Cvrx, Inc. · NASDAQ:CVRX
Cvrx — Technical Presentation (May 2013)
11 slides from Cvrx's technical presentation, May 2013
Slide 1: Barostim Therapy: Ongoing/Upcoming Trials
Barostim Therapy Ongoing/Upcoming Trials Professor William T. Abraham, MD, FACC The Ohio State University Columbus, OH CAUTION: The Rheos® System is an investigational device and is limited by Federal (or United States) law to investigational use. Note: The Barostim neo is CE Mark approved, but is n
Slide 2: Presenter Disclosure Information
Presenter Disclosure Information Dr. William T Abraham DISCLOSURE INFORMATION: The following relationships exist related to this presentation: CVRx Consulting fees and speaker honoraria
Slide 3: ANS Modulation Competitive Landscape
ANS Modulation Competitive Landscape Hypertension Heart Failure Number of Para- Para- Therapy Companies Sympathetic sympathetic Sympathetic sympathetic Spinal Cord 2 Stimulation Renal Nerve Ablation 12 Vagal Nerve 1 Stimulation Baroreflex 2 Activation
Slide 4: Current Status of Hypertension
Current Status of Hypertension Long-term efficacy of Barostim demonstrated in a large cohort 33 mm Hg reduction in SBP over 2+ years 13% reduction in LV mass over 12 months Rheos Pivotal Trial demonstrated long-term Barostim therapy safety, including reductions in events compared to control
Slide 5: Next Steps for Hypertension
Next Steps for Hypertension Market launch of Barostim in Europe A randomized, controlled trial to obtain US and Canadian Regulatory Approval European Post-Market registry and trials to demonstrate long-term protective effect of Barostim on patient outcomes
Slide 6: Potential Trial Design
Potential Trial Design Patients with Resistant Hypertension SBP ≥ 160 mm Hg 24-hour ambulatory SBP ≥ 135 mm Hg ≥3 antihypertensive medications including ≥ 1 diuretic Medical therapy optimized prior to enrollment and remaining constant throughout trial unless medically necessary Randomize
Slide 7: Endpoints for Hypertension RCT
Endpoints for Hypertension RCT Primary Efficacy Objective: SBP reduction in Barostim versus control group from pre-implant baseline Secondary Efficacy Objective: Ambulatory BP Primary Safety Objective: 30-day system- and procedure-related complications compared to an appropriate performance
Slide 8: Current Status of Heart Failure
Current Status of Heart Failure Substantial body of pre-clinical data demonstrating Barostim efficacy in Heart Failure Clinical data validate therapeutic effects relevant across the HF spectrum Randomized, controlled trial in Class III HF with EF < 35% ongoing in Europe and Canada
Slide 9: All EF Groups Feasibility Study
All EF Groups Feasibility Study Implant SCREENING O DEVICE 1-MONTH F ON STABILITY F LONG-TERM -0.5 0 1 2 3 4 5 6 FOLLOW-UP Months US and Canada NYHA Class III HF Optimal stable heart failure therapy for at least 4 weeks No EF restriction Enrollment quotas in EF Groups to assure coverage of
Slide 10: HTN Centers
HTN Centers HTN Center Requirements Large treated HTN patient population Large physician practice Expertise in optimizing HTN medications in drug resistant population Strong collaboration with implanting surgeon Electronic medical records (ability to access for patient search) Prior experience with
Slide 11: HF Centers
HF Centers HF Center Requirements Large HF patient population Large cardiology practice Early adopters of novel technologies Strong collaboration with vascular surgeon Electronic medical records Prior experience with device RCTs Significant patient recruitment in previous HF studies Dedicated resear