EBR Systems Boosts WiSE Production with ISO-Certified Facility and FDA Approval in Sight
EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.
- Santa Clara facility achieves ISO 13485 certification
- Automated assembly to increase WiSE production capacity by 500%
- FDA Pre-Approval Inspection scheduled for September 2026
- Facility supports US commercial scale-up of WiSE System
- Transition from manual to automated assembly underway
ISO Certification Marks Manufacturing Milestone
EBR Systems (ASX:EBR) has reached a significant operational milestone with its new manufacturing facility in Santa Clara, California, achieving ISO 13485 certification. This internationally recognised quality standard for medical device manufacturing was awarded following an assessment by the British Standards Institution (BSI), underscoring EBR’s commitment to quality as it expands production capacity for its wireless cardiac pacing device, the WiSE System.
Automated Assembly to Drive Fivefold Capacity Increase
With the ISO certification in hand, EBR is installing automated assembly machinery to replace manual processes at the facility. This shift is expected to boost production capacity by approximately 500%, a scale-up critical to meeting growing commercial demand in the US market. The move to automation also aims to improve manufacturing efficiency, reduce costs, and enhance yield, aligning with EBR’s broader strategy to accelerate its commercial rollout.
FDA Approval Pending After Scheduled Inspection
The company is targeting FDA approval for the new facility by the end of 2026. A Pre-Approval Inspection is scheduled for September, after which EBR anticipates addressing any observations to secure regulatory clearance. FDA approval is a prerequisite for commencing the transition to automated manufacturing, which will underpin the company’s ability to scale production in line with its US commercial ambitions.
Facility Expansion Supports US Commercial Growth
The expanded manufacturing footprint in Santa Clara is designed to support the increasing demand for the WiSE System, the world’s only wireless, endocardial pacing technology currently available for sale in the US. EBR’s CEO John McCutcheon highlighted the facility’s role in underpinning the company’s commercial execution strategy, emphasizing the importance of a scalable manufacturing platform to sustain growth.
Scaling Amidst Growing Market Momentum
This development follows EBR’s recent commercial progress, including surpassing 100 WiSE implants and securing major US healthcare contracts, supported by a substantial capital raise to fund expansion. The manufacturing scale-up complements these advances, positioning EBR to meet anticipated market demand as Medicare coverage discussions continue and physician adoption grows.
Bottom Line?
EBR’s manufacturing scale-up hinges on FDA approval this year, setting the stage for a significant production leap that could reshape its US market footprint.
Questions in the middle?
- Will FDA approval proceed smoothly given the tight timeline?
- How quickly can EBR transition to full automated production post-approval?
- What impact will increased manufacturing capacity have on WiSE System pricing and margins?
