Whether you are a clinician interested in our research, a potential strategic partner, or an investor, we welcome the opportunity to discuss the future of heart failure therapy. Reach out to our team to learn more about the Harmony™ System and our global clinical roadmap.
We focus on addressing the significant unmet clinical need of chronic heart failure. The Harmony™ System is designed for patients who remain symptomatic despite optimal medical therapy, specifically targeting a reduction in left-ventricular workload through autonomic nervous system modulation.
The Harmony™ System is implanted via a minimally invasive, transcatheter-based procedure. This approach utilizes standard femoral or jugular venous access, significantly reducing procedural risk, patient trauma, and hospital recovery times compared to traditional cardiac surgery.
The Harmony™ System is currently an investigational device and is limited by law to investigational use in clinical trial settings. We are actively conducting trials to gather the robust safety and efficacy data required for global regulatory approvals, including the CE Mark and FDA pathways.
We adhere to the highest global standards for clinical data management, including HIPAA and GDPR compliance. Every device and clinical data point is integrated into a secure digital infrastructure that ensures 100% traceability and auditable results for regulatory review.
Yes. The Harmony™ System provides titratable therapy, allowing clinicians to adjust stimulation parameters based on the patient's specific hemodynamic response. This real-time optimization ensures that the therapeutic effect is tailored to the individual’s physiological needs.
Clinical success is measured through a combination of primary and secondary endpoints, including improvements in NYHA functional class, increased 6-minute walk distance, and objective hemodynamic markers such as heart rate reduction and increased cardiac efficiency.
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