EBR Systems Submits New Technology Add-On Payment Application

EBR Systems, Inc. (ASX: EBR), a leading developer of wireless cardiac pacing devices for heart failure, has taken a significant step in its commercialization strategy by submitting the New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services (CMS) for its WiSE® CRT System. The WiSE® CRT System, recognized as a breakthrough device by the FDA, positions EBR Systems to meet critical new technology and clinical improvement standards set by CMS.

FDA Breakthrough Designation Supports Strong Case for NTAP Approval

The WiSE CRT System has already received breakthrough device designation from the FDA, which ensures it meets the "Newness" and "Substantial Clinical Improvement" requirements of the NTAP application. EBR Systems is confident that the cost criterion will also be met, based on its pricing strategy for the WiSE CRT System. This innovative system represents a groundbreaking advancement in cardiac pacing, eliminating the need for pacing leads and reducing the risks associated with traditional cardiac pacing methods.

Significant Milestone for US Market Expansion and Reimbursement

Securing NTAP designation would be a major achievement for EBR Systems, allowing reimbursement for in-patient procedures involving the WiSE CRT System in the Medicare patient population. The NTAP payments, which cover up to 65% of the technology’s cost or the amount exceeding standard Medicare Severity Diagnosis Related Groups (MS-DRG) rates, would help eliminate financial barriers for patients and further boost the commercialization and market adoption of the system in the US.

Timeline for Regulatory Approval and Market Adoption

EBR anticipates receiving FDA approval for the WiSE CRT System in Q1 2025, ensuring the NTAP coverage can begin by October 2025. This would align with CMS’s fiscal year 2026, providing timely support for patients and healthcare providers looking to adopt this revolutionary technology.

CEO Commentary: Moving Towards Market Leadership in Cardiac Pacing

John McCutcheon, President & CEO of EBR Systems, expressed his excitement regarding the NTAP application submission, stating, “This milestone brings us closer to delivering our unique technology to patients in need. We are focused on accelerating market adoption and enabling widespread access in the US.”

Conclusion: EBR Systems Paves the Way for Innovative Cardiac Pacing

With the NTAP application submission, EBR Systems continues to execute its broader commercialization strategy, leveraging the WiSE CRT System's groundbreaking capabilities and FDA breakthrough designation. As the company moves towards FDA approval and reimbursement, it is poised to revolutionize cardiac pacing and improve the quality of care for heart failure patients in the US.