A transcatheter implantable diastolic heart pump to treat advanced stage Heart Failure with preserved Ejection Fraction.
Heart Failure with preserved Ejection Fraction (HFpEF) is an unmet medical need. HFpEF patients comprise more than 50% of the total number of Heart Failure (HF) patients. This diastolic HF cohort is growing at 1% per year due the increase in population age, increase in obesity and the number of survivors of Cardiac Arterial Disease (CAD).
HFpEF patients are typically obese, hypertensive or diabetic, and the condition predominantly affects female patients (female:male ratio 2:1) and represent a significantly under-served cohort of cardiac patients. HFpEF patients experience very high re-hospitalization rates which impacts their quality of life and has a high-cost burden on healthcare systems globally. In the USA & Europe, the cost of direct medical care of HF patients will grow to over $100 Billion in 2030 with the majority of these being HFpEF patients. Globally, there are more than 18 Million HFpEF patients reliant on drug therapy that does not improve mortality.
Primary market research indicates the immediate addressable market for ‘PReduction’ is approximately 29% of Stage C or D HFpEF patients, that is estimated to be 640k HFpEF patients in the USA and Europe. Research indicates a price of $50k for ‘PReduction’ i.e., a USA and European market of $32B.
Pumpinheart is seeking seed capital from business angel networks and venture capital funds to complete further preclinical research including product engineering, animal trials and regulatory filings and to submit an application for an Investigational Device Exemption (IDE) to the United States Food and Drug Administration (FDA) for a First-in-Human (FIH) clinical trial in 2027.
