Cardiac Dimensions Raises Financing for Pivotal Trial of Carillon Mitral Contour System

January 5, 2023—Cardiac Dimensions announced it has closed a $35 million Series D financing round. Proceeds will be used for enrollment in the United States EMPOWER pivotal study of the company’s Carillon mitral contour system.

EMPOWER commenced in the summer of 2021 and includes leading centers such as the Cleveland Clinic in Cleveland, Ohio; Columbia University Medical Center in New York, New York; and Ronald Reagan UCLA Medical Center in Los Angeles, California.

Funds will also support expanded sales of the Carillon device in several European countries where it has full reimbursement. The Carillon mitral contour system has received CE Mark approval in Europe and Therapeutic Goods Approval in Australia. It is an investigational device in the United States.

Cardiac Dimensions advised that the financing was led by existing investor Horizon 3 Healthcare and an undisclosed strategic investor. All other existing investors participated, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.

The company’s CEO Rick Wypych stated in the press release, “Having two high quality colead investors, including a new strategic investor, as well as the continued financial support of all existing investors, continues to validate Cardiac Dimensions’ solution for heart failure patients suffering from mitral regurgitation (MR).”

Mr. Wypych continued, “This funding will enable us to continue providing Carillon therapy to a large population of patients in dire need of treatment. We anticipate accelerating enrollment in our EMPOWER pivotal trial where we can now bring Carillon’s benefits to earlier-stage patients with much lower grades of MR. With strong reimbursement in place in key European markets, we also look forward to expanding adoption in these markets and adding new geographies this year.”

According to the company, the device is designed to restore natural mitral valve function without damaging the mitral valve leaflets using a short, simple procedure. The Carillon is intended to induce favorable remodeling while reducing MR, improve patient quality of life, and extend survival for a broad range of patients, including those with earlier stage MR.

In 2021, Carillon therapy was added to the European Society of Cardiology’s guidelines covering the diagnosis and treatment of acute and chronic heart failure for the treatment of secondary MR. The guidelines noted that the therapy met its primary endpoint in the blinded, sham-controlled, randomized REDUCE FMR trial; has a shorter learning curve and fewer technical requirements than clipping; and does not preclude other heart failure-related procedures.

Finally, the company reported that data from the CINCH European postmarket registry of the Carillon device were recently presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

The data, which encompassed 101 patients across Germany, showed that an MR grade ≤ 2+ was achieved for 96% of patients at 12 months and 100% of patients by 5 years. More than 69% of patients had a New York Heart Association class of ≤ II+ at 1 year, which improved to 79% of patients at 5 years. Safety data showed no device-related significant adverse events out to 1 year.

At 2 years, the mortality and heart failure hospitalization rates were also notably better than both standard medical management and published data from other commercial device therapies. Previously published survival data on the Carillon device out to 6 years show favorable survival when compared to medical management, stated the company.