EBR system (ASX:EBR) announced that the U.S. Food and Drug Administration (FDA) will conduct pre-approval inspections of its manufacturing facilities during the week beginning January 6, 2025.

The test is part of the FDA’s review of EBR’s premarket approval application for the WiSE Cardiac Resynchronization Therapy (CRT) System, a wireless cardiac pacing device.

FDA will begin substantive review of submissions in September 2024, with the 100th meeting scheduled for December 20, 2024.

The stock price rose 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 with additional benefits. For example, pacemakers are a standard treatment for people with slow or irregular heart rhythms. In contrast, CRT devices resynchronize the heart when the left and right ventricles are beating out of sync.

Modern CRT machines use leads (thin insulated wires) to send electrical impulses to the heart. One of these leads is passed through a vein and placed on the outer surface of the left ventricle of the heart. This process can be technically difficult and is prone to complications such as infection, shedding, and breakage.

EBR’s WiSE technology is the only wireless CRT system in development. A small implant, approximately the size of a grain of rice, is used to stimulate the heart’s left ventricle directly from within. This approach is safer, reduces the risk of complications, device failure, and repeat surgery, and may also improve heart function.

Regulatory approval

Devices follow a different approval path than medicines.

Pre-approval inspection (PAI) is one of the final stages of the review.

EBR’s technology has already undergone clinical trials to evaluate its safety and effectiveness, and has received “Breakthrough Device Designation.” This designation is only given to technologies that have a significant clinical advantage over existing treatments and allow for expedited review.

As part of the PAI, FDA inspectors visit facilities and audit the entire manufacturing environment to ensure that compliant devices can be manufactured reliably and at scale. The visit will assess manufacturing, quality control, training and documentation, and supplier management.

next step

FDA inspection announcements are often seen as an indication that a company is nearing the finish line. Many device developers remain silent about testing unless they believe their equipment is well prepared and problems will be minimized.

If successful, EBR’s system has no direct competitors and could replace lead-based systems, and cardiac resynchronization therapy (CRT) is a multibillion-dollar global market.

After the issues are resolved at the PAI and 100-day meeting, the FDA will perform a final review and issue approval if all is well.

The timeline from PAI to approval can vary significantly. Most approvals occur within 3-6 months after PAI. If serious issues are identified, the process can take 6 to 12 months, and in the worst case scenario, up to two years.