DESolve® SERIES OF CLINICAL STUDIES

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Presentation transcript:

DESolve® SERIES OF CLINICAL STUDIES Stefan Verheye, MD, PhD ZNA Middelheim Antwerp, Belgium On behalf of the EXCELLA investigators DESolve is CE Mark approved; Not available for sale in the U.S. PMN 420-A Rev A

Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Company Names Elixir

DESolve Key Features Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration 70% mass loss (resorption) within 1 year Overexpansion capability for optimal deployment Unique self correction designed to reduce malapposition and prevent chronic recoil Early lumen and scaffold enlargement at 6 months Sustained safety and efficacy out to 4 years Post- Procedure 6-Month Follow-up 36-Month Follow-up DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Study Single Arm Registry 126 patients 13 sites Europe, Brazil, New Zealand Coordinating Investigators: A. Abizaid, Sao Paulo, Brazil; S. Verheye, Antwerpen, Belgium Inclusion Criteria Treatment of a single de novo coronary artery lesion Reference vessel diameter: 2.5 -3.5mm Lesion length: <12mm, DAPT 12 months MACE 30d 6mo 1yr 18m 2yr 3yr 4yr 5yr Imaging QCA, IVUS, OCT, MSCT (subset) STUDY PURPOSE: To assess performance of DESolve Scaffold System through clinical and imaging endpoints PRIMARY IMAGING ENDPOINT: 6-month in-scaffold late lumen loss PRIMARY CLINICAL ENDPOINT: Major Adverse Cardiac Events (MACE), a composite of Cardiac Death, Target Vessel MI and Clinically Indicated TLR at 6 months SECONDARY ENDPOINTS: MACE: At 30 days, 1, 2, 3, 4 and 5 years; scaffold thrombosis QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis IVUS: In-scaffold percent volume obstruction, malapposition OCT: In-scaffold percent obstruction, strut coverage MSCT: Percent diameter stenosis, lumen area DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Trial 6 to 48 Month Clinical Outcomes Hierarchical Events 0 to 1440 days, n (%) 6M (N=122)* 12M (N=122) 24M 36M 48M Major Adverse Cardiac Events 3.3% 5.7% 7.4% 8.2% 9.0% Cardiac Death** 1 (0.8%) 2 (1.6%) 3 (2.5%) 4 (3.3%) Target Vessel MI*** Q-wave MI Non-Q- wave MI Clinically Indicated-TLR 5 (4.1%) Definite Scaffold Thrombosis *Modified Intent to Treat = those patients in which a scaffold was implanted in target lesion. **One death with probable ST based on ARC, scaffold undersized as assessed by IVUS; one death with suspected pulmonary embolus with right heart failure, non-scaffold related; one death due to non-target vessel occlusion and PCI, non-scaffold related; one death due to sudden death at home. ***MI during follow up attributed to multi modality imaging procedure ; MI due to proximal segment stenosis + ARC-defined DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Trial Primary Imaging Endpoint QCA Results Paired Analysis Dante ZNA In-Scaffold Analysis Post Procedure NL= 122* 6 Months NL= 113 18 Months N = 19 36 Months RVD (mm) 3.05 ± 0.25 2.96 ± 0.28 3.01 ± 0.29 2.95 ± 0.33 MLD (mm) 2.64 ± 0.28 2.44 ± 0.43 2.39 ± 0.43 2.45 ± 0.45 LLL (mm) - 0.20 ± 0.32 0.29 ± 0.34 0.22 ± 0.33 Median Late Loss (mm) 0.11 [0.03 , 0.19] 0.20 [0.09, 0.36] 0.16 [0.04, 0.31] Diameter Stenosis (%) 13.2 ± 7.5 17.8 ± 13.2 20.8 ± 11.1 16.4 ± 13.5 Paired LLL at 6 and 18m, p=ns; LLL at 6 and 36m, p=ns. Slide combines all QCA time points DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Trial IVUS Results In-Scaffold Analysis