EBR Systems (ASX:EBR) announced that the United States Food and Drug Administration (FDA) will conduct a pre-approval inspection of its manufacturing facility during the week beginning January 6, 2025.
The inspection is part of the FDA’s review of EBR’s premarket approval application for its WiSE Cardiac Resynchronization Therapy (CRT) System, a wireless heart pacing device.
The FDA began its in-depth review of the submission in September 2024, with a Day 100 meeting scheduled for December 20, 2024.
Shares jumped 14.53% to $0.98 following the news.
So what does it do?
EBR’s product is a “CRT device”. It’s like a pacemaker, but it has added benefits. For example, a pacemaker is standard treatment for someone with a slow or irregular heartbeat. In contrast, CRT devices resynchronize the heart when the left and right ventricles beat out of sync.
Current CRT devices use wires (thin insulated wires) to deliver electrical impulses to the heart. One of these leads is threaded through the veins and positioned on the outer surface of the left ventricle of the heart. The process can be technically difficult and prone to complications, such as infection, dislodgement or breakage.
EBR’s WiSE technology is the only wireless CRT system in development. It stimulates the left ventricle of the heart directly from the inside using a small implant the size of a grain of rice. This approach is safer – it reduces the risk of complications, device failure and repeat surgeries – and could also provide better heart function.
Regulatory approval
Devices follow different approval pathways than drugs.
The Pre-Approval Inspection (PAI) is one of the final stages of the review.
EBR’s technology has already undergone clinical trials to evaluate safety and effectiveness, and received “Breakthrough Device Designation.” This designation is only granted to technologies that provide major clinical advantages over existing treatments and allow for more rapid review.
Under the PAI, FDA inspectors will visit their facilities and audit the entire production environment to ensure it can produce compliant devices reliably and at scale. The visit will evaluate manufacturing, quality control, training and documentation, supplier monitoring.
Next steps
FDA inspection announcements are often seen as a signal that a company is close to the finish line. Many device developers remain silent about inspections unless they believe their installations are well prepared and that problems will be minimal.
If successful, the EBR system could replace lead-based systems, with no direct competitors, and cardiac resynchronization therapy (CRT) represents a multibillion-dollar global market.
Once all issues have been resolved at the IAP and Day 100 meeting, the FDA then conducts a final review and issues approval if everything is in order.
The time between an IAP and approval can vary significantly. Most approvals occur within three to six months of the IAP. If critical issues are identified, the process could take six to 12 months, or up to two years in a worst-case scenario.
