Landmark European Feasibility Data — Strong Efficacy and Safety
European feasibility study (n=177) showed outstanding outcomes: 100% procedure success at 6 months (95/95 evaluable), 96% procedure success at 1 year (24-hour Holter evaluable), and a 90% Kaplan‑Meier estimated freedom from recurrent AF/atrial flutter/atrial tachycardia at 1 year. Safety profile: serious adverse event rate of 1.7% across 177 treated subjects.
U.S. IDE Pivotal Trial Initiated and Enrollment Accelerated
Commenced NANOPULSE‑AF IDE pivotal study in early April; first 7 patients treated in one day at St. Bernards (demonstrating short learning curve). Company tightened timeline and now expects enrollment completion in early Q4 2026 (accelerated from prior guidance of end-2026).
Procedural Efficiency and Single‑Shot Capability
nPulse catheter demonstrates single‑shot pulmonary vein ablation workflow (single 5‑second applications per target), with reported reductions in atrial dwell time, average number of applications, procedure time and fluoroscopy time — positioning the system as faster, reproducible and potentially capacity‑expanding for EP procedures.
Regulatory Pathway Momentum — CE and PMA Preparation
Plan to finalize CE submission in H2 2026 with potential CE Mark in mid‑2027 using European feasibility data; pivotal IDE design includes Bayesian analysis to shorten follow‑up and accelerate PMA module timing.
Surgical and Percutaneous Programs Advancing
Surgical clamp feasibility in Europe: >60 patients treated across 6 sites, average total ablation time ~41 seconds per patient and PVI success ~94% at ~3 months. Vybrance percutaneous system generated ~$400,000 in Q1 revenue; PRECISE‑BTN reached first 50 patients and expanded to 100. MD Anderson PTMC first‑in‑human enrollments completed in Q1.
Strategic Realignment and Strengthened Leadership
Company strategically prioritized the nPulse cardiac catheter program and increased R&D/clinical resourcing; Dr. David Kenigsberg transitioned to full‑time CMO and Liane Teplitsky hired as COO to support clinical, regulatory, quality and commercial execution.
Available Financing Flexibility
Cash and cash equivalents of $68.3M as of March 31, 2026, plus a $200M shelf registration and an ATM program with approximately $60M availability; Board approved participation by insiders in ATM and executives signaled intent to purchase shares, providing optionality to support operations.