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 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. reported a record-breaking first quarter for its IsoPet Animal Cancer Division, with a 150% year-over-year increase in treatment volume, highlighting its growing role in veterinary oncology [1][2] Group 1: Treatment Volume Surge - IsoPet treated 15 pets in Q1 2025, a 150% increase from Q1 2024, with a biweekly production schedule ensuring a steady supply of yttrium-90 (Y-90) hydrogel for targeted radiation [2] - Recent treatments included five pets in New Jersey and Texas, demonstrating the therapy's effectiveness in reducing tumors and improving quality of life [2] Group 2: Breakthrough Clinical Applications - IsoPet made significant advancements in equine oncology, treating four horses with ocular squamous cell carcinoma using direct cornea injections, a novel approach for this challenging condition [3] - Additional applications include palliative therapy for advanced equine jaw cancer and margin therapy post-tumor resection [3] Group 3: Clinic Expansion - Vivos Inc. activated three new certified clinics in Q1 2025, increasing the total to 14 clinics, with plans for further expansion to enhance access for pet owners [4] - The new clinics include specialized facilities for both small animals and equines, emphasizing the importance of trained veterinarians in the success of IsoPet [4] Group 4: Strategic Marketing and Community Engagement - IsoPet increased its presence at major veterinary conferences and utilized targeted newsletters and social media to drive treatment inquiries and community support [5] - Positive feedback from pet owners on social media highlights the effectiveness of IsoPet's non-surgical approach [5] Group 5: Market Positioning - The global veterinary oncology market, valued at $1.18 billion in 2023, is projected to grow at an 11.3% CAGR through 2030, driven by rising cancer diagnoses in pets [6] - IsoPet's minimally invasive therapy is well-positioned to meet this growing demand, offering a cost-competitive alternative to traditional radiation [6] Group 6: Leadership Perspective - The President & CEO of Vivos Inc. emphasized the transformative impact of IsoPet on veterinary oncology and the commitment to expanding access and exploring new applications [7][8]