StimCardio's NeuroPulse Study Reports Substantial Reduction in Recurrent Atrial Fibrillation Events Via Non-Invasive Wearable Neuromodulation Following Ablation

• 90% freedom from atrial arrhythmias at six months with neuromodulation vs. 80.8% with sham
• Randomized, double-blind, sham-controlled results presented as late-breaking clinical science at HRX Live 2026 and simultaneously published in peer-reviewed Heart Rhythm

ATLANTA and LOS ANGELES, Sept. 20, 2026 /PRNewswire/ -- StimCardio Medical today announced positive results from the randomized, double-blind, sham-controlled NeuroPulse pilot study evaluating non-invasive median nerve stimulation (MNS) following atrial fibrillation (AF) ablation. The study was selected for late-breaking clinical science presentation at HRX Live 2026 and simultaneously published in the peer-reviewed journal Heart Rhythm.

The results were presented by Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and lead investigator of the study.

Key Findings

• Statistically Significant reduction in recurrent atrial arrhythmia events: 12 events with MNS compared with 28 with sham in the post-blanking sensitivity analysis (p = 0.025)
• 90.0% freedom from atrial arrhythmias at six months following the 60-day blanking period compared with 80.8% with sham. This difference was not statistically significant.
• No MNS- or device-related serious adverse events

Expanding the Impact of Ablation

Advances in mapping, catheter technology and energy delivery have transformed AF ablation. Pulsed field ablation (PFA) represents the latest major advancement, yet for nearly two decades, a persistent efficacy gap has remained. In the 2023 randomized ADVENT trial led by Reddy, one-year treatment success, a composite measure that included freedom from recurrent atrial arrhythmia, was 73.3% with PFA and 71.3% with conventional thermal ablation.

NeuroPulse investigates a different biological mechanism. Rather than further ablating cardiac tissue, MNS is designed to engage peripheral neural pathways that influence autonomic regulation of cardiac rhythm. The non-invasive, wearable approach could give electrophysiologists an additional therapeutic tool beyond the ablation procedure, extending AF care into the home and patients' daily lives.

"The question is not whether ablation works. It clearly does," said Reddy. "The question is how we continue to improve outcomes for patients who experience recurrent arrhythmia despite increasingly advanced ablation technologies. The NeuroPulse results provide an encouraging clinical signal that non-invasive, wearable neuromodulation following ablation may offer a fundamentally different way to approach that remaining challenge. These findings warrant confirmation in a larger multi-center clinical trial."

StimCardio is developing Rhyvive™, an investigational, physician-prescribed, wrist-worn device designed as a non-invasive treatment adjunct to AF ablation. The closed-loop system is designed to deliver personalized neuromodulation informed by continuous physiological sensing and under physician oversight.

"Our vision is to extend what electrophysiologists can do for patients beyond the ablation procedure," said Amos Ziv, MSc, founder and chief scientific officer of StimCardio Medical. "Despite extraordinary advances in ablation and the work EPs are doing for patients, an efficacy glass ceiling remains. The NeuroPulse pilot provides a clinical signal that the next frontier in AF treatment may lie outside the heart itself, with non-invasive, wearable neuromodulation opening the possibility of an entirely new treatment category for EPs and their patients. We look forward to building on these findings in our upcoming pivotal trial."

The peer-reviewed article, "Non-Invasive Median Nerve Stimulation with a Wearable Stimulator to Reduce Atrial Arrhythmia Recurrence after Atrial Fibrillation Ablation: The NEUROPULSE Pilot," is published in Heart Rhythm.

About the NeuroPulse Pilot Study

NeuroPulse is a prospective, three-center, randomized, double-blind, sham-controlled pilot study evaluating non-invasive median nerve stimulation (MNS) following catheter ablation in adults with paroxysmal or persistent atrial fibrillation. The study included 77 patients randomized 1:1 to active MNS or sham treatment, with therapy initiated within 48 hours following ablation and continued for six months. The modified intention-to-treat analysis included 59 patients, assessed following a 60-day blanking period.

About StimCardio Medical

StimCardio Medical is a clinical-stage medical device company headquartered in Los Angeles, developing physician-prescribed, non-invasive wearable neuromodulation technologies for personalized cardiac rhythm care across cardiovascular and neuro-cardiac indications.

The company's lead product, Rhyvive™, is designed as a physician-prescribed, wrist-worn, non-invasive wearable device that delivers personalized neuromodulation through a closed-loop approach. The system integrates physiological sensing, adaptive algorithms, and neuromodulation delivery to enable individualized care strategies and facilitate patient participation in their own care in a home setting under physician oversight.

For more information, visit stimcardio.com and follow us on LinkedIn.

CAUTION: Investigational device. Limited by United States law to investigational use.

Sources

Reddy VY, Nair D, Turagam M, et al. Non-invasive median nerve stimulation with a wearable stimulator to reduce atrial arrhythmia recurrence after atrial fibrillation ablation: The NEUROPULSE pilot. Heart Rhythm. 2026.

Winkle RA, Mead RH, Engel G, et al. Very long-term outcomes of atrial fibrillation ablation. Heart Rhythm. 2023;20(5):680-688. doi:10.1016/j.hrthm.2023.02.002.

Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi:10.1056/NEJMoa2307291.

SOURCE StimCardio Medical Inc.