Vivos Inc. Provides IDE Submission Status Update – Conversion to Pre-Sub Filing Accepted by the FDA
Vivos Inc. (OTCQB: RDGL) has provided an update on its IDE submission status for Radiogel®. The FDA has been reviewing the extensive material submitted within the 30-day statutory time limit. Due to time constraints, Vivos has converted the IDE submission (G240159) to a Pre-Sub filing (Q241925) with FDA consent. This strategic move allows for comprehensive addressing of FDA feedback and maintains open communication through quick review sessions.
The company expects to receive follow-up questions from the FDA this week to fully analyze the risk/benefit assessment of Radiogel®. Vivos is confident that 90-95% of required information has been provided and plans to resubmit the refined IDE application within 45 days. The company is collaborating with Mayo Clinic and aims to promptly submit a treatment plan to Mayo Clinic's Independent Review Board (IRB) after receiving FDA approval. The initial treatment target for Radiogel® will be solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.
Vivos Inc. (OTCQB: RDGL) ha fornito un aggiornamento sullo stato della sua richiesta IDE per Radiogel®. La FDA ha esaminato il vasto materiale presentato entro il termine di legge di 30 giorni. A causa di vincoli temporali, Vivos ha convertito la richiesta IDE (G240159) in una presentazione Pre-Sub (Q241925) con il consenso della FDA. Questa mossa strategica consente di affrontare in modo completo il feedback della FDA e mantiene una comunicazione aperta attraverso sessioni di revisione rapide.
La società si aspetta di ricevere domande di follow-up dalla FDA questa settimana per analizzare completamente la valutazione rischio/beneficio di Radiogel®. Vivos è fiduciosa che il 90-95% delle informazioni richieste sia stato fornito e prevede di reinviare la domanda IDE raffinata entro 45 giorni. L'azienda sta collaborando con il Mayo Clinic e mira a inviare prontamente un piano di trattamento al Comitato di Revisione Indipendente (IRB) del Mayo Clinic dopo aver ricevuto l'approvazione della FDA. Il target iniziale del trattamento per Radiogel® saranno i tumori solidi metastatici nei linfonodi associati al cancro della tiroide papillare.
Vivos Inc. (OTCQB: RDGL) ha proporcionado una actualización sobre el estado de su presentación IDE para Radiogel®. La FDA ha estado revisando el extenso material presentado dentro del plazo legal de 30 días. Debido a limitaciones de tiempo, Vivos ha convertido la presentación IDE (G240159) en una presentación Pre-Sub (Q241925) con el consentimiento de la FDA. Este movimiento estratégico permite abordar de manera integral los comentarios de la FDA y mantener una comunicación abierta a través de sesiones de revisión rápidas.
La empresa espera recibir preguntas de seguimiento de la FDA esta semana para analizar completamente la evaluación de riesgo/beneficio de Radiogel®. Vivos confía en que se ha proporcionado del 90 al 95% de la información requerida y planea volver a enviar la solicitud IDE refinada dentro de 45 días. La compañía está colaborando con Mayo Clinic y tiene como objetivo enviar rápidamente un plan de tratamiento a la Junta de Revisión Independiente (IRB) de la Mayo Clinic después de recibir la aprobación de la FDA. El objetivo inicial del tratamiento para Radiogel® serán los tumores metastaticos sólidos en los ganglios linfáticos asociados con el cáncer de tiroides papilar.
Vivos Inc. (OTCQB: RDGL)는 Radiogel®의 IDE 제출 상태에 대한 업데이트를 제공했습니다. FDA는 30일 법정 기한 내에 제출된 방대한 자료를 검토하고 있습니다. 시간 제약으로 인해 Vivos는 IDE 제출(G240159)을 FDA의 동의를 받아 Pre-Sub 제출(Q241925)으로 전환했습니다. 이 전략적 조치는 FDA 피드백을 종합적으로 다루고 빠른 검토 세션을 통해 원활한 소통을 유지할 수 있게 합니다.
회사는 FDA로부터 Radiogel®의 위험/이익 평가를 완전히 분석하기 위한 후속 질문을 이번 주에 받을 것으로 예상하고 있습니다. Vivos는 요구된 정보의 90-95%가 제공되었다고 확신하며 정제된 IDE 신청서를 45일 이내에 다시 제출할 계획입니다. 이 회사는 Mayo Clinic과 협력하고 있으며 FDA 승인을 받은 후 Mayo Clinic의 독립 검토 위원회(IRB)에 치료 계획을 신속하게 제출할 계획입니다. Radiogel®의 초기 치료 목표는 유두甲状腺암과 관련된 림프절의 고형 전이성 종양이 될 것입니다.
Vivos Inc. (OTCQB: RDGL) a fourni une mise à jour sur l'état de sa soumission IDE pour Radiogel®. La FDA a examiné le vaste matériel soumis dans le délai légal de 30 jours. En raison de contraintes de temps, Vivos a converti la soumission IDE (G240159) en un dépôt Pre-Sub (Q241925) avec le consentement de la FDA. Ce mouvement stratégique permet de traiter de manière exhaustive les retours de la FDA et maintient une communication ouverte à travers des sessions de révision rapides.
