EBR Systems Reports Revenue Growth Following FDA Approval, Despite Increased Net Loss

EBR Systems, Inc. reported its financial results for the third quarter and the first nine months of 2025, revealing a significant increase in revenue following the FDA approval of its WiSE CRT System in April 2025. For the three months ended September 30, 2025, the company generated revenue of $512,093, compared to no revenue in the same period of 2024. For the nine months ended September 30, 2025, total revenue reached $681,797, marking a substantial increase from zero in the prior year. Despite this revenue growth, EBR Systems recorded a net loss of $12.2 million for the third quarter, up from a loss of $10.1 million in the same quarter of 2024, and a net loss of $34.7 million for the nine-month period, compared to a loss of $30.7 million in 2024.

The company's operating expenses increased significantly, driven primarily by a 103.6% rise in selling, general, and administrative expenses, which totaled $5.9 million for the third quarter. This increase was attributed to workforce expansion to support sales and marketing efforts following the product's FDA approval. Research and development expenses slightly decreased by 0.9% to $6.2 million in the third quarter, reflecting a reduction in contract manufacturing costs. The overall increase in operating expenses contributed to the higher net loss reported for the period.

EBR Systems also reported a notable increase in its balance sheet figures, with total assets rising to $105 million as of September 30, 2025, compared to $73.6 million at the end of 2024. This increase was largely due to a rise in cash and cash equivalents, which reached $12.6 million, and marketable securities, which totaled $55.7 million. The company’s working capital improved to $71.9 million, bolstered by proceeds from recent capital raises, including an institutional placement and a rights offering that collectively generated approximately $46.2 million.

Operationally, EBR Systems has focused on expanding its market presence through a Limited Market Release (LMR) strategy, targeting high-volume hospitals in the U.S. As of September 30, 2025, the company had established partnerships with seven active LMR hospitals. The company plans to expand its commercial activities internationally once it secures the necessary regulatory approvals in markets such as Australia and the United Kingdom. The Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-On Payment (NTAP) for the WiSE CRT System, which is expected to enhance reimbursement rates and facilitate broader adoption.

Looking ahead, EBR Systems anticipates continued net losses as it invests in sales and marketing to drive adoption of the WiSE CRT System. The company believes its existing cash, cash equivalents, and marketable securities, along with projected revenue, will be sufficient to fund operations for at least the next 12 months. However, the company acknowledges the need for additional capital to support its growth and operational needs, which may involve seeking further equity or debt financing in the future.