We are a clinical-stage MedTech company dedicated to transforming the treatment of heart failure through advanced neuromodulation technology.
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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