Pulse Biosciences (PLSE) investor relations material

Clinical data and technology insights

• Six-month efficacy of 100% and 12-month rhythm control of 96% were achieved in the EFS study, with 90% freedom from all atrial arrhythmias at 12 months, surpassing industry benchmarks.

• The nanosecond PFA technology delivers lower total energy but achieves deeper, more consistent lesions with a single-shot approach, reducing mechanical errors and improving outcomes.

• Catheter design enables a contiguous lesion in five seconds, minimizing gaps and reconnections common in other systems.

• Integration with mapping systems is advancing, with higher fidelity registration expected in the U.S. IDE, potentially improving procedural efficiency.

• The IDE study will use improved mapping integration, aiming to reduce lesions per case and enhance workflow speed.

IDE study plans and enrollment

• IDE approval was received in late December, with enrollment expected to begin early Q2 and complete by Q4, targeting 155 patients in a single-arm study.

• High patient flow and broad inclusion criteria are expected to drive rapid enrollment, with major centers able to enroll multiple patients per month.

• Investigators show strong interest due to the technology's ease of use and compelling clinical results, supporting enrollment objectives.

• The study is positioned as attractive to patients, with no randomization and promising European data, simplifying consent and participation.

Strategic direction and partnerships

• The company is prioritizing a partnership strategy over building a standalone commercial organization, citing high capital requirements and market risks.

• The disruptive nature of the technology and compatibility with multiple mapping systems make it an attractive asset for strategic collaborations.

• No specific partnership structure is confirmed; focus remains on execution and delivering clinical milestones to enhance attractiveness.