Silicon Valley-based company EBR Systems (ASX:EBR) is paving the way towards US Food and Drug Administration (FDA) approval for its Wireless Stimulation Endocardially (WiSE) technology following results from the SOLVE-CRT trial.
The company reports the study results from the SOLVE-CRT trial have demonstrated that patients implanted with the WiSE device saw a 16.4% reduction in heart volume, indicating improved heart function, with more than 80.9% of patients free from device or procedure-related complications exceeding the predetermined benchmarks.
All other outcomes analysed to date have been concordant with these results showing ‘significant’ improvement in reversing heart failure symptoms and improving physiology.
“This represents the culmination of decades of diligent research and development and teamwork”
EBR reports the clinically ‘significant’ outcome builds on previous trials and validates WiSE as a ‘ground-breaking’ CRT treatment for patients who are unable to recieve CRT from a traditional lead-based system.
A manuscript will be submitted to a medical journal for peer-review and publication. The company says it will continue to progress its regulatory agenda and is aiming to finalise its pre-market approval submission to the FDA in Q1 2024, paving the way for FDA approval.
EBR notes it has maintained ‘significant’ engagement with the FDA, which includes granting the WiSE device a Breakthrough Device Designation. The company says it looks forward to engaging with the FDA during the final stages of the approval process.
Additionally, EBR reports it is well-funded to support its commercialisation objectives with ‘substantial’ cash reserves totalling $84.3 million as of March 2023, and a growth capital facility with Runway Growth Finance.
In light of the trial results, the company says it now has the option to draw down on the US$20 million second tranche of its facility. EBR will now mobilise to execute its clear and targeted commercialisation strategy focused on 4 patient groups in the US, which represent a combined market opportunity of US$5.2 billion per year.
Commenting on the trial results, EBR Systems Chairman Allan Will said: “I am thrilled and immensely proud of the entire EBR team for achieving this positive trial result. This represents the culmination of decades of diligent research and development and teamwork, enabling us to deliver what we did today.
The SOLVE trial not only demonstrates the ability of our device to provide safe and effective cardiac resynchronisation therapy but also valides EBR’s technology as a key treatment for those suffering from cardiac arrhythmia. This breakthrough will significantly improve the lives of countless patients currently suffering from this disorder.”
Also commenting, EBR Systems President and Chief Executive Officer (CEO) John McCutcheon says he is incredibly encouraged by all aspects of the top-line data presented, noting the data exceeds the company’s pre-specified regulatory primary efficacy and safety endpoints, and paves the way for regulatory approval.
“The results validate our novel approach for delivering CRT and treating heart arrhythmia in heart failure patients. We are eager to advance our commercialisation strategy and will continue to work with the FDA to deliver a seamless pathway forward to approval.
We look forward to leveraging our established partnerships and presence in the US to drive initial sales growth, targeting a US$5.2 billion market and improving patient outcomes for those with no other treatment options>
EBR Systems is a Silicon Valley-based company dedicated to treating cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented WiSE technology was developed to eliminate the need for cardiac pacing leads, which have historically caused complications in cardiac rhythm disease management.
The company says the initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring cardiac resynchronisation therapy (CRT). Future products may potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.