L'entreprise s'attend à recevoir des questions de suivi de la FDA cette semaine pour analyser pleinement l'évaluation risque/bénéfice de Radiogel®. Vivos est convaincue que 90 à 95 % des informations requises ont été fournies et prévoit de soumettre à nouveau la demande IDE affinée dans un délai de 45 jours. L'entreprise collabore avec la Mayo Clinic et vise à soumettre rapidement un plan de traitement au Comité de Révision Indépendant (IRB) de la Mayo Clinic après avoir obtenu l'approbation de la FDA. Le objectif initial du traitement pour Radiogel® sera de cibler les tumeurs solides métastatiques dans les ganglions lymphatiques associées au cancer de la thyroïde papillaire.
Vivos Inc. (OTCQB: RDGL) hat ein Update zu seinem IDE-Antrag für Radiogel® bereitgestellt. Die FDA hat das umfangreiche Material, das innerhalb der gesetzlich vorgeschriebenen Frist von 30 Tagen eingereicht wurde, überprüft. Aufgrund zeitlicher Einschränkungen hat Vivos den IDE-Antrag (G240159) mit Zustimmung der FDA in eine Pre-Sub-Einreichung (Q241925) umgewandelt. Dieser strategische Schritt ermöglicht eine umfassende Bearbeitung des Feedbacks der FDA und hält die Kommunikation durch schnelle Überprüfungssitzungen offen.
Das Unternehmen erwartet, in dieser Woche Folgefragen von der FDA zu erhalten, um die Risiko-Nutzen-Analyse von Radiogel® vollständig zu untersuchen. Vivos ist zuversichtlich, dass 90-95% der erforderlichen Informationen bereitgestellt wurden, und plant, den verfeinerten IDE-Antrag innerhalb von 45 Tagen erneut einzureichen. Das Unternehmen arbeitet mit der Mayo Clinic zusammen und beabsichtigt, nach Erhalt der FDA-Zulassung schnell einen Behandlungsplan an das unabhängige Überprüfungsgremium (IRB) der Mayo Clinic einzureichen. Das anfängliche Behandlungsziel für Radiogel® sind solide metastatische Tumoren in Lymphknoten, die mit papillärem Schilddrüsenkrebs in Verbindung stehen.
- Strategic conversion of IDE submission to Pre-Sub filing maintains open communication with FDA
- 90-95% of required information already provided to FDA
- Collaboration with Mayo Clinic for treatment plan submission
- Initial treatment target identified for Radiogel®: solid metastatic tumors in lymph nodes associated with papillary thyroid cancer
- IDE submission review not completed within 30-day statutory period
- Delay in FDA approval process due to conversion to Pre-Sub filing
- Additional 45 days needed for refined IDE application resubmission
Richland WA, July 29, 2024 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. Provides IDE Submission Status Update
The FDA has been working diligently to review the extensive amount of material that we provided in our IDE submission within the 30-day statutory time limit. We have been in regular communication with the FDA and provided responses to five sets of Interactive Review Requests. Based on our communication with the FDA on Friday, we concluded that there was not sufficient time for completion of the IDE review process within the 30-day statutory period. Therefore, with the consent of the FDA, Vivos has elected to convert the IDE submission (G240159) to a Pre-Sub filing (Q241925). This strategic decision allows us to address the FDA's feedback comprehensively and effectively, while maintaining open communication through quick review sessions made available to Vivos with the FDA.
Based on our current discussions with the FDA, this week we should receive follow-up questions to fully analyze the risk/benefit device assessment of Radiogel®. We are confident that thus far our submissions have provided 90
We have been in regular contact with our collaboration partners at the Mayo Clinic and are well positioned to promptly submit, following receipt of the IDE from the FDA, our treatment plan to Mayo Clinic’s Independent Review Board (IRB). As previously discussed, the initial treatment target with Mayo for Radiogel® will be treating solid metastatic tumors in lymph nodes associated with papillary thyroid cancer. We remain dedicated to achieving full compliance and are confident that we will demonstrate a compelling risk/benefit profile to the FDA.
Michael K. Korenko, Sc.D.
President & CEO Vivos Inc
Email: MKorenko@RadioGel.com
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About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. has developed an Yttrium-90-based injectable Precision Radionuclide Therapy™ medical device to treat tumors in animals (IsoPet®) and humans (RadioGel®). Using the company's proprietary hydrogel technology, PRnT™ uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers.
RadioGel® is a hydrogel liquid containing tiny yttrium-90 phosphate microparticles that may be administered directly into a tumor. The hydrogel is a yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
RadioGel® also has a short half-life – delivering more than
University veterinary hospitals use the IsoPet® Solutions division to demonstrate animal cancers' safety and therapeutic effectiveness. Testing on feline sarcoma at Washington State University was completed in 2018, and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019. The Company has obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling, which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices, so no additional approval was required to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.
IsoPet® for treating animals uses the same technology as RadioGel® for treating humans. The Food and Drug Administration advised using different product names to avoid confusion and cross-use.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners, and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.
FAQ
What is the current status of Vivos Inc's (RDGL) IDE submission for Radiogel®?
When does Vivos Inc. (RDGL) expect to resubmit the refined IDE application for Radiogel®?
What is the initial treatment target for Radiogel® in Vivos Inc's (RDGL) collaboration with Mayo Clinic?
How much of the required information has Vivos Inc. (RDGL) provided to the FDA for Radiogel®?
