Cardiac Dimensions has secured $53m in a Series E funding round to support its ongoing pivotal trial assessing the company’s mitral valve repair device.

The round was led by investment management firm Ally Bridge Group, with participation from new investor Claret Capital Partners and existing investors Hostplus, M.H. Carnegie, Horizon 3 Healthcare, and Lumira Ventures.

US-based Cardiac Dimensions is investigating the device, called the Carillon Mitral Contour System, in the EMPOWER study (NCT03142152). The randomised trial is designed to assess the safety and efficacy of Carillon in treating heart failure patients with functional regurgitation. Funds will go towards completing the pivotal study and progressing commercialisation activities.

Heart failure occurs when a heart valve fails to open and close properly. In the case of mitral valve dysfunction, the result is a leakage of blood backward through in between the valve leaflets into the left atrium instead of fully flowing onwards to the ventricle.

Cardiac Dimension’s device is designed to restore natural mitral valve function without damaging the valve leaflets. Carillon consists of two anchors connected by a shaping ribbon that remodels the mitral annulus – the junctional region between the left atrium and left ventricle. The company claims that early clinical studies have shown that the platform reduces mitral regurgitation, improves quality of life, and extends survival.

Functional mitral regurgitation is a prevalent condition among individuals with heart failure, contributing to just under 60% of cases. A range of pharmacological and surgical approaches are available for the disease. Cardiac Dimension says Carillon could offer a front-line option because it does not prevent the use of therapies further down the road in a patient’s treatment journey.  

Cardiac Dimension is one of several companies developing technology for heart valve repair. The mitral valve device market is dominated by Medtronic’s MitraClip, an implant that attaches to the mitral valve. Medtech giant Edwards Lifesciences made a move in the sector when it bought Israeli mitral valve device specialist Innovalve Bio Medical for $300m.

However, the rise in prevalence of heart disease means the market is still set for substantial growth. The global cardiovascular device market was worth $72bn last year and is expected to grow to nearly $117bn by 2033, according to analysis by GlobalData.

Rick Wypych, CEO of Cardiac Dimensions, said: “With these additional resources, we are also well-positioned to continue our global commercial expansion of the Carillon therapy to improve the lives of patients with this debilitating disease.”