Artivion, Inc. · NYSE:AORT
Artivion — Investor Presentation (December 2020)
28 slides from Artivion's investor presentation, Dec 7, 2020
Slide 1: Investor and Analyst Discussion
Investor and Analyst Discussion December 7, 2020 | 4:00 pm EST 1
Slide 2: Forward Looking Statement
Forward Looking Statement Statements made in this presentation that look forward in time or that express management's beliefs, expectations, or forecasts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect
Slide 3: Our Vision
Our Vision TOBER AS A ECOGNIZED LEADER IN PROVIDING TECHNOLOGIES FOR PATIENTS WITH AORTIC DISEASE
Slide 4: CryoLife Strategy
CryoLife Strategy We will deliver double-digit growth from 2021-2023 by focusing globally on cardiac and vascular surgeons who treat patients with aortic disease. AMDS Stent Graft Technologies Hybrid Prosthesis* We will win through a deep understanding of our customer’s most significant clinical cha
Slide 5: Aortic Disease Focused Product Portfolio $6B TAM
Aortic Disease Focused Product Portfolio $6B TAM Surgical Sealant Thoracic Aorta Stent Grafts BioGlue® PerClot® AMDS® E-vita® OPEN NEO NEXUS™️ E-nya® Surgical Sealant Hemostat Surgical Acute Type A Arch Aneurysm & Endovascular Endovascular Dissection Chronic Dissection Branched Arch Descending Aorti
Slide 6: CryoLife R&D Pipeline
CryoLife R&D Pipeline 2021 2022 2023 2024 2025 BioGlue China 2021 PerClot US 2021 PROACT Mitral US 2022 Project X US 2024 NEXUS US 2024 NEXUS Japan 2024 AMDS US 2024 AMDS China 2025 AMDS Japan 2025 PROACT Xa US 2025 E-vita OPEN NEO US 2025 E-nside US 6 = PMA
Slide 7: >40% of US Aortic Valve Procedures <70 Years Old
>40% of US Aortic Valve Procedures <70 Years Old 13% 40% 30% 17% Mean Age at Implant1,2,3 <58 75 85+ 1 38 Pulmonary Allograft 2 56 On-X® Valve 2 68 Bioprosthetic Valve 3 73 TAVR Valve 1 Mazine A et al., JACC 2018;72(22):2761-77 2.Weighted national estimates from HCUP National (Nationwide) Inpatient
Slide 8: John H. Alexander, MD, MHS
John H. Alexander, MD, MHS ▪ Co-Chair of the PROACT Xa Trial ▪ Professor of Medicine/Cardiology, Duke University ▪ Co-chair of the Clinical Trial Transformation Initiative (CTTI) 8
Slide 9: Reimagining Prosthetic Valve Antithrombotic Therapy: PROACT Xa
Reimagining Prosthetic Valve Antithrombotic Therapy: PROACT Xa John H. Alexander, MD, MHS Professor of Medicine/Cardiology Duke Clinical Research Institute Duke Health
Slide 10: Disclosures
Disclosures Research Support: Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CryoLife, CSL Behring, Ferring, U.S. FDA, U.S. NIH, XaTek Consultant: AbbVie, Bayer, Bristol-Myers Squibb, CryoLife, Novo Nordisk, Pfizer, Portola, Quantum Genomics, U.S. VA CSP, XaTek, Zafgen Conflict of interest discl
Slide 11: Aortic Valve Replacement and Antithrombotic Therapy
Aortic Valve Replacement and Antithrombotic Therapy • Transcatheter: Aspirin + Clopidogrel • FDA device (CDRH) approval = reasonable assurance of safety and effectiveness • Prosthetic valves developed with an antithrombotic regimen (guess, extrapolation, • Bioprosthetic: Aspirin ± Vitamin K Antagoni
Slide 12: Mechanical and Tissue Heart Valves
Mechanical and Tissue Heart Valves Patients Aged 50-65 Years Distribution of tissue and mechanical aortic valve implants over time Iribarne A, et al. J Thorac Cardiovasc Surg. 2019
Slide 13: Antithrombotic Guideline Recommendations for Bioprosthetic Aortic Heart Valves
Antithrombotic Guideline Recommendations for Patients with BioProsthetic Aortic Heart Valves COR LOE Recommendation TAVR IIb C Clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVR in addition to life-long aspirin 75-100 mg daily IIb B-NR Anticoagulation with a VKA to achieve a
Slide 14: Post-TAVR Antithrombotic Therapy Questions Remain
Post-TAVR Antithrombotic Therapy Questions Remain GALILEO: Death or Thromboembolic Events Subclinical Leaflet Thrombosis Less w/ OAC than DAPT Dangas GD, et al. NEJM 2020;382:120-129 Ole De Backer OD, et al. NEJM 2020;382:130-9
