EBR Faces Commercial Scaling Risks Despite Medicare Reimbursement Boost for WiSE CRT

Medicare Reimbursement Unlocks Commercial Potential

EBR Systems, the Silicon Valley-based innovator behind the WiSE CRT System, has taken a significant step forward in commercialising its wireless cardiac pacing technology. In its Q3 2025 report, the company announced that the Centers for Medicare & Medicaid Services (CMS) approved two critical reimbursement pathways, the New Technology Add-on Payment (NTAP) for inpatient use and the Transitional Pass Through (TPT) for outpatient procedures. Both programs commenced on October 1, 2025, providing hospitals with a clear and comprehensive Medicare payment framework for the novel WiSE CRT System.

NTAP offers an add-on payment of up to US$41,145 per eligible inpatient case, supplementing existing Diagnosis-Related Group (DRG) payments. Meanwhile, TPT facilitates reimbursement for outpatient cases, supporting adoption in day procedure settings. Together, these approvals address a key barrier to hospital uptake by reducing financial uncertainty and aligning reimbursement with the device’s cost and clinical value.

Rapid Uptake and Revenue Growth

Following FDA approval in April 2025, EBR Systems has seen encouraging early commercial traction. The number of WiSE CRT System implants tripled from 3 in Q2 to 12 by the end of Q3, reflecting growing confidence among implanting physicians and hospitals. Notably, two sites performed three cases each during the quarter, indicating the development of internal referral pathways and procedural familiarity.

This momentum translated into a 201% jump in quarterly revenue to US$0.512 million, a strong signal of market acceptance during the pilot launch phase. The company also expanded its commercial footprint by signing eight additional purchasing agreements and training 14 new physicians, preparing for the Limited Market Release (LMR) program that began in early October 2025.

Financial Position and Operational Outlook

EBR Systems reported a net loss of US$12.2 million for Q3 and US$34.7 million for the nine months ended September 30, 2025, reflecting ongoing investments in sales, marketing, and manufacturing scale-up. The company holds a robust cash position of US$73 million in cash, equivalents, restricted cash, and marketable securities, providing a runway to support commercial expansion and manufacturing facility completion in Santa Clara, California, expected in 2026.

Gross margins for the quarter were 43.8%, positively influenced by the use of inventory previously expensed during clinical trials. However, excluding this inventory, margins would have been negative, underscoring the early-stage nature of commercial operations and the need for scale to improve profitability.

Strategic Focus and Risks Ahead

CEO John McCutcheon emphasised the company’s focus on consistent execution and patient outcomes as it navigates the transition from clinical trials to commercial adoption. The upcoming post-marketing study mandated by the FDA will be critical to maintaining regulatory approval and supporting broader market acceptance.

EBR Systems also faces external risks including evolving reimbursement policies, competitive pressures from established cardiac device manufacturers, and macroeconomic uncertainties such as trade policies and inflationary pressures. The company’s ability to scale manufacturing, expand its sales force, and secure durable reimbursement will be key determinants of its future trajectory.

Overall, the Q3 report marks a pivotal moment for EBR Systems as it moves from regulatory approval to commercialisation, leveraging Medicare reimbursement to accelerate adoption of its innovative wireless cardiac pacing technology.