Baseline N = 40 6 months Dante 18 months N = 18 ZNA 36 months N = 15 Mean Lumen Area (mm2) 5.93 ± 1.17 6.51 ± 1.43 6.60 ± 1.54 6.68 ± 1.82 Min Lumen Area (mm2) 4.84 ± 1.09 4.77 ± 1.11 4.44 ± 1.23 4.47 ± 1.27 Mean Vessel Area (mm2) 12.96 ± 3.48 13.74 ± 3.37 15.28 ± 3.95 15.04 ± 4.70 Mean Scaffold Area (mm2) 5.94 ± 1.18 6.87 ± 1.55 NA Values are mean ± SD Dante Pazzanese, Sao Paulo, Brazil – single center follow-up 18m ZNA Antwerpen, Belgium – single center follow-up 36m NA = No visible struts for analysis at 18m and 36m time points DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Trial OCT Results In-Scaffold Analysis Baseline N = 38 6 months Dante 18 months N = 20 ZNA 36 months N = 19 Mean NIH Obstruction (%) N/A 11.21 ± 4.19 22.05 ± 5.94 NA Covered struts per patient (%) 98.79 ± 1.69 99.98 ± 0.11 NIH thickness- covered struts (µm) 0.1 ± 0.03 0.2 ± 0.05 Values are mean ± SD Dante Pazzanese, Sao Paulo, Brazil – single center follow-up 18m ZNA Antwerpen, Belgium – single center follow-up 36m NA = No visible struts for analysis PMN 395 Rev A DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Case Study: 28-07 PRE POST 6m FU LLL: 0.01 mm 36m FU LLL: -0.19 mm Courtesy of S. Verheye, ZNA Middelheim, Belgium PMN 332 Rev A DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Case Study: 28-07 Post-Procedure 6-Month FU 36-Month FU 0.4 mm 4.8 mm 7.9 mm 10.2 mm 12.1 mm LA: 7.04 mm2 SA: 7.08 mm2 LA: 7.99 mm2 SA: 7.99 mm2 LA: 6.85 mm2 SA: 6.76 mm2 LA: 6.66 mm2 SA: 6.60 mm2 LA: 8.05 mm2 SA: 8.11 mm2 LA: 6.61 mm2 SA: 7.87 mm2 LA: 10.82 mm2 SA: 12.50 mm2 LA: 7.87 mm2 SA: 9.99 mm2 LA: 6.70 mm2 SA: 8.82 mm2 LA: 6.53 mm2 SA: 8.97 mm2 LA: 9.68 mm2 LA: 16.07 mm2 LA: 9.81 mm2 LA: 7.70 mm2 LA: 10.37 mm2 OCT serial evaluation show lumen growth overtime with no visible struts at 36months Courtesy of S. Verheye, ZNA Middelheim, Belgium Lumen gain overtime – no scaffold at 36m DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Nx Clinical Trial: Conclusions 4-year data demonstrates sustained safety and efficacy, well beyond full resorption of the scaffold Safety Low 48-month overall MACE (9.0%) No late or very late scaffold thrombosis (definite or probable) Efficacy Low late lumen loss at 6m maintained through 18 and 36m Sustained neointimal suppression at 18 and 36m (IVUS and OCT) Early lumen gain at 6m sustained through 36m (IVUS) DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve Cx Clinical Study Single Arm Registry ~15 to 20 sites Europe and Brazil 50-pt imaging study 100-pt post market study Coordinating Investigators: A. Abizaid, Sao Paulo, Brazil; S. Verheye, Antwerpen, Belgium Inclusion Criteria Treatment of a single de novo coronary artery lesion Reference vessel diameter: 2.5 -3.5mm Lesion length: <12mm, DAPT 12 months Clinical: MACE 30d 6mo 1yr 2yr Imaging: QCA, IVUS, OCT STUDY PURPOSE: To assess performance of DESolve CX Scaffold System through clinical and imaging endpoints PRIMARY IMAGING ENDPOINT: 6-month in-scaffold late lumen loss PRIMARY CLINICAL ENDPOINT: Major Adverse Cardiac Events (MACE), a composite of Cardiac Death, Target Vessel MI and Clinically Indicated TLR at 6 months SECONDARY ENDPOINTS: MACE: At 30 days, 1 and 2 years; scaffold thrombosis QCA: In-segment late lumen loss, binary restenosis, and percent diameter stenosis IVUS: In-scaffold percent volume obstruction, malapposition OCT: In-scaffold percent obstruction, strut coverage DESolve CX is not available for sale.

