EBR Systems Showcases WISE Leadless CRT Launch, Reimbursement Wins at JPM Healthcare Conference

EBR Systems (ASX:EBR) used its presentation at the 2026 J.P. Morgan Healthcare Conference to highlight the commercial launch of its WISE system, which management described as the world’s first and only leadless pacemaker technology designed specifically for left ventricular pacing in cardiac resynchronization therapy (CRT). President and CEO John McCutcheon said the company received FDA approval in 2025 and began a limited market release in the fourth quarter of 2025, positioning the company to ramp commercialization as reimbursement and contracting fall into place.

Positioning in cardiac rhythm management and CRT

McCutcheon framed EBR’s opportunity within the cardiac rhythm management (CRM) market, which he described as consisting of three major areas: standard pacing, defibrillation (ICDs), and CRT. CRT is used to treat a form of heart failure in which the left and right sides of the heart do not beat in synchrony, leading to worsening cardiac efficiency and patient outcomes.

In conventional CRT systems, the left-sided pacing lead is placed on the outside of the heart. McCutcheon said this approach is used because placing a lead inside the left ventricle has historically increased stroke risk. He argued that endocardial pacing (inside the heart) is a superior method, and said EBR’s WISE system enables leadless pacing within the left ventricle without a traditional lead.

How the WISE system works alongside existing devices

McCutcheon emphasized that EBR’s technology is complementary to devices sold by large incumbents including Medtronic, Boston Scientific, and Abbott. He described WISE as consisting of a subcutaneous transmitter and a small implant placed inside the left ventricle. The implant is energized by ultrasound, which he said allows the implant to be miniaturized to roughly one-twentieth the size of other leadless pacemakers.

He said the implanted component becomes covered in heart tissue, which he stated makes it non-thrombogenic and therefore not a stroke risk. According to McCutcheon, the transmitter detects a pacing pulse from the right side—whether generated by a conventional lead-based system or a leadless pacemaker—and then delivers focused ultrasound energy to trigger left ventricular pacing for synchrony.

Leadless adoption trends and EBR’s target market

McCutcheon said lead-related complications have historically been the “Achilles heel” of pacing, ICD, and CRT systems, citing risks such as fracture, migration, and infection. He also described a broader industry shift toward leadless systems, pointing to growth in leadless pacing since Medtronic’s Micra launch and subsequent product introductions by Abbott and Boston Scientific.

During the presentation, he cited Abbott’s view that the U.S. pacemaker market is now roughly 50% leadless, and said the direction of travel is toward leadless becoming the standard over time. However, he argued that incumbent leadless platforms address pacing and defibrillation but not CRT’s left ventricular component, which he said is where WISE is differentiated.

EBR updated its total addressable market (TAM) assumptions, increasing its per-system selling price estimate from $45,000 to $55,000. McCutcheon said the company’s U.S.-only TAM totals about $5.8 billion. He described several segments contributing to that opportunity, including:

• Leadless upgrades: patients with leadless pacemakers who develop pacing-induced heart failure and require CRT, which McCutcheon said can only be achieved as an upgrade with WISE
• High-risk upgrades: patients with lead-based systems who may be poor candidates for conventional CRT leads due to factors such as infection risk or contraindications
• Acute and chronic lead failures: patients where left-sided leads cannot be placed or later fail and must be addressed

Commercial rollout, reimbursement, and early indicators

McCutcheon said EBR is taking a “disciplined approach” to commercialization, focusing first on high-volume centers and early adopters rather than broad initial deployment. As of the end of 2025, he said the company had eight U.S. territories in place, each staffed with two people (a salesperson and a field clinical associate), with plans to scale hiring cautiously over the next year.

He also detailed reimbursement milestones, stating that EBR received Transitional Pass-Through Payment (TPT) for outpatient procedures and New Technology Add-on Payment (NTAP) for inpatient procedures, each paying “up to $63,300” for the device per procedure, in addition to procedure costs. McCutcheon said the company’s contracts are being written at that price level. He added that EBR was invited to participate in Medicare’s Transitional Coverage for Emerging Technologies (TCET) program and is negotiating a “coverage with evidence” study with CMS, which he said could accelerate a national coverage decision compared with the typical multi-year process for new technologies.

Discussing early commercialization metrics, McCutcheon said the company performed cases in the second and third quarters of 2025 despite not yet having reimbursement, citing physician pull. He said fourth-quarter 2025 marked the limited market release after add-on payments began. He also said EBR ended 2025 with 22 U.S. contracts signed, describing contracting progress as a leading indicator for future case growth.

Manufacturing expansion and early revenue

McCutcheon said EBR is preparing for scale by moving from its Sunnyvale, California location to a new facility in Santa Clara, about a mile away. He said the move will triple the company’s space, providing room to expand manufacturing and R&D and enabling EBR to bring more assembly capabilities in-house over time to better control supply chain and cost of goods.

On financial traction, he said EBR doubled cases from the third quarter to the fourth quarter of 2025 and expects to exit the year with roughly $1.5 million in revenue. He described the commercial effort as “very nascent” and said the company remains selective and cautious in the early launch phase.

In the Q&A, McCutcheon said early use cases have reflected the TAM categories the company outlined, including leadless upgrades, high-risk upgrades, and lead failures. He also cited a recent case involving a patient with an existing leadless pacemaker who needed both defibrillation and CRT, describing a combination of a Medtronic Micra, a Boston Scientific Emblem, and an EBR WISE implant. McCutcheon said the case illustrated the modular approach enabled by leadless systems and characterized patient outcomes as “fantastic.”

Looking into 2026, McCutcheon said adoption is tracking where the company expects, and he emphasized that early priorities include clinical success, patient outcomes, and ensuring hospitals are properly reimbursed—areas he said are progressing well.

About EBR Systems (ASX:EBR)

EBR Systems, Inc develops implantable systems for wireless tissue stimulation. The company offers WiSE cardiac resynchronization therapy system that uses a proprietary wireless technology to deliver pacing stimulation directly to the inside of the left ventricle of the heart. Its products are used to eliminate lead complications, such as placement difficulty, unintended nerve stimulation, dislodgement, extraction, and repositioning. EBR Systems, Inc was incorporated in 2003 and is based in Sunnyvale, California.