Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA
Vivos Inc. (OTCQB: RDGL) announced that the FDA has declined approval of their Radiogel® Investigational Device Exemption (IDE) submission following the 30-day review period. The company plans to address the FDA's feedback and will have an initial call within 10 days, followed by a pre-sub meeting with the FDA review team to prepare for resubmission.
Despite this setback, Radiogel® maintains its FDA Breakthrough Device Designation and has demonstrated strong safety profile and therapeutic ratio. The company remains committed to pursuing US market approval for Radiogel®.
Vivos Inc. (OTCQB: RDGL) ha annunciato che la FDA ha rifiutato l'approvazione della loro domanda di Investigational Device Exemption (IDE) per Radiogel® al termine del periodo di revisione di 30 giorni. L'azienda intende rispondere ai rilievi della FDA e avrà una chiamata iniziale entro 10 giorni, seguita da un incontro pre-submission con il team di revisione della FDA per preparare la nuova presentazione.
Nonostante questo contrattempo, Radiogel® mantiene la designazione FDA Breakthrough Device e ha dimostrato un solido profilo di sicurezza e un favorevole rapporto terapeutico. L'azienda rimane impegnata a ottenere l'approvazione per il mercato statunitense di Radiogel®.
Vivos Inc. (OTCQB: RDGL) anunció que la FDA negó la aprobación de su solicitud de Investigational Device Exemption (IDE) para Radiogel® tras el periodo de revisión de 30 días. La compañía planea atender los comentarios de la FDA y mantendrá una llamada inicial dentro de los 10 días, seguida de una reunión previa con el equipo revisor de la FDA para preparar la nueva presentación.
A pesar de este contratiempo, Radiogel® conserva la designación FDA Breakthrough Device y ha demostrado un sólido perfil de seguridad y una relación terapéutica favorable. La compañía sigue comprometida con la búsqueda de la aprobación en el mercado estadounidense para Radiogel®.
Vivos Inc. (OTCQB: RDGL)는 30일 심사 기간 종료 후 FDA가 자사의 Radiogel®에 대한 Investigational Device Exemption(IDE) 신청을 승인하지 않았다고 발표했습니다. 회사는 FDA의 피드백을 반영할 계획이며, 10일 이내에 초기 통화를 갖고 재제출 준비를 위해 FDA 심사팀과 사전 회의를 진행할 예정입니다.
이러한 차질에도 불구하고 Radiogel®은 FDA 혁신 의료기기(Breakthrough Device) 지정을 유지하고 있으며, 우수한 안전성 프로필과 유리한 치료지수를 입증했습니다. 회사는 Radiogel®의 미국 시장 허가를 계속 추진할 의지를 유지하고 있습니다.
Vivos Inc. (OTCQB: RDGL) a annoncé que la FDA a refusé d'approuver leur demande de Investigational Device Exemption (IDE) pour Radiogel® à l'issue de la période d'examen de 30 jours. La société prévoit de répondre aux remarques de la FDA et tiendra un premier appel dans les 10 jours, suivi d'une réunion pré-submission avec l'équipe d'examen de la FDA pour préparer une nouvelle soumission.
Malgré ce contretemps, Radiogel® conserve sa désignation FDA Breakthrough Device et a démontré un solide profil de sécurité et un rapport thérapeutique favorable. La société demeure déterminée à obtenir l'autorisation de mise sur le marché de Radiogel® aux États-Unis.
Vivos Inc. (OTCQB: RDGL) gab bekannt, dass die FDA nach Ablauf der 30-tägigen Prüfungsfrist die Genehmigung ihres Antrags auf eine Investigational Device Exemption (IDE) für Radiogel® abgelehnt hat. Das Unternehmen plant, die Rückmeldungen der FDA aufzugreifen und wird innerhalb von 10 Tagen ein erstes Telefonat führen, gefolgt von einem Pre-Submission-Meeting mit dem FDA-Review-Team zur Vorbereitung einer erneuten Einreichung.
Trotz dieses Rückschlags behält Radiogel® die FDA Breakthrough Device Designation und hat ein starkes Sicherheitsprofil sowie ein günstiges therapeutisches Verhältnis nachgewiesen. Das Unternehmen bleibt verpflichtet, die Zulassung von Radiogel® auf dem US-Markt weiter zu verfolgen.
- Radiogel® maintains FDA Breakthrough Device Designation status
- Product has demonstrated strong safety profile and therapeutic ratio
- Company has opportunity for FDA discussion within 10 days
- FDA declined approval of Radiogel® IDE submission
- Delay in clinical trial timeline due to required resubmission
- Additional regulatory hurdles before potential approval
Kennewick, WA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) Following the 30-day review period, the FDA declined approval of the Radiogel® IDE submission.
We are now focused on addressing the items we received in the FDA letter and will have an initial call with the FDA within 10 days as provided in the FDA correspondence. We also intend to participate in a pre-sub meeting with the FDA review team in the coming weeks, with the goal of resubmitting the application for the IDE. Radiogel® received the FDA Breakthrough Device Designation and has demonstrated an unparalleled therapeutic ratio and strong safety profile. Vivos remains committed to pursuing approval for Radiogel® in the US market.
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.
FAQ
What was the FDA's decision on Vivos Inc's (RDGL) Radiogel® IDE application in August 2025?
What are the next steps for Vivos Inc (RDGL) after the FDA's IDE rejection?
Does Radiogel® still maintain its FDA Breakthrough Device Designation despite the IDE rejection?
When can Vivos Inc (RDGL) resubmit the Radiogel® IDE application?
