PICSOHF, A minimally invasive cardiac intervention medical device to regenerate a damaged heart and extend the life of patients with Heart Failure

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Worldwide 26 million people live with HF (Heart Failure) which is a major burden, not only for the patient, but one that also threatens the sustainability of national healthcare systems. Despite advances in treatment solutions over the last 30 years, improvements have not met the expectations for cardiac recovery and prognosis following heart attack. Current treatments are only partial solutions as they cannot regenerate the damaged heart tissue, and are thus unable to stop the progressive loss of heart function, low short- and medium-term life expectancy, and impoverished quality of life due to co-morbidities and/or frequent and continuous re-hospitalisations. Regenerative concepts, such as cellular therapies to regain cardiac function, once of the greatest hope for heart failure patients, have been recently discredited as they have been unable to show scientific proof of efficacy. Miracor, developed and clinically tested PiCSO, a breakthrough cardiac intervention triggering myocardial regeneration. Our therapy consists of a percutaneous right heart catheter intervention using proprietary software for feedback control that temporarily elevates the pressure in cardiac veins reactivating innate regeneration pathways. We have tested PiCSO in chronic HF patients (8 patients versus 22 controls) and demonstrated that 30 minutes of intervention changed the pattern of regenerative biomarkers in cardiac veins that resulted in significantly improved survival at 10 years follow up. Our patented technology (PiCSOHF ) is changing the market in HF, as no similar device is currently available. Our strategic goal is to become Europe´s leading reference in treating HF. After full technological, clinical and commercial development, PICSOHF profits will increase by +€66M within 5 years after commercial launch.