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After years of effort developing its WiSE® CRT System – the world’s only wireless cardiac pacing device for heart failure – EBR Systems Ltd (ASX:EBR) is now at the final approval stage, which should facilitate its entry into US markets early next year.
The company told investors recently that it had submitted the final Premarket Approval (PMA) module for WiSE® to the US Food and Drug Administration (FDA) – and to put icing on the cake, the regulator designated the product as a ‘Breakthrough Device’, allowing EBR a prioritised review and interactive communication with the FDA throughout the process.
So what does the WiSE® CRT System do?
The value of this product derives from the fact that it can stimulate the heart’s left ventricle through a wireless pacing system operating within the heart itself.
This is built around the longstanding belief by cardiac pacing companies that internal stimulation of the left ventricle is the superior approach – or that this is a superior location for such a system.
More specifically, the WiSE® technology uses a novel cardiac implant – approximately the size of a large grain of rice – to enable pacing of the left ventricle.
Crucially, this technology eliminates the need for a pacing wire on the outside of the heart’s left ventricle – an approach which has brought a suite of problems.
Looking towards a wireless future in medical technology
It is precisely due to these problems with cardiac pacing leads- which include effectiveness, reliability and complication – that EBR Systems came into being, dedicated to developing wireless cardiac pacing technology to enable more effective stimulation of the heart.
As the company’s centrepiece, EBR Systems designed its Wireless Stimulation Endocardially (WiSE®) technology to eliminate the need for coronary sinus leads to stimulate the heart’s left ventricle among heart patients needing Cardiac Resynchronisation Therapy (CRT).
And EBR Systems is hoping to expand on its achievements with WiSE®, looking ahead to future products which will allow wireless endocardial stimulation for bradycardia (slow heart rate) and other non-cardiac indications.
A history of reaching testing goals
A key moment for EBR Systems in its journey towards getting the WiSE® CRT System on the market was its SOLVE-CRT trial, from which it reported successful achievement of primary and secondary endpoints in May 2023.
The trial – which concluded early due to these successes – showed that patients implanted with the WiSE® device saw a -16.4% reduction in heart volume (indicating improved heart function).
Additionally, more than 80.9% of patients were shown to be free from device or procedure-related complications – with this result far exceeding the pre-determined benchmarks.
Ultimately, the positive results yielded from the SOLVE trial which enabled EBR Systems to anticipate completion of its PMA modules for the FDA by the end of 2024 – another goal which it has reached ahead of the targeted time.
What does the FDA approval process entail?
WiSE®’s movement through the FDA approval system will happen in two main stages. First, it will be subject to mandated ‘filing period’, in which checks will be done to ensure that the application is administratively complete, and that its technical elements are up to standard.
Then, the technology will move into a period of ‘substantive review’, in which the FDA will consider the application’s content, provide feedback and request responses, before finally making a decision on its approval.
Individual assessments attached to this substantive review will include a Bioresearch Monitoring (BIMO) audit to assess the quality and integrity of the company’s trial study data, and a Pre-Approval Inspection (PAI) to check that EBR’s manufacturing, processing and packing procedures are in-line with Quality System regulations.
This means that and the facility can consistently produce devices that meet the approved specifications.
And now…plans for commercialisation in 2025
EBR Systems president and CEO John McCutcheon said the company was delighted to have reached the significant approval milestone.
“This submission is the result of years of effort and collaboration between our clinical, regulatory, and engineering teams,” he said.
“With this application, we are now one step closer to making WiSE® available to physicians for their patients across the United States.
“If approved, this PMA package will allow us to launch WiSE® in 2025.
“We look forward to sharing further updates as we progress through the regulatory review process.”
EBR Systems has been trading at $1.05.
