait dans le traitement du cancer.
Vivos Inc. (OTCQB: RDGL) hat bei der FDA einen Antrag auf eine Investigational Device Exemption (IDE) für RadioGel® eingereicht, ihre innovative, auf Hydrogel basierende radioaktive Therapie zur gezielten Tumorbehandlung. Die Einreichung stellt einen wichtigen Fortschritt in ihrem Precision Radionuclide TherapyTM (PRnT)-Programm dar.
Der IDE-Antrag wurde in enger Zusammenarbeit mit der FDA im Rahmen des Breakthrough Device Sprint-Prozesses entwickelt und durch umfassende Tier- und Humanstudien gestützt. RadioGel® soll präzise Strahlung an Tumore abgeben und gleichzeitig das umliegende gesunde Gewebe schützen, um einen ungedeckten medizinischen Bedarf in der Krebsbehandlung zu adressieren.
- Breakthrough Device designation status expedites the development process
- IDE submission includes both animal and human data supporting safety and efficacy
- Close collaboration with FDA through Breakthrough Device sprint process enhances submission quality
- FDA approval is not guaranteed and review process may take considerable time
- Regulatory challenges and potential delays could impact development timeline
Kennewick, WA, July 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), a pioneer in Precision Radionuclide TherapyTM (PRnT) solutions, today announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for RadioGel®, a novel hydrogel-based radioactive therapy designed to deliver targeted radiation to solid tumors. This comprehensive submission, supported by extensive animal and human data, marks a significant milestone in Vivos Inc.’s mission to provide innovative cancer treatments.
RadioGel® is a novel medical device that enables precise radiation delivery to tumors, while minimizing damage to surrounding healthy tissue. The IDE application, developed through months of close collaboration with the FDA under the Breakthrough Device sprint process, addresses regulatory concerns with robust evidence of RadioGel’s safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs.
“This is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA,” said Dr. Michael Korenko, CEO of Vivos Inc. “The strong evidence of RadioGel’s safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need.”
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, identified by terms such as “will,” “expects,” “plans,” “anticipates,” and “intends.” These statements involve risks and uncertainties that may cause actual results to differ materially, including challenges in executing business strategies, economic conditions, competition, regulatory changes, delays in clinic certifications, and other factors beyond Vivos Inc.’s control. For a detailed discussion of these risks, refer to the company’s filings with the Securities and Exchange Commission.
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