Vivos Inc Board Authorizes Vivios Inc to Establish a Corporate Entity in India
Vivos Inc (OTCQB:RDGL) has received board authorization to establish a wholly-owned subsidiary, Vivos Scientific India LLP, marking a significant expansion into the Indian market. This strategic move follows the company's initiation of first-in-human trials announced in December 2024.
The company is actively pursuing DCGI approval for expanded human trials in India, which will support their IDE process with the FDA. The new protocol will include post-treatment PET full-body scans to validate RadioGel's safety profile. This expansion aligns with Vivos's long-term strategy to establish their first international manufacturing center for RadioGel and IsoPet products, expand developmental animal testing, and provide commercial treatments for both humans and animals in India.
[ "Establishment of wholly-owned subsidiary in India demonstrates international expansion", "Progress in human trials with potential FDA IDE application support", "Plans for first international manufacturing center for RadioGel and IsoPet", "Strategic expansion of both human and animal treatment capabilities" ]Vivos Inc (OTCQB:RDGL) ha ricevuto l'autorizzazione del consiglio per costituire una controllata interamente controllata, Vivos Scientific India LLP, segnando una significativa espansione nel mercato indiano. Questa mossa strategica segue l'avvio dei primi studi sull'uomo annunciati nel dicembre 2024. L'azienda sta attivamente perseguendo l'approvazione DCGI per ampliati studi sull'uomo in India, che sosterranno il loro processo IDE con la FDA. Il nuovo protocollo includerà scansioni PET a tutto corpo post-trattamento per convalidare il profilo di sicurezza di RadioGel. Questa espansione è in linea con la strategia a lungo termine di Vivos per istituire il primo centro di produzione internazionale di RadioGel e IsoPet, espandere i test su animali di sviluppo e fornire trattamenti commerciali sia per l'uomo che per gli animali in India.
Vivos Inc (OTCQB:RDGL) ha recibido la aprobación del consejo para establecer una subsidiaria 100% propia, Vivos Scientific India LLP, marcando una expansión significativa en el mercado indio. Este movimiento estratégico sigue al inicio de ensayos en humanos anunciados en diciembre de 2024. La empresa está buscando activamente la aprobación de la DCGI para ampliar los ensayos humanos en India, lo que respaldará su proceso IDE con la FDA. El nuevo protocolo incluirá escaneos PET de cuerpo entero tras el tratamiento para validar el perfil de seguridad de RadioGel. Esta expansión se alinea con la estrategia a largo plazo de Vivos para crear su primer centro de fabricación internacional para RadioGel e IsoPet, ampliar las pruebas de desarrollo en animales y proporcionar tratamientos comerciales para humanos y animales en la India.
Vivos Inc (OTCQB:RDGL)는 지분 전액 출자 자회사인 Vivos Scientific India LLP를 설립하기 위한 이사회 승인을 받았으며, 이는 인도 시장으로의 중요한 확장을 표시합니다. 이 전략적 조치는 2024년 12월에 발표된 첫 사람 대상 시험의 시작에 이어 나왔습니다. 회사는 인도에서 확대된 인간 대상 시험에 대한 DCGI 승인을 적극 추진 중이며, 이는 FDA의 IDE 프로세스를 지원할 것입니다. 새로운 프로토콜에는 치료 후 전신 PET 스캔이 포함되어 RadioGel의 안전성 프로파일을 검증합니다. 이 확장은 RadioGel 및 IsoPet 제품의 국제 최초 생산 센터를 설립하고, 개발 동물 시험을 확장하며, 인도에서 인간과 동물 모두를 위한 상용 치료를 제공하려는 Vivos의 장기 전략과 일치합니다.
Vivos Inc (OTCQB:RDGL) a reçu l'autorisation du conseil d'administration de créer une filiale en propriété exclusive, Vivos Scientific India LLP, marquant une expansion significative sur le marché indien. Cette démarche stratégique fait suite au démarrage des essais chez l'homme annoncés en décembre 2024. L'entreprise poursuit activement l'obtention de l'approbation DCGI pour des essais humains élargis en Inde, ce qui soutiendra leur procédure IDE avec la FDA. Le nouveau protocole comprendra des tomographies PET tout le corps après traitement pour valider le profil de sécurité de RadioGel. Cette expansion s'aligne sur la stratégie à long terme de Vivos consistant à établir leur premier centre de fabrication international pour RadioGel et IsoPet, à élargir les essais de développement chez les animaux et à fournir des traitements commerciaux pour les humains et les animaux en Inde.
