StimCardio Medical closed an oversubscribed $30M Series A for Rhyvive, a wrist-worn device used at home after catheter ablation for atrial fibrillation. Metis Medtech led. Catalyst Health Ventures, several corporate strategic investors and existing backers joined.
Rhyvive is a closed-loop system that senses physiological signals and delivers non-invasive median nerve stimulation, aimed at the autonomic pathways that feed atrial arrhythmia recurrence. The NeuroPulse pilot randomized 77 patients 1:1 against sham, double-blind, with 59 in the modified intention-to-treat analysis. Recurrent events ran 12 with active stimulation against 28 with sham in a post-blanking sensitivity analysis, p = 0.025. Freedom from atrial arrhythmias was 90.0 percent against 80.8 percent, which did not reach significance.
The money goes toward a De Novo classification request and NeuroPulse 2, a multicenter trial testing ablation plus the wearable against ablation alone. Rhyvive is investigational and not authorized for sale. De Novo over 510(k) is the right read: there is no cleared predicate for a wearable neuromodulation adjunct to ablation.