Vivos Inc. Announces Launch of Groundbreaking RadioGel® Precision Radionuclide Therapy™ Human Clinical Trial
Vivos Inc. (OTCQB: RDGL) has launched its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. The trial has successfully treated five patients with cancerous lymph nodes in the neck, with imaging confirming precise treatment placement and patients recovering well without complications. The study has approval to expand to 30 patients targeting cancerous nodes throughout the body.
The trial aligns with Vivos' planned Mayo Clinic study protocol in the United States, and results will be shared with the FDA to support their Investigational Device Exemption submission. The company expects to complete the trial in the first half of 2025, with results to be published in a leading medical journal.
Vivos Inc. (OTCQB: RDGL) ha avviato il suo primo trial clinico umano per la terapia radionuclide con RadioGel® Precision Radionuclide Therapy™ in India. Il trial ha trattato con successo cinque pazienti con linfonodi cancerosi nel collo, con immagini che confermano la corretta localizzazione del trattamento e pazienti che si stanno riprendendo bene senza complicazioni. Lo studio ha ricevuto l'approvazione per espandersi a 30 pazienti targeting linfonodi cancerosi in tutto il corpo.
Il trial è in linea con il protocollo di studio previsto da Vivos presso il Mayo Clinic negli Stati Uniti, e i risultati saranno condivisi con la FDA per supportare la loro richiesta di esenzione per dispositivo investigativo. L'azienda prevede di completare il trial nella prima metà del 2025, con risultati che saranno pubblicati su una rivista medica di prestigio.
Vivos Inc. (OTCQB: RDGL) ha lanzado su primer ensayo clínico humano para la terapia radionucléido RadioGel® Precision Radionuclide Therapy™ en India. El ensayo ha tratado con éxito a cinco pacientes con ganglios linfáticos cancerosos en el cuello, confirmando la colocación precisa del tratamiento a través de imágenes y los pacientes se están recuperando bien sin complicaciones. El estudio tiene aprobación para expandirse a 30 pacientes que tienen ganglios cancerosos en todo el cuerpo.
El ensayo está alineado con el protocolo de estudio planeado por Vivos en la Clínica Mayo en los Estados Unidos, y los resultados serán compartidos con la FDA para apoyar su solicitud de exención para dispositivos en investigación. La empresa espera completar el ensayo en la primera mitad de 2025, con resultados que serán publicados en una revista médica líder.
Vivos Inc. (OTCQB: RDGL)가 인도에서 RadioGel® 정밀 방사성 동위원소 치료™에 대한 첫 번째 인간 임상 시험을 시작했습니다. 이 시험은 목의 암성 림프절을 가진 다섯 환자를 성공적으로 치료했으며, 이미지는 정확한 치료 위치를 확인하고 환자들은 합병증 없이 잘 회복되고 있습니다. 이 연구는 신체 전반의 암성 림프절을 대상으로 하는 30명의 환자로 확대할 수 있도록 승인받았습니다.
이 시험은 미국의 Mayo Clinic에서 Vivos의 연구 프로토콜과 일치하며, 결과는 FDA의 조사 장치 면제 제출을 지원하기 위해 공유될 것입니다. 이 회사는 2025년 상반기 내에 시험을 완료할 것으로 예상하며, 결과는 저명한 의학 저널에 발표될 수 있습니다.
Vivos Inc. (OTCQB: RDGL) a lancé son premier essai clinique humain pour la thérapie par radionucléides RadioGel® Precision Radionuclide Therapy™ en Inde. L'essai a traité avec succès cinq patients présentant des ganglions lymphatiques cancéreux dans le cou, les images confirmant le placement précis du traitement et les patients récupérant bien sans complications. L'étude a obtenu l'autorisation de s'étendre à 30 patients ciblant des ganglions cancéreux dans tout le corps.
L'essai est en accord avec le protocole d'étude prévu par Vivos à la Mayo Clinic aux États-Unis, et les résultats seront partagés avec la FDA pour soutenir leur demande d'exemption pour dispositif d'investigation. L'entreprise s'attend à compléter l'essai au premier semestre 2025, les résultats devant être publiés dans une revue médicale de premier plan.
