EBR Systems Secures A$55.9M to Launch FDA-Approved Wireless Cardiac Device

Capital Raise Fuels Commercial Ambitions

EBR Systems, a Silicon Valley-based medical device innovator, has successfully completed a fully underwritten institutional placement raising A$55.9 million at a discounted price of A$1.00 per CDI. This capital injection is earmarked to accelerate the commercialisation of its novel WiSE® Cardiac Resynchronisation Therapy (CRT) system, which recently secured FDA approval in April 2025. The placement attracted strong support from both existing and new investors, underscoring confidence in EBR’s growth trajectory.

Alongside the placement, EBR plans to offer a non-underwritten Security Purchase Plan (SPP) targeting an additional A$6 million from eligible shareholders, further bolstering its financial position.

Strategic Commercialisation Pathway

The company is adopting a measured approach to market entry, initially targeting a Limited Market Release (LMR) in the second half of 2025. This strategy leverages established relationships with Key Opinion Leaders (KOLs) and legacy accounts to build early adoption momentum. EBR aims for a sustainable utilisation rate of two implants per hospital per month once reimbursement pathways are active.

Crucially, EBR has secured eligibility for inpatient add-on payments through the Centers for Medicare & Medicaid Services (CMS) New Technology Add-on Payment (NTAP) program, with outpatient reimbursement requirements met but awaiting final CMS approval. Both reimbursement programs are anticipated to commence in October 2025, providing a critical financial foundation for commercial uptake.

Scaling Manufacturing and Sales Capabilities

Proceeds from the capital raise will also support scaling manufacturing operations and expanding the sales force. EBR has secured a lease for a new state-of-the-art manufacturing facility, expected to be fully operational by the first half of 2026, to meet anticipated demand. Recent key appointments, including a new Chief Commercial Officer, signal a strengthening of the commercial leadership team to drive market penetration.

With a pro-forma cash balance of approximately US$84 million (around A$131 million) post-placement, EBR is well-positioned to fund its operations and commercialisation efforts into late 2026, providing a runway to execute its growth plans.

Looking Ahead

EBR’s wireless cardiac pacing technology represents a significant advancement in heart failure treatment by eliminating the need for traditional pacing leads, which have historically posed complications. The company’s progress from FDA approval to commercial launch, supported by secured reimbursement pathways and robust funding, marks a pivotal phase in its evolution from innovator to commercial player.

Investors and industry watchers will be closely monitoring the initial market response, reimbursement finalisations, and the operational ramp-up of manufacturing and sales capabilities as EBR moves toward broader commercial distribution in 2026.