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MedTech Outlook | Monday, February 06, 2023
The company develops innovations addressing heart failure and other cardiovascular conditions and has closed a $35 million Series D financing round.
FREMONT, CA: “We have been impressed with Carillon's ability to improve patients' lives both in clinical studies and in real-world use, and with the company's ability to leverage these results to grow adoption and commercial sales," says Matt McNamara, Chief Investment Officer and Board Director for Horizon 3 Healthcare. Cardiac Dimensions®, a leader in developing new, minimally invasive treatment modalities for heart failure and related cardiovascular disorders, has finalized a $35 million Series D investment round, the company said today. Horizon 3 Healthcare and an undisclosed strategic investor led the fundraising, with participation from all previous investors, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.
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"We are enthusiastic about the device's potential to treat heart failure at a much earlier stage than other device therapies, which could make it a frontline treatment with the potential to change the course of the disease,” adds McNamara.
The company's flagship product, the Carillon Mitral Contour System®, restores natural mitral valve function with a gentle, minimally invasive technique that does not harm the mitral valve leaflets. The Carillon® device is designed to induce positive remodeling while lowering mitral regurgitation (MR), enhance patient quality of life, and increase survival for a wide range of patients, including those with earlier-stage MR, in a brief, straightforward procedure.
The cash will be utilized to enroll patients in the U.S. EMPOWER pivotal research of the Carillon therapy, which began late last summer and involves prestigious medical institutions such as the Cleveland Clinic, Columbia University Medical Center, and Ronald Reagan UCLA Medical Center. Funds will also promote the expansion of Carillon gadget sales in many European nations where it is fully reimbursed.
Carillon therapy for secondary mitral regurgitation was included in the European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure in 2021. (SMR). The guidelines state that the therapy fulfilled its primary aim in the double-blind, randomized, sham-controlled REDUCE FMR study, has a shorter learning curve and fewer technical requirements than clipping, and does not prevent other heart failure-related procedures.
Recent presentations at the 2022 Transcatheter Therapies (TCT) conference included information about 101 German patients from the CINCH European post-marketing registry. The data revealed that 96 percent of patients attained an MR grade of 2+ or less at 12 months and 100 percent of patients at five years. At one year, more than 69 percent of patients had an NYHA class of II+ or less, which increased to 79 percent at five years. One year of safety data revealed no device-related severe adverse events. Mortality and heart failure hospitalization rates at two years were significantly lower than normal medical management and published data for alternative commercial device therapies. Compared to medical therapy, previously published survival data on the Carillon device for up to six years indicate favorable survivability.
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