Initiating Coverage: AI Nose for Better Point-of-Care Testing
Diversified medtech and therapeutics company. Ainos develops AI-powered point-of-care testing (POCT) devices to detect diseases and other health conditions, in addition to a low-dose interferon-a (IFN-a) therapeutic for infectious and autoimmune diseases. AI Nose enables portable, fast, and convenient POCT. Ainos utilizes electronic nose (E-nose) technology and a proprietary AI algorithm to recognize and distinguish between different digital smell patterns of volatile organic compounds (VOCs) emitted by certain diseases. The POCT devices are small, non-invasive, and telehealth friendly. Lead AI Nose device Ainos Flora for women’s vaginal health. An Ainos Flora clinical study will evaluate accuracy in identifying vaginal infections and common sexually transmitted infections (STIs) compared with conventional tests. Ainos Flora provides instant results (minutes versus days) and a more economical option through multi-use compared with single-use at-home tests, while maintaining convenience and privacy. Phase 3 ready VELDONA for oral warts and Sjogren’s. VELDONA, a low-dose oral IFN-a, has shown benefits in multiple indications, with a benign safety profile, across human and animal clinical studies. Ainos will prioritize oral warts in HIV+ and Sjogren’s syndrome for human drug development. In animals, Ainos will initiate a clinical study in feline chronic gingivostomatitis (FCGS). Lead products address compelling markets. The STI diagnostic market continues to expand as the global STI incidence increases annually, and at-home tests grow in popularity. Ainos Flora will provide the advantages of clinic (instant results) and at-home (convenience) testing at a more affordable price. VELDONA should offer an effective and safe therapeutic option for the underserved oral warts and Sjogren’s markets, which have no approved drugs. Capital-efficient business strategy. Ainos minimizes costs by operating in Taiwan, where personnel, R&D, and clinical trial expenses are lower than in the US. Manufacturing and sales distribution responsibilities are outsourced to strategic partners. Ainos expects to commercialize POCT products through a B2B sales model and by out-licensing VELDONA, which reserves capital for R&D and business development.