Catheter Precision, Inc. (NYSE American: VTAK) has completed its acquisition of heart failure-related assets from Cardionomic, Inc., marking a strategic expansion into neuromodulation therapy for acute decompensated heart failure (ADHF). The transaction was finalized through the company's 82% owned subsidiary following a definitive agreement announced in April 2025.
Novel Neuromodulation Approach for Heart Failure
The acquired technology centers on the Cardiac Parasympathetic Nerve Stimulation (CPNS) System, which represents a novel approach to treating ADHF through targeted neuromodulation. The system delivers electrical stimulation via a temporary catheter inserted into the pulmonary artery, specifically targeting autonomic cardiac nerves to restore autonomic balance in heart failure patients.
ADHF affects over 1 million Americans annually, requiring hospitalization with associated high in-hospital morbidity, frequent rehospitalization, and subsequent mortality. The condition represents a significant unmet medical need, with current treatment options often providing limited long-term benefits.
"Completing this acquisition is a significant milestone in the expansion of our product offering," said David Jenkins, CEO of Catheter Precision. "Cardionomic's unique solution to ADHF represents an exciting opportunity for Catheter Precision and the chance to bring advanced treatment options to millions of patients in the future."
Clinical Development and Regulatory Challenges
Initial pilot studies of the CPNS System have demonstrated positive results, though the company has identified several key development challenges that must be addressed before commercialization. These include nerve fatigue when stimulation is delivered for extended periods, potential hemodynamic instability and rhythm disturbances with high-amplitude stimulation, and the need for device modifications to reduce procedure complexity.
The pilot studies revealed that stimulation beyond 48 hours provided no additional benefit, and optimal therapeutic response depends on factors beyond simple contractility enhancement. Minor catheter modifications are also needed to accommodate the larger cardiac anatomy typically seen in heart failure patients.
Regulatory and Commercial Pathway
The CPNS System will require FDA review and approval, which the company acknowledges will likely be costly and lengthy with no guarantee of success or favorable timing. The device-based neuromodulation therapy will compete in a crowded field of both emerging device technologies and established pharmaceutical treatments for heart failure.
Catheter Precision's core business focuses on developing advanced products for the cardiac electrophysiology market, particularly for treating cardiac arrhythmias. The acquisition represents a significant expansion into the broader cardiovascular device market, though it comes with substantial development and regulatory risks.
Financial Structure and Future Development
The acquisition was structured through a subsidiary that includes minority investors beyond Catheter Precision's 82% ownership stake. Future financing rounds are expected to involve additional securities issuance by the subsidiary, which will dilute Catheter Precision's ownership percentage and may grant special governance rights to other investors.
The company has indicated that adequate financing for the CPNS System development remains uncertain, and the subsidiary structure may limit Catheter Precision's control over future strategic decisions regarding the technology.
The medical device industry's competitive landscape presents additional challenges, with many competitors possessing greater financial and technical resources than Catheter Precision. The company must also navigate ongoing supply chain uncertainties and regulatory complexities that could impact development timelines and costs.
