0796 AIO BREATHE for OSA: Matching Airflow to Oxygen Demand with CONNECTED-ARC-OF-MOTION, AI-PREDICTIVE Oral Device Geometry and ON-DEMAND-AIRFLOW Delivery

Abstract Introduction AIOMEGA’s FDA-cleared (K233754) AIO BREATHE™ is a unique Total Antero-Vertical Mandibular-Lingual Repositioning Device (TAVMLRD™) from patented inventions by the first author. Its flanges display unique geometry that result in CONNECTED-ARC-OF-MOTION™ that provides REVIVE ON-DEMAND-AIRFLOW™, a method of calibrating incremental reduction in airflow resistance by increasing the SMCA (Smallest Cross-sectional Area) of the collapsible part of the airway during sleep or wake. Methods Subjects with suspected OSA underwent pretreatment and post-treatment clinical examination with ESS, Ghuge Fatigue Scale. Pre-RX and post-RX Home Sleep Studies were performed. AI-Predictive device flange geometry specified production of AIO BREATHE for entire group and forecasted post-RX AHI/LSAT. Pre-AHI, Pre-LSAT, Post-AHI and Post-LSAT were tabulated, univariate and multi-variate regression analysis were performed. Results Goup included mild, moderate and severe OSA. N = 50. Mean pre-RX AHI was 20.07, AHI range was 9-38, 1 Std. dev was 11.01. Mean pre-LSAT was 84.60%, LSAT range was 78% - 91% with mean of 84.60%. Mean Post-RX AHI was 2.13, AHI range was 0 – 4.5 with 1 Std. Dev of 1.46. Mean Post RX-LSAT was 92.4%, LSAT range was 90% - 96%. Ability to predict Post-RX AHI with AI-driven algorithms was 98.5% with p-value of 0.065 and T-stat of 2.141. Lower 95th% -1.773 and upper 95th% 2.468. Ability to predict Post-RX LSAT with AI-driven Algorithms was 99% with p-value of 0.15, adjusted R square of 0.131. Lower 95th% -0.095 and upper 95th% 0.472. Conclusion AIO BREATHE effectively treated all severities of OSA (up to AHI 38 and LSAT 78%) in this group. All participants experienced improvement in clinical symptoms. HSAT proved effective therapy (AHI < 5, LSAT >90%) with AI-predictive modeling of AIO BREATHE geometry. Design geometry reduced therapeutic uncertainty, minimized side effects like TMJ or dental movement and built dentist/physician/patient trust. AIOMEGA’s AI-predictive algorithms are device geometry-specific. Support (if any) AIOMEGA LLC.