Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — PCR London Valves 2025
19 slides from Anteris Technologies Global's conference presentation, 2025
Slide 1: Outcomes of a Novel Biomimetic Balloon Expandable Valve in Small Aortic Annuli
Outcomes of a Novel Biomimetic Balloon Expandable Valve in Small Aortic Annuli Ole De Backer, MD, PhD Rigshospitalet, Copenhagen, Denmark
Slide 2: Potential conflicts of interest
Potential conflicts of interest Speaker's name: Ole De Backer Potential conflicts of interest to report: none. pcrlondonvalves.com
Slide 3: DurAVR THV: A New Class of TAVR
DurAVR® THV: A New Class of TAVR Single piece, native-shaped biomimetic design built to mimic the performance of a healthy aortic valve pcrlondonvalves.com
Slide 4: DurAVR Only THV to Demonstrate Restoration of Physiologic Laminar Flow
DurAVR® Only THV to Demonstrate Restoration of Physiologic Laminar Flow Healthy Aortic Valve Post DurAVR® THV Post DurAVR® THV FD = 10% FRR = 1% FD = 14% FRR = 4% FD = Flow Displacement, FRR = Flow Reversal Ratio Courtesy of Dr. Pankaj Garg, Norwich UniversityHospital (UK) Data presented at New York
Slide 5: DurAVR THV Small Aortic Annuli Pooled Cohort
DurAVR® THV Small Aortic Annuli Pooled Cohort Symptomatic Severe Native Aortic Stenosis EMBARK Study US EFS EU EFS DurAVR S Valve DurAVR S Valve DurAVR S Valve N=74 N=15 N=11 30-Day Follow-up 30-Day Follow-up 30-Day Follow-up N=74 N=15 N=11 DurAVR® THV Small Aortic Annuli (SAA) Pooled Cohort N=100 p
Slide 6: DurAVR THV Small Aortic Annuli Pooled Cohort
DurAVR® THV Small Aortic Annuli Pooled Cohort Symptomatic Severe Native Aortic Stenosis DurAVR® THV EMBARK Study US EFS EU EFS Small Valve DurAVR S Valve DurAVR S Valve DurAVR S Valve N=74 N=15 N=11 30-Day Follow-up 30-Day Follow-up 30-Day Follow-up N=74 N=15 N=11 Area: 346-452 mm2 DurAVR® THV Small
Slide 7: Baseline Characteristics
Baseline Characteristics DurAVR® THV Baseline Characteristics (mean ± SD or %) (N=100) Age, years 77.0 ± 7.3 Female sex 78% STS-PROM score, % 4.7 ± 4.0 Body mass index, kg/m2 28.6 ± 5.1 NYHA functional class III/IV 61% Diabetes mellitus 33% Hypertension 91% Renal insufficiency or failure 56% Previou
Slide 8: Baseline Echo and CT Characteristics
Baseline Echo and CT Characteristics DurAVR® THV Baseline Echo and CT Characteristics (N=100) Aortic annulus area, mm2 404 ± 37 Aortic annulus mean diameter, mm 22.7 ± 1.0 Aortic valve area, cm2 0.8 ± 0.2 Mean transvalvular gradient, mmHg 48.1 ± 17.0 Left ventricular ejection fraction, % 58.0 ± 7.0
Slide 9: Procedural Characteristics
Procedural Characteristics DurAVR® THV Procedural Characteristics (N=100) Anesthesia type General anesthesia 69% Conscious sedation 31% Access and delivery Transfemoral 94% Transaortic 5% Transcarotid 1% DurAVR® THV Small valve size 100% Pre-dilatation* 57% Post-dilatation 8% Implantation time, min
Slide 10: Procedural Success Across Variety of Anatomies
Procedural Success Across Variety of Anatomies Challenging anatomies treated Technical success: 93% Severe annular calcium Extreme leaflet calcium Device success: 91% Type 1 bicuspid Extreme LVOT calcium Predictable BE placement pcrlondonvalves.com
Slide 11: Clinical Outcomes at 30 Days
Clinical Outcomes at 30 Days 30-Day VARC-3 Clinical Outcomes (DurAVR, N=100) N (%) All-cause mortality 0 (0%) Cardiovascular mortality 0 (0%) All stroke 2 (2%) Disabling stroke 2 (2%) Nondisabling stroke 0 (0%) Myocardial infarction 0 (0%) Major vascular complication 5 (5%) Bleeding, type 2-4 7 (7%)
Slide 12: Favorable Hemodynamics Through 30 Days
Favorable Hemodynamics Through 30 Days Single-digit mean gradient and No moderate or severe 97% freedom from ≥ moderate large effective orifice area paravalvular leak prosthesis-patient mismatch DVI = 0.60 pcrlondonvalves.com
Slide 13: DurAVR THV Small Annuli Cohort vs. SMART1
DurAVR® THV Small Annuli Cohort vs. SMART1 DurAVR® THV SEV (SMART1) BEV (SMART1) Baseline Characteristics (N=100) (N=355) (N=361) Age, years 77.0 ± 7.3 80.1 ± 6.3 80.3 ± 6.1 Female sex 78% 88% 86% STS-PROM score, % 4.7 ± 4.0 3.3 ± 1.9 3.2 ± 1.7 <3% 49% 51% 53% 3 to 5% 21% 35% 34% ≥5% 30% 14% 13% NYH
Slide 14: Hemodynamics and PPM in Small Annuli at 30 Days
Hemodynamics and PPM in Small Annuli at 30 Days Single-digit mean gradient Large EOA Low rate of moderate or severe prosthesis-patient mismatch 1,2 1,2 1,2 Error bars represent standard deviation 1. Hermann HC et al. NEMJ. 2024;390:1957-71. 2. Presented by Hermann HC SCAI 2024: SEV vs. BEV TAVR in p
Slide 15: Limitations
Limitations • Single arm study does not allow direct comparisons with other contemporary TAVI • DurAVR® THV Small annulus cohort included very early first- in-human procedures and more recent implants, reflecting a learning curve and device improvements over time • Longer term data needed to confirm
Slide 16: Conclusion
Conclusion • Over 100 patients treated with DurAVR® THV • Excellent safety outcomes at 30 days with no valve-related mortality in 100 small aortic annuli patients • Favorable hemodynamics through 30 days with single digit mean gradient, large EOAs, and no moderate or severe PVL • 97% freedom of mode
Slide 17: PARADIGM Trial Design
PARADIGM Trial Design Severe Native Aortic Stenosis Failed Surgical Bioprosthesis Cohort All Comers Randomized Cohort Low Risk Randomized Cohort Valve-in-Valve Cohort Assessment for Eligibility Assessment for Eligibility Assessment for Eligibility All Risk Candidate Low Risk Candidate High-Risk Cand
Slide 18: Simultaneous Publication
Simultaneous Publication pcrlondonvalves.com
Slide 19: pcronline.com
pcronline.com