Vivos Inc. Reports Continued Progress in India Human Clinical Trial for RadioGel® Precision Radionuclide Therapy™
Vivos Inc. (OTCQB: RDGL) has reported significant progress in its India human clinical trial for RadioGel® Precision Radionuclide Therapy™, an FDA-designated Breakthrough Device for solid tumor treatment. The trial has successfully treated ten patients with cancerous nodes, demonstrating both safety and early efficacy signals.
Key highlights include:
- All patients met primary safety endpoints with precise Yttrium-90 isotope retention
- No adverse events or complications reported
- Successful treatment of high-risk tumors near trachea and carotid artery
- Trial approval expanded to treat up to 30 patients, with plans to request increase to 50 patients
The company plans to submit an IDE to FDA within 90 days and is establishing operations in India, including a corporate office and manufacturing facility. The Indian cancer treatment market, valued at USD 4.21 billion in 2023, is projected to reach USD 5.89 billion by 2030, representing a significant opportunity for RadioGel®.
Vivos Inc. (OTCQB: RDGL) ha riportato progressi significativi nel suo trial clinico umano in India per RadioGel® Precision Radionuclide Therapy™, un dispositivo designato dall'FDA come Breakthrough Device per il trattamento dei tumori solidi. Lo studio ha trattato con successo dieci pazienti con noduli cancerosi, dimostrando sia la sicurezza che segnali di efficacia precoce.
Punti chiave includono:
- Tutti i pazienti hanno raggiunto gli endpoint di sicurezza primari con un preciso mantenimento dell'isotopo Yttrio-90
- Non sono stati segnalati eventi avversi o complicazioni
- Trattamento riuscito di tumori ad alto rischio vicino alla trachea e all'arteria carotidea
- L'approvazione del trial è stata estesa per trattare fino a 30 pazienti, con piani per richiedere un aumento a 50 pazienti
L'azienda prevede di presentare una richiesta IDE alla FDA entro 90 giorni e sta avviando operazioni in India, includendo un ufficio aziendale e uno stabilimento produttivo. Il mercato indiano per il trattamento del cancro, valutato a 4,21 miliardi di USD nel 2023, è previsto raggiungere 5,89 miliardi di USD entro il 2030, rappresentando un'opportunità significativa per RadioGel®.
Vivos Inc. (OTCQB: RDGL) ha informado de avances significativos en su ensayo clínico humano en India para RadioGel® Precision Radionuclide Therapy™, un dispositivo designado por la FDA como Breakthrough Device para el tratamiento de tumores sólidos. El ensayo ha tratado con éxito a diez pacientes con nódulos cancerosos, demostrando tanto seguridad como señales tempranas de eficacia.
Aspectos destacados incluyen:
- Todos los pacientes cumplieron los criterios de seguridad primarios con una retención precisa del isótopo Ytrio-90
- No se reportaron eventos adversos ni complicaciones
- Tratamiento exitoso de tumores de alto riesgo cerca de la tráquea y la arteria carótida
- Se amplió la aprobación del ensayo para tratar hasta 30 pacientes, con planes para solicitar un aumento a 50 pacientes
La compañía planea presentar una solicitud IDE a la FDA dentro de 90 días y está estableciendo operaciones en India, incluyendo una oficina corporativa y una planta de fabricación. El mercado indio de tratamiento del cáncer, valorado en 4.21 mil millones de USD en 2023, se proyecta alcanzar 5.89 mil millones de USD para 2030, representando una oportunidad significativa para RadioGel®.
Vivos Inc. (OTCQB: RDGL)는 고형 종양 치료를 위한 FDA 지정 혁신 기기인 RadioGel® Precision Radionuclide Therapy™의 인도 인체 임상 시험에서 중요한 진전을 보고했습니다. 이번 임상 시험에서는 암 결절이 있는 10명의 환자를 성공적으로 치료하여 안전성과 초기 효능 신호를 모두 입증했습니다.
주요 내용은 다음과 같습니다:
- 모든 환자가 Yttrium-90 동위원소의 정확한 유지와 함께 1차 안전성 목표를 충족
- 부작용이나 합병증 보고 없음
- 기관과 경동맥 근처의 고위험 종양 성공적 치료
- 임상 시험 승인 범위가 최대 30명으로 확대되었으며, 50명으로 추가 확대 요청 계획
회사는 90일 이내에 FDA에 IDE 신청서를 제출할 계획이며, 인도에 법인 사무실과 제조 시설을 포함한 운영 기반을 구축하고 있습니다. 2023년 42억 1천만 달러 규모인 인도 암 치료 시장은 2030년까지 58억 9천만 달러에 이를 것으로 예상되며, RadioGel®에 큰 기회를 제공합니다.
