MINNEAPOLIS, July 16, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (「CVRx」), a commercial-stage medical device company, announced today that the Centers for Medicare and Medicaid Services (CMS) has proposed to keep the Barostim implant procedure as part of the New Technology Ambulatory Payment Classification (APC) 1580, with an associated payment of approximately $45,000 for procedures performed in the outpatient setting. CMS is also soliciting comments about the need for a Level 6 Neurostimulator APC. We expect CMS will publish the 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule in November, which is expected to take effect on January 1, 2026.

This proposal follows two other positive developments in the last nine months relating to reimbursement rates. As of Oct. 1, 2024, Barostim was assigned to a higher paying MS-DRG for inpatient procedures. In that same month it was announced that Barostim will transition from Category III to Category I CPT codes for physician payments as of Jan. 1, 2026. These reimbursement updates underscore the clinical value of Barostim and reinforce its role in the heart failure care continuum.

「We appreciate CMS’ proposal to keep Barostim in APC 1580, ensuring appropriate payment for the Barostim implant procedure,」 said Kevin Hykes, President and CEO of CVRx. 「These reimbursement updates, along with the favorable proposed payment levels included in the recently released physician fee schedule, allow us to continue our progress toward expanding access to Barostim for patients suffering from heart failure with reduced ejection fraction, which we believe will help support its broader market adoption and long-term growth.」

About CVRx, Inc.

CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements about the proposal to maintain the APC for the Barostim implant procedure and progress toward expanded access to Barostim are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about future events, and are subject to a number of known and unknown risks and uncertainties that could cause actual results to differ from our expectations, including the final OPPS rule, which could differ from the proposed rule, following the public comment period, and the actual impact of the APC on actual reimbursement and patient access. These forward-looking statements speak only as of the date of this press release. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
emeyers@cvrx.com

Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
ir@cvrx.com