Slide 15: Antithrombotic Guideline Recommendations for Mechanical Prosthetic Aortic Heart Valves
Antithrombotic Guideline Recommendations for Patients with Mechanical Prosthetic Aortic Heart Valves COR LOE Recommendation I A Anticoagulation with a VKA and INR monitoring is recommended in patients with a mechanical prosthetic valve I B Anticoagulation to achieve an INR of 2.5 is recommended for
Slide 16: On-X Mechanical Aortic Valve
On-X Mechanical Aortic Valve • Original PMA in 2001 with more than 200,000 implants • Leaflets are pyrolytic carbon deposited on a graphite substrate • Orifice inflow area has a flared inlet • Leaflets form a nominal angle of 90º relative to the orifice plane • Multiple studies evaluating safety and
Slide 17: On-X PROACT Trial Design
On-X PROACT Trial Design • PROACT: Prospective Randomized On-X Anticoagulation Clinical Trial • Multicenter (n=50), Randomized, Non-inferiority study • 6 Study arms (4 AVR and 2 MVR) • Patients are randomized ≥3 months post-valve implant • Follow-up: minimum 1 year and maximum 8 years • Home INR mon
Slide 18: PROACT AVR Trial Results
PROACT AVR Trial Results High-Risk AVR Low-Risk AVR VKA INR 2 to 3 vs. INR 1.5 to 2 VKA INR 2 to 3 vs. Clopidogrel 11 10.07 10 9.35 9 8 7.43 %/patient-year 7 6.25 6 5.50 5 4 3.78 3.49 3.82 2.64 2.86 3 1.93 2 1 0.29 0 Primary TE Events Bleeding Primary TE Events Bleeding Outcome Outcome Puskas et al.
Slide 19: Non-Vitamin K Antagonist Anticoagulants (NOACs) in Atrial Fibrillation
Non-Vitamin K Antagonist Anticoagulants (“NOACs”) in Atrial Fibrillation Dabigatran Rivaroxaban Apixaban Edoxaban RE-LY ROCKET-AF ARISTOTLE ENGAGE-AF Mechanism of action Selective direct Selective direct Selective direct Selective direct FIIa inhibitor FXa inhibitor FXa inhibitor FXa inhibitor T½ 12
Slide 20: RE-ALIGN Dabigatran for Mechanical Heart Valves
RE-ALIGN Dabigatran for Mechanical Heart Valves Any mechanical valve type • Mostly St. Jude MVR or AVR
Slide 21: RE-ALIGN Dabigatran for Mechanical Heart Valves: Trial Stopped Early
RE-ALIGN Dabigatran for Mechanical Heart Valves Trial stopped early (n=252) • 24% of dabigatran patients required dose adjustment for plasma drug levels out of range • 8% of dabigatran patients discontinued dabigatran due to low trough plasma drug levels despite maximal dose • Stroke in 5% of dabiga
Slide 22: RE-ALIGN Lessons Learned
RE-ALIGN Lessons Learned • Patients with mechanical valves are different from those with atrial fibrillation & venous thromboembolism • Early enrollment post-op may have impacted bleeding (pericardial) and possibly valve thrombosis & stroke • Mechanical valves may not all be the same • On-X vs. St.
Slide 23: Apixaban vs Warfarin Preclinical Study
• Apixaban 30D • Warfarin 30D • 1 mg/kg PO, BID • 2.5-4.5 mg PO, QD • Average INR = 2.46 Lester et al. (Arterioscler Thromb Vasc Biol 2017)
Slide 24: PROACT Xa Trial Design
PROACT Xa Trial Design Patients with On-X aortic valve replacement >3 months prior (n=1000) Randomize Apixaban 5 mg BID Open Continued warfarin Apixaban 2.5 mg BID in selected patients Label INR goal 2.0 – 3.0 2 year follow-up (≥800 patient-years in each arm) Primary endpoint: composite of valve thr
Slide 25: PROACT Xa Status
PROACT Xa Status* • First participant randomized May 7, 2020 at CHI St. Vincent Medical Center, Littlerock, AK. • 39 US sites open • 21 enrolling • 60 planned • 77 participants enrolled • Median (Q1, Q3) months 22.8 (8.4, 43.0) from AVR • 33% 3-12 months post-AVR • 67% >12 months post-AVR • Currentl
Slide 26: Thank you!
Reimagining Prosthetic Valve Antithrombotic Therapy: PROACT Xa Thank you!
Slide 27: PROACT Xa – Project Milestones
PROACT Xa – Project Milestones 2020 2021 2022 2023 2024 2025 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Enrollment Q2 Follow Up Q2 PMA Submission Q3 FDA Approval Q1 27
Slide 28: Thank You!
Thank You! 28
CryoLife (Artivion, Inc.) — Investor Presentation (December 2020) on 6ix