Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (April 2009)
15 slides from Cvrx's technical presentation, Apr 8, 2009
Slide 1: Disclosure of Relationships
American Society of Hypertension, Inc. (ASH) Disclosure of Relationships Over the past 12 months J.D. Bisognano, CVRx, Modest: Research Grant, Other Research Support , Consultant/Advisory Board. P.W. de Leeuw, CVRx, Modest: Research Grant, Other Research Support, Consultant/Advisory Board. D.S. Bach
Slide 2: Baroreflex Hypertension Therapy Improves Cardiac Structure and Arterial Compliance in Resistant Hypertension
Baroreflex Hypertension Therapy Improves Cardiac Structure and Arterial Compliance in Resistant Hypertension: Results from European and United States Trials of the Rheos® System John D. Bisognano, Peter W. de Leeuw, David S. Bach, Eric G. Lovett, Christopher L. Kaufman, for the DEBuT-HT and Rheos Fe
Slide 3: Majority of US Hypertensive Patients Not at Systolic BP Goal of < 140 mmHg
Majority of US Hypertensive Patients Not at Systolic BP Goal of < 140 mmHg Hypertensive N = 73.6 million Aware (79%) Unaware (21%) 57.9 million 15.7 million Treated (69%) Untreated (10%) 50.8 million 7.1 million 40.2 million (55%) not at goal Controlled (45%) Uncontrolled (24%) 33.4 million 17.4 mil
Slide 4: Background
Background • Patients with resistant hypertension (HTN) are at higher risk to have abnormalities in cardiac structure and increased arterial stiffness. • Mechanisms other than elevated blood pressure (BP) alone may be responsible for these abnormalities. • Although Rheos therapy has been shown to be
Slide 5: The CVRx Rheos System
The CVRx® Rheos System Wireless Programming System Baroreflex Activation Lead Baroreflex Activation Therapy®: • Established Mechanism of Action • Targeted and specific therapy • Personalized and programmable Implantable Pulse Generator • Guarantees compliance 5 Bisognano, American Society of Hyperte
Slide 6: Methods
Methods • N=33 patients participated in the prospective, Echo sub- study of the open-label DEBuT-HT and U.S. Feasibility trials of Rheos Therapy. • Participants were Stage 2 (JNC VII) Hypertensive patients with Systolic BP ≥ 160 mmHg taking ≥ 3 anti- hypertensive medications including at least 1 diu
Slide 7: Demographics
Demographics Male, N (%) 18 (55%) Caucasian, N (%) 27 (82%) Age (years) 52.4 ± 10.4 BMI (kg/m2) 33.0 ± 7.3 Medications (#) 5.2 ± 1.7 Diabetes, N (%) 8 (24%) Previous Myocardial Infarct, N (%) 4 (12%) History of CAD, N (%) 6 (18%) NYHA 0 / I / II / III, N (%) 6 (18%) / 9 (27%) / 14 (42%) / 1 (3%) LV
Slide 8: Cardiac Structure & Workload, Medication
Cardiac Structure & Workload, Medication Variable Baseline ∆ 3 Month (N=33) ∆ 12 Month (N=21) LV Mass Index 138.8 ± 35.4 -17.8 ± 16.0 † -24.6 ± 17.9 † (g/m2) LV Mass Index 68.7 ± 28.7 -9.1 ± 8.7 † -12.3 ± 10.7 † (g/m2.7) Left Atrial 21.1 ± 3.5 -0.5 ± 1.2 ° -1.2 ± 1.6 * Dimension Index (mm/m2) IVS Th
Slide 9: Left Ventricular Mass Index and Geometry
Left Ventricular Mass Index and Geometry Left Ventricular Mass Index Left Ventricular Geometry 100% 100% 80% 80% 60% 60% 40% 40% 20% 20% P < 0.01 P < 0.01 P < 0.01 P < 0.01 N=33 N=33 N=21 N=33 N=33 N=21 0% 0% Baseline 3 Months 12 Months Baseline 3 Months 12 Months Severely Abnormal Eccentric Hypertr
Slide 10: Reduction of LVMi as a Function of SBP Reduction
Reduction of LVMi as a Function of SBP Reduction 0.95 0.9 ∆ LVMi / ∆ SBP (g/m2 / 0.85 0.8 mmHg) 0.75 0.7 0.65 0.6 0.55 0.5 Calcium ACEi ARB Rheos Added to Antagonist Monotherapy Monotherapy Continued Monotherapy Intensive Drug Rx *Drug data from: Klingbeil et al. A meta-analysis of the effects of tr
Slide 11: LVMi and BP Reduction Following 3 Months of Rheos Therapy Case Study
LVMi and BP Reduction Following 3 Months of Rheos Therapy Case Study Pre-Implant 3-Months of Therapy ∆ LVMi 119.9 g/m2 97.0 g/m2 -22.9 IVS Thickness 1.16 cm 0.90 cm -0.26 LV End-Diastolic 5.16 cm 4.12 cm -1.04 Diameter Blood Pressure 185/95 mmHg 155/81 mmHg -30/-14 ATI 22.5 22.5 0 BMI 34.4 kg/m2 33.
Slide 12: Arterial Compliance
Arterial Compliance 1.8 Arterial Compliance (mL/mmHg) * 1.6 * 1.4 1.2 1 0.8 0.6 0.4 0.2 0 e th th in on on el M as M 3 B 12 * P < 0.01 vs. baseline; Data are mean ± SD 12 Bisognano, American Society of Hypertension 2009
Slide 13: Conclusions
Conclusions • Chronic Rheos Therapy leads to a persistent reduction in arterial pressure and improvement in arterial compliance. • Cardiac structure changes accompany pressure reductions but are not significantly correlated suggesting involvement of other mechanisms. • Benefits are incremental to th
Slide 14: Disclosure of Relationships
American Society of Hypertension, Inc. (ASH) Disclosure of Relationships Over the past 12 months J.D. Bisognano, CVRx, Modest: Research Grant, Other Research Support , Consultant/Advisory Board. P.W. de Leeuw, CVRx, Modest: Research Grant, Other Research Support, Consultant/Advisory Board. D.S. Bach
Slide 15: Caution: Rheos System Investigational Device
CAUTION: The CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only. The Rheos System is CE Marked for the treatment of resistant hypertension. CVRx, Rheos, Baroreflex Activation Therapy, and BAT are trademarks of CVRx, Inc. © CVRx