CVRx (CVRX) 46th Annual William Blair Growth Stock Conference summary

Market opportunity and unmet need

• Heart failure affects 6.7 million Americans, with annual costs projected to reach $70 billion by 2030 and significant unmet needs in quality of life and symptom management.

• Only 1% of patients reach therapeutic doses of all four guideline-directed drugs, and most discontinue at least one drug within a year, with limited impact on quality of life.

• Barostim targets the 'forgotten middle' of heart failure patients, offering a new device-based therapy for those not adequately helped by medications and is positioned for patients with persistent symptoms after guideline-directed medical therapy.

• The addressable U.S. market is estimated at $10.5 billion, with less than 1% current penetration, defined by specific clinical criteria.

• Most heart failure patients experience poor quality of life, and many value symptom relief over longevity.

Technology and clinical evidence

• Barostim is an implantable neuromodulation therapy that restores signaling to the brain, reducing the fight-or-flight response and neurohormonal storm that drives heart failure progression.

• The device is implanted in under 60 minutes, is extravascular, and has a strong safety profile with 97% freedom from major complications.

• The pivotal BeAT-HF trial showed a twofold improvement in exercise capacity and quality of life, with a 94% responder rate and positive trends in reducing mortality and hospitalizations.

• Real-world data from the Premier Healthcare Database showed an 85% reduction in hospitalizations post-therapy.

• The BENEFIT-HF trial, enrolling 2,500 patients, aims to expand the eligible population and could triple the addressable market to $30 billion if successful.

Regulatory and reimbursement progress

• FDA guidance in 2025 and 2026 supports the use of high-quality real-world evidence for label and indication expansion.

• Humana, the second-largest Medicare Advantage provider, issued a written coverage policy for Barostim in May 2026, covering both FDA-indicated and trial patients, including 5.2 million members.

• Category I CPT codes have improved access, with 30-day Medicare Advantage approval rates now above 60% and 49% in early 2026.

• All Medicare Administrative Contractors are processing claims, with 96% of traditional Medicare and outpatient claims being paid.

• Category I coding has improved access across Medicare, Medicaid, TRICARE, VA, and some commercial payers.