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 搁补诲颈辞骋别濒庐, 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. 搁补诲颈辞骋别濒庐 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 搁补诲颈辞骋别濒庐, 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 猫 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. 搁补诲颈辞骋别濒庐 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 Exenci贸n para Dispositivo en Investigaci贸n (IDE) a la FDA para 搁补诲颈辞骋别濒庐, su innovadora terapia radiactiva basada en hidrogel dise帽ada para el tratamiento dirigido de tumores. Esta presentaci贸n representa un avance crucial en su programa de Terapia de Radion煤clidos de Precisi贸nTM (PRnT).
La solicitud IDE se desarroll贸 mediante una extensa colaboraci贸n con la FDA bajo el proceso acelerado para Dispositivos Innovadores, respaldada por datos completos en animales y humanos. 搁补诲颈辞骋别濒庐 busca administrar radiaci贸n precisa a los tumores mientras protege el tejido sano circundante, abordando una necesidad m茅dica no satisfecha en el tratamiento del c谩ncer.
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IDE 鞁犾箔靹滊姅 順侅嫚 鞚橂旮瓣赴 鞁犾啀觳橂Μ 頂勲靹胳姢 頃橃棎 FDA鞕�鞚� 甏戨矓鞙勴暅 順戨牓鞚� 韱淀暣 臧滊皽霅橃棃鞙茧┌, 霃欕 氚� 鞚胳泊鞐� 雽�頃� 韽磩鞝侅澑 雿办澊韯半ゼ 氚旐儠鞙茧 頃╇媹雼�. 搁补诲颈辞骋别濒庐鞚� 欤茧硛 瓯搓皶 臁办鞚� 氤错樃頃橂┐靹� 膦呾枒鞐� 鞝曧檿頃� 氚╈偓靹犾潉 鞝勲嫭頃橃棳 鞎� 旃橂 攵勳暭鞐愳劀 於╈”霅橃 鞎婌潃 鞚橂鞝� 頃勳殧毳� 頃搓舶頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�.
Vivos Inc. (OTCQB : RDGL) a soumis une demande d'Exemption pour Dispositif d'Investigation (IDE) 脿 la FDA pour 搁补诲颈辞骋别濒庐, leur th茅rapie innovante 脿 base d'hydrogel radioactif con莽ue pour le traitement cibl茅 des tumeurs. Cette soumission marque une avanc茅e majeure dans leur programme de Th茅rapie par Radionucl茅ides de Pr茅cisionTM (PRnT).
La demande IDE a 茅t茅 茅labor茅e gr芒ce 脿 une collaboration 茅troite avec la FDA dans le cadre du processus acc茅l茅r茅 pour dispositifs innovants, soutenue par des donn茅es compl猫tes issues d'茅tudes animales et humaines. 搁补诲颈辞骋别濒庐 vise 脿 d茅livrer une radiation pr茅cise aux tumeurs tout en prot茅geant les tissus sains environnants, r茅pondant ainsi 脿 un besoin m茅dical non satisfait dans le traitement du cancer.
Vivos Inc. (OTCQB: RDGL) hat bei der FDA einen Antrag auf eine Investigational Device Exemption (IDE) f眉r 搁补诲颈辞骋别濒庐 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 gest眉tzt. 搁补诲颈辞骋别濒庐 soll pr盲zise Strahlung an Tumore abgeben und gleichzeitig das umliegende gesunde Gewebe sch眉tzen, 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庐, 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.鈥檚 mission to provide innovative cancer treatments.
RadioGel庐 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鈥檚 safety and promising efficacy. The Breakthrough Device designation expedites development for devices that address life-threatening conditions with unmet medical needs.
鈥淭his is our most comprehensive IDE submission to date, backed by both animal and human data and months of productive dialogue with the FDA,鈥� said Dr. Michael Korenko, CEO of Vivos Inc. 鈥淭he strong evidence of RadioGel鈥檚 safety and efficacy brings us closer to delivering a transformative therapy to cancer patients in need.鈥�
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email: 听
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel庐 and IsoPet庐 at
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 鈥渨ill,鈥� 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥渁nticipates,鈥� and 鈥渋ntends.鈥� 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.鈥檚 control. For a detailed discussion of these risks, refer to the company鈥檚 filings with the Securities and Exchange Commission.
FAQ
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