Data Presented at Late-Breaking Session at Heart Rhythm Society 2023: Paves Way for Premarket Approval Application for Federal Drug Administration Approval and Commercialisation
The pivotal SOLVE-CRT study evaluated EBR Systems' WiSE® CRT System, the 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 percent improvement in heart function (p = 0.003) and an absence of device and procedure related complications in 80.9 percent of patients (p < 0.001)
Results were presented by Co-Principal Investigator, Dr. Jagmeet P. Singh, MD, DPhil, at a Late-Breaking Clinical Trial Session at the annual Heart Rhythm Society's (HRS) meeting in New Orleans, Louisiana, USA.
Excellent interim analysis results lead to early trial success and are a major company milestone, significantly de-risks EBR Systems, and paves the way for Premarket Approval (PMA) Federal Drug Administration (FDA) application for approval in 2024.
The FDA has granted the WiSE CRT System a Breakthrough Device designation, supporting priority review.
SUNNYVALE, Calif., May 22, 2023 /PRNewswire/ -- 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 system is on track to submit a Premarket Approval (PMA) application to the Food and Drug Administration (FDA) in early 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.
Primary Efficacy Endpoint
Improvement in heart function measured by reduction in
p = 0.003
Primary Safety Endpoint
Freedom from device and procedure related complications
p < 0.001
SOLVE-CRT was an international, multicenter clinical 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 centers 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.
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, MA; and Mary Norine (Minnow) Walsh, MD, Medical Director, Ascension St. Vincent Heart Center, Indianapolis, IN.
The SOLVE-CRT trial results were presented by Dr. Singh 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.
Speaking about the results presented at the HRS conference, Dr. Singh said, "The trial data showed a significant, 16.4 percent improvement in the health of the left side of the heart at the six-month follow-up for patients. The safety level was significantly better than our target and on par with other studies treating this patient population. The future of pacing seems to be heading towards leadless solutions, and this is the first wireless pacing technology used inside the left ventricle of the heart to be studied and that met its primary safety and efficacy endpoints so favourably. We're thrilled with these results and eagerly anticipate making this advancement available to our patients."
"The SOLVE-CRT trial opens a new chapter of hope for many heart failure patients who could benefit from CRT but are unable to with conventional wired devices due to issues with the wires connecting to the left side of their heart," said Dr. Walsh. "This exciting breakthrough was observed in patients who didn't respond well to standard CRT, despite being on optimal heart failure medications. Once this technology hits the market, it will serve as an additional lifeline for those battling heart failure."
"We are very excited to announce the success of the SOLVE-CRT pivotal trial," said John McCutcheon, CEO and President of EBR Systems. "This is a 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 who had failed conventional treatment."
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, which use wires, or leads, to deliver electrical pulses to the heart, the WiSE CRT System uses a small electrode implanted inside the heart, which receives 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.
EBR Systems plans to submit the results of the SOLVE-CRT trial to the FDA later this year for approval in 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 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 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 additional US$7.1 billion 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 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.
Note to Editors:
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 Endocardial (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.
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SOURCE EBR Systems