Vivos Inc. (OTCQB : RDGL) a annoncé des progrès significatifs dans son essai clinique humain en Inde pour RadioGel® Precision Radionuclide Therapy™, un dispositif désigné par la FDA comme Breakthrough Device pour le traitement des tumeurs solides. L’essai a traité avec succès dix patients présentant des nodules cancéreux, démontrant à la fois la sécurité et des signes précoces d’efficacité.
Points clés :
- Tous les patients ont atteint les critères de sécurité principaux avec une rétention précise de l’isotope Yttrium-90
- Aucun événement indésirable ni complication rapporté
- Traitement réussi de tumeurs à haut risque proches de la trachée et de l’artère carotide
- Extension de l’approbation de l’essai pour traiter jusqu’à 30 patients, avec des plans pour demander une augmentation à 50 patients
L’entreprise prévoit de soumettre une demande IDE à la FDA dans les 90 jours et établit ses opérations en Inde, incluant un bureau corporate et une unité de fabrication. Le marché indien du traitement du cancer, évalué à 4,21 milliards USD en 2023, devrait atteindre 5,89 milliards USD d’ici 2030, représentant une opportunité importante pour RadioGel®.
Vivos Inc. (OTCQB: RDGL) hat bedeutende Fortschritte in seiner klinischen Humanstudie in Indien für RadioGel® Precision Radionuclide Therapy™, ein von der FDA als Breakthrough Device für die Behandlung solider Tumore eingestuftes Gerät, gemeldet. Die Studie hat erfolgreich zehn Patienten mit krebsartigen Knoten behandelt und dabei sowohl Sicherheit als auch erste Wirksamkeitssignale gezeigt.
Wichtige Highlights umfassen:
- Alle Patienten erreichten die primären Sicherheitsendpunkte mit präziser Retention des Isotops Yttrium-90
- Keine unerwünschten Ereignisse oder Komplikationen gemeldet
- Erfolgreiche Behandlung von Hochrisikotumoren nahe der Luftröhre und der Halsschlagader
- Studiengenehmigung wurde erweitert, um bis zu 30 Patienten zu behandeln, mit Plänen, die Zahl auf 50 zu erhöhen
Das Unternehmen plant, innerhalb von 90 Tagen einen IDE-Antrag bei der FDA einzureichen und baut seine Aktivitäten in Indien auf, einschließlich eines Firmensitzes und einer Produktionsstätte. Der indische Markt für Krebstherapie, der 2023 auf 4,21 Milliarden USD geschätzt wurde, soll bis 2030 auf 5,89 Milliarden USD wachsen und bietet somit eine bedeutende Chance für RadioGel®.
- Successful safety results in 10 patients with no adverse events
- Effective treatment of high-risk tumors near critical organs
- FDA Breakthrough Device designation
- Planned expansion of trial from 30 to 50 patients
- Strategic expansion into $4.21B Indian market
- Regulatory uncertainty with new FDA administration
- Timeline dependencies on regulatory approvals
- No commercial revenue generation yet
Kennewick, WA, April 15, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) is pleased to share new developments in its ongoing human clinical trial in India for RadioGel® Precision Radionuclide Therapy™, an FDA-designated Breakthrough Device for the treatment of solid tumors. The latest results highlight both technical progress and growing clinical validation.
This update builds upon the initial results released in February 2025, which confirmed the safety of RadioGel® in the first five patients. As of this report, ten patients with cancerous nodes have now been successfully treated, further establishing a strong safety profile while generating promising early evidence of efficacy.
Clinical Milestones: Safety, Precision, and Innovation
Every patient in the trial has met the primary safety endpoint, confirmed through PET imaging showing precise retention of the therapeutic Yttrium-90 isotope at the injection site—with no observed adverse events. Patients continue to recover well with no complications, monitored under disciplined clinical follow-up protocols.
Importantly, two of the ten patients presented with tumors in direct contact with the trachea and carotid artery, anatomical regions often considered inoperable or high-risk for radiation damage. Yet, RadioGel® achieved successful treatment without injuring adjacent critical tissues, underscoring the therapy’s high Therapeutic Ratio and the core rationale behind the FDA’s Breakthrough Device designation.
