CVRx (CVRX) investor relations material

Market opportunity and therapy overview

• Commercializing a novel autonomic neuromodulation device for heart failure, targeting the 'walking wounded' segment with a $10 billion TAM in the US.

• Device addresses patients with NYHA Class II/III, ejection fraction <35%, and NT-proBNP <1,600.

• Only 1% of patients tolerate all four guideline-directed medications; most face poor quality of life.

• Device is implanted in a 30-minute, minimally invasive procedure.

• Market remains largely untapped by devices despite high disease burden and cost.

Commercialization strategy and execution

• New go-to-market strategy launched in late 2024, focusing on targeted account-level adoption and stakeholder alignment.

• Three-pronged approach: optimized sales force, deep account selling programs, and addressing barriers of access, awareness, and evidence.

• Execution challenges in four of nine regions due to rapid hiring and onboarding; productivity lag attributed mainly to training, not personnel.

• Enhanced onboarding, practical training, and increased support for Area Sales Directors to improve new hire effectiveness.

• Five regions with seasoned leaders are showing strong double-digit growth.

Reimbursement and payer landscape

• Traditional Medicare covers nearly 100% of eligible patients; all seven MACs provide coverage.

• Medicare Advantage coverage improving, with Humana issuing a written policy and approval rates rising above 60%.

• UnitedHealthcare approval rates dropped from 80% to 25%, but Humana improved from 10% to over 90%.

• Category I CPT code effective January 2026, further supporting reimbursement.

• Administrative law judge appeals are used to challenge denials, with success driving policy changes among payers.