Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (May 2013)
19 slides from Cvrx's technical presentation, May 2013
Slide 1: Results from the Rheos Pivotal Trial
Results from the Rheos Pivotal Trial Baroreflex Activation Therapy Sustainably Lowers Blood Pressure in Patients with Resistant Hypertension
Slide 2: Resistant Hypertension Background
Resistant Hypertension Background Drug therapy has been the mainstay of hypertension treatment for over sixty years Even with that success, 20-30% of patients continue to have resistant hypertension even while on optimal medical regimens There is no approved therapy for patients with resistant
Slide 3: 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 ↑ Diuresis ↓ Stiffness ↓ Renin secretion
Slide 4: The CVRx Rheos System
Baroreflex Activation Therapy (BAT) The CVRx Rheos® System Programming System Baroreflex Activation Leads Implantable Pulse Generator 3
Slide 5: Rheos Hypertension Pivotal Trial Design
Rheos Hypertension Pivotal Trial Design Trial Hypothesis: Baroreflex Activation Therapy is Safe and Effective for the Treatment of Resistant Hypertension Prospective randomized double-blind trial 322 patients at 49 sites 55 roll-in patients / 265 randomized (2:1) Co-primary endpoints 1. Sh
Slide 6: Key Inclusion Criteria
Key Inclusion Criteria Systolic Blood Pressure ≥ 160 mmHg Diastolic Blood Pressure ≥ 80 mmHg 24-hour Average Ambulatory Blood Pressure ≥ 135 mmHg At least one month of maximally tolerated therapy with at least three appropriate antihypertensive medications, including a diuretic
Slide 7: 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
Slide 8: 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%
Slide 9: 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% 7.7% 10 N = 181 N = 84 0 Month-6 Month-6 ON OFF Month-6 Group A Group B A-B
Slide 10: 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 Group A
Slide 11: 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
Slide 12: 4th Endpoint – Short Term HTN Therapy Adverse Events
4th Endpoint – Short Term HTN Therapy Adverse Events 6-Month Event Free Rate 100 92% % of Patients Event Free at 6 Months 89% 80 40% Reduction of Hypertensive Crises 23% Reduction of Events 60 40 p-value < 0.001 20 N = 181 N = 84 2.4% 0 Month-6 Month-6 ON OFF Month-6 Group A Group B A-B Goal Diff (A
Slide 13: 5th Endpoint – Long Term Device Adverse Events
5th Endpoint – Long Term Device Adverse Events 12-Month Event Free Rate 100 % of Patients Event Free at 12 Months p-value < 0.001 90 87% 80 OPC: 72% 70 60 N = 265 12 Months Groups A+B
Slide 14: Endpoint Summary
Endpoint Summary Description Timeframe N p-value 7.7% Short Term Acute 6 months 265 0.97 Efficacy 0% 20% 88% Long Term Sustained 12 months 97 <0.001 65% 100% Efficacy 75% Short Term Procedure 30 days 265 1.00 82% 100% Adverse Events 2.4% Short Term BAT 6 months 265 <0.001 Adverse Events -15% 0% 87%
Slide 15: Pre-Specified Ancillary Efficacy Analysis
Pre-Specified Ancillary Efficacy Analysis % of Patients at SBP ≤ 140mmHg; Pre-implant SBP176-179 mm Hg 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
Slide 16: Pre-specified Echo Sub-Study
Pre-specified Echo Sub-Study Long Term Regression in Left Ventricular Hypertrophy 120 LV Mass Index (kg/m2) 117 115 p-value < 0.01 110 105 102 100 95 N = 60 N = 60 90 Baseline 12 Months
Slide 17: 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 SBP ≤ 140 mmHg 40 60% 35 54% SBP Reduction (mmHg) 30 45% 43% 26 20 3
Slide 18: Conclusions
Conclusions 3 primary endpoints achieved: long term efficacy, long term device safety, and short term therapy safety 2 primary endpoints not achieved: short term efficacy and procedure adverse events Weight of overall evidence suggests long term efficacy of BAT to reduce blood pressure in resi
Slide 19: Investigators and Participating Centers
Investigators and Participating Centers US Mark Passman; University of Alabama, AL James Fogartie; Rex HealthCare, NC Mason Weiss; Apex Cardiology Consultants, CA Deepak Gangahar; Nebraska Heart Institute, NE Fred Weaver; University of Southern California, CA Massimo Napolitano; Hackensa