Oventus Medical Ltd. provided an update on clinical trial and regulatory matters. 1. Predictive algorithm developed to provide treatment solutions for Obstructive Sleep Apnea (OSA) patients, using O2Vent? technology as a first-line therapy instead of Continuous Positive Airway Pressure (CPAP). Clinical study outcomes to date: The partnership between Oventus and the CRC-P yielded earlier compelling clinical data showing that O2Vent technology improved treatment efficacy over traditional oral appliances by over 50%. When the ExVent EPAP valve was added, efficacy increased a further 30% and reduced the apnea hypopnea index (AHI) to below 10 events per hour for 45% of patients who had failed alternative therapies (as published in SLEEP, August 2019). This data has previously been reported and presented at the American Academy of Dental Sleep meeting (AADSM), June 2017, in Boston and at the Australasian Sleep Association's (ASA) "Sleep DownUnder" conference (October 2018). 2. Recent study demonstrates that O2Vent therapy, or combination therapy including O2Vent Optima and ExVent?, successfully treats 100% of patients without the need for CPAP. Clinical study details- using Machine Learning in Algorithm Development: Out of the 112 patients enrolled in the three-year clinical study, 62 men and women with OSA (aged 29?71 years) were studied to investigate whether a clinically applicable predictive algorithm could be developed using standard data points collected in a typical patient diagnostic process. Seven standard variables from a diagnostic sleep study, plus age and BMI were included in a machine learning analytical model designed to predict O2Vent therapy response and obstructive sleep apnea treatment resolution (e.g. AHI<5 events/hr). Predictive algorithm: responders vs. non-responders: The model used data from the first 45 participants with 10-fold cross-validation. A blinded independent validation was then performed on the data from the remaining 17 participants. Mean accuracy of the model to predict responders vs. non-responders to Mandibular Advancement Splint therapy (using O2Vent Optima) using 10-fold cross-validation was 91?8%. All 17 individuals were correctly classified in this independent validation. Predicting optimal combination therapy: In a therapeutic application of the model, eleven people with OSA, not fully resolved with O2Vent Optima alone (apnea-hypopnea index (AHI)>10 events/h) were recruited. Initially, OSA subtypes were assessed via a detailed diagnostic sleep test. Step one of combination therapy focused on anatomical interventions including O2Vent Optima therapy plus ExVent and a device to avoid sleeping face up (supine). Participants with residual OSA (the subjective complaint of excessive daytime sleepiness and AHI>10 events/h) following the test were then given one or more targeted supplemental therapies per the protocol. These included: Oxygen (4L/min) to reduce unstable respiratory control (high loop gain); 10mg zolpidem to increase arousal threshold; or 80/5mg atomoxetine-oxybutynin (ato-oxy) for poor pharyngeal muscle responsiveness. Following the addition of supplemental therapies with O2Vent, OSA was successfully treated (AHI<10 events/h) in all participants. O2Vent Optima combined with ExVent and supine- avoidance therapy resolved OSA in 65% of participants (O2Vent Optima alone vs. combination therapy: 17?4 vs. 5?3, events/h, n=7). For the remaining participants, OSA resolved with the addition of oxygen (n=2), one with 80/5mg ato-oxy and one other required both oxygen and 80/5mg ato-oxy.