Vivos Inc Board Authorizes Vivos Inc to Establish a Corporate Entity in India

On September 29, 2025, Vivos Inc. (OTCQB: RDGL) announced that its Board of Directors has authorized the establishment of a wholly owned subsidiary in India, to be named Vivos Scientific India LLP. This strategic move reflects the company's long-term commitment to expanding its business operations in the Indian market, aiming to centralize its international manufacturing efforts for its innovative products, RadioGel and IsoPet. Vivos is currently in the process of securing formal approvals from the Indian government to finalize the establishment of the subsidiary.

Vivos Inc. has actively engaged in initiating first-in-human clinical trials in India, which commenced in December 2024. The company is working towards obtaining additional approvals from the Drug Controller General of India (DCGI) for expanded human trials, which it believes will complement its Investigational Device Exemption (IDE) application with the FDA. A key aspect of the upcoming trial phase in India will involve conducting immediate post-treatment PET full-body scans to further validate the safety profile of RadioGel, as per the guidance received from the FDA.

Dr. Michael K. Korenko, CEO of Vivos Inc., emphasizes that India represents a crucial region for the company’s growth and innovation initiatives, particularly in developmental animal testing and providing treatment options for both humans and animals. The establishment of a local corporate entity is expected to streamline these activities and enhance Vivos’ ability to respond to regional market needs.

Investors and market observers are encouraged to stay informed about Vivos Inc.'s developments by following their updates on social media platforms and through their official website. However, it is essential to consider the potential risks associated with forward-looking statements in the press release, as the company navigates its strategic vision.

Vivos Inc.'s recent announcement regarding the establishment of a wholly owned subsidiary in India marks a significant strategic move that investors and market analysts should closely monitor. This decision underscores Vivos' commitment to expanding its international footprint, particularly in a rapidly emerging market for biotechnology and healthcare.

The formation of Vivos Scientific India LLP is aimed at bolstering the company's research and manufacturing capabilities for its innovative products, RadioGel and IsoPet. This strategic initiative aligns with the company’s broader goal of enhancing its operational capacity while also tapping into India's growing market for human and veterinary medical treatments. Given India’s diverse population and expanding healthcare needs, the potential for Vivos’ products could be substantial.

Moreover, the ongoing human trials initiated in December 2024 and the pursuit of Drug Controller General of India (DCGI) approvals reflect a proactive approach towards regulatory compliance and market penetration. The FDA's involvement, particularly in the context of the Investigational Device Exemption (IDE) process, is an encouraging sign that the company is laying down a robust pathway for future commercialization.

However, investors should remain cautious, as the forward-looking statements indicate inherent risks, including regulatory challenges and economic fluctuations that could influence Vivos' growth prospects. Market dynamics in India, such as competition from local biotech firms and potential delays in approvals, are worth considering.

From an investment perspective, Vivos Inc. could present an attractive opportunity for those looking to leverage growth in the biotech sector. Yet, it’s essential to balance the potential upside against the risks involved. Keeping an eye on the upcoming regulatory approvals and trial results will be critical in assessing Vivos' forward trajectory and overall market performance.