EBR Systems (ASX:EBR) has announced that the US Food and Drug Administration (FDA) will conduct a Pre-Approval Inspection of its manufacturing facility during the week commencing 6 January 2025.
The inspection is part of the FDA’s review of EBR’s Pre-Market Approval submission for its WiSE Cardiac Resynchronisation Therapy (CRT) System, a wireless cardiac pacing device.
The FDA began its substantive review of the submission in September 2024, with a Day-100 Meeting scheduled for 20 December 2024.
Shares have jumped 14.53% to $0.98 on the news.
So, what does it do?
EBR's product is a "CRT device". It's like a pacemaker, but has additional benefits. For instance, a pacemaker is standard treatment for someone with a slow or irregular heart rhythm. CRT devices, in contrast, resynchronise the heart when the left and right ventricles beat out of sync.
Current CRT devices use leads (thin insulated wires) to deliver electrical impulses to the heart. One of these leads is threaded through veins and positioned on the outer surface of the heart's left ventricle. The process can be technically challenging and prone to complications, like infection, dislodgement or breakage.
EBR’s WiSE technology is the only wireless CRT system in development. It stimulates the heart’s left ventricle directly from the inside using a small implant roughly the size of a grain of rice. This approach is safer — it reduces the risk of complications, device failure and repeat surgeries — and it also could offer better heart function.
Regulatory approval
Devices follow different approval pathways from drugs.
The pre-approval inspection (PAI) is one of the final stages of review.
EBR's technology has already undergone clinical trials to assess safety and efficacy, and received "Breakthrough Device Designation". This designation is only given to technologies that offer major clinical benefits over existing treatments and allows faster review.
As part of the PAI, FDA inspectors will visit their facility and audit the entire production environment to ensure it can produce compliant devices reliably and at scale. The visit will assess manufacturing, quality control, training and documentation, supplier control.
Next steps
FDA inspection announcements are often seen as a signal that a company is near the finish line. Many device developers stay silent about inspections unless they believe their facility is well-prepared and issues will be minimal.
If successful, EBR’s system could replace lead-based systems, with no direct competitors, and Cardiac Resynchronization Therapy (CRT) is a multi-billion-dollar global market.
After any issues are addressed from the PAI and the Day-100 Meeting, the FDA then performs a final review, and issues an approval if everything is in order.
The timeline from a PAI to approval can vary significantly. Most approvals occur within three to six months post-PAI. If there are critical issues identified, then the process could take six to 12 months, or up to two years in the worst cases.
