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

Project Information

PICSOHF

Grant agreement ID: 889906

DOI

10.3030/889906

Project closed

EC signature date 3 December 2019

Start date 1 January 2020

End date 30 April 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

MIRACOR MEDICAL
Belgium

Periodic Reporting for period 1 - PICSOHF (PICSOHF, A minimally invasive cardiac intervention medical device to regenerate a damaged heart and extend the life of patients with Heart Failure)

Reporting period: 2020-01-01 to 2020-04-30

Summary of the context and overall objectives of the project

Heart failure (HF) is affecting 26 million people worldwide, which not only threatens patient’s life, but the sustainability of healthcare systems. Despite advances in treatment 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-hospitalizations. Miracor has developed PiCSOHF, 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. The objectives of this project are to improve the technical design of catheter, console, and software, conduct the clinical study, and get market certifications.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Our Feasibility Study has guaranteed the viability of the project. 1) We have identified the technical improvements for the final catheter, console, and software, and prepared a complete execution plan. We have designed a follow-up monitoring program to prove PiCSOHF clinical significance. We have identified candidate suppliers for manufacturing. We have also performed a full IPR review to ensure FTO in our target markets. 2) We have assessed the target markets and competitors to consolidate our marketing strategy. We have built our business and revenue models. We have developed our commercialization roadmap and evaluate Miracor’s financial stability. 3) We have prepared a realistic 10-year financial plan, in which we will generate €159M cumulative profit with a ROI of 17.36 (€8.64M total investment) and increase 124 employees by 2032.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PiCSOHF will have a positive impact on patients, cardiologists, hospitals, and healthcare systems. Patients will benefit from a safe treatment that will bring back their normal life. Cardiologists will have an innovative and effective alternative to improve HF clinical outcomes. Hospitals and healthcare systems will benefit as PiCSOHF reduces the costs of repeated hospitalisation, tests, and treatments. Miracor’s strategic goal is to become Europe´s leading reference in treating HF.

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