Cardionomic Announces Enrollment Completion in the STIM-ADHF and STOP-ADHF Pilot Studies

Cardionomic, Inc., a Cleveland Clinic portfolio company, has completed its pilot studies evaluating the safety and performance of the Cardiac Pulmonary Nerve Stimulation (CPNS™) System for Acute Decompensated Heart Failure (ADHF) patients. The preliminary results suggest that CPNS therapy may address the unmet need for more effective treatment options for hospitalized heart failure patients. The company treated 35 patients in seven countries, and the data from both studies will be published in early 2024.

Press Release via PR Newswire

MINNEAPOLIS, Jan. 3, 2024 /PRNewswire/ — Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of enrollment in both their STIM-ADHF and STOP-ADHF pilot studies. Both studies were designed to evaluate the safety and performance of the Cardiac Pulmonary Nerve Stimulation (CPNS™) System in patients suffering from Acute Decompensated Heart Failure (ADHF), defined as new or worsening symptoms of heart failure. Thirty-five (35) patients were treated with the CPNS System in Hungary, Poland, Slovakia, Panama, Belgium, The Netherlands, and the United States. Data from the two studies will be pooled, with results from that analysis planned for publication in early 2024.

Cardionomic’s treatment is founded on the principle that autonomic nerve stimulation improves the patient’s clinical condition through a triggered rebalancing of the autonomic system, shifting it from a maladaptive state into a cycle that improves the patient beyond CPNS therapy duration. The Cardionomic CPNS System is comprised of a stimulation console and an endovascular catheter that delivers targeted stimulation to the cardiac plexus located in the right pulmonary artery.

“This is a significant milestone for Cardionomic, and more importantly for patients suffering from acute decompensated heart failure. The preliminary results from the STIM-ADHF and STOP-ADHF studies suggest that CPNS therapy may address the large unmet need for alternative, and more effective, treatment options for patients hospitalized for heart failure,” said Steve Goedeke, President and Chief Executive Officer of Cardionomic, Inc.

“Despite numerous advancements in the treatment of chronic heart failure, therapies to treat ADHF remain limited, especially for those patients who remain congested despite the use of IV diuretics. Such patients have significant disruptions that leave them at high risk for poor outcomes, but unfortunately, current strategies to treat these patients inadequately address the underlying pathophysiology,” said Dr. Sitaramesh Emani, Research Director for Advanced Heart Failure Trials at the Christ Hospital Health Network in Cincinnati, Ohio. “By stimulating the cardiac autonomic nervous system, CPNS therapy can rebalance parasympathetic/sympathetic disruptions, which can lead to meaningful improvement in acute heart failure at a fundamental level, and perhaps have a lasting impact beyond the ADHF event.”

About Acute Decompensated Heart Failure
Acute decompensated heart failure (ADHF) is defined as the sudden or gradual onset of heart failure signs or symptoms. These include severe breathlessness, rapid weight gain, and fluid build-up in the lungs and around the body. The condition requires a doctor’s care, which leads to unplanned office appointments, emergency room visits, hospitalization, and readmission. Inpatient care for these patients is costly, accounting for about 60% of total heart failure expenditures.

About Cardionomic, Inc.
Cardionomic, Inc. is a privately held U.S. company that designs and produces devices to address heart failure. For more information on the company and its products, please visit www.cardionomicinc.com

The CPNS System is an investigational device and is limited by Federal (or United States) Law to investigational use.

SOURCE Cardionomic, Inc.