Ann: DurAVR First in Human Study 12 Month Results, page-2

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Update: 12 Month Results for Anteris DurAVRTM Transcatheter Heart Valve (THV) Aortic Stenosis First in Human Study

Key Highlights:

1. The DurAVR™ Transcatheter Heart Valve (THV) First-in-Human Study met all performance endpoints with remarkable hemodynamic function sustained to 12 months.

2. DurAVR™ THV demonstrated an outstanding safety profile. All safety endpoints were met: No mortality (all causes), no disabling stroke, no life-threatening bleeding, and no myocardial infarction at 12 months.

3. These encouraging preliminary First-in-Human study results will be further validated in an FDA-approved Early Feasibility Study (EFS) in early 2023.