Pulse Biosciences (PLSE) investor relations material

Strategic vision and technology differentiation

• Focus on life-changing therapies using a proprietary nanosecond pulsed field ablation (NSPFA) platform targeting multiple diseases.

• NSPFA delivers nonthermal ablation with shorter pulse durations, reducing thermal risk and enabling deeper, safer lesions.

• Strong intellectual property, multiple FDA clearances, and breakthrough designations support a robust clinical and commercial foundation.

• Hybrid market entry strategy: direct entry for greenfield opportunities like thyroid, partnerships for established markets such as electrophysiology (EP).

• Leadership team with deep medtech experience and a strong financial position, including over $100 million in cash.

Market opportunities and clinical focus

• Initial focus on three markets: thyroid intervention, cardiac surgery ablation, and EP ablation, with a combined addressable market exceeding $6 billion.

• Thyroid intervention aims to replace surgical removal of benign nodules with a minimally invasive, thyroid-sparing alternative.

• Cardiac surgery ablation targets underpenetrated market by offering safer, faster, and more effective ablation during open heart procedures.

• EP ablation leverages NSPFA's speed and depth to reduce procedure time and improve outcomes, with pivotal studies planned.

• Expansion plans include global market growth and additional indications as clinical evidence and partnerships develop.

Clinical progress and commercialization

• Active pilot and limited launch underway for thyroid indication, with expansion to more centers and ongoing data collection.

• IDE submissions for cardiac surgery and EP ablation are under review, with pivotal studies expected to begin before 2025.

• Published and upcoming clinical data support adoption and reimbursement efforts, especially for thyroid therapy.

• Reimbursement strategy leverages existing codes for irreversible electroporation, with pre-authorization processes in progress.

• Early adoption targeted at high-volume endocrine surgery centers, with low resistance due to lack of competition and strong patient demand.