Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D., J.D., to Support IDE Submission for RadioGel®
Vivos Inc (OTCQB: RDGL) announced on October 27, 2025 that it retained Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as lead regulatory advisors to support its FDA Investigational Device Exemption (IDE) submission for RadioGel®. The company said Dr. Smith has direct experience with the FDA Division reviewing radiological devices and will help address remaining IDE deficiencies.
RadioGel® is described as an injectable, high‑dose, localized radiation device intended for tumors. Securing IDE approval is stated as a critical step toward initiating U.S. clinical trials at the Mayo Clinic. RadioGel® is not yet authorized for pre‑market use.
Vivos Inc (OTCQB: RDGL) ha annunciato il 27 ottobre 2025 di aver incaricato il Dott. John J. Smith, M.D., J.D., e il suo team di Hogan Lovells come principali consulenti regolatori per supportare la sua presentazione per l'Esenzione di Dispositivo Sperimentale (IDE) presso RadioGel®. L'azienda ha affermato che il Dott. Smith ha un'esperienza diretta con la divisione della FDA che revisiona dispositivi radiologici e che contribuirà a risolvere le carenze IDE residue.
RadioGel® è descritto come un dispositivo di radioterapia localizzata, ad alto dosaggio, somministrabile per via iniettiva, destinato a tumori. L'ottenimento dell'approvazione IDE è indicato come un passo critico per avviare i trial clinici negli Stati Uniti presso la Mayo Clinic. RadioGel® non è ancora autorizzato per l'uso pre-market.
Vivos Inc (OTCQB: RDGL) anunció el 27 de octubre de 2025 que contrató al Dr. John J. Smith, M.D., J.D., y a su equipo en Hogan Lovells como asesores regulatorios principales para apoyar su presentación de Exención de Dispositivo Experimental (IDE) ante RadioGel®. La empresa indicó que el Dr. Smith tiene experiencia directa con la división de la FDA que revisa dispositivos radiológicos y que ayudará a abordar las deficiencias de IDE restantes.
RadioGel® se describe como un dispositivo de radiación localizado, inyectable, de alta dosis, destinado a tumores. Se considera que obtener la aprobación IDE es un paso crítico para iniciar ensayos clínicos en EE. UU. en la Mayo Clinic. RadioGel® aún no está autorizado para uso precomercial.
Vivos Inc (OTCQB: RDGL)는 2025년 10월 27일에 RadioGel®의 FDA 연구용 의료기기 면제(IDE) 제출을 지원하기 위해 Hogan Lovells의 Dr. John J. Smith, M.D., J.D., 및 그의 팀을 규제 고문으로 선임했다고 발표했습니다. 회사는 Smith 박사가 방사선 장치를 검토하는 FDA 부서와 직접적인 경험이 있으며 남아 있는 IDE 결점들을 해결하는 데 도움을 줄 것이라고 말했습니다.
RadioGel®은 종양을 위한 고용량의 국소 방사선 치료용 주사형 기기로 설명됩니다. IDE 승인을 확보하는 것이 Mayo Clinic에서 미국 임상 시험을 시작하는 중요한 단계로 여겨집니다. RadioGel®은 아직 시판 전 사용이 허가되지 않았습니다.
Vivos Inc (OTCQB: RDGL) a annoncé le 27 octobre 2025 avoir retenu le Dr John J. Smith, M.D., J.D., et son équipe chez Hogan Lovells comme principaux conseillers réglementaires pour soutenir sa dépôt de l'Exemption de Dispositif Expérimental (IDE) pour RadioGel®. La société a déclaré que le Dr Smith a une expérience directe avec la division de la FDA qui évalue les dispositifs radiologiques et qu'il aidera à remédier aux déficiences IDE restantes.
RadioGel® est décrit comme un dispositif d'irradiation localisée injectable, à dose élevée, destiné aux tumeurs. L'obtention de l'approbation IDE est présentée comme une étape cruciale pour démarrer les essais cliniques américains à la Mayo Clinic. RadioGel® n'est pas encore autorisé à des fins pré-commercialisation.
