Core Insights - Vivos Inc. is focused on obtaining FDA Investigational Device Exemption (IDE) approval to start human clinical studies at Mayo Clinic, having engaged with over 40 FDA reviewers to address their inquiries [1][3] - The company is preparing a second Pre-Submission to the FDA, targeting high-impact areas identified in previous feedback, which will help streamline the IDE submission process [4][5] - Vivos has established Vivos Scientific India LLP (VISL) to facilitate regulatory approvals and manufacturing in India, aiming to tap into the $2 billion human oncology and $100 million veterinary therapy markets [6][7][8] Regulatory Strategy - The company has hired regulatory expert John Smith to guide its IDE approval process, leveraging his extensive experience with brachytherapy devices [3][5] - A proactive approach is being taken with the second Pre-Submission to address recurring FDA feedback on radiation dosimetry and clinical protocol design [4][5] International Expansion - Vivos is expanding its presence in India with plans for clinical trials and a manufacturing center, which will support both human and veterinary applications of RadioGel [7][8] - The company is also exploring international markets with unmet needs in oncology and veterinary care, aiming to establish a global platform for RadioGel [9][10] Veterinary Market Growth - The IsoPet division has seen an 800% year-over-year increase in administered therapies, indicating strong demand and adoption in the veterinary sector [11] - A strategic partnership with Exubrion Therapeutics aims to promote IsoPet in the equine oncology segment, which presents significant growth opportunities [13] Manufacturing and Technology - Vivos plans to transition from fully outsourced manufacturing to establishing its own production centers, with operations expected to begin in the second quarter of 2026 [14] - The company maintains a comprehensive intellectual property portfolio, including patents and developmental data related to its hydrogel technologies [15]

Core Insights - Vivos Inc. and Exubrion Therapeutics have announced enhanced cooperation to advance targeted radioactive isotope technology for companion animals [1][2] - The collaboration will focus on shared clinic relationships, licensing coordination, and manufacturing optimization, building on previous efforts in device classification and clinician training [2] - Both companies aim to leverage their complementary strengths in treating different conditions in companion animals, with Vivos focusing on cancer therapy and Exubrion on osteoarthritis pain [3] Company Overview - Vivos Inc. is a radiotherapeutic company developing isotope-based products for cancer treatment and other therapeutic applications, including RadioGel for human use and IsoPet for veterinary applications [4] - Exubrion Therapeutics specializes in veterinary radiotherapeutics, with its lead product, Synovetin OA, targeting osteoarthritis in companion animals [5]

Core Insights - Vivos Inc. has appointed Dr. John J. Smith and his team at Hogan Lovells as lead regulatory advisors for the FDA Investigational Device Exemption (IDE) submission for their product RadioGel [1][3] - Dr. Smith is a recognized expert in FDA regulatory consulting within the medical device sector and has prior experience with Vivos [2][3] - RadioGel is an innovative injectable device aimed at delivering high-dose, localized radiation to tumors, and obtaining IDE approval is essential for starting U.S. clinical trials at the Mayo Clinic [3] Company Developments - The appointment of Dr. Smith is expected to enhance Vivos' confidence and clarity in addressing remaining deficiencies in their IDE submission [3] - RadioGel is currently not authorized for pre-market use, indicating that regulatory approval is a critical step for the company [3]

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]