Cvrx, Inc. · NASDAQ:CVRX

Cvrx — Technical Presentation (October 2011)

23 slides from Cvrx's technical presentation, October 2011

  1. Slide 1: First Generation BAT Results in Resistant Hypertension

    First Generation BAT Results in Resistant Hypertension Baroreflex Activation Therapy Sustainably Lowers Blood Pressure in Patients with Resistant Hypertension 0

  2. Slide 2: Baroreflex Activation Therapy (BAT)

    Baroreflex Activation Therapy (BAT) Continuously Modulates the Autonomic Nervous System Carotid Baroreceptor Stimulation Brain Autonomic Nervous System Inhibited Sympathetic Activity Enhanced Parasympathetic Activity Heart Vessels Kidneys ↓ HR ↑ Vasodilation ↑ Natriuresis ↓ Stiffness ↓ Renin secreti

  3. Slide 3: The 1st Generation Rheos System

    Baroreflex Activation Therapy (BAT) The 1st Generation Rheos® System Programming System Baroreflex Activation Leads Implantable Pulse Generator 2

  4. Slide 4: Immediate Dose Response

    Immediate Dose Response ≈ 4 min 3

  5. Slide 5: Acute Muscle Sympathetic Nerve Activity After Months of Therapy

    Acute Muscle Sympathetic Nerve Activity After 3 Months of Therapy Blood Pressure (mmHg) MSNA (%) Time (mins) Heusser et al, HTN 2010 4

  6. Slide 6: Feasibility Study Results: Sustained Reduction of SBP over years

    Feasibility Study Results Sustained Reduction of SBP over 4 years Systolic Diastolic (Baseline = 193 ± 36 mmHg) (Baseline= 111 ± 20 mmHg) 0 Anti-hypertensive Medications Changes Baseline 5.0  1.3 Change in BP (mmHg) -10 1 year -0.2  0.3 -18 2 years -0.7  0.4 -22 -21 -20 3 years -0.8  0.4 4 years

  7. Slide 7: Feasibility Study Results: Acute Reduction of Aortic Augmentation Pressure

    Feasibility Study Results Acute Reduction of Aortic Augmentation Pressure 60 yo female Radial Aortic Control BAT Georgakopoulos et al, JCF 2010 6

  8. Slide 8: Feasibility Study Results: Baroreflex Sensitivity is Chronically Maintained

    Feasibility Study Results Baroreflex Sensitivity is Chronically Maintained 90 85 PRE-implant HR (beats/min) 80 Chronic ON 75 Acute OFF 70 33° 32° 38° 65 60 100 110 120 130 140 150 MAP (mmHg) No evidence for impaired baroreceptor sensitivity No evidence for chronic baroreflex resetting during therapy

  9. Slide 9: Barostim Reduces Left Ventricular Mass Index

    Barostim Reduces Left Ventricular Mass Index at 3 and 12 Months 100% Severely Abnormal Range Women: > 122 g/m2 Men: > 149 g/m2 80% 60% Moderately Abnormal range Women: 96 – 122 g/m2 Men: 116 – 149 g/m2 40% 20% Reference Range P < 0.01 Women: <96 (g/m2) P < 0.01 Men: <116 (g/m2) 0% Baseline 3 Months

  10. Slide 10: Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension

    Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension: Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial John D. Bisognano, George Bakris, Mitra K. Nadim, Luis Sanchez, Abraham A. Kroon, Jill Schafer, Peter W. de Leeuw, and Domeni

  11. Slide 11: Rheos Hypertension Pivotal Trial Design

    Rheos Hypertension Pivotal Trial Design  Prospective randomized double-blind trial  322 patients at 49 sites  55 roll-in patients / 265 randomized (2:1)  Co-primary endpoints 1. Short Term Acute Response 2. Long Term Sustained Response 3. Short Term Procedural AEs 4. Short Term Hypertension Ther

  12. Slide 12: Key Inclusion Criteria

    Key Inclusion Criteria  SBP ≥ 160 mmHg  DBP ≥ 80 mmHg  24 hour ABPM ≥ 135 mmHg  At least one month of maximally tolerated therapy with at least three appropriate antihypertensive medications, including a diuretic 11

  13. Slide 13: Pivotal Trial Baseline Characteristics

    Pivotal Trial Baseline Characteristics Group A Group B (N = 181) (N = 84) Gender 64% Male 55% Male Race 73% Caucasian 78% Caucasian Age (mean years ± sd) 54 ± 11 53 ± 10 BMI (mean kg/m2 ± sd) 33 ± 5 32 ± 6 Antihypertensive Meds (mean # ± sd) 5.2 ± 2 5.2 ± 2 Systolic BP (mean mmHg ± sd) 179 ± 22 176

  14. Slide 14: Pivotal Trial Baseline Medications

    Pivotal Trial Baseline Medications Group A Group B (N = 181) (N = 84) Diuretic 96% 92% Beta Blocker 86% 83% Calcium Channel Blocker 65% 71% ACE Inhibitor 57% 54% ARB 47% 43% Alpha Blocker 12% 18% Sympatholytic 44% 54% Minoxidil 14% 15% 13

  15. Slide 15: 1st Endpoint – Short Term Acute Response

    1st Endpoint – Short Term Acute Response 20% super-superiority – Responder rate device ON vs. device OFF 70 % of Patients with ≥ 10mmHg 60 SBP Reduction at 6 Months 54% 50 46% 40 30 20 Goal Diff (A-B) >20% 10 N = 181 N = 84 8% 0 Month-6 Month-6 ON OFF Month-6 ON - OFF 14

  16. Slide 16: 2nd Endpoint – Long-term Sustained Response

    2nd Endpoint – Long-term Sustained Response Percent of Sustained Responders at 12 Months % of Sustained Responders at 12 months 100 90 88% 80 p-value < 0.001 70 OPC: 65% 60 N = 97 Month-12 ON OPC: Objective Performance Criteria 15

  17. Slide 17: 3rd Endpoint – Short Term Procedure Adverse Events

    3rd Endpoint – Short Term Procedure Adverse Events 30-Day Event Free rate 90 % of Patients Event Free at 30 days Types of Adverse Events OPC: 82% 4.4% permanent nerve injury 80 (numbness, dysphagia, 75% dysphonia) 70 4.8% transient nerve injury 4.4% general surgical 60 complications (86% resolved) 2

  18. Slide 18: 4th Endpoint – Short Term HTN Therapy Adverse Events

    4th Endpoint – Short Term HTN Therapy Adverse Events 6-Month Event Free Rate 100 % of Patients Event Free at 6 Months 91.7 90 87.6 80 15% + C.I. 72.6 Goal Diff (A-B) < 15% 70 60 p-value < 0.001 N = 85 N= 170 Month-6 Month-6 OFF ON 17 40% Reduction of Hypertensive Crises, 23% Reduction of Events

  19. Slide 19: 5th Endpoint – Long Term Device Adverse Events

    5th Endpoint – Long Term Device Adverse Events 12-Month Event Free Rate % of Patients Event Free at 12 Months 100 p-value < 0.001 90 88% 80 OPC: 72% 70 60 N = 265 12 Months OPC: Objective Performance Criteria Groups A+B 18

  20. Slide 20: Pre-Specified Ancillary Efficacy Analysis

    Pre-Specified Ancillary Efficacy Analysis % of Patients at SBP ≤ 140mmHg p = 0.70 60 p = 0.005 53% 51% SBP ≤ 140 mmHg 45 42% % of Patients 30 24% 15 N = 172 N = 80 N = 171 N = 81 0 Month-6 Month-6 Month-12 Month-12 ON OFF ON ON Group A Group B Group A Group B 19

  21. Slide 21: Pre-specified Echo Sub-Study

    Pre-specified Echo Sub-Study Long Term Regression in Left Ventricular Hypertrophy 120 117 LV Mass Index (g/m2) 115 p-value < 0.01 110 105 102 100 95 N = 60 N = 60 90 Baseline 12 Months 20

  22. Slide 22: Additional Observations – Post-Hoc Efficacy Analysis

    Additional Observations – Post-Hoc Efficacy Analysis Results at 12 Months and Beyond  81% of patients were responders (SBP ≥ 10 mmHg relative to pre- implant)  Therapeutic efficacy continued to improve over time: Percent Patients at SBP Goal 40 60% 35 54% SBP Reduction (mmHg) 30 26 45% 43% 20 30%

  23. Slide 23: Summary

    Summary  Baroreflex Activation Therapy in resistant hypertension  Programmable device with ability to personalize therapy  Significant & sustained BP reduction with regression of LV Hypertrophy  MSNA measurements suggest sympathetic drive reduction is the mechanism of action  Pivotal Trial resu

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