Partnership and collaboration strategy, R&D and funding strategy, partnership progress and strategic collaborations, clinical trial and PMA submission strategy, compatibility with mapping systems are the key contradictions discussed in Pulse Biosciences' latest 2025Q2 earnings call.
Thyroid Ablation Market Penetration:
-
has treated over
140 patients in the pilot program for thyroid ablation using its NSPFA percutaneous electrode, with procedure volumes and treatment centers growing.
- The market potential is significant as the device addresses unmet clinical needs, offers a nonsurgical and thyroid-sparing treatment option for several hundred thousand patients per year.
Cardiovascular Device Development:
- Pulse Biosciences submitted an IDE for treating atrial fibrillation with its NSPFA 360-catheter, with over
140 patients treated in Europe, showing positive outcomes.
- Early clinical results suggest that NSPFA could represent a significant step forward from current market standards, with procedure times reduced and deeper lesions.
Financial and Operational Growth:
- Total GAAP costs and expenses increased by
$8.5 million to
$20.3 million, driven by organizational expansion and increased compensation costs.
- The company ended the quarter with
$106.3 million in cash, aligning with planned cash usage, and expects an uptick in cash usage as IDE clinical studies and commercial infrastructure are developed.
Partnership and Collaboration Strategy:
- Pulse Biosciences is pursuing strategic partnerships, with a focus on collaboration with market leaders in the electrophysiology space to drive value for stakeholders.
- The company recognizes the benefits of partnerships for clinical stage and commercial goals, particularly in competitive market dynamics.
Regulatory Progress and Approval:
- Pulse Biosciences' cardiac surgical clamp ablation device received FDA's Breakthrough Device designation and is enrolled in the TAP program, which is