EBR Systems Secures 11-Year Lease to Scale Manufacturing in Silicon Valley
EBR Systems has signed a long-term lease for a 51,000 sq ft facility in Santa Clara, California, positioning itself for significant manufacturing expansion and future growth in wireless cardiac pacing technology.
- Signed 11-year lease for 51,000 sq ft facility in Santa Clara
- Facility expansion to support manufacturing, R&D, and distribution
- Landlord to finance US$4M in tenant improvements; EBR budgets additional US$1.3M
- Move expected to complete in H1 2026 with phased rent commencement
- FDA Post-Approval Inspection required after facility qualification
Strategic Expansion in Silicon Valley
EBR Systems, the ASX-listed developer of the world’s only wireless cardiac pacing device, has taken a decisive step to scale its operations by signing an 11-year lease for a new 51,000 square feet facility in Santa Clara, California. This move significantly increases the company’s manufacturing footprint, nearly doubling its current space, and is designed to accommodate anticipated growth in demand for its innovative WiSE technology.
The new facility, located just 4.2 km from EBR’s existing Sunnyvale headquarters, will house manufacturing, research and development, storage, and distribution operations. The proximity ensures minimal disruption for employees, a point emphasised by CEO John McCutcheon, who highlighted the favourable lease terms and strategic location as key benefits for shareholders, staff, and future customers alike.
Phased Transition and Financial Commitments
EBR plans a gradual transition into the new site, aiming to complete the move during the first half of 2026. The lease terms include a phased rent schedule, with payments commencing in January 2026 on a portion of the space and scaling up to the full 51,000 square feet by the fourth year. This staggered approach provides financial flexibility as the company upgrades and qualifies the facility.
Significantly, the landlord will finance approximately US$4 million in tenant improvements, while EBR has allocated an additional US$1.3 million for furniture, equipment, and contingencies. These investments underscore the company’s commitment to establishing a state-of-the-art manufacturing environment capable of supporting commercial-scale production.
Regulatory Milestones Ahead
Following the build-out and installation of critical equipment, EBR will undergo a Post-Approval Inspection (PAI) by the FDA. This inspection is crucial to verify that manufacturing processes comply with Quality System regulations and that the facility can consistently produce devices meeting approved specifications. The PAI mirrors the recent successful inspection of EBR’s current facility, marking an important regulatory milestone before full commercial operations commence.
The expanded manufacturing capacity is vital for EBR as it transitions from development to commercialisation of its WiSE technology, which offers a wireless, leadless cardiac pacing solution for heart failure patients. This technology addresses a significant unmet medical need by eliminating complications associated with traditional pacing leads.
Looking Ahead
EBR’s facility expansion reflects confidence in the commercial potential of its wireless pacing system and positions the company to meet growing market demand. The move also signals a broader strategic shift as EBR prepares to scale production and distribution capabilities in a highly competitive medical device sector.
Bottom Line?
EBR’s new facility lease sets the stage for scaling production, but regulatory approvals and execution will be critical to watch.
Questions in the middle?
- How smoothly will EBR manage the phased transition without disrupting current operations?
- What timeline can investors expect for FDA approval post-move and its impact on commercial rollout?
- How will the increased manufacturing capacity translate into revenue growth and market penetration?
