Orangeburg, New York, May 10, 2018 – Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. The study results were presented by Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, at the Heart Rhythm Society Late-Breaking Clinical Trials today in Boston, Massachusetts, with a simultaneous publication in the JACC: Heart Failure Journal.

CCM™ is a therapy unique to the Optimizer® family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure.  The FIX-HF-5C study was designed to prospectively confirm a subgroup analysis of the prior FIX-HF-5 pivotal trial, showing that CCM™ significantly improved exercise tolerance and quality of life in patients with NYHA class III and IV heart failure symptoms, ejection fraction 25-45%, and a QRS <130ms. A Bayesian statistical analysis plan was developed to combine the data already available from the original FIX-HF-5 study with the FIX-HF-5C study data. The results presented today at HRS supplement and confirm the results from the prior study, meeting the safety and effectiveness objectives of the study.

Highlights of the results include:

• CCM™ is safe; the study met its primary and secondary safety endpoints.
• Patients receiving CCM™ showed significantly better exercise tolerance and quality of life compared to their control-group counterparts.
• The composite of cardiovascular deaths and heart failure hospitalizations was statistically significantly reduced in comparison to the control group.
• Clinical effectiveness was even greater in patients with EF >35%.

“The results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM™ on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM™ to reduce heart failure morbidity and mortality” said Prof. Abraham. “These findings support the use of CCM™ as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement.”

“I would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics’ team for completing this important study with its very encouraging results.” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO.  “We anticipate submission of the final PMA module to the U.S. FDA in June 2018.”