EBR Systems (ASX:EBR), developer of a wireless cardiac pacing device for heart failure, completed 40 commercial WiSE System implants during the third quarter ended 30 September 2026, bringing total commercial implants across the pilot launch phase and Limited Market Release to 157, according to its Quarterly Activity Report and Form 10-Q submission.

Key Points

  • 40 commercial WiSE System implants completed in Q3 2026, taking the total to 157 across the pilot launch and Limited Market Release phases
  • Santa Clara manufacturing facility achieved ISO 13485 certification; FDA pre-approval inspection completed with two observations identified
  • Medicare inpatient reimbursement for eligible WiSE procedures increased effective 1 October 2026, with maximum total reimbursement potentially reaching approximately US$77,839 and US$66,566 for relevant MS-DRGs
  • EBR holds cash, cash equivalents, restricted cash and marketable securities of US$95.8m / A$137.4m as at 30 September 2026
  • CMS proposed National Coverage Determination decision expected in early December 2026, with a final decision expected in March 2027

U.S. Commercial Organisation Realignment and Implant Activity

EBR completed 40 commercial WiSE System implants during Q3 2026, though implant activity was lower in September, with monthly cases approximately half the average monthly volume recorded in July and August. During the quarter, the Chief Commercial Officer departed and President and Chief Executive Officer John McCutcheon assumed responsibility for the commercial organisation. EBR is actively recruiting a Chief Commercial Officer and other key commercial roles. Five additional purchasing contracts were signed during the quarter, bringing the total to 57, and 100 physicians are now trained to implant the WiSE System, including 10 trained during Q3 2026.

Manufacturing Certification and FDA Regulatory Matters

EBR's new Santa Clara manufacturing facility achieved ISO 13485 certification during Q3 2026. Once fully operational, the expanded facility is expected to have capacity to manufacture up to 9,600 WiSE Systems annually. The FDA completed its pre-approval inspection of the facility in connection with EBR's premarket approval supplement to add the site as a WiSE manufacturing location, identifying two observations in its Form 483, for which EBR selected 'Promised to Correct' for both. EBR continues to anticipate approval of the new manufacturing site by the end of 2026, subject to FDA review. The FDA also agreed no immediate field corrective action or recall relating to WiSE was warranted following its cybersecurity review.

Medicare Reimbursement Increase and Coverage Determination Timeline

The U.S. Centers for Medicare and Medicaid Services finalised increased Medicare inpatient reimbursement for eligible WiSE System procedures under the FY2027 Inpatient Prospective Payment System final rule, effective 1 October 2026. Eligible WiSE procedures were reassigned to higher-value Medicare Severity Diagnosis Related Groups, increasing base Medicare inpatient payment rates by approximately 58% and 93% for the relevant categories. Eligible procedures continue to qualify for a New Technology Add-on Payment of up to US$41,145. With the maximum NTAP, total Medicare reimbursement may reach approximately US$77,839 and US$66,566 for the relevant MS-DRGs, with actual payments depending on hospital- and case-specific factors and CMS criteria.