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庐 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庐 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庐.
Vivos Inc. (OTCQB: RDGL) ha annunciato che la FDA ha rifiutato l'approvazione della loro domanda di Investigational Device Exemption (IDE) per Radiogel庐 al termine del periodo di revisione di 30 giorni. L'azienda intende rispondere ai rilievi della FDA e avr脿 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庐 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庐.
Vivos Inc. (OTCQB: RDGL) anunci贸 que la FDA neg贸 la aprobaci贸n de su solicitud de Investigational Device Exemption (IDE) para Radiogel庐 tras el periodo de revisi贸n de 30 d铆as. La compa帽铆a planea atender los comentarios de la FDA y mantendr谩 una llamada inicial dentro de los 10 d铆as, seguida de una reuni贸n previa con el equipo revisor de la FDA para preparar la nueva presentaci贸n.
A pesar de este contratiempo, Radiogel庐 conserva la designaci贸n FDA Breakthrough Device y ha demostrado un s贸lido perfil de seguridad y una relaci贸n terap茅utica favorable. La compa帽铆a sigue comprometida con la b煤squeda de la aprobaci贸n en el mercado estadounidense para Radiogel庐.
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鞚措煬頃� 彀鞐愲弰 攵堦惮頃橁碃 Radiogel庐鞚� FDA 順侅嫚 鞚橂旮瓣赴(Breakthrough Device) 歆�鞝�鞚� 鞙犾頃橁碃 鞛堨溂氅�, 鞖办垬頃� 鞎堨爠靹� 頂勲頃勱臣 鞙犽Μ頃� 旃橂歆�靾橂ゼ 鞛呾頄堨姷雼堧嫟. 須岇偓電� Radiogel庐鞚� 氙戈淡 鞁滌灔 項堦皜毳� 瓿勳啀 於旍頃� 鞚橃毳� 鞙犾頃橁碃 鞛堨姷雼堧嫟.
Vivos Inc. (OTCQB: RDGL) a annonc茅 que la FDA a refus茅 d'approuver leur demande de Investigational Device Exemption (IDE) pour Radiogel庐 脿 l'issue de la p茅riode d'examen de 30 jours. La soci茅t茅 pr茅voit de r茅pondre aux remarques de la FDA et tiendra un premier appel dans les 10 jours, suivi d'une r茅union pr茅-submission avec l'茅quipe d'examen de la FDA pour pr茅parer une nouvelle soumission.
Malgr茅 ce contretemps, Radiogel庐 conserve sa d茅signation FDA Breakthrough Device et a d茅montr茅 un solide profil de s茅curit茅 et un rapport th茅rapeutique favorable. La soci茅t茅 demeure d茅termin茅e 脿 obtenir l'autorisation de mise sur le march茅 de Radiogel庐 aux 脡tats-Unis.
Vivos Inc. (OTCQB: RDGL) gab bekannt, dass die FDA nach Ablauf der 30-t盲gigen Pr眉fungsfrist die Genehmigung ihres Antrags auf eine Investigational Device Exemption (IDE) f眉r Radiogel庐 abgelehnt hat. Das Unternehmen plant, die R眉ckmeldungen der FDA aufzugreifen und wird innerhalb von 10 Tagen ein erstes Telefonat f眉hren, gefolgt von einem Pre-Submission-Meeting mit dem FDA-Review-Team zur Vorbereitung einer erneuten Einreichung.
Trotz dieses R眉ckschlags beh盲lt Radiogel庐 die FDA Breakthrough Device Designation und hat ein starkes Sicherheitsprofil sowie ein g眉nstiges therapeutisches Verh盲ltnis nachgewiesen. Das Unternehmen bleibt verpflichtet, die Zulassung von Radiogel庐 auf dem US-Markt weiter zu verfolgen.
- Radiogel庐 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庐 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庐 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庐 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庐 in the US market.
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email:
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
What was the FDA's decision on Vivos Inc's (RDGL) Radiogel庐 IDE application in August 2025?
What are the next steps for Vivos Inc (RDGL) after the FDA's IDE rejection?
Does Radiogel庐 still maintain its FDA Breakthrough Device Designation despite the IDE rejection?
When can Vivos Inc (RDGL) resubmit the Radiogel庐 IDE application?
