We are a clinical-stage MedTech company dedicated to transforming the treatment of heart failure through advanced neuromodulation technology.
Heart failure remains the leading unmet clinical need globally. Traditional surgical interventions are often too invasive for high-risk patients, leaving a critical gap in cardiac care.
EnoPace bridges this gap with the Harmony™ System—a breakthrough, catheter-based solution designed to improve cardiac efficiency and patient quality of life.
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A history of innovation in cardiovascular neuromodulation.
Founded by serial entrepreneur Yossi Gross and the Rainbow Medical Group, EnoPace was established with a mission to treat heart failure through minimally invasive neuromodulation.
Italy’s Sorin Group (now LivaNova) leads a $7 million investment round to fund initial clinical studies, recognizing EnoPace as a solution for the cardiovascular world’s largest unmet clinical need.
The Harmony™ System is voted the #1 medical innovation at the TCT Congress Shark Tank competition in Denver, validated for its potential to transform patient outcomes through reduced left-ventricular workload.
To support global clinical trial expansion and serial production, EnoPace implements a comprehensive ERP infrastructure, ensuring 100% traceability from manufacturing to patient delivery.
Our journey began with extensive bench testing and animal studies to validate the safety and efficacy of RF-powered neuromodulation.
Mechanism of Action: Validation of heart rate reduction through neurostimulation.
Biocompatibility: Rigorous testing of lead and pulse generator materials.
Hemodynamic Modeling: Establishing the theoretical impact on cardiac output.
We execute meticulously planned clinical trials designed to meet the rigorous standards of global regulatory bodies.
Protocol Design: Defining primary endpoints for heart failure patient recovery.
Site Selection: Partnering with world-class cardiovascular research centers.
Ethical Compliance: Maintaining the highest standards of patient safety and oversight.
EnoPace operates under a strict Quality Management System (QMS) ensuring 100% traceability from manufacturing to implantation.
CE Mark & FDA Pathways: Navigating the complex global regulatory landscape.
ISO 13485 Certification: Adherence to international medical device quality standards.
Data Integrity: Ensuring robust, auditable clinical trial results.
Leveraging successful clinical data, we architect the pathway for global distribution and physician training.
Serial Production: Scaling manufacturing for the Harmony™ System.
Physician Education: Training top-tier electrophysiologists on implantation techniques.
Market Access: Establishing reimbursement pathways for widespread patient access.
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