Vivos Inc (OTCQB:RDGL) hat der Vorstandsbeschluss erhalten, eine 100% Tochtergesellschaft zu gründen, Vivos Scientific India LLP, was eine bedeutende Expansion auf dem indischen Markt markiert. Dieser strategische Schritt folgt auf den im Dezember 2024 angekündigten Start der ersten Humanversuche. Das Unternehmen verfolgt aktiv eine DCGI-Zustimmung für erweiterte Humane Versuche in Indien, die ihren IDE-Prozess mit der FDA unterstützen wird. Das neue Protokoll wird Ganzkörper-PET-Scans nach der Behandlung umfassen, um das Sicherheitsprofil von RadioGel zu validieren. Diese Expansion steht im Einklang mit Vivos' langfristiger Strategie, erstes internationales Herstellzentrum für RadioGel und IsoPet zu etablieren, die Entwicklungs- Tierversuche zu erweitern und kommerzielle Behandlungen für Menschen und Tiere in Indien bereitzustellen.
وافقت شركة Vivos Inc (OTCQB:RDGL) على تأسيس شركة فرعية مملوكة بالكامل هي Vivos Scientific India LLP، وهو ما يمثل توسعاً هاماً في السوق الهندي. تتابع هذه الخطوة الاستراتيجية بدء التجارب البشرية الأولية التي أُعلنت في ديسمبر 2024. تسعى الشركة بنشاط للحصول على موافقة DCGI على توسيع التجارب البشرية في الهند، وهو ما سيدعم إجراء IDE الخاص بها مع FDA. سيتضمن البروتوكول الجديد فحوص PET كامل الجسم بعد العلاج للتحقق من ملف السلامة لـ RadioGel. يتماشى هذا التوسع مع استراتيجية Vivos الطويلة الأجل لإنشاء أول مركز تصنيع دولي لـ RadioGel وIsoPet، وتوسيع اختبارات التطوير الحيواني، وتوفير علاجات تجارية للبشر والحيوانات في الهند.
Vivos Inc（OTCQB:RDGL）已获董事会授权设立全资子公司 Vivos Scientific India LLP，标志着在印度市场的重大扩张。此举紧随公司在 2024 年 12 月宣布的人体第一阶段试验的开启。公司正积极推动在印度获得 扩展人体试验的 DCGI 批准，以支持其与 FDA 的 IDE 程序。新方案将包括治疗后全身 PET 扫描，用于验证 RadioGel 的安全性档案。这一扩张符合 Vivos 的长期战略，即建立其首个国际制造中心，用于 RadioGel 与 IsoPet 产品；扩大开发阶段的动物测试，并在印度为人类和动物提供商业治疗。
- None.
- Pending regulatory approvals from Indian government still required
- Additional clinical validation needed through PET scans for safety profile
Kennewick, WA, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL)
The Vivos Board granted authorization to form a wholly owned corporate subsidiary in India. Vivos Inc filed for the name of Vivos Scientific India LLP. Vivos is completing the steps remaining to obtain formal approvals from the Indian government.
“This demonstrates our long-term commitment to doing business in India and supports our long-term plan of establishing our first international manufacturing center for RadioGel and IsoPet, for expanding our developmental animal testing, and for commercially treating humans and animals in India.”
India is an important region for us, having initiated first in human trials, which we announced in December of 2024. We are actively pursuing DCGI (Drug Controller General of India) approval for additional expanded human trials in India. As we have previously stated, we believe our India trials are supportive of our IDE process with the FDA. Based on feedback from the FDA, as part of our IDE application process, our formal protocol for the next phase of human trials in India will include immediate post treatment PET full- body scans to further validate RadioGel’s safety profile.
Michael K. Korenko, Sc.D.
CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
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 “will,” “expects,” “plans,” “anticipates,” and “intends.” 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.’s control. For a detailed discussion of these risks, refer to the company’s filings with the Securities and Exchange Commission.
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