Millions worldwide live with the burden of heart failure, facing hospitalizations and a decline in quality of life. A significant number of these patients suffer from functional mitral regurgitation (FMR)—a condition that worsens heart failure symptoms by causing blood to leak backward through the heart’s mitral valve.
Addressing this challenge, Cardiac Dimensions has developed the Carillon Mitral Contour System, a groundbreaking minimally invasive device designed to reshape the mitral valve’s structure and reduce regurgitation—all without damaging the delicate valve leaflets. By restoring proper valve function, this innovative therapy offers heart failure patients a chance at improved outcomes and fewer hospital visits.
$53M Series E Funding Boosts Carillon Therapy’s Global Expansion
In a major milestone, Cardiac Dimensions has secured $53 million in an oversubscribed Series E funding round, fueling its mission to expand global commercialization of the Carillon Mitral Contour System and complete its pivotal U.S. clinical trial.
The round was led by Ally Bridge Group, known for backing disruptive healthcare technologies, with participation from new investor Claret Capital Partners and a strong showing from existing backers like Hostplus, M.H. Carnegie, Horizon 3 Healthcare, Lumira Ventures, and an unnamed strategic investor.
This investment further solidifies confidence in the Carillon system’s potential, building on Cardiac Dimensions’ previous successful raises, including $35 million in Series D (2023) and $39 million in Series B (2018). With total funding now surpassing $214 million, the company is well-positioned to advance its clinical and commercial goals.
Powering Clinical Trials and Global Reach
The new capital injection will support two key priorities:
- Finalizing the U.S. EMPOWER Trial — a landmark randomized, blinded, sham-controlled study poised to be the most scientifically rigorous evaluation of FMR treatment to date.
- Accelerating global commercial expansion — bringing the Carillon therapy to more patients worldwide suffering from this under-treated heart failure complication.
“Our Carillon therapy offers a safe, simple, and effective solution for heart failure patients battling FMR,” said Rick Wypych, President and CEO of Cardiac Dimensions. “This financing reflects our investors’ strong belief in the system’s potential to transform treatment for this large, high-need patient population.”
Wypych emphasized that the new resources will enable the company to scale globally and reach more patients struggling with the debilitating effects of FMR.
Redefining Heart Failure Treatment with the Carillon System
Founded in 2001 by Scott Wolf, Cardiac Dimensions has stayed committed to developing therapies that improve heart function while working with the heart’s natural anatomy. The company’s flagship innovation—the Carillon Mitral Contour System—stands out as a minimally invasive, transcatheter device designed to tackle the root cause of FMR.
Unlike traditional procedures, the Carillon system reshapes the mitral valve annulus from the right side of the heart, preserving the native valve and minimizing risk. Clinical studies have shown remarkable results, including a significant reduction in regurgitation in over 83% of patients, as reported by Prof. Dr. Andreas Hagendorff through echo imaging post-implantation.
A Game-Changer for Millions of Heart Failure Patients
FMR impacts nearly 59% of heart failure patients, dramatically increasing hospital admissions and mortality risk. Left untreated, it significantly diminishes quality of life. The Carillon system offers a new therapeutic pathway that:
- Reduces mitral regurgitation
- Improves heart function
- Enhances patient survival rates
- Supports early-stage treatment without limiting future options
Moreover, the therapy promotes favorable left ventricular remodeling, further benefiting patients with advanced heart failure.
EMPOWER Trial Aims to Set a New Benchmark in Heart Research
The ongoing EMPOWER Trial is a critical step toward U.S. regulatory approval. Designed with rigorous scientific standards, the study involves randomized, sham-controlled procedures—a first in the mitral valve repair space.
Data insights drawn from 250 patients across four earlier studies helped shape the trial’s robust design. Independent safety reviews and third-party lab analyses ensure the credibility of results, positioning the Carillon system as a potential first-line therapy for FMR.
Investors Back a Promising Future
Steve Plachtyna, Partner at Ally Bridge Group and now a Cardiac Dimensions board member, praised the company’s momentum:
“We’re thrilled to support Cardiac Dimensions as they advance their clinical programs and expand their global footprint. Their progress over the years has been impressive, and we’re confident this financing will accelerate their impact on heart failure treatment.”
Operating from Kirkland (Washington), Sydney, and Frankfurt, Cardiac Dimensions continues to innovate solutions that improve cardiovascular health worldwide. This latest funding brings the company a step closer to making minimally invasive heart failure treatments accessible on a global scale.
