Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — EuroPCR 2024
13 slides from Anteris Technologies Global's conference presentation, Aug 19, 2024
Slide 1: DurAVR Biomimetic THV: EFS and FIH trial update
DurAVR™ Biomimetic THV: EFS and FIH trial update Christopher U. Meduri, MD Karolinska University Hospital, Stockholm (Sweden)
Slide 2: Potential conflicts of interest
Potential conflicts of interest Speaker's name : Christopher Meduri ☑ I have the following potential conflicts of interest to declare: Advisory Board: X-Dot Co-Founder: V2V Non-Employed Chief Medical Officer: Anteris Technologies Receipt of honoraria or consultation fees: Abbott, Alleviant, Boston S
Slide 3: History of Innovation by Solving Problems Differently
History of Innovation by Solving Problems Differently Extensive history of cutting-edge tissue science and commercialization ü FDA-approved tissue since 2014 ü Clinically proven to be calcium-free for up to 10 years ü Distributed for use in over 55K patients globally (as a cardiac and vascular patch
Slide 4: DurAVR: A New Class of TAVR
DurAVR™ A New Class of TAVR Single-piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve Caution: Investigational Device. Limited by Federal law to investigational use only. Exclusively for clinical investigations. EuroPCR.com
Slide 5: FIH and EFS Study Design and Baseline Characteristics
DurAVR™ FIH and EFS Study Design and Baseline Characteristics FIH EFS Study & Baseline Characteristics sign N = 41 N = 15 De Prospective, Number of Centers 1 (Tbilisi, Georgia) 7 (United States) non-randomized single-arm, Population Severe symptomatic AS Severe symptomatic AS studies (Nov 2021 – May
Slide 6: FIH and EFS Procedural Results
DurAVR™ FIH and EFS Procedural Results 100% Precise placement & Implant Success (N = 56) PLACEHOLDER PLACEHOLDER Fluoro from FIH5 Fluoro from FIH5 Rotation & Comm. Valve expansion Alignment (Chris) (Chris) ComASUR™ DS rotation & Balloon-expandable delivery Long coaptation length = 8.3 mm Commissure
Slide 7: EFS: Excellent 30-Day Results
DurAVR™ EFS: Excellent 30-Day Results Paradigm Shifting 30-Day Hemodynamic Results* Excellent Safety Profile 30 Day Events N = 15 EOA (Effective Orifice 2.18 Mean Annulus Size: 22.2 mm Primary Safety Endpoints All-cause mortality or disabling stroke 0 (0) Area) cm2 Secondary Safety Endpoints All-cau
Slide 8: FIH: Consistent Hemodynamic Results through 1 Year
DurAVR™ FIH: Consistent Hemodynamic Results through 1 Year Excellent Post-procedure Hemodynamic Results Sustained Hemodynamics Through 1 Year (N=41) FIH 1 Year (to date) Mean Annulus Size: 2,5 60 22.57 mm 53,4 EOA (Effective Orifice 2.20 2,0 2,03 2,00 2,02 50 Area) cm2 40 EOA (cm2) & DVI MPG (mmHg)
Slide 9: FIH Confirms Good Safety Profile through 1 Year
DurAVR™ FIH Confirms Good Safety Profile through 1 Year Early (≤30 days) Late (>30 days) Events N = 41 N = 20 Primary Safety Endpoints All-cause mortality 0 (0) 1 (5) Myocardial infarction 0 (0) 0 (0) Disabling strokes 0 (0) 0 (0) Life-threatening bleeding 0 (0) 0 (0) VARC-3 Endpoints Valve-related
Slide 10: THV Biomimetic Design Superiority
DurAVR™ THV Biomimetic Design Superiority ADAPT® Tissue Treatment Technology ü Clinically proven to be calcium- Laminar Flow free for up to 10 years1 (Intra-op TEE) ü Distributed for use in over 55’000 patients globally ü Anti-calcification, Anti-fibrotic No Pinwheeling seen on Hydrodynamic Tests Si
Slide 11: DurAVR: the THV to Restore Normal Aortic Flow
DurAVR™: the THV to Restore Normal Aortic Flow Normal Flow Impaired Aortic Flow Severe AS Edwards Sapien 3 Healthy FD = 10% Aortic FRR = 1% Valve (n=5) FD = 46% FRR = 23% FD = 48% FRR = 35% Medtronic Evolut R CEP Magna Ease Post FD = 14% DurAVR FRR = 4% THV (n=5) FD = 25% FRR = 4% FD = 27% FRR = 30%
Slide 12: A New Class of TAVR
DurAVR™ A New Class of TAVR DurAVR™ Biomimetic valve has demonstrated excellent hemodynamic performance in both the First-in-Human and Early Feasibility Studies ComASUR™ Delivery System was intuitive and easy to use Both DurAVR™ First-in-Human and Early Feasibility Studies confirm excellent safety p
Slide 13: PCRonline.com
PCR PCRonline.com