DESolve Cx Clinical Trial Baseline Patient Demographics Patient Characteristics DESolve Cx (N = 50) Age, years (± SD) 60.0±10.3 Male 68.0% Diabetes mellitus 20.0% Current Smoker 26.0% Hypercholesterolemia 84.0% Hypertension 70.0% Previous myocardial infarction 40.0% Previous CABG 0.0% Previous PCI Unstable angina 6.0% DESolve CX is not available for sale.

DESolve Cx Clinical Trial Lesion Characteristics Baseline Characteristics Lesion Characteristics DESolve Cx (N = 25) DESolve Nx (N = 126) Target Vessel % (LAD/LCX/RCA) 36/32/32 38/31/31 Lesion Length, mm (± SD) 17.74 ± 7.59 11.2 ± 3.8 Reference Vessel, mm (± SD) 3.05 ± 0.39 3.00 ± 0.30 AHA/ACC Lesion class C 43.5% 2.9% Ostial Lesion 4% 3.2% Moderate to Heavy Calcification 28% 18.3% Moderate to Severe Tortuosity 0% 1.6% Pre-dilatation 96% 100% Post dilatation 84% 57.9% DESolve CX is not available for sale.

DESolve Cx Clinical Trial 6 Month Clinical Outcomes Hierarchical Events 0 to 180 days 30 days (N=50) 6 months (N=25) Major Adverse Cardiac Events Cardiac Death Target Vessel MI Q-wave MI Non-Q- wave MI Clinically Indicated-TLR Definite/probable Scaffold Thrombosis 1 patient with non-ischemic driven TLR DESolve CX is not available for sale.

DESolev Cx Clinical Trial Preliminary Imaging Endpoint QCA Results In-Scaffold Analysis DESolve Cx Post N = 25 DESolve Nx Post N = 126 6 months DESolve Nx N = 113 RVD (mm) 3.08 ± 0.43 3.05 ± 0.25 3.03 ± 0.42 2.96 ± 0.28 MLD (mm) 2.76 ± 0.36 2.64 ± 0.28 2.58 ± 0.45 2.44 ± 0.43 Mean Late Loss (mm) - 0.18 ± 0.29 0.20 ± 0.32 Median Late Loss (mm) 0.09 [0.02,0.26] 0.11 [0.03,0.19] Diameter Stenosis (%) 10.1 ± 6.7 13.2 ± 7.5 14.7 ± 11.0 17.8 ± 3.2 Values are mean ± SD; % (n), or Median (interquartile range 25%, 75%). MLD – Minimum luminal diameter; LLL – late lumen loss. *Modified Intent to Treat = those patients in which a scaffold was implanted in target lesion. DESolve CX is not available for sale.

DESolve Cx Case Example – Matched OCT Cross-Sections Post-Procedure – Mean scaffold area: 7.76 mm2; MSA: 6.17 mm2 6 Months – Mean scaffold area: 8.13 mm2; MSA: 6.87 mm2; 98.93% strut coverage; mean NIH thickness: 50 μm 0.9 mm 6.7 mm 11.4 mm 16.8 mm 17.5 mm DESolve CX is not available for sale.

DESolve Cx: Vasomotion at 6m follow up Pre-Nitrate Preliminary evaluation of vasomotion in scaffold pre and post nitroglycerin infusion of DESolve Cx during the 6m angiographic follow-up Increase in scaffold vessel max diameter from 3.19mm to 3.56 mm observed for an max increase of 0.37 mm and mean increase of 0.16 mm Post-Nitrate Courtesy of S. Verheye, ZNA Middelheim, Belgium (non-core lab, off-line QCA analysis) DESolve CX is not available for sale.

DESolve Cx Clinical Trial Conclusions Interim analysis (25 pts) shows promising results Safety No major adverse cardiac events reported to date No stent thrombosis Efficacy Late lumen loss of 0.18mm is similar to the DESolve Nx trial results of 0.20mm 6-month follow-ups complete in Q1 2017 DESolve CX is not available for sale.