These outcomes affirm the unique advantage of RadioGel®: internal, highly localized beta radiation delivered directly within the tumor, sparing healthy tissue and enabling outpatient treatment with minimal post-procedure restrictions.
Ongoing Innovation and Technical Exchange with U.S. Investigators
Led by a highly experienced principal investigator in India, the clinical team has introduced new technical refinements to the treatment methodology, including deep-needle injection techniques, precision image guidance, and the use of saline spacers to enhance dose control and organ protection. These protocol advancements are being actively reviewed in discussions with Mayo Clinic investigators who are preparing for a parallel clinical study in the United States.
The study in India, has been approved to treat 30 patients. A formal request is being prepared for the Ethics Committee to approve up to 50 patients, enabling evaluation of RadioGel® in a broader range of tumor types, including those located deeper in the body such as lung and pancreatic cancers.
Strategic Presence in India and Global Pathway
Vivos is concurrently laying the groundwork for a permanent operational footprint in India, including plans to open a corporate office and to establish a regional manufacturing facility for yttrium phosphate microparticles. This infrastructure will support the clinical rollout and eventual commercial availability of RadioGel® in India—serving as a strategic hub for future global expansion.
The results of the India trial, including comprehensive clinical and imaging data, will be submitted for peer-reviewed publication later this year. This milestone is expected to significantly enhance the therapy’s visibility among physicians and oncologists and support regulatory submissions globally.
Regulatory Engagement and Market Entry Strategy
Building on the FDA “Breakthrough Device” status of Radiogel® Precision Radionuclide Therapy™, Vivos is sharing preliminary India trial data directly with the FDA to support the company’s goal to submit an Investigational Device Exemption (IDE) within the next 90 days
While the company is encouraged by its regulatory progress, it also acknowledges the inherent unpredictability of the U.S. regulatory environment, particularly amid shifting priorities and evolving review protocols under the new FDA administration. As such, Vivos continues to pursue a multi-track global strategy to ensure momentum regardless of domestic regulatory timing. Importantly, the clinical and commercial potential for RadioGel® outside the U.S. is significant, particularly in regions with streamlined regulatory pathways and increasing demand for innovative, minimally invasive cancer therapies. Vivos views its expanding presence in India not only as a foundation for local commercialization, but also as a strategic hub for broader international adoption—especially in markets where the burden of solid tumors remains high and treatment innovation is urgently needed.
The cancer treatment market in India presents a significant and growing opportunity for innovative therapies like RadioGel®. In 2023, the market was valued at approximately USD 4.21 billion and is projected to reach USD 5.89 billion by 2030. Given the substantial size and growth of the Indian cancer treatment market, progress and adoption of RadioGel® in international markets like India present a substantial opportunity to enhance long-term shareholder value. By establishing a presence in these expanding markets, Vivos can diversify its revenue streams and accelerate the global recognition of Radiogel® as a globally relevant oncology solution.
CEO Statement
Dr. Michael Korenko, President and CEO of Vivos Inc., stated:
“With every patient treated, the value of RadioGel® becomes more evident. We are witnessing precise, safe, and promising therapy outcomes in tumors that traditionally pose high treatment risk. These results not only reinforce our confidence in the technology, but also validates the FDA’s designation of RadioGel® as a Breakthrough Device. We are optimistic about what lies ahead in India and globally—as we move toward making this therapy accessible to patients in urgent need of new cancer treatment options.” Additionally, our companion IsoPet® animal data has been generating impressive results which complement the human therapy data. We will share the exciting developments from our Isopet® animal health division in the near future.
About Vivos Inc. (OTCQB: RDGL)
Vivos Inc. is a radiotherapeutic oncology company pioneering the use of Yttrium-90-based injectable hydrogel technology to treat tumors in both animals (IsoPet®) and humans (RadioGel®). The company’s Precision Radionuclide Therapy™ (PRnT™) platform delivers targeted internal radiation from within the tumor, minimizing damage to healthy tissue and reducing patient recovery time.
RadioGel®, designated as a Breakthrough Device by the U.S. FDA, uses a hydrogel matrix to confine beta radiation within the tumor, delivering more than
For more information, please visit: www.vivosinc.com
For media inquiries, contact:
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
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