World first left ventricle heart failure device gears up for approval

EBR Systems (ASX: EBR) has developed the world’s first wireless device that is capable of delivering cardiac resynchronization therapy (CRT) to patients. EBR’s Wireless Stimulation Endocardially (‘WiSE’) CRT system fills a massive gap in the market as the only leadless solution for left ventricle pacemaking.

Traditional pacemakers are generally suboptimal for most of their intended applications, but are still the standard of care in most cases of cardiac arrhythmias that require electrical intervention. They are difficult to place, can migrate and sometimes fracture, are a pathway for pathogens to the myocardium and are associated with phrenic nerve stimulation. Critically for EBR’s utility, the coronary sinus limits left ventricle (LV) lead placement locations, and the LV lead must be placed outside the heart in order to avoid blood clots.

The company is in the final stages of submitting a Premarket Approval Application (PMA) to the FDA, having submitted four out of the required five modules required for PMA submission. EBR has recently stated they expect approval to be granted in the first quarter of 2025, and have already attained Breakthrough Device Designation from the FDA.

The results for the company’s pivotal SOLVE-CRT study met all its designed endpoints and confirmed the WiSE CRT System is a highly effective treatment option for patients with heart failure. The primary efficacy endpoint measured was a reduction in left ventricular end systolic volume, with the target of a 9.3% reduction being significantly surpassed – averaging a 16.4% reduction. This demonstrated the desired improvement in heart function.

The primary safety endpoint was the measurement of patients who were free of type one complications, with the result of 80.9% beating the target of 70% and being roughly equal to the current standard of care (SoC). Other studies using SoC treatment for CRT upgrades have shown 81.3% freedom from device & procedure related complications. Notably, complication rates were higher during the earlier phases and decreased with experience. 

Given that EBR is on the home stretch of its approval pathway after many years of research and clinical trials, investors are likely taking significant interest in their go to market strategy. EBR plans on leveraging its existing partnerships and presence in the US in order to launch a sales campaign from H1 of 2025. 

This will begin with driving initial sales through the clinical trial sites that are naturally familiar with the product, while making a push into the high volume CRT procedure sites – which tend to be highly concentrated. By 2027, EBR plans to have targeted 20 out of 250 of these locations, representing more than 50% of the US CRT market. EBR’s initial addressable market totals over US$2.6 billion, which could grow to more than US$9.6 billion with some additional approvals for applications that are currently being investigated.

The WiSE CRT System is protected by over 97 issued patents across the globe, and does not require a battery. Horizon 3’s Matt McNamara explains the technology: “It’s a receiver of ultrasound, which is synchronized to what the heart needs,and it converts that ultrasound into an electrical stimulus”.

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