Vivos Inc (OTCQB: RDGL) gab am 27. Oktober 2025 bekannt, dass es Dr. John J. Smith, M.D., J.D., und sein Team von Hogan Lovells als führende regulatorische Berater gewonnen hat, um seine FDA Investigational Device Exemption (IDE)-Einreichung für RadioGel® zu unterstützen. Das Unternehmen sagte, Dr. Smith habe direkte Erfahrung mit der FDA-Abteilung, die radiologische Geräte prüft, und werde helfen, verbleibende IDE-Mängel zu beheben.
RadioGel® wird als injizierbares, hochdosiertes, lokales Strahlen-Device beschrieben, das für Tumore bestimmt ist. Die Sicherung der IDE-Zulassung wird als entscheidender Schritt zur Einleitung von US-Klinikstudien an der Mayo Clinic bezeichnet. RadioGel® ist noch nicht für den Vor- marktzugang freigegeben.
Vivos Inc (OTCQB: RDGL) أعلنت في 27 أكتوبر 2025 أنها احتفظت بالدكتور جون ج. سميث، دكتور في الطب، ومحامٍ، وفريقه في Hogan Lovells كمستشارين تنظيميين رئيسيين لدعم تقديم استثناء الجهاز التجريبي (IDE) الخاص بـ RadioGel®.
تم وصف RadioGel® بأنه جهاز إشعاعي موضعي قابل للحقن بجرعة عالية مخصص للأورام. وقالت الشركة إن الحصول على موافقة IDE يعتبر خطوة حاسمة لبدء التجارب السريرية الأمريكية في Mayo Clinic. RadioGel® لم يتم اعتماده حتى الآن للاستخدام قبل التسويق.
Vivos Inc (OTCQB: RDGL) 于 2025年10月27日 宣布已聘请 Dr. John J. Smith, M.D., J.D., 及其在 Hogan Lovells 的团队担任主要法规顾问，以支持其对 RadioGel® 的 FDA 药物/设备研究豁免（IDE） 提交。公司表示 Smith 博士在FDA负责审核放射性设备的部门有直接经验，将有助于解决剩余的 IDE 缺陷。
RadioGel® 被描述为一种可注射的高剂量局部放射治疗装置，用于肿瘤。获得 IDE 批准被视为在 Mayo Clinic 启动美国临床试验的关键步骤。RadioGel® 尚未获准用于市场前使用。
- Retained experienced FDA regulatory lead (Dr. John J. Smith)
- Advisors familiar with RadioGel® and FDA review panel
- Move intended to address remaining IDE deficiencies
- RadioGel® is not authorized for pre‑market use
- IDE submission currently has remaining deficiencies
Richland, WA, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) announced today that they have appointed Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as the company’s lead regulatory advisors for its FDA Investigational Device Exemption (IDE) submission for RadioGel®.
Dr. Smith, a board-certified diagnostic radiologist and former associate professor at Harvard Medical School, is widely recognized as one of the nation’s leading FDA regulatory consultants in the medical device sector. He is currently a partner in the Global Regulatory group at Hogan Lovells, based in Washington, D.C.
“We are excited to re-engage Dr. Smith—someone we have worked with before and who is very familiar RadioGel®, said Dr. Michael Korenko, CEO of Vivos Inc. He brings not only unmatched expertise but current, first-hand experience with the FDA’s Division of Radiological Imaging and Radiation Therapy Devices review panel where we are working through the remaining deficiencies in our IDE submission. Bringing Dr. Smith and his team on-board positions us to move forward with confidence and clarity.”
Vivos’ RadioGel® is a groundbreaking injectable device designed to deliver a high-dose, localized, targeted radiation safely and effectively to tumors. Securing IDE approval remains a critical step toward initiating U.S. clinical trials at the Mayo Clinic. RadioGel® is not yet authorized for pre-market use.
Mike Korenko, ScD
CEO Vivos Inc
Contact:
Investor Relations
Vivos Inc.
Email: info@vivosinc.com
Website: 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.
FAQ
Who did Vivos (RDGL) retain to support the RadioGel IDE submission?
What is the goal of hiring Dr. John J. Smith for RDGL's RadioGel program?
Does RadioGel (RDGL) have FDA pre‑market authorization as of October 27, 2025?
What is the next clinical milestone mentioned for RDGL's RadioGel?
What expertise does Vivos say Dr. Smith brings to the RDGL RadioGel IDE work?
