EBR's WiSE accepted into the CMS’ newly enacted TCET reimbursement pathway

EBR Systems’ (ASX: EBR) WiSE System has been accepted CMS into the TCET pathway and that the US Food and Drug Administration (FDA) has completed the manufacturing Pre-Approval Inspection (PAI) of EBR's facilities, with no observations made.

This programme is designed to expedite Medicare coverage for a highly selective subset of FDA-designated Breakthrough Devices. This allows patients early access to especially important innovative medical technologies. Acceptance into the TCET pathway provides several key benefits for EBR Systems, including:

• Early CMS engagement: Collaborating early with the CMS supports an efficient review process and aligns evidence generation with regulatory and Medicare expectations
• Expedited Medicare coverage: Enables Medicare coverage for the WiSE system, including transitional coverage of up to five years
• Selective acceptance into the programme: CMS has Indicated that they expect to only accept five new technologies each year into the pathway

EBR Systems’ WiSE technology is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle.

This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location.

WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle – and the attendant problems – are potentially eliminated. WiSE is an investigational device and is not currently available for sale in the US.

“EBR 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,” John McCutcheon, EBR Systems’ President and CEO, said.

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