Pulse Biosciences (PLSE) Goldman Sachs 47th Annual Global Healthcare Conference 2026 summary

Leadership vision and technology differentiation

• Attracted by the unique nanosecond pulsed field ablation (PFA) technology, which offers a non-thermal ablation method with broad therapeutic potential and strong patent protection, especially in atrial fibrillation (AFib).

• The platform technology has received multiple FDA clearances and is positioned for both benign and malignant applications, with a current focus on AFib based on compelling clinical data.

• Resource allocation prioritizes AFib while maintaining progress in other indications, leveraging a single console adaptable via software for various applications.

• A partnership strategy is emphasized for large markets like electrophysiology (EP), aiming for capital efficiency and rapid patient access.

Clinical data and regulatory milestones

• Feasibility data show 96% efficacy for AFib freedom at 12 months, outperforming competitors with typical rates in the 70s.

• Over 175 patients have been treated, with about half followed for a year, providing robust initial data ahead of pivotal studies.

• The pivotal U.S. IDE study targets paroxysmal AFib, aiming to complete enrollment by October, with a Bayesian statistical plan blending 6- and 12-month follow-up periods.

• FDA review could be completed by late 2027, with commercial launch anticipated around early 2028.

Commercial and operational strategy

• Go-to-market approach in EP is partner-driven, with manufacturing already underway via contract manufacturers to ensure scalability and strong margins.

• The catheter is designed for ease of use, low learning curve, and broad applicability, with rapid ablation times (5–10 minutes) and suitability for both high- and medium-volume labs.

• The device integrates with any mapping system, enabling efficient single-catheter workflows and supporting the shift of AFib procedures to ambulatory surgery centers (ASCs).

• The technology supports sedation protocols and high throughput, addressing market needs for efficiency and capacity.