EBR Systems
(ASX: EBR)Share Price and News
About EBR Systems
EBR Systems is a med-tech stock focused on heart diseases. The company’s flagship innovation, the EBR’s WiSE system (Wireless Stimulation Endocardially) CRT System, is the world’s first and only leadless left ventricular endocardial pacing device.
It stimulates the heart, delivering it when the heart slows, becomes irregular, or when the two ventricles become unsynchronised – and yes, it can detect when this happens. WiSE is the size of a coked grain of rice – 5% the size of a conventional pacemaker – because it has no battery in the heart.
This technology addresses the limitations of traditional CRT by eliminating the need for leads and wires, thereby reducing complications associated with lead placement and longevity. Lead or wires can be an impediment for some to have cardiac systems for a variety of reasons.
The system's design allows for compatibility with a range of existing pacing devices, enhancing its versatility in clinical applications. WiSE has been shown to improve patients’ clinical status and reduce heart failure hospitalisations and mortality.
EBR's Company History
EBR Systems was established in 2003 with a mission to develop innovative therapies for cardiac rhythm diseases - specifically a wireless method of stimulating the heart.
In 2011, the company initiated its first human clinical trial for the WiSE CRT System. By 2015, EBR achieved the first regulatory approval - CE Mark Approval. In 2018, it accomplished the world's first totally leadless CRT implant and it initiated a pivotal clinical trial to get FDA approval.
The U.S. FDA granted the WiSE System Breakthrough Device Designation in 2019, recognising its potential to offer more effective treatment options for patients with heart failure.
And so a clinical trial ensured and it was a complete success. The Phase 3 trial, completed in early 2023, there was a significant improvement in heart function compared to the benchmark – as measured by a 16.4% reduction in left ventricular end systolic volume compared to 9.3% for the benchmark. WiSE also saw 80.9% safety vs 70% for the benchmark.
In April 2025, EBR received FDA approval for the WiSE CRT System, marking a significant milestone in the company’s history.
Future Outlook of EBR Systems (ASX: EBR)
The FDA approval of the WiSE CRT System positions EBR Systems for substantial growth in the American cardiac rhythm management market.
At this stage it is only approved for adult patients indicated for cardiac resynchronisation therapy (CRT), have an existing implanted right ventricular pacing system and either have had previous unsuccessful implantations or who have had pacemakers where a standard upgrade is not advised due to the risks. This market is at least US$3.6bn, but the worldwide market is US$13.6bn.
A limited market release will occur in the second half of this year amongst sites where the company has existing relationships with Key Opinion Leaders. A stronger push for sales growth will come in 2026, once the company has expanded its sales team.
EBR recently completed a follow-on equity offering, raising $50m in September 2024, providing the company with additional capital to support its commercialisation efforts and further clinical studies. This capital infusion is expected to aid in expanding market adoption of the WiSE CRT System and exploring new indications for its technology.
Is EBR a Good Stock to Buy?
EBR Systems presents a compelling investment opportunity for those interested a medtech that is just rolling out a product into the market. The company's WiSE CRT System addresses a significant unmet need in heart failure treatment, offering a less invasive and potentially more effective alternative to traditional CRT devices.
However, investors should be mindful of the company's current lack of profitability and the risks associated with commercialising new medical technologies. Trump's tariffs may impact the company - if in no other way, causing share price volatility.
Our Stock Analysis
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Frequently Asked Questions
EBR Systems manufactures and sells the WiSE CRT System. EBR’s WiSE system (Wireless Stimulation Endocardially) uses wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart, thus preventing heart failure.