0603 Tavmlr (Total Antero-Vertical Mandibular-Lingual Repositioning) Device: A Breath-to-Breath Real-Time Demand-Based Optimization of Airflow in OSA

Abstract Introduction OSA with multi-level obstructive phenotype limits success of OAT/COAT devices and surgeries (HNS and Hyoid lift). TAVMLR® (Total Antero-Vertical Mandibular-Lingual Repositioning device) delivers incremental airflow with antero-vertical mandibular rotation and optimization of alveolar oxygenation. Methods 200 consecutive patients who were diagnosed with OSA with HST, underwent dental scan, AIO AI-predictive flange/plateau customization of AIO Breathe®. The device had single prescription strength, namely, Resting Anterior Position (RAP) of 2mm and Mandibular Plateau (MP1) of 4mm. Flange design customization permitted voluntary mouth opening to guide anterior translation up to 8mm on demand with incremental mandibular rotation up to 13 degrees clinically confirmed at device delivery. Post-treatment HST was performed after 2 weeks. Follow-up at 3M, 6M and 12M with assessment of TMJ and dental movement were performed. Results Retrospective comparison (N=200) of Pretreatment DX HST DX-AHI, DX-LSAT, DXHB< 90% (Hypoxic Burden< 90%), treatment RX-AHI, RX-LSAT, RXHB< 90% (Hypoxic Burden< 90%) are detailed below. 1. Severe OSA: N = 60. Mean DX-AHI 41.8, DX-AHI range 30-80, 1 Std. dev. 13.2. Mean DX-LSAT 79.8%, DX-LSAT range 58% - 89%. Mean RX-AHI 2.4, RX-AHI range 0 – 4.8, 1 Std. Dev of 1.7. Mean RX-LSAT 91.2%, RX-LSAT range 90% - 95%. Mean DXHB< 90% 37% and Mean RXHB< 90% 0.0%. 2. Moderate OSA: N = 100: Mean DX-AHI 22.5, DX-AHI range 15-29.7, 1 Std. dev. was 4.03. Mean DX-LSAT 83.5%, range of LSAT 64% - 89%. Mean RX-AHI 2.0, RX-AHI range 0 – 4.5, 1 Std. Dev 1.68. Mean RX-LSAT 91.2%, RX-LSAT range 90% - 95%. Mean DXHB< 90% 28%, RXHB< 90% 0.0%. 3. Mild OSA: N = 40: Mean DX-AHI 8.3, DX-AHI range 5-14.9, 1 Std. dev. 4.0. Mean DX-LSAT 86.1%, DX-LSAT range 73% - 90%. Mean RX-AHI 1.1, RX-AHI range 0 – 5, 1 Std. Dev. 1.5. Mean RX-LSAT 93.1%, RX-LSAT range 90% - 98%. Mean DXHB< 90% 21%, RXHB< 90% 0.0%. Conclusion Single strength prescription TAVMLR® delivered optimal airflow to meet patient’s oxygen demand with residual AHI< 5, LSAT>90%, HB< 90% 0%. Unique AI-predictive flange/plateau design geometry is a novel approach at breath-to-breath real-time demand-based optimization of airflow, irrespective of OSA severity or phenotype. Support (if any) AIOMEGA®