DESolve Post-Market Clinical Follow-up (PMCF) Study purpose A post-market observational study to evaluate long-term safety and performance of the CE Mark approved DESolve Scaffold N = 102 Key Inclusion: Up to 2 de novo native coronary artery lesions Reference vessel diameters of 2.25 - 3.5 mm Lesion length ≤ 24 mm Vessel or lesion characteristics: Major artery or branch Stenosis ≥ 50% and < 100 % Excludes excessive tortuosity, angulation, and moderate or heavy calcification DAPT recommended for 12 months Key Endpoints: Clinically-indicated major adverse cardiac events (cardiac death, target vessel MI, and clinically indicated TLR) 1, 6 months and 1, 2, 3, 4, 5 years Acute success Stent Thrombosis H. Nef PhD, MD “DESolve platform(s) real world experience”, TCT 2016 DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve PMCF Clinical Results Hierarchical Events 0 to 180 days, n (%) 30 D N=100 6 M 12 M MACE 1 (1.0%) 2 (2.0%) 4 (4.0%) Cardiac Death 0 (0.0%) TV-MI* CI-TLR 3 (3.0%) Definite/Probable ST* TV-MI – target vessel myocardial infarction CI-TLR – clinically-indicated target lesion revascularization *Incomplete coverage of a proximal lesion resulting in acute closure, MI and TLR DESolve is CE Mark approved; Not available for sale in the U.S.

DESolve PMCF Trial Conclusions Results from the DESolve PMCF demonstrate the continued safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System through 6 months Patient demographics and lesion/vessel distribution was similar to the DESolve Nx pivotal trial Low composite endpoint of cardiac death, TV-MI and CI-TLR at 12 months (4.0%) Clinical results are in-line with the DESolve Nx pivotal study and similar to DES platforms DESolve is CE Mark approved; Not available for sale in the U.S.

DESappear SFA Study (Akesys PRAVA) Prospective, Single-Arm Safety and Performance Study ~60 patients ~12 International Sites Europe & New Zealand Coordinating Investigators: Dr. Marc Bosiers, Belgium; Prof. Dierk Scheinert, Germany Key Inclusion Criteria: Symptomatic claudication (Rutherford 2-4) Vessel diam ≥ 5.0 mm to ≤ 6.0mm, lesion ≤ 53 mm in length Target lesion is ≥ 50% DS Clinical and DUS follow-up 3d 6m 1yr 2yr 3yr Imaging QCA, OCT PRIMARY SAFETY ENDPOINT: Composite of freedom from perioperative death through 30-day & freedom from major adverse limb events defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization through 6 month follow up PRIMARY EFFECTIVENESS ENDPOINT: Primary patency defined as freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months PRAVA is not available for sale and developed by Akesys Medical

AKESYS PRAVA DEVICE DESCRIPTION PLLA-based polymer scaffold Elution rate: approximately 30% of the drug is eluted over 4 weeks and 90% at 6 months Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration PRAVA is not available for sale and developed by Akesys Medical

First PRAVA Implant 67 yr old male Rutherford 4 - severe claudication CAD, Type 2 diabetes, hypertension, hyperlipidemia, former smoker, chronic kidney disease Pre-dilatation 6.0x40 at 6 atm with <20% residual stenosis 6.0x57mm Prava Scaffold- inflated to 13 atm 6.0x40mm post-dilatation at 14 atm and final 7% DS Pre-procedure Final Courtesy of Dr. Holden, Auckland City Hospital, NZ PRAVA is not available for sale and developed by Akesys Medical

Akesys Prava Summary Elixir is expanding BRS technology into clinical indications with significant unmet clinical needs First implant of PRAVA (SFA) performed on 11 October 2016 Below-The-Knee Clinical study enrollment to begin H2 2017 PRAVA is not available for sale and developed by Akesys Medical

Summary Elixir has the broadest portfolio of bioresorbable scaffolds DESolve Sustained safety and efficacy out to 4 years Degrades within 6 months and fully resorbs within 2 years allowing early vascular restoration 70% mass loss (resorption) within 1 year US and Japan randomized trials to follow DESolve Cx Interim angiographic data with the 120µm scaffold looks very promising 6-month follow-up completed in Q1 2017 Commercial launch Q1 2017 DESolve NXT Plus Clinical study enrollment to begin Q2 2017 Elixir is expanding BRS technology into clinical indications with significant unmet clinical needs DESappear SFA study is ongoing DESolve is CE Mark approved; Not available for sale in the U.S. DESolve Cx and DESolve NXT are not available for sale. PRAVA is not available for sale and developed by Akesys Medical