Anteris Technologies Ltd. announced a summation of the Company?s presentation at the New York Valves annual Conference held at the Jacob K. Javits Convention Center in New York City. DurAVR THV demonstrated excellent post-procedure hemodynamic results in 41 patients, with large effective orifice areas (2.20 cm2), single-digit mean gradients (8.5 mmHg) and a Doppler Velocity Index (DVI) of 0.62. These hemodynamic results resemble those seen in healthy subjects.

Dr. Cavalcante commented that the current market-leading balloon-expandable valve would be unable to achieve these results in small annuli patients (mean annulus size: 22.57mm), before proceeding to explain the clinical relevance of healthy flow dynamics beyond traditional echo gradients. Dr. Cavalcante explained that aortic stenosis is not just a disease of the valve, it is also a disease of the arteries and the myocardium. In normal healthy aortic flow, the flow is laminar; there is little-to-no flow displacement (FD), the flow is non-eccentric and there is limited-to-no flow reversal (FRR) even in systole (when the ventricle contracts).

Using cardiac MRI data courtesy of Dr. Pankaj Garg, Dr. Cavalcante explained the same phenomenon could be seen with DurAVR THV, which restored laminar flow with near equivalence to a normal healthy aortic valve. Studies performed on commercially available transcatheter valves, either balloon-expandable or self-expanding, do not appear to restore normal aortic flow. Normal Healthy Aortic Valve: FD = 10%, FRR = 1% (n=5) · DurAVR THV: FD = 15%, FRR = 5% (n=11) Severe AS: FD = 46%, FRR = 23% Edwards Sapien 3: FD = 48%, FRR = 35% Medtronic Evolut R: FD = 25%, FRR = 4% CEP Magna Ease: FD = 27%, FRR = 30%.

Dr. Cavalcante also reported that in patients treated with DurAVRTM THV, cardiac MRI also detected a significant left ventricular mass index regression at 6 months post-TAVR. A recent meta-analysis of other TAVR platforms demonstrated an average LV mass index regression of around 15 g/m2, in comparison to DurAVR THV, which demonstrated a difference of almost 20 g/m2. The full downstream effect of restoring laminar flow will need to be further studied and validated in ongoing and future studies, including a larger pivotal imaging sub-study.