Strong Clinical Efficacy in nPulse Electrophysiology Feasibility Studies
European feasibility data presented at AF Symposium: 100% procedural success (6 months) and 96% procedural success (1 year) for evaluable patients; 90% freedom from atrial arrhythmia at 12 months (Kaplan–Meier). Reported routine ablation procedure times of 6–8 minutes (company assertion) with potential to cut total procedure times by over 50% versus legacy approaches.
Multiple IDE Approvals and Pivotal Trial Progress
Company secured IDE approvals for both the electrophysiology catheter (nPulse) and the cardiac surgical clamp (NANOCLAMP AF) and plans to commence and complete nPulse IDE enrollment in 2026 (protocol cited ~155 patients); NANOCLAMP AF pivotal study targets ~136 patients across ~20 sites with enrollment expected to conclude in 2026.
Expanding Intellectual Property Estate
Pulse added 67 issued and 77 pending patents in 2025 (equivalent to ~one new piece of IP every 2.5 days). Total IP: 250 granted patents and ~180 pending patents, strengthening barriers to entry for nsPFA technology.
Vybrance Initial Commercial Traction
Vybrance revenue in Q4 2025 was $264,000 (company described as 'nominal' revenue), up from $86,000 in Q3 2025 — a sequential increase of approximately 207% — driven by both system and disposable (electrode) sales during an intentionally limited launch.
Focused Strategic Partnerships and Regulatory Pathway Planning
Management is actively pursuing mapping and EP ecosystem partnerships to accelerate commercial launch; plans to finalize CE submission for the nPulse catheter in H2 2026 with potential CE Mark in 2027 and intends to file for CE Mark for the surgical clamp by end of 2026.
Operational Discipline and Liquidity Tools
GAAP costs and expenses decreased by $1.7M year-over-year to $18.5M in Q4 2025 (approx. 8% reduction vs prior-year period). Company completed a $200M shelf registration to provide flexibility for financing if needed and stated cash runway to support clinical programs through major 2026 inflection points.