EBR Systems meets endpoints early in pivotal SOLVE-CRT trial: paves way for FDA approval application and commercialisation
May 22, 2023
- EBR Systems’ WiSE® CRT System is world’s first and only wireless, inside the left ventricle of the heart, pacing system for heart failure.
- The SOLVE-CRT trial met its safety and efficacy endpoints with a 16.4% improvement in heart function (p = 0.003) and an absence of device and procedure related complications in 80.9% of patients (p < 0.001).
- Excellent interim analysis results presented at the Late-Breaking Session at Heart Rhythm Society 2023 lead to early trial conclusion due to success.
- Trial success is a major company milestone, significantly de-risks EBR Systems, and paves the way for Premarket Approval (PMA) application for Federal Drug Administration (FDA) approval in 2024.
- The FDA has granted the WiSE CRT System a Breakthrough Device designation, supporting priority review.
- EBR Systems has an initial addressable market of US$2.5 billion, with the opportunity to expand this up to US$7.1 billion with further technological advances.
Melbourne, 22 May 2023 – EBR Systems, Inc. (ASX: EBR), the medical device company developing wireless cardiac pacing systems, has met its primary safety and efficacy endpoints in its pivotal SOLVE-CRT trial of the WiSE® Cardiac Resynchronization Therapy (CRT) System.
EBR Systems’ WiSE CRT System is on track for the Premarket Approval (PMA) application to the Food and Drug Administration (FDA) approval and commercialisation by the end of 2024 after successfully achieving primary and secondary endpoints in its pivotal trial, which ended early due to success.
The FDA has granted the WiSE CRT System a Breakthrough Device designation, which supports a priority of the WiSE CRT System PMA submission.
|Primary Efficacy EndpointImprovement in heart function measured by reduction in left ventricular end systolic volume
|p = 0.003
|Primary Safety EndpointFreedom from device and procedure related complications
|p < 0.001
“We are very excited to announce the success of the SOLVE-CRT pivotal trial,” says John McCutcheon, 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 Co-Principal Investigator of the study, Dr Jagmeet P. Singh, MD, DPhil, Professor of Medicine at Harvard Medical School, Director, Massachusetts General Hospital, Boston at the Heart Rhythm Society (HRS) 2023 annual meeting, the largest gathering of heart rhythm professionals globally.
The inclusion of the presentation in the Late Breaking Clinical Trials session during the premier global electrophysiology conference underpins the importance of EBR’s SOLVE-CRT study within the cardiovascular field, with the aim to materially improve patient outcomes.
EBR Systems estimates an addressable market of US$2.5 billion for WiSE, initially targeting patients who cannot receive CRT from existing devices or are at high risk from conventional upgrades.
There is an expansion opportunity up to US$7.1 billion as the WiSE technology platform can be potentially expanded into other patient groups, indications, and geographies in the future.
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,” says 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.”
The WiSE CRT System is a wireless, endocardial pacing system that 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.
CRT is currently recommended for patients with worsening heart failure. It works by synchronizing the contractions of the left and right ventricles of the heart. CRT has been proven to improve heart function and consequently improves patients’ quality of life while reducing heart-failure hospitalisations and mortality.
“The WiSE CRT System represents a major advancement in cardiac pacing technology,” says Professor Prash Sanders, MBBS, PhD, FRACP, a Clinician-Scientist at the University of Adelaide and the Royal Adelaide Hospital and Principal Investigator of the Australian trial. “I am impressed by the results of the SOLVE-CRT trial and look forward to seeing this product become available to patients who need it most. It is exiting to have a technology that may change the way we eventually undertake pacing.”
“For heart failure patients who do not respond to traditional cardiac resynchronisation therapy, this technology is life changing. The difference between living a normal life as opposed to being constantly short of breath, often housebound, and unable to perform simple daily tasks is stark,” Professor Sanders continues.
EBR Systems plans to complete its PMA submission to the FDA early next year for and hopes for approval in late 2024. There are currently 64 million heart failure patients worldwide. Once approved the WiSE CRT System could potentially offer a new treatment option for patients including the 3 million heart failure patients worldwide who were previously untreatable by conventional CRT or at high-risk for upgrades.
The SOLVE-CRT study was an international, multi-centre trial designed to enrol up to 300 patients in randomized 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. SOLVE-CRT was powered for an interim analysis such that if the primary efficacy and safety were met with 183 patients at the 6-month follow-up, the study could be declared a success and be halted early.
The primary safety efficacy endpoint was Freedom from Type I complications (device and procedure-related complications, as determined by an independent Clinical Events Committee), and the primary efficacy endpoint was reverse heart remodelling caused by heart failure (as determined by an independent core echocardiography lab).
The study was led by Co-Principal Investigators, Drs. Jagmeet P Singh, MD, DPhil, Professor of Medicine at Harvard Medical School Director, Massachusetts General Hospital, Boston and Mary Norine (Minnow) Walsh, MD, Medical Director, Ascension Saint Vincent Heart Center, Indianapolis.
The excellent SOLVE-CRT results confirm the positive results from earlier published studies of the WiSE CRT System including SELECT-LV, the WiSE European Registry, and the SOLVE-CRT Roll-in study. This body of data firmly establishes the safety, efficacy, and clinical need for the WiSE CRT system.
EBR Systems had an AU$110m listing on the ASX in November 2021. Existing investors, including, Brandon Capital, M.H. Carnegie & Co, Hostplus, TelstraSuper and HESTA contributed more than AU$30m of the funds raised under the offer.
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Key results from the SOLVE-CRT trial of the WiSE CRT System
The trial efficacy endpoint was to see a greater than 9.3 percent improvement in heart function measured by a reduction in left ventricular end-systolic volume. The safety endpoint was to see greater than 70 percent of patients without a device or procedure-related complication.
The WiSE CRT System has eclipsed the 9.3 percent and 70 percent targets, showing an improvement of 16.4 percent reduction in left ventricular end-systolic volume (p = 0.003) and 80.9 percent freedom from Type I complications (p < 0.001), leading to an early termination of the study for success at this interim look. This result is a testament to the technology’s safety and effectiveness.
About EBR Systems (ASX: EBR)
Silicon Valley-based EBR Systems (ASX: EBR) is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. 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 potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.