Wireless cardiac pacing device developer EBR Systems, Inc. (ASX: EBR) has received positive results from its pivotal SOLVE trial.
Top-line data was released at the 2023 Heart Rhythm Society (HRS) Conference during the high-profile late-breaking clinical trials session in New Orleans. The trial met its primary objectives, with the WiSE device demonstrated to be safe, well tolerated, and efficacious.
Pivotal trial results
The study results 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 pre-determined benchmarks. All other outcomes analysed to date have been concordant with these results showing significant improvement in reversing heart failure symptoms and improving physiology.
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,” Chairman, Allan Will, said.
“The SOLVE trial not only demonstrates the ability of our device to provide safe and effective cardiac resynchronisation therapy but also validates 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.”
Next steps
This clinically significant outcome builds on successful previous trials and validates WiSE as a ground-breaking CRT treatment for patients who are unable to receive CRT from a traditional lead-based system. A manuscript will be submitted to a medical journal for peer-review and publication.
The company will continue to progress its regulatory agenda and is aiming to finalise its pre-market approval (PMA) submission to the FDA in Q1 2024, paving the way for FDA approval. EBR has maintained significant engagement with the FDA, which includes gaining prior approval for the trial re-design to include a single-arm only treatment phase and the FDA granting the WiSE device a Breakthrough Device Designation.
The company is well funded to support its commercialisation objectives with substantial cash reserves of US$56.6/A$84.31 million as of March 2023 and a growth capital facility with Runway Growth Finance.
In light of the positive trial results, EBR now has the option to draw down on the US$20m second tranche of this facility. EBR will now mobilise to execute its clear and targeted commercialisation strategy, focused on four patient groups in the US market (acute lead failure, high risk upgrades, leadless upgrades and chronic lead failure), which represent a combined market opportunity of US$2.5bn per annum.