Cardionomic’s CPNS System Pilot Studies Complete Enrollment

January 15, 2024—Cardionomic, Inc. announced the completion of enrollment in the STIM-ADHF and STOP-ADHF pilot studies.

Both studies were designed to evaluate the safety and performance of the company’s cardiac pulmonary nerve stimulation (CPNS) system in patients with acute decompensated heart failure (ADHF). Data from the two studies will be pooled, with results from that analysis planned for publication in early 2024.

In the studies, 35 patients were treated with the CPNS system in Hungary, Poland, Slovakia, Panama, Belgium, the Netherlands, and the United States.

According to Cardionomic, CPNS 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 consists of a stimulation console and an endovascular catheter that delivers targeted stimulation to the cardiac plexus located in the right pulmonary artery.

Sitaramesh Emani, MD, Research Director for Advanced Heart Failure Trials at the Christ Hospital Health Network in Cincinnati, Ohio, commented on the CPNS system in the company’s press release.

“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 intravenous diuretics,” stated Dr. Emani. “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.”

Dr. Emani continued, “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.”