EBR Systems, Inc.

What they do

EBR developed WiSE, an implantable cardiac pacing system that delivers stimulation to endocardial heart tissue without leads using ultrasound energy converted to electrical energy. WiSE is used with a co-implanted pacemaker, ICD, or CRT device that provides right ventricular pacing, and essentially replaces the pacing function of a traditional left ventricular lead. The company is commercializing WiSE in the U.S. through a Limited Market Release focused on high-volume hospitals, with plans to later target select markets outside the U.S.

Revenue drivers

• WiSE CRT System — The company's only product; revenue comes from commercial implants of the WiSE CRT System at U.S. hospitals. Annual revenue for 2025 was $1.6 million, with quarterly revenue rising from $170,000 in Q2 2025 to $2.6 million in Q2 2026.

Recent performance

For Q2 2026, EBR reported net sales of $2.6 million from 46 commercial implants at 23 U.S. hospitals. For the six months ended June 30, 2026, net sales were $5.0 million from 87 commercial implants at 29 hospitals. Full-year 2025 revenue was $1.6 million, while net loss widened to $48.8 million from $40.8 million in 2024 and operating cash use increased to $53.2 million. As of June 30, 2026, the company held $59.4 million in cash and equivalents, with total liabilities of $69.8 million and shareholder equity of $68.9 million.

Strategy

EBR is focused on driving adoption of WiSE at key high-volume U.S. hospitals under its Limited Market Release, followed by select high-volume hospitals outside the U.S. after evaluating regulatory and reimbursement considerations. The company intends to make significant investments in its sales and marketing organization by increasing the number of U.S. sales representatives and expanding international marketing programs. During the six months ended June 30, 2026, an additional 48 physicians were trained and 32 additional purchase agreements were signed with target LMR sites. Management also cited continued enrollment in the WiSE-UP post-approval study and the TLC-AU feasibility study.

Risks

• Going concern — The company states there is substantial doubt regarding its ability to continue as a going concern and may need to raise additional capital.
• Limited commercial experience — The company has limited sales and marketing resources and limited experience manufacturing products in commercial quantities.
• Supply chain dependence — EBR depends on third-party suppliers, including single-source suppliers, making it vulnerable to supply disruptions and price fluctuations.
• Reimbursement and adoption — Commercial success depends on significant market acceptance among hospitals, physicians, patients, and payors, and on appropriate physician training.

Outlook

Management points to continued commercial momentum under the Limited Market Release, with case volumes more than doubling from Q4 2025 to Q1 2026 and expansion of physician training and site activations. The company expects to report Q1 2026 revenue between $2.25 million and $2.36 million based on preliminary unaudited results. EBR also advanced its clinical programs, including the WiSE-UP post-approval study and TLC-AU feasibility study, to broaden evidence across patient populations.