CVRx Inc

• CVRx's Barostim device, designed to treat heart failure by stimulating baroreceptors, has been assigned a new payment classification by CMS, enhancing its market accessibility. • The Centers for Medicare and Medicaid Services (CMS) has classified Barostim under New Technology APC 1580, ensuring a payment of approximately $45,000, set to continue in 2025. • CMS also reassigned Barostim to a higher-paying MS-DRG for inpatient procedures, effective October 1, increasing payment from a previous range of $17,000-$23,000 to $43,000. • The American Medical Association CPT Editorial Panel approved transitioning Barostim from Category III to Category I CPT codes, expected to be implemented on January 1, 2026.

• CVRx reported that its Barostim device provides sustained improvements in heart failure patients over 24 months, enhancing their physical and psychosocial well-being. • The Barostim device, which uses baroreflex activation therapy, electrically stimulates baroreceptors to restore balance to the autonomic nervous system. • The study, published in the Journal of the American College of Cardiology: Heart Failure, builds on earlier data demonstrating long-term symptomatic benefits. • Barostim received FDA approval in 2019 for advanced heart failure and expanded its label in 2023 for broader use in heart failure patients.

• Device-based therapies are increasingly integral in managing chronic heart failure, offering solutions for structural and neurohormonal abnormalities. • The FDA's Breakthrough Device Program expedites access to innovative heart failure devices, fostering development and evaluation of these therapies. • Recent approvals and novel therapies target structural or neurohormonal issues, complementing pharmacological treatments and filling gaps in unmet needs, such as HFpEF. • Approved devices include MitraClip for mitral regurgitation, Barostim neo for autonomic modulation, and the remedē System for central sleep apnea.