• EBR’s novel WiSE CRT system has been accepted into CMS’s TCET reimbursement pathway
• US FDA completes manufacturing Pre-Approval Inspection
• EBR now expects regulatory approval on or before April 13, 2025

Special Report: The Centers for Medicare and Medicaid Services (CMS) has accepted EBR’s WiSE CRT system into the highly selective Transitional Coverage for Emerging Technologies (TCET) reimbursement pathway.

The TCET pathway is designed for select FDA-designated breakthrough devices and facilitates an expedited Medicare explicit coverage for those devices deemed particularly impactful.

EBR Systems (ASX:EBR) is a developer of the world’s only wireless cardiac pacing device for heart failure.

Its WiSE CRT (cardiac resynchronisation therapy) system uses proprietary wireless technology to deliver pacing stimulation directly inside the left ventricle of the heart.

The patented proprietary Wireless Stimulation Endocardial (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications, effectiveness and reliability issues in cardiac rhythm disease management.

One of a handful of technologies approved

EBR president and CEO John McCutcheon said the company is honoured that WiSE is one of the first five technologies that CMS indicated will be approved to participate in the inaugural year of the CMS TCET pathway.

“This is a new program that provides a faster path to a national coverage decision for medical devices that have the FDA breakthrough device designation status,” he said.

“This program runs parallel with the New Technology Add-on Payment and Transitional Pass-Through Payment programs for new devices with breakthrough status.

“We will provide further updates as we make progress through this exciting, new program.”

Commercial launch in H2 2025

EBR has been gearing up for the commercial launch of WiSE in 2025, initially targeting the significant US market opportunity of US$3.6bn.

The health-tech company spent the second half of last year undertaking commercialisation activities such as manufacturing scale-up (including initial tooling) to leverage established partnerships and presence in the US to drive initial sales, targeting sites that participated in the SOLVE-CRT trial.

In another boost, the US Food and Drug Administration (FDA) has completed the manufacturing Pre-Approval Inspection (PAI), with no material observations made.

This means the premarket approval (PMA) is now in its final phase.

EBR expects regulatory approval on or before April 13, 2025 with commercial launch in H2 2025.

“These audits are very rigorous, and the result is a clear indication of our team’s commitment to following good manufacturing practices,” McCutcheon said.

“Given this favourable PAI outcome and the ongoing collaboration with the PMA review, we can now tighten our FDA approval timing expectations, and we believe that the approval should come on or before the April 13 this year.

“Although the FDA does not make any firm commitments to precise approval dates, there is every indication that this is a likely timeline.”

This article was developed in collaboration with EBR Systems, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.