CVRx (CVRX) 44th Annual J.P. Morgan Healthcare Conference summary

Market Opportunity and Therapy Overview

• Barostim targets a $10.5 billion U.S. heart failure market with less than 1% penetration, addressing a large, underserved patient population suffering from poor quality of life despite existing drug therapies.

• Heart failure affects 6.7 million Americans, with costs projected to reach $70 billion annually by decade's end and $70B by 2030.

• Barostim is an implantable neuromodulation device that complements standard drug therapy by restoring neurohormonal balance, improving quality of life, exercise tolerance, and offering a high response rate.

• Clinical trials and real-world data show significant improvements in patient outcomes, including reduced hospitalizations, enhanced functional status, and potential reductions in all-cause mortality, LVAD, and transplant rates.

• The upcoming BENEFIT-HF trial aims to expand the addressable market to over $30 billion by broadening patient eligibility, potentially tripling the U.S. market to $30.5B and increasing the indicated population from 339K to 983K.

Commercial Strategy and Adoption

• Focused on salesforce productivity, deep adoption in targeted centers, and overcoming barriers such as awareness, evidence, and patient access.

• Redesigned sales approach emphasizes program selling, stakeholder alignment, workflow integration, and replicating high-utilization center ecosystems.

• Advanced practice providers play a key role in patient identification and therapy adoption due to their frequent patient interactions.

• Over 150 medical education events and enhanced direct-to-consumer outreach are increasing awareness and referrals.

• Significant progress in coding, payment, and coverage, with new Category I CPT codes and improved Medicare Advantage approvals.

Evidence Generation and Regulatory Progress

• Ongoing investment in clinical and real-world evidence, including secondary outcomes, physiologic mechanisms, and increasing frequency of publications.

• Four recent publications and FDA IDE approval for the BENEFIT-HF trial, which will enroll 2,500 patients and could triple the market size.

• CMS Category B coverage application underway to support trial costs, with anticipated enrollment start later this year.

• Category I CPT code implemented, improving reimbursement and reducing payer denials, with formalized physician and hospital payments.

• Medicare Advantage approval rates rose to 46% in 2025, indicating improved payer acceptance.