Kennewick, WA, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) today announced enhanced cooperation with Exubrion Therapeutics to advance the use of targeted radioactive isotope technology for multiple indications in companion animals. The two companies have agreed to broaden their joint efforts in several key areas — including shared clinic relationships, licensing coordination, and manufacturing optimization. These initiatives build upon prior collaborations involving device classification, dev ...

Richland, WA, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) announced today that they have appointed Dr. John J. Smith, M.D., J.D., and his team at Hogan Lovells as the company’s lead regulatory advisors for its FDA Investigational Device Exemption (IDE) submission for RadioGel®. Dr. Smith, a board-certified diagnostic radiologist and former associate professor at Harvard Medical School, is widely recognized as one of the nation’s leading FDA regulatory consultants in the medical device sector. ...

Core Points - Vivos Inc. has authorized the formation of a wholly owned subsidiary in India named Vivos Scientific India LLP, and is in the process of obtaining formal approvals from the Indian government [1] - The establishment of the subsidiary reflects Vivos's long-term commitment to the Indian market, aiming to set up its first international manufacturing center for RadioGel and IsoPet, and to expand developmental animal testing and commercial treatments in India [2] - Vivos has initiated first-in-human trials in India and is pursuing additional approvals for expanded human trials from the Drug Controller General of India (DCGI), which are believed to support the IDE process with the FDA [2] Company Strategy - The company plans to include immediate post-treatment PET full-body scans in the next phase of human trials in India to validate the safety profile of RadioGel, based on feedback from the FDA [2]

Core Points - Vivos Inc. has received authorization to establish a wholly owned subsidiary in India named Vivos Scientific India LLP, and is in the process of obtaining formal approvals from the Indian government [1] - The establishment of the subsidiary reflects Vivos Inc.'s long-term commitment to the Indian market, aiming to set up an international manufacturing center for RadioGel and IsoPet, and to expand developmental animal testing and commercial treatments for humans and animals in India [2] - Vivos Inc. has initiated first-in-human trials in India and is pursuing approval from the Drug Controller General of India (DCGI) for expanded human trials, which are expected to support the IDE process with the FDA [2] Company Strategy - The company plans to include immediate post-treatment PET full-body scans in the next phase of human trials in India to validate the safety profile of RadioGel, based on feedback from the FDA [2]

Core Insights - Vivos Inc. has submitted an Investigational Device Exemption (IDE) application to the FDA for its innovative RadioGel therapy, aimed at delivering targeted radiation to solid tumors while minimizing damage to healthy tissue [1][2][3] - The IDE application is supported by extensive animal and human data, indicating strong evidence of RadioGel's safety and efficacy, which is crucial for addressing life-threatening conditions with unmet medical needs [2][3] Company Developments - The IDE application represents the most comprehensive submission by Vivos Inc. to date, developed through close collaboration with the FDA under the Breakthrough Device sprint process [2][3] - Dr. Michael Korenko, CEO of Vivos Inc., emphasized that the strong evidence of RadioGel's safety and efficacy brings the company closer to providing transformative therapy for cancer patients [3]