EBR Systems, Inc. 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. 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 declined a success and be halted early. 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.