PICSO^HF, a trans-coronarysinus catheter intervention as game changer in myocardial regeneration

Worldwide, 26 million people live with HF (Heart Failure), a major burden not only for the patient, but also threatening the sustainability of healthcare systems. Despite treatment evolution over the last 30 years, improvements in therapeutic options haven’t met expectations sustaining cardiac recovery. Current therapy solves the problem only partially as it cannot regenerate damaged heart tissue and is unable to effectively influence life expectancy, quality of life or continuous rehospitalisation.

Regenerative concepts as cellular therapies to regain cardiac recovery have been recently discredited, unable to show proof of clinical significance, albeit increased biohazards and cumbersome procedures.

Pressure controlled intermittent coronary sinus occlusion, normally applied in acute myocardial syndromes PICSO^AMI, was applied in HF patients. Clinical observations, cardiomyocyte proliferation and molecular signals tested allow the assumption of triggering myocardial regeneration stopping structural decay. Our therapy consists of a percutaneous right heart catheter intervention using proprietary software for feedback control temporarily elevating pressures in cardiac veins, activating and restoring innate regeneration pathways. Applying only 20 minutes of PICSO ^HF changed the time course of patients with ischemic cardiomyopathies. Only 20 minutes of intervention changed the pattern of biomarkers in cardiac veins and 10 years follow up suggest improved survival.

The target population would be patients with ischemic cardiomyopathies at any timepoint of disease. Clinical rollout would be a staged approach, starting with patients on the transplant waiting list with the endpoint of delisting and continue to all stages of the disease. The attractive option of using a mechanical catheter intervention without any biohazards applying PICSO^HF for less than one hour may be a game changer for HF patients, as unparalleled minimal invasive catheter intervention.

The team consist of the inventor of PICSO ^HF WM as well as the CMO of the developing company JT as well as technological and regulatory support.