Medical device company EBR Systems (ASX:EBR) says the primary safety and efficacy endpoints have been achieved in its pivotal SOLVE-CRT trial of the WiSE Cardiac Resynchronization Therapy (CRT) System.
The company said its CRT System is on track for the Premarket Approval application to the US FDA with potential approval and commercialisation by the end of 2024.
The FDA has granted the WiSE CRT System a Breakthrough Device designation.
The wireless, endocardial pacing system uses ultrasound energy to stimulate the heart’s left ventricle, improving synchronization and enhancing cardiac function.
Unlike traditional CRT systems that use wires or leads to deliver electrical pulses to the heart, the WiSE CRT System uses a small electrode implanted inside the heart to receive signals from a small ultrasound transmitter placed on the chest.
The SOLVE-CRT study was an international, multi-centre trial designed to enrol up to 300 patients in randomised and single-arm parts. The study was conducted across 43 sites in the US, 10 in Australia, and 15 centres in the United Kingdom, Germany, France, Italy, and the Netherlands.
“We are very excited to announce the success of the SOLVE-CRT pivotal trial,” said John McCutcheon, the CEO and President of EBR Systems. “This is the most significant milestone in our company’s history and an important step forward in our path towards our Premarket Approval application to the FDA, achieving regulatory approvals, and commencing our commercialisation strategy.”
“The global unmet need for our wireless pacing technology is compelling. We are proud to provide state-of-the art technology to our physicians who have implanted the WiSE CRT System in over 450 patients around the world so far and enabled significant improvement in the condition of their patients, most of whom had failed conventional treatment.”
The SOLVE-CRT trial results were presented by the study's co-principal investigator of the study, Dr Jagmeet P. Singh, at the Heart Rhythm Society 2023 annual meeting.
Pending regulatory approvals, EBR Systems intends to initially go to market in the US, Australia, and major European countries.
“EBR Systems is one of the most exciting healthcare companies in Australia right now,” said Bill Ferris AC, pioneer venture capitalist, chair of Brandon BioCatalyst, and investor in EBR Systems.
“It’s one of a new generation of healthcare companies with the potential to join the greats such as Cochlear and CSL. “Australian investors have demonstrated a strong and growing appetite for healthcare companies and Australia is a global leader in clinical cardiology research programmes, with a proud history of pioneering pacemaker technologies. This is a perfect pairing for success.”