- The Vivos Inc. Board has authorized the formation of **Vivos Scientific India LLP**, a wholly-owned corporate subsidiary in India, with formal approvals from the Indian government currently being completed.  **[1449349_617d9e7bb546407c93ac7761f0133381_0]** 
- This initiative demonstrates a **long-term commitment to India** and aims to establish the company's first international manufacturing center for **RadioGel and IsoPet**.  **[1449349_617d9e7bb546407c93ac7761f0133381_0]** 
- The subsidiary will also support the expansion of developmental animal testing and the commercial treatment of humans and animals in India.  **[1449349_617d9e7bb546407c93ac7761f0133381_0]** 
- Vivos Inc. is actively pursuing **DCGI approval for additional expanded human trials** in India, following the initiation of first-in-human trials in December 2024.  **[1449349_617d9e7bb546407c93ac7761f0133381_0]** 
- Future human trials in India will include immediate post-treatment PET full-body scans to validate RadioGel's safety profile, based on feedback from the FDA for the IDE application process.  **[1449349_617d9e7bb546407c93ac7761f0133381_0]**

Vivos Inc. Board Authorizes Indian Subsidiary for Manufacturing and Trials

- Vivos Inc.'s Board has authorized the formation of a **wholly owned corporate subsidiary in India**, to be named Vivos Scientific India LLP.  **[1449349_5f6bad25d75d4833b446539b21e75171_0]** 
- This move is part of the company's long-term commitment to India and aims to establish its **first international manufacturing center** for RadioGel and IsoPet, expand developmental animal testing, and facilitate commercial treatment for humans and animals in the region.  **[1449349_5f6bad25d75d4833b446539b21e75171_0]** 
- Vivos initiated first-in-human trials in India in **December 2024** and is actively pursuing Drug Controller General of India (DCGI) approval for additional expanded human trials.  **[1449349_5f6bad25d75d4833b446539b21e75171_0]** 
- These India trials are intended to support the company's Investigational Device Exemption (IDE) process with the FDA, with future trials including immediate post-treatment PET full-body scans to validate RadioGel's safety profile.  **[1449349_5f6bad25d75d4833b446539b21e75171_0]**

Vivos Inc. Board Authorizes Establishment of Indian Subsidiary

- Vivos Inc. has successfully validated a new **electron beam (E-Beam) sterilization process** for its hydrogel, following nearly a year of testing and validation under **ISO 11137** by an international medical device accredited organization.  **[1449349_e95ffd88476f4f778f61c9f06285e626_0]** 
- This E-Beam process achieves a **sterility assurance level of 10-6**, which is the most rigorous level, minimizing infection risk for critical medical devices.  **[1449349_e95ffd88476f4f778f61c9f06285e626_0]** 
- The process is more **cost-effective**, improves production yield, and significantly enhances scalability for commercial growth.  **[1449349_e95ffd88476f4f778f61c9f06285e626_0]** 
- It benefits both **human (Radiogel®) and animal (IsoPet®) therapies**, driving greater manufacturing efficiency and enabling more consistent supply and cost-effective production.  **[1449349_e95ffd88476f4f778f61c9f06285e626_0]**

VIVOS (RDGL)