EBR Systems, Inc. has submitted an NTAP application

Oct 16, 2024

EBR Systems, Inc. (ASX: EBR) has submitted the New Technology Add-On Payment application to the Centers for Medicare & Medicaid Services for its WiSE CRT System. With the FDA breakthrough device designation, EBR's WiSE CRT System meets the new technology and substantial clinical improvement requirements and sets a new standard for innovation in the industry. This pivotal step represents a significant leap forward in EBR's mission to secure US reimbursement, ensuring patients have access to this life-changing technology and driving widespread adoption in the US market. EBR is poised for FDA regulatory approval in Q1 2025, with NTAP coverage anticipated to begin in Q4 2025.

This achievement brings it closer to delivering its unparalleled technology to needy patients. The unwavering focus remains on executing its comprehensive commercialization strategy to accelerate market adoption and provide broad access throughout the US.

 

 

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