What's Happening?
Vivos Inc has announced the formation of a wholly owned subsidiary in India, named Vivos Scientific India LLP, to establish a manufacturing center for its RadioGel and IsoPet products. This move is part of Vivos Inc's long-term strategy to expand its operations internationally and conduct human trials in India. The company is seeking approval from the Drug Controller General of India for expanded human trials, which are expected to support its Investigational Device Exemption process with the FDA. The subsidiary aims to enhance developmental animal testing and commercial treatment capabilities for both humans and animals in India.
Why It's Important?
The establishment of Vivos Inc's subsidiary in India marks a significant step in the company's global expansion strategy, potentially increasing its market presence and operational capabilities. By conducting human trials in India, Vivos Inc can leverage the country's regulatory environment to advance its product development and gain valuable data for FDA approval processes. This expansion could lead to increased collaboration between U.S. and Indian healthcare sectors, fostering innovation and potentially improving treatment options for patients. The move also highlights the growing importance of India as a hub for medical research and manufacturing.
What's Next?
Vivos Inc will continue to pursue necessary approvals from Indian authorities to commence expanded human trials. The company plans to integrate feedback from the FDA into its trial protocols, including post-treatment PET scans to validate the safety of RadioGel. As the subsidiary becomes operational, Vivos Inc may explore further partnerships and collaborations within the Indian healthcare industry. The success of these trials could pave the way for broader commercial applications of RadioGel and IsoPet, potentially leading to increased revenue streams and market expansion.
