Medicare Add-on Payments Support U.S. Commercialization

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing device for heart failure, today announced that Centers for Medicare & Medicaid Services (CMS) has finalized New Technology Add-On Payment (NTAP) reimbursement for the WiSE System in inpatient settings, effective October 1, 2025. Additionally, the company confirmed that CMS has issued a Healthcare Common Procedure Coding System (HCPCS) code for Transitional Pass-Through (TPT) reimbursement for use of the WiSE System in outpatient settings, also effective October 1, 2025. Together, these reimbursement milestones establish a clear pathway to broad adoption of the WiSE System for eligible Medicare beneficiaries.

John McCutcheon, President & Chief Executive Officer said: “We are pleased that the WiSE System has secured both NTAP and TPT reimbursement. These important add-on payments expand patient access to our groundbreaking leadless left ventricular endocardial pacing (LVEP) technology for heart failure patients, by providing additional hospital reimbursement. These awards support hospital adoption of WiSE across inpatient and outpatient settings as a key element of our U.S. rollout.”

Erik Strandberg, Chief Commercial Officer, added: “The NTAP and TPT approvals support our commercial plan to bring the WiSE System to heart failure patients who could benefit from leadless LVEP. We are now commencing our limited market release (LMR) with all the elements in place to support a successful commercial launch.”

For more information about EBR, please visit https://www.ebrsystemsinc.com/.

About EBR Systems

EBR Systems is a cardiac rhythm management company on a clear mission: to transform the lives of people with heart failure by helping physicians deliver optimal cardiac pacing. The WiSE System—the first FDA approved system for leadless left ventricular endocardial pacing (LVEP) in CRT—combines advanced engineering with peer-reviewed clinical evidence to expand access for patients who previously lacked options and to improve outcomes.

About the WiSE Technology

The WiSE System delivers LV endocardial pacing without a transvenous LV lead using targeted ultrasound. A subcutaneous transmitter and battery detect the RV pacing signal and, within milliseconds, emit ultrasound energy that a rice-sized endocardial electrode converts into an electrical pulse—enabling synchronized biventricular pacing. This LVEP approach is engineered for versatility across patient anatomies and is supported by peer-reviewed outcomes from SOLVE-CRT pivotal trial. WiSE is approved for commercial use in the United States and limited to clinical study use outside of the United States.

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions, and expectations and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond the Company’s control, subject to change without notice and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct.

All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our products and achieve broad market adoption including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products; our expectations with respect to our clinical trials, including enrollment in or completion of our clinical trials and our associated regulatory applications and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. These forward-looking statements are based on EBR Systems’ current expectations and inherently involve significant risks and uncertainties. EBR Systems’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of certain risks and uncertainties including those risks described in more detail in its most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other documents on file with the SEC from time to time and available on the SEC’s website at www.sec.gov.

Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. EBR does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. EBR may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

Foreign Ownership Restriction

EBR’s ASX-traded (ASX: EBR) CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. The holders of EBR’s CDIs are unable to sell the CDIs into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.

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