Vivos Inc. (OTCQB: RDGL) hat seine erste klinische Studie am Menschen für die RadioGel® Präzisions-Radionuklid-Therapie™ in Indien gestartet. Die Studie hat fünf Patienten mit bösartigen Lymphknoten im Nacken erfolgreich behandelt, wobei Bildgebungsverfahren die präzise Platzierung der Behandlung bestätigten und die Patienten ohne Komplikationen gut genesen. Die Studie hat die Genehmigung erhalten, auf 30 Patienten zu erweitern, die bösartige Lymphknoten im ganzen Körper aufweisen.
Die Studie steht im Einklang mit dem geplanten Studienprotokoll von Vivos an der Mayo-Klinik in den Vereinigten Staaten, und die Ergebnisse werden der FDA zur Unterstützung ihres Antrags auf Genehmigung von Untersuchungsgeräten zur Verfügung gestellt. Das Unternehmen erwartet, die Studie in der ersten Hälfte des Jahres 2025 abzuschließen, und die Ergebnisse sollen in einer führenden medizinischen Zeitschrift veröffentlicht werden.
- Successfully initiated first human clinical trial with positive initial results in 5 patients
- Received regulatory approval to expand trial to 30 patients
- Secured all necessary regulatory clearances in India
- Established dual-track strategy for both US and international markets
- FDA approval for US trials still pending
- Results and efficacy data not yet available
- Complete trial results won't be available until H1 2025
Richland, WA, Dec. 23, 2024 (GLOBE NEWSWIRE) -- – Vivos Inc. (OTCQB: RDGL) proudly announces the initiation of its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. This milestone trial, which has commenced with the successful treatment of five patients with cancerous lymph nodes, represents a transformative step in advancing innovative cancer therapies.
This initial trial in India closely aligns with the protocol designed for Vivos’ planned study at the Mayo Clinic in the United States. In the initial phase, five patients with cancerous nodes in the neck have been successfully treated, with a primary focus on demonstrating the therapy’s safety. Imaging has confirmed precise placement of the RadioGel® treatment, and the patients are currently recovering well without complications.
Vivos continues active discussions with the FDA to initiate human clinical trials at the Mayo Clinic. These trial results will be shared with the U.S. Food and Drug Administration (FDA) to reinforce RadioGel®’s safety profile, support Vivos’ Investigational Device Exemption (IDE) submission, and advance expanded indications for use in the United States. The company’s dual-track international strategy is accelerating the global introduction of this cutting-edge cancer therapy.
The study has received regulatory approval to expand to 30 patients, targeting cancerous nodes throughout the body, enabling broader therapeutic applications. Upon anticipated completion of this trial in the first half of 2025, the trial’s comprehensive data will be submitted for publication in a leading medical journal under the guidance of the lead investigator.
Key Milestones Enabling the Clinical Trial in India
The successful launch of this clinical trial reflects the dedication, expertise, and strategic planning of the Vivos team. Key achievements include:
- Regulatory Approvals: Secured clearances from the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, and was issued the Clinical Trial Registry-India (CTRI) number required for publishing results.
- Logistical Coordination: Acquired liability insurance, expanded the treatment institution’s radioactive material license to include RadioGel®, and established robust international shipping protocols and an alternate contingency shipping path for the Yttrium-90 (Y-90)-based product.
- Protocol Development: Finalized the Clinical Trial Protocol, incorporating Mayo Clinic study designs and feedback from FDA pre-submission discussions.
- Operational Readiness: Re-validated RadioGel® manufacturing at IsoTherapeutics to ensure compliance with Quality Management System standards and FDA sterility and validation recommendations.
- Administrative Preparations: Signed agreements with the Ethics Committee and treatment institution while confirming trademark and patent protections in the region.
- Training and Certification: Conducted comprehensive certification training for the treatment team.
Statement from Vivos CEO, Dr. Michael Korenko
“At Vivos, our policy is to communicate results—not just promises. The initiation of this clinical trial marks an historic moment in the evolution of cancer treatment. It is the result of meticulous preparation, strategic execution, and our unwavering commitment to innovation.
We are making history by advancing RadioGel® Precision Radionuclide Therapy™ into its first human trials. This trial represents not just a milestone for Vivos, but a pivotal moment for the entire field of oncology. We eagerly anticipate sharing preliminary results soon and comprehensive findings upon trial completion”
For more information as it develops, please visit www.vivosinc.com or contact us at info@vivosinc.com
Michael K. Korenko, Sc.D.
President & CEO Vivos Inc
Email: MKorenko@RadioGel.com
Follow Vivos Inc @VivosIncUSA, Radiogel® and Isopet® on X (Twitter):
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.
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