EBR Faces Regulatory Hurdles Despite Preliminary Medicare Reimbursement Win

EBR Systems Advances Reimbursement Milestone

EBR Systems, a Silicon Valley-based medical device company, has achieved a significant regulatory milestone with preliminary approval from the U.S. Centers for Medicare & Medicaid Services (CMS) for its WiSE® Cardiac Resynchronisation Therapy (CRT) System. This approval under the Transitional Pass-Through (TPT) reimbursement scheme is expected to take effect in October 2025 and will remain valid for three years.

The TPT reimbursement program is designed to accelerate hospital adoption of innovative medical technologies that offer substantial clinical benefits but whose costs are not yet fully reflected in standard Medicare payment rates. For EBR, this means hospitals treating heart failure patients with the WiSE CRT System in outpatient settings will receive Medicare reimbursement, removing a significant barrier to wider use.

Implications for Market Adoption and Patient Access

The WiSE CRT System is notable for being the world’s only wireless, endocardial pacing device for the left ventricle, eliminating the need for traditional pacing leads that have historically caused complications. With this reimbursement pathway, EBR’s commercial team can now present a clearer financial case to hospitals, potentially driving faster adoption and expanding patient access to this cutting-edge therapy.

EBR’s CEO John McCutcheon highlighted the importance of this development, noting that the combination of outpatient TPT reimbursement and the previously proposed inpatient New Technology Add-On Payment (NTAP) scheme positions the company to target broad patient access across care settings in the US.

Next Steps and Regulatory Engagement

While preliminary approval is a major step forward, EBR will continue to engage with CMS through the upcoming annual rulemaking and public comment process before final reimbursement determinations are made. The final terms and timing could still evolve, but the current outlook is positive for EBR’s commercial trajectory.

Investors and industry watchers will be keen to monitor how this reimbursement approval influences hospital uptake, competitive dynamics in cardiac pacing, and ultimately, EBR’s financial performance in the coming years.