Our Technology

Clinical Need

Mitral regurgitation (MR) is a common heart valve disease affecting nearly 10 percent of Americans aged ≥75 years.1 MR occurs when the mitral valve leaflets do not close properly and allow blood in the left ventricle to leak back into the left atrium. It is a progressive disease and if left untreated, MR can lead to atrial fibrillation, pulmonary hypertension, heart failure and death.

Fifty percent of all symptomatic MR patients are not eligible for open-heart surgery due to the procedure risk,2 leaving many patients untreated and in need of a minimally invasive solution. Current transcatheter mitral valve replacement (TMVR) technologies rely on placement and fixation in the native mitral annulus and left ventricle. These technologies replace the native valve entirely to treat leakage (i.e. mitral regurgitation). Hence, current TMVR technologies are associated with complications such as device embolization, left ventricular outflow tract obstruction, left ventricular dysfunction (e.g. chordae tendineae rupture), and death.

Our Solution

4C Medical Technologies, Inc. is a medical device company developing a novel minimally invasive solution for the treatment of mitral regurgitation (MR). We are the first transcatheter MR therapy that directly addresses mitral regurgitation without replacing the native mitral valve, thus preserving the native mitral annulus and left ventricle. The device is positioned supra annular to the leaking native mitral valve to stop the leak from entering the left atrium. Its atrial only fixation ensures minimal disruption to critical cardiac structures within the left ventricle including the chordae tendineae and the left ventricular outflow tract. Our initial focus is to develop a novel therapy for mitral regurgitation (MR), and subsequently for tricuspid regurgitation (TR).


Sources:
1. Nkomo VT, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368:1005-11. doi: 10.1016/S0140-6736(06)69208-8.
2. Mirabel M, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007;28:1358-65.