EBR’s Medicare Approval: A Boost with Uncertain Long-Term Coverage

• CMS grants Transitional Pass-Through reimbursement for WiSE CRT System
• Reimbursement effective from October 1, 2025, lasting three years
• Complements existing New Technology Add-On Payment for inpatient use
• Supports broader patient access and hospital adoption in U.S. outpatient settings
• EBR’s wireless cardiac pacing technology addresses heart failure treatment challenges

EBR Systems Secures Medicare Reimbursement Milestone

EBR Systems, a Silicon Valley-based medical device innovator, has achieved a significant regulatory and commercial milestone with the U.S. Centers for Medicare & Medicaid Services (CMS) granting final approval for Transitional Pass-Through (TPT) reimbursement for its WiSE® Cardiac Resynchronisation Therapy (CRT) System. This approval, effective from October 1, 2025, marks a critical step in facilitating hospital adoption of the company’s novel wireless pacing technology in outpatient settings.

The TPT reimbursement program is designed to support breakthrough medical technologies that demonstrate substantial clinical benefits but whose costs are not yet fully reflected in standard Medicare payment rates. By securing this status, EBR Systems ensures that hospitals receive incremental Medicare payments when treating heart failure patients with the WiSE CRT System, which could accelerate uptake and patient access across the United States.

Complementing Existing Inpatient Coverage

This latest approval complements a previously announced New Technology Add-On Payment (NTAP) for inpatient use of the WiSE System, also commencing October 1, 2025. Together, these reimbursement pathways provide comprehensive Medicare coverage for both inpatient and outpatient settings, enhancing the commercial attractiveness of EBR’s technology and offering hospitals a clear financial incentive to adopt the wireless pacing system.

John McCutcheon, EBR Systems’ President and CEO, highlighted the importance of this dual reimbursement framework, noting that it advances the company’s mission to expand patient access to a therapy that eliminates the need for traditional pacing leads, which have historically been a source of complications and reliability issues in cardiac rhythm management.

Innovating Cardiac Care with Wireless Technology

The WiSE CRT System represents a pioneering approach in cardiac pacing by delivering wireless, endocardial stimulation of the left ventricle. This method is considered more physiologically effective and anatomically appropriate compared to conventional lead-based systems. The implant itself is remarkably small, roughly the size of a large grain of rice, and aims to reduce complications associated with leads placed on the heart’s surface.

Currently available for sale only in the U.S., the WiSE technology is positioned to disrupt the cardiac rhythm disease treatment landscape by offering a safer, more reliable alternative to existing therapies. The CMS reimbursement approvals are expected to play a pivotal role in driving hospital adoption and patient access, which are critical for the company’s commercial success.

Looking Ahead

While the TPT reimbursement is granted for a three-year period, providing a window for market penetration, the company and investors will be closely watching how hospitals respond to the new payment incentives and how quickly patient uptake grows. The milestone also sets the stage for potential future reimbursement extensions or permanent coverage, which would be essential for sustained commercial viability.

Bottom Line?

EBR’s dual Medicare reimbursement approvals unlock new growth avenues but raise questions about long-term coverage sustainability.

Questions in the middle?

• How quickly will U.S. hospitals adopt the WiSE CRT System under the new reimbursement framework?
• What is the anticipated revenue impact for EBR Systems over the next three years?
• Will CMS extend or make permanent the Transitional Pass-Through reimbursement after the initial period?