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 Viewpoint - Pheton Holdings Ltd has received a notification from Nasdaq indicating that it no longer meets the minimum bid price requirement for continued listing, with a compliance period until April 20, 2026, to regain compliance [1][2][3] Group 1: Nasdaq Compliance Notification - The Company was notified by Nasdaq that it does not meet the continued listing requirement under Rule 5550(a)(2) due to the Class A ordinary shares' closing bid price being below $1 for the last 30 consecutive business days [1] - Nasdaq has granted the Company a compliance period of 180 calendar days, until April 20, 2026, to regain compliance [2] - If the Company fails to regain compliance within this period, it may be eligible for an additional 180 days if it meets other listing standards and provides written notice of its intention to cure the deficiency [2] Group 2: Company's Response and Future Plans - The Company is currently evaluating options to regain compliance and is committed to making reasonable efforts to meet Nasdaq's continued listing requirements [3] - There is no assurance that the Company will successfully regain compliance with the bid price requirement or other Nasdaq listing standards [3] Group 3: Company Overview - Pheton Holdings Ltd, founded in 1998, specializes in healthcare solutions for brachytherapy, a targeted radiation therapy for cancer treatment [4] - The Company's lead product, the Treatment Planning System, is designed to ensure safe and effective brachytherapy using radioactive sources to treat cancer [4] - Pheton Holdings aims to establish a new standard of care across multiple malignant tumor applications through its products and services [4]