April 26, 2018
Cardiac Dimensions notes the round includes new investor, Australia-based Hostplus, venture debt from Oxford Finance LLC, as well as support from existing investors M. H. Carnegie & Co., Arboretum Ventures, Lumira Capital, LSP Health Economics Fund and Aperture Venture Partners.
The financing will be used to continue to build clinical evidence for Cardiac Dimensions’ Carillon® Mitral Contour System® for the treatment of functional mitral regurgitation (FMR) in patients with heart failure, including continuing The CARILLON Trial U.S. pivotal study and completing the follow-up and publication of the landmark randomized, double-blinded REDUCE FMR global study.
The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life.
“Our clinical data and commercial experience suggest that the Carillon System offers a viable treatment option that addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. This funding will provide the resources to complete and publish the landmark REDUCE FMR trial, continue to support enrollment in The CARILLON pivotal trial here in the U.S., and enhance our presence throughout world markets,” said Gregory D. Casciaro, president and CEO of Cardiac Dimensions. “We welcome our newest investors to the team and are grateful to our returning investors for their continued support.”
Functional mitral regurgitation affects approximately seven million people in the United States, and occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The primary therapy for patients with this disease is to treat them with medical management.
“Hundreds of thousands of people around the world, and an estimated 50,000 Australians, have heart failure and FMR, and could benefit from treatment with the Carillon System,” said David Elia, chief executive officer of Hostplus. “We are excited to work with Cardiac Dimensions to expand access to the Carillon System to patients in need, not only here in Australia, but across the globe.”
Note: The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a simple, minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.
To date, more than 850 patients worldwide have been treated with the Carillon System. The Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, the Netherlands and Italy. Clinical data from three completed international studies of the Carillon System (AMADEUS, TITAN, and TITAN II) have demonstrated the performance of the device. In addition, the company is completing the follow up period of the landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR. The results of the REDUCE FMR Trial are expected before the end of 2018. Additionally, The CARILLON Trial, the company‘s U.S. pivotal study, is currently enrolling participants.