Vivos Inc. Demonstrates Precision in Precision Radionuclide Therapy
Vivos Inc. (OTCQB: RDGL) has reported new data demonstrating the high precision of its RadioGel® and IsoPet® radionuclide therapy technologies. The company's therapeutic solutions have shown exceptional results in both veterinary and human applications, achieving high therapeutic ratios that maximize tumor destruction while minimizing damage to surrounding healthy tissue.
Key clinical successes include successful treatment of Ocular Squamous Cell Carcinoma (OSCC) in horses with no damage to surrounding eye tissue, and effective treatment of cancerous lymph nodes near critical structures in human trials, with tumors becoming undetectable after 90 days. RadioGel® has received FDA Breakthrough Device designation, though it is not yet FDA-approved for commercial use in the United States.
Vivos Inc. (OTCQB: RDGL) ha reso noti nuovi dati che dimostrano l’elevata precisione delle sue tecnologie di radioterapia RadioGel® e IsoPet®. Le soluzioni terapeutiche dell’azienda hanno mostrato risultati notevoli in applicazioni veterinarie e umane, ottenendo elevati rapporti terapeutici che massimizzano la distruzione dei tumori limitando al minimo i danni ai tessuti sani circostanti.
Tra i successi clinici principali si annoverano il trattamento efficace del carcinoma squamocellulare oculare (OSCC) nei cavalli senza danni ai tessuti oculari adiacenti, e la cura di linfonodi cancerosi vicini a strutture critiche in studi sull’uomo, con tumori non più rilevabili dopo 90 giorni. RadioGel® ha ottenuto la designazione FDA di Breakthrough Device, pur non essendo ancora approvato per l’uso commerciale negli Stati Uniti.
Vivos Inc. (OTCQB: RDGL) ha comunicado nuevos datos que demuestran la alta precisión de sus tecnologías de terapia radiactiva RadioGel® e IsoPet®. Las soluciones terapéuticas de la compañía han mostrado resultados sobresalientes en aplicaciones veterinarias y humanas, alcanzando altas ratios terapéuticas que maximizan la destrucción tumoral y minimizan el daño a los tejidos sanos circundantes.
Entre los éxitos clínicos clave se incluye el tratamiento exitoso del carcinoma escamoso ocular (OSCC) en caballos sin daño a los tejidos oculares adyacentes, y el tratamiento eficaz de ganglios linfáticos cancerosos cercanos a estructuras críticas en ensayos humanos, con tumores indetectables tras 90 días. RadioGel® ha recibido la designación de Dispositivo Breakthrough de la FDA, aunque todavía no cuenta con la aprobación de la FDA para su uso comercial en Estados Unidos.
Vivos Inc. (OTCQB: RDGL)는 자사의 방사성 치료 기술인 RadioGel® 및 IsoPet®의 높은 정밀도를 입증하는 신규 데이터를 보고했습니다. 회사의 치료 솔루션은 수의학 및 인간 적용 사례 모두에서 뛰어난 결과를 보였으며, 주변의 정상 조직 손상을 최소화하면서 종양 파괴를 극대화하는 높은 치료 지수를 달성했습니다.
주요 임상 성과로는 주변 안구 조직 손상 없이 말의 안구 편평세포암(OSCC)을 성공적으로 치료한 사례와, 중요한 구조물 근처의 암성 림프절을 인간 임상에서 효과적으로 치료해 90일 후 종양이 검출되지 않게 된 사례가 포함됩니다. RadioGel®은 FDA 혁신 의료기기(Breakthrough Device) 지정을 받았지만, 현재 미국에서 상업적 사용을 위한 FDA 승인은 받지 않았습니다.
Vivos Inc. (OTCQB: RDGL) a publié de nouvelles données montrant la grande précision de ses technologies de thérapie par radionucléides RadioGel® et IsoPet®. Les solutions thérapeutiques de la société ont donné des résultats remarquables en applications vétérinaires et humaines, obtenant des rapports thérapeutiques élevés qui maximisent la destruction tumorale tout en réduisant au minimum les dommages aux tissus sains environnants.
Parmi les réussites cliniques majeures figurent le traitement réussi du carcinome épidermoïde occulaire (OSCC) chez les chevaux sans atteinte des tissus oculaires adjacents, et le traitement efficace de nœuds lymphatiques cancéreux proches de structures critiques dans des essais humains, avec des tumeurs devenues indétectables après 90 jours. RadioGel® a reçu la désignation FDA Breakthrough Device, bien qu’il ne soit pas encore approuvé par la FDA pour un usage commercial aux États-Unis.
Vivos Inc. (OTCQB: RDGL) hat neue Daten veröffentlicht, die die hohe Präzision seiner Radionuklid-Therapie-Technologien RadioGel® und IsoPet® belegen. Die therapeutischen Lösungen des Unternehmens zeigten herausragende Ergebnisse in veterinärmedizinischen und humanen Anwendungen und erzielten hohe therapeutische Verhältnisse, die die Tumorzerstörung maximieren und gleichzeitig Schäden an gesundem umliegendem Gewebe minimieren.
Wesentliche klinische Erfolge umfassen die erfolgreiche Behandlung des okularen Plattenepithelkarzinoms (OSCC) bei Pferden ohne Schädigung des umliegenden Augenbereichs sowie die wirksame Behandlung krebsbefallener Lymphknoten in der Nähe kritischer Strukturen in Humanstudien, wobei die Tumoren nach 90 Tagen nicht mehr nachweisbar waren. RadioGel® erhielt die FDA Breakthrough Device-Zulassung, ist jedoch noch nicht für die kommerzielle Verwendung in den Vereinigten Staaten von der FDA zugelassen.
- Received FDA Breakthrough Device designation for RadioGel®
- Successful treatment of eye tumors in horses with no damage to surrounding tissue
- Human trial showed complete tumor elimination after 90 days with no adverse effects
- Technology demonstrates ability to treat tumors near vital organs
- RadioGel® not yet FDA-approved for commercial use in United States
Kennewick, WA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) announced new data demonstrating the exceptional precision of its proprietary Precision Radionuclide Therapy (RadioGel® for human therapies and IsoPet® for veterinary applications)
Advancing Targeted Cancer Therapies
The therapeutic ratio is the amount of radiation delivered to a tumor compared to surrounding healthy tissue and is a critical measure of treatment precision. A high therapeutic ratio minimizes collateral damage while maximizing tumor destruction.
The high therapeutic ratio achieved in clinical studies with RadioGel®, was a key factor in the technology receiving FDA Breakthrough Device designation. This ratio was initially validated through rigorous health physics calculations performed by internationally respected physicists.
Now, the company has supporting data from our animal health division and human trial data that confirms these calculations.
- Veterinary Success:
Dr. Ben Buchanan of Brazos Valley Equine Hospital in Navasota, Texas, successfully treated Ocular Squamous Cell Carcinoma (OSCC) in multiple horses. Treatments included injections directly into eyelid tumors and even onto the cornea, with no damage to surrounding eye tissue and no reported adverse effects.
- Human Clinical Data:
In the international human trial, cancerous lymph nodes near critical structures, including the trachea and carotid artery, were treated effectively. At 90 days post-treatment, these tumors were undetectable by imaging. No measurable damage or reported adverse effects were observed. Analysis of CT/PET scans confirmed no radiation uptake by surrounding critical structures or adjacent areas of the neck.
A Unique Capability for Treating Challenging Tumors
“These demonstrations give us confidence that RadioGel® and IsoPet® have the potential to treat tumors located near vital organs, which is a capability that sets them apart and can significantly expand the size of the addressable market,” said Michael K. Korenko, Sc.D., President & CEO of Vivos Inc.
“Vivos will continue to expand and strengthen our data through domestic animal therapies and international human clinical trials.”
RadioGel® is not FDA-approved for commercial use in the United States at this time. The human clinical data cited in this release comes from an international clinical trial conducted under U.S. regulatory standards.
About Vivos Inc.
Vivos Inc. is dedicated to advancing innovative, targeted cancer therapies through its patented radionuclide delivery platforms, RadioGel® and IsoPet®.
The company has trademarked the term Precision Radionuclide Therapy™ to describe this targeted treatment approach.
To learn more, visit www.VivosInc.com.
Follow Vivos Inc. on X (Twitter):@VivosIncUSA
Media Contact:
Michael K. Korenko, Sc.D.
Email: MKorenko@RadioGel.com
Safe Harbor Statement
This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including terms such as “will,” “expects,” “plans,” “anticipates,” and “intends.” Actual results may differ materially due to risks and uncertainties, including challenges in executing business strategies, economic conditions, competitive pressures, regulatory changes, and delays in clinic certifications. For a detailed discussion of these risks, please refer to the company’s filings with the U.S. Securities and Exchange Commission.
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