EBR Systems, Inc. (ASX: EBR), developer of the world’s only leadless left ventricular endocardial pacing (LVEP) system for heart failure, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has initiated a National Coverage Determination (NCD) to evaluate uniform Medicare coverage for leadless LV endocardial pacing used in cardiac resynchronization therapy (CRT).

The initiation of the NCD process is a key outcome of EBR’s engagement with CMS through the Transitional Coverage for Emerging Technologies (TCET) pathway and represents a significant milestone in establishing uniform national Medicare coverage for the WiSE System.

Key highlights:

• EBR’s WiSE® System is the first technology to enter CMS’s TCET program, underscoring the differentiated clinical significance and innovation of leadless left ventricular endocardial pacing.
• The TCET program expedites Medicare coverage for FDA-designated Breakthrough Devices, and CMS has formally initiated the NCD process for the WiSE System – a major step toward broad national access for patients.
• CMS's projected timeline, which would deliver WiSE NCD approval by early 2027, is significantly faster than the typical pathway of more than three to five years without TCET.
• A positive NCD decision would establish a uniform Medicare coverage framework, materially expand patient access, and support scaled U.S. commercialization.

EBR was the first company selected for the TCET program by CMS, which was launched in 2025 after an earlier pilot phase. TCET provides a meaningfully accelerated pathway compared with the typical three- to five-year timeframe for companies pursuing national Medicare coverage. The WiSE System received U.S. FDA Breakthrough Device designation and U.S. FDA approval, supporting EBR’s progress through TCET toward a national Medicare coverage pathway. A positive NCD outcome would support broader Medicare coverage, expanded patient access, and U.S. commercialization efforts.

The WiSE System received FDA approval in April 2025. CMS granted approval for both the New Technology Add-on Payment (NTAP) program for inpatient procedures and the Transitional Pass-Through (TPT) payment for outpatient procedures, effective 1 October 2025. The ongoing NCD process is intended to establish a national Medicare coverage framework for eligible patients and providers, further supporting access and adoption of the therapy across the U.S.

CMS publishes updates regarding the NCD process through its publicly available tracking sheet: LINK

Under the published timeline, CMS expects the NCD for WiSE to begin in early 2027. Until a national coverage determination takes effect, the WiSE System will continue to be evaluated on an individual basis for coverage of Medicare beneficiaries based on medical necessity.

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.

EBR Systems’ 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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