KIRKLAND, Wash. – January 26, 2023 – Cardiac Dimensions®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Angie Swenson as Vice President of Clinical Operations.

Ms. Swenson has spent most of the last 20 years leading clinical trials in the U.S., Europe, Japan and Canada and collaborating on reimbursement strategies for therapies targeting cardiovascular disease developed by leading medtech innovators. Most recently, she served as Vice President, Clinical and Regulatory for HLT, Inc., developer of transcatheter aortic heart valve replacement (TAVR) technology, where for five years she led their early feasibility studies. Prior to that, she was an Associate Director of Clinical Research for C.R. Bard subsidiary Lutonix, overseeing global clinical trials for its drug coated balloons for angioplasty. As Clinical Director for therapeutic hypothermia firm Velomedix, she managed all aspects of a multicenter pilot study of its technology in acute STEMI patients. For St. Jude Medical, she handled overall management of a large multicenter heart valve clinical trial supporting FDA clearance and approvals in Europe, Australia, Canada and Japan, as well as post-market heart valve and renal denervation studies. Earlier in her career, she worked for Beckman Coulter as a Clinical Studies Scientist validating projects for FDA submissions. Her broad experience also includes serving as a medical technologist for Cardiac BioMarkers Trial Lab managing cardiac in vitro diagnostics trials for external sponsors, and as a medical technologist for Hennepin County Medical Center. She holds a Bachelor of Science degree in Medical Technology from Minnesota State University and a certificate in Clinical Trial Management from the University of Chicago Graham School.

“Angie’s rich experience in the successful planning and execution of clinical trials and approvals for medtech therapies addressing important valvular and other cardiovascular diseases is ideally suited to our innovative therapy for mitral valve disease,” said Cardiac Dimensions CEO Rick Wypych. “We look forward to benefitting from her insights and expertise as we focus on enrolling the U.S. pivotal EMPOWER Trial of our Carillon™ Mitral Contour System and exploring reimbursement strategies to support it.”

 About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.

To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial of the Carillon system is currently enrolling patients in the U.S., as well as in select centers worldwide. The EMPOWER Trial is a randomized, blinded, sham-controlled study of a broad population of patients with heart failure caused by early- through late- stage mitral regurgitation defined as MR grades 1-4. Upon FDA approval, it would be the only medical device solution commercially available as front-line therapy for earlier-stage MR patients with MR grade 1-2 not adequately managed with medications.

The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S.  For more information, please visit www.CardiacDimensions.com.

 About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.

Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

Media Contact
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274

KIRKLAND, Wash. – January 5, 2023 – Cardiac Dimensions^®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced it has closed a $35 million Series D financing round. The financing was co-led by existing investor Horizon 3 Healthcare and an undisclosed strategic investor, with all other existing investors participating, including Arboretum Ventures, Hostplus, EQT Life Sciences (formerly LSP), Lumira Ventures, and M. H. Carnegie & Co.

The company’s lead product – the Carillon Mitral Contour System^® – uses a gentle, minimally-invasive approach designed to restore natural mitral valve function without damaging the mitral valve leaflets. In a short, simple procedure, the Carillon^® device is intended to induce favorable remodeling while reducing mitral regurgitation (MR), improve patient quality of life, and extend survival for a broad swath of patients, including those with earlier-stage MR.

Proceeds from the financing will be used to enroll the U.S. EMPOWER pivotal study of the Carillon therapy, which commenced late last summer and includes leading centers such as the Cleveland Clinic, Columbia University Medical Center, and Ronald Reagan UCLA Medical Center. Funds will also support expanded sales of the Carillon device in several European countries where it has full reimbursement.

“Having two high quality co-lead 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. This funding will enable us to continue providing Carillon therapy to a large population of patients in dire need of treatment,” said Cardiac Dimensions CEO Rick Wypych. “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 mitral regurgitation. 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.”

“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,” said Matt McNamara, Chief Investment Officer and Board Director for Horizon 3 Healthcare. “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.”

In 2021, Carillon therapy was added to the European Society of Cardiology (ESC) Guidelines covering the Diagnosis and Treatment of Acute and Chronic Heart Failure for the treatment of secondary mitral regurgitation (SMR). The guidelines note 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.

Data encompassing 101 patients across Germany from the CINCH European post-market registry were recently presented at the 2022 Transcatheter Therapies (TCT) conference. The data showed that an MR grade of 2+ or less was achieved for 96 percent of patients at 12 months and 100 percent of patients by five years. More than 69 percent of patients had a NYHA class of II+ or less at one year, which improved to 79 percent of patients at five years. Safety data showed no device-related significant adverse events out to one year. At two 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 six years show favorable survival when compared to medical management.

About the Carillon Mitral Contour System
Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System, is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed.

To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial is currently enrolling patients in the U.S., as well as in select centers worldwide.

The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com.

About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery.

Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

Media Contact
Michelle McAdam, Chronic Communications Inc.
michelle@chronic-comm.com, +1 310-902-1274