Ancora Heart AccuCinch® System Shows Positive 12-Month Outcomes in Multi-Study Analysis

Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced results from an analysis of multiple studies that showed positive outcomes with its investigational AccuCinch^® Ventricular Restoration System. The results were presented during a Featured Clinical Research Session at the 33^rd Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Orlando, Florida.

The abstract, titled "AccuCinch: 12-Month Outcomes of Transcatheter LV Volume Reduction in HFrEF with a Transcatheter Ventricular Restoration System" was an analysis of a group of 41 patients who had symptomatic heart failure with reduced ejection fraction (HFrEF). The analysis demonstrated that treatment with the AccuCinch System resulted in significant and progressive reduction in left ventricular (LV) volumes with significant and sustained improvement in quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire or KCCQ) and six-minute walk test (6MWT).

"We know that, by reducing the left ventricular volume and reshaping of the left ventricle, we can reduce stress on the myocardial wall and improve overall cardiac function, which thereby reduces symptoms and improves quality of life for our patients with heart failure," said Ulrich P. Jorde, MD, professor of medicine, Albert Einstein College of Medicine, and section head of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Montefiore Health System in New York, and global co-principal investigator of the CORCINCH-HF Study. "Complementing the clinically meaningful improvements in KCCQ scores and 6MWT distances seen in this analysis, the progressive reduction in LV volumes out to 12 months suggests that transcatheter treatment with the AccuCinch System may also initiate a biological process of reverse remodeling, an important objective for new heart failure therapies."¹

The primary outcome measure for this analysis was the change of LV end-diastolic volume (EDV) compared to baseline through 12 months. Other efficacy assessments included changes from baseline in 6MWT distances and KCCQ scores. The patients were followed with serial echocardiograms, KCCQ scores, and 6MWT distances over one year. The safety outcome measure included freedom from major adverse events (MAEs) related to the device implantation or femoral artery access through six months post-procedure.

Key findings include:

• Significant and progressive reduction in LV end diastolic volumes at 12 months compared to baseline (41.8±31.4 ml, p<0.001),
• Significant and sustained improvements in KCCQ overall quality-of-life scores compared to baseline (19.6±18.2 points, p<0.001)
• Significant and sustained improvements in six-minute walk test distances at 12 months compared to baseline (46.5±90.8 m, p=0.010)

"We continue to see encouraging results from across our studies that demonstrate the clinical benefits of the AccuCinch System in heart failure patients," said Jeff Closs, president and CEO of Ancora Heart. "We are eager to be able to further educate the heart failure and structural heart communities about AccuCinch as we continue to work toward completion of the CORCINCH-HF pivotal trial and eventual submission to the FDA."

About the AccuCinch Ventricular Restoration System and the CORCINCH Studies

The AccuCinch System is designed to augment the existing care cardiologists provide their heart failure (HF) patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide an effective therapy option by filling the treatment 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 may help reduce symptoms, improve quality of life and potentially increase life expectancy.

The AccuCinch System is currently being studied in the CORCINCH-HF pivotal trial, a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation, which is designed to enroll 400 patients at up to 80 centers worldwide. The study has a unique design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up. (ClinicalTrials.gov Identifier: NCT04331769)

______________________________________

¹ Dr. Jorde received compensation from Ancora Heart for a speaking engagement in 2020.

About Ancora Heart

Ancora Heart is a medical device company dedicated to providing new treatment options for people with heart failure (HF). The company's proprietary AccuCinch^® Ventricular Restoration System is the only completely transcatheter device designed to restore the structure and function of the enlarged left ventricle of the heart, thereby addressing the fundamental issue in the progression of heart failure in patients with reduced ejection fraction (HFrEF). The AccuCinch System is an investigational device, which is currently under clinical evaluation. Ancora Heart is a privately held company located in Santa Clara, Calif. For more information, please visit www.ancoraheart.com and connect on Twitter (@AncoraHeart) and LinkedIn.