EBR Systems (ASX:EBR) Advances Leadless Pacemaker Technology with Successful Trials
Operational Achievements
EBR Systems has developed the world’s first and only leadless pacemaker for heart failure, targeting an initial addressable market of US$3.6 billion. The WiSE CRT System is unique in delivering cardiac resynchronisation therapy without leads, complemented by over 97 global patents.
Clinical Trial Success
The pivotal SOLVE-CRT trial met all safety and efficacy endpoints, demonstrating significant improvements in heart function and a safety profile comparable to standard care. Results showed a 16.4% decrease in left ventricular end systolic volume and 80.9% of patients remained free from type I complications.
FDA Approval Pathway
EBR Systems has finalized its PMA submission to the FDA, with Breakthrough Device Designation ensuring a prioritised review process. FDA approval is expected on or before 13 April 2025, paving the way for commercialisation in the US market.
Commercial Strategy
The company is well-capitalised with US$66.0 million and is progressing its commercialisation activities to achieve initial revenue in the second half of 2025. EBR is focusing on high-volume procedure sites in the US and expanding its manufacturing capabilities with a new 51,000 sq ft facility.
Motley Fool contributor Lianne Eastty has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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