Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (2011)
19 slides from Cvrx's technical presentation, Oct 5, 2011
Slide 1: New Generation Barostim neo System Preliminary Results and Discussion
New Generation Barostim neo™ System Preliminary Results and Discussion Gerd Hasenfuss Heart Center and Heart Research Center University of Goettingen Germany
Slide 2: Presenter Disclosure Information
Presenter Disclosure Information Gerd Hasenfuss DISCLOSURE INFORMATION: The following relationships exist related to this presentation: Servier Honorarium for presentations Consultant CVRx Honorarium for presentations Impulse Dynamics Honorarium for presentations
Slide 3: Autonomic Modulation Clinical Development
Autonomic Modulation Clinical Development Sympathetic Parasympathetic Approach Disease States Companies Modulation Modulation Baroreflex Hypertension CVRx Yes Yes Activation Heart Failure Vagal Stimulation Heart Failure Biocontrol No Yes Spinal Cord Heart Failure MDT No Yes Stimulation MDT, BSX, St
Slide 4: Moving Forward: Barostim neo System
Moving Forward: Barostim™ neo™ System Single Sided 1mm Electrode First Generation Lead (Bilateral) New Generation Lead (Unilateral) Rheos neo 2
Slide 5: Moving Forward: Barostim neo System
Moving Forward: Barostim™ neo™ System Smaller Pulse Generator with Longer Battery Life First Generation New Generation Rheos neo 3
Slide 6: Hypertension Verification Trial Design
Hypertension Verification Trial Design Single arm open label trial 40 patients at 10 sites Enrollment to be completed in September: 32 de-novo subjects and 8 subjects with renal nerves ablated Endpoints Reduction in office cuff systolic blood pressure at 3 and 6 months with Barostim neo sy
Slide 7: Trial Demographics
Trial Demographics Mean ± SD or N (%) Gender (N = 33) 16 Male (48.5%) Age (yrs) (N = 33) 56.5 ± 11.9 BMI (kg/m2) (N = 33) 29.5 ± 4.1 Number of meds (N = 26) 6.8 ± 3 Systolic BP (mean mmHg ± sd) (N = 33) 172.3 ± 20.3 Diastolic BP (mean mmHg ± sd) (N = 33) 100.2 ± 14 Heart Rate (mean bpm ± sd) (N = 33
Slide 8: Trial Baseline Medications
Trial Baseline Medications Baseline Diuretic 77% Beta Blocker 88% Calcium Channel Blocker 69% ACE Inhibitor 38% ARB 65% Alpha Blocker 35% Sympatholytic 58% Minoxidil 19% n = 26 Data on file at CVRx, Inc. 6
Slide 9: Safety Profile
Safety Profile New smaller lead design Substantially improved Unilateral incision procedure safety profile Shorter procedure time as compared to first Conscious sedation sub-study generation Complications • 1 Hematoma resulting in swelling and pain in pocket area. Was resolved by draining. •
Slide 10: Preliminary Efficacy Compared to Previous Trials
Preliminary Efficacy Compared to Previous Trials neo Rheos System System 0 ON ON ON ON OFF -5 - 6.7 - 10 ∆ Systolic BP (mmHg) Barostim at: - 15 3 months for XR-1 3 months for Feasibility -20 6 months for Pivotal -25 - 26.8 28.7 -28.9 -29.1 -30 Mean ± s.e -35 -40 XR-1 Feasibility Pivotal Pivotal Pivo
Slide 11: Hypertension Trial Design Randomized Phase
Hypertension Trial Design Randomized Phase Randomized Controlled Trial 120 patients randomized 1:1 at 30 sites in Europe and Canada Status: enrollment ongoing Endpoints Reduction in office cuff systolic blood pressure at 3 and 6 months with Barostim neo system Safety of the Barostim neo
Slide 12: Key Inclusion Criteria
Key Inclusion Criteria SBP ≥ 140 mmHg within 14 days prior to implant 2 measurements at least 24 hours apart ≥ 3 antihypertensive medications, including a diuretic Medications optimized and stable for ≥ 4 weeks prior to obtaining blood pressure measurements Serum creatinine ≤ 2.5 mg/dL and
Slide 13: Clinical Results Motivating Further Study Of Barostim for Heart Failure
Clinical Results Motivating Further Study Of Barostim for Heart Failure 11
Slide 14: Heart Rate Variability and Turbulence
Heart Rate Variability and Turbulence After 3 Months of Continuous Barostim Therapy N = 21 Wustmann et al, Hypertension 2009. 12
Slide 15: Barostim Reduces Left Ventricular Mass Index
Barostim Reduces Left Ventricular Mass Index at 3 and 12 Months 12 months follow up of 21 pts. With resistant hypertension. Echo/Doppler 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
Slide 16: Barostim neo Heart Failure Trial Overview
Barostim neo Heart Failure Trial Overview 1:1 Randomization Randomize Medical Management Only (N=60) Barostim neo with Medical Management (N=60) 1 2 3 6 Months Implant Open Label Phase • First 10 patients treated open-label Randomized Phase • 120 patients randomized 1:1 18
Slide 17: Barostim neo Heart Failure Trial Overview Key Inclusion Criteria
Barostim neo Heart Failure Trial Overview Primary Efficacy Objective To determine whether the Barostim neo system produces an increase in Left Ventricular Ejection Fraction (LVEF) from screening through 6 months of follow-up Key Inclusion Criteria LVEF ≤ 35% NYHA Class III On stable, gui
Slide 18: Secondary Objectives
Secondary Objectives To compare between the randomized groups 6-month changes in the following measures: Six-Minute Hall Walk NYHA Classification Quality of Life, using the Minnesota Living With Heart Failure Questionnaire NT-pro BNP Creatinine Central pressure and hemodynamic parameters
Slide 19: Summary
Summary Barostim neo System For Hypertension Substantial improvement in safety profile and procedure duration Preliminary results suggest equivalent efficacy to first generation Rheos system Successfully completed conscious sedation procedures Preliminary results suggest Barostim effective