Findings from early clinical studies show sustained reverse remodeling, improved heart function and quality of life, and reduced hospitalizations

The safety and effectiveness of the AccuCinch System are being evaluated in the ongoing CORCINCH-HF pivotal trial

Ancora Heart, Inc., a medical device company developing a transcatheter device-based therapy to address heart failure (HF), today announced that two-year results from an analysis of early clinical studies evaluating the AccuCinch^® Transcatheter Left Ventricular Restoration System were published in Structural Heart. The findings demonstrate that reverse remodeling achieved with the AccuCinch System was sustained through two years, along with improvements in heart function, quality of life, and reduced heart failure hospitalizations.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251027204437/en/

“Reverse remodeling is usually associated with reduced heart failure events and mortality,” said Daniel Burkhoff, MD, PhD, Director, Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation^®. “From a clinical perspective, the fact that reverse remodeling is maintained at two years is particularly meaningful.”

These findings build on previously reported 12-month data, which were presented at the 2023 Technology and Heart Failure Therapeutics conference and simultaneously published in the Journal of Cardiac Failure. Patients included in the analysis matched key inclusion criteria (LVEF 20–40%, MR ≤ 2+) of the ongoing CORCINCH-HF pivotal trial.

“These two-year data reinforce that the AccuCinch System has the potential to deliver meaningful and sustained reverse remodeling of the heart,” said Jeff Closs, President & CEO of Ancora Heart. “We are excited to build on this research in our ongoing CORCINCH-HF pivotal trial designed to evaluate the safety and effectiveness of AccuCinch. With the first 250 enrolled patients nearing completion of their six-month follow-up assessments that will be the basis for our PMA submission, we are making important progress toward bringing this therapy to more patients.”

The analysis evaluated clinical outcomes from 51 symptomatic HFrEF patients from multiple sites in the U.S. and Europe. Key outcomes include:

• Sustained reverse remodeling with a mean decrease in LV end-diastolic volume of 30.0 ± 38.8 mL (p<0.001) and an increase in ejection fraction of 5.4 ± 9.0% (mean ± SD; p<0.001).
• Improvements in functional status and symptoms, including a median 19.5-point increase in Kansas City Cardiomyopathy Questionnaire score (p<0.001), improvement by at least one NYHA class in 60% of patients, and 98% either improved or remained stable.
• The rate of heart failure hospitalization two years following implant was significantly reduced compared to the year prior to the implant (p<0.001).

The CORCINCH-HF (NCT04331769) pivotal trial will enroll 400 patients. The study recently achieved its first enrollment milestone of 250 randomized patients, with six-month follow-up data from that cohort to support the company’s planned Premarket Approval (PMA) submission to the U.S. Food and Drug Administration. The FDA previously granted the AccuCinch System Breakthrough Device Designation.

About Heart Failure

An estimated 6.7 million adults in the U.S. live with heart failure, a condition in which the heart’s muscles weaken and lose their ability to pump enough oxygen-rich blood to the body.^1,2 Heart failure patients suffer from debilitating symptoms, including persistent exhaustion, trouble breathing and confusion, as well as frequent hospitalizations. About half of HF patients have heart failure with a reduced ejection fraction (HFrEF) and an enlarged left ventricle, the main pumping chamber of the heart, which causes more stress on the heart and leads to reduced pumping efficiency. Up to 50% of people who develop heart failure die within five years of diagnosis.³

About the AccuCinch^® Transcatheter Left Ventricular Restoration System

The AccuCinch System is an investigational device designed to augment the existing care cardiologists provide their heart failure patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant. During the minimally invasive AccuCinch System procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. The AccuCinch System is under clinical evaluation to determine its potential benefits related to patient symptoms, quality of life and life expectancy.

About Ancora Heart, Inc.

Ancora Heart is a medical device company dedicated to providing new treatment options for people with heart failure (HF). The company’s lead product is the AccuCinch^® Transcatheter Left Ventricular Restoration System, an investigational device currently being studied in the CORCINCH-HF pivotal trial. Ancora Heart is a privately held company located in Santa Clara, Calif. For more information about Ancora Heart and its products, visit www.ancoraheart.com and follow the company on Facebook, LinkedIn and X.

¹ Martin SS, Aday AW, Almarzooq ZI, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee; Stroke Statistics Subcommittee. 2024 heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2024;149:e347–913.

² Murphy S, Ibrahim N, Januzzi J. Heart Failure with Reduced Ejection Fraction, A Review. JAMA. 2020;324(5):488-504

³ Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-596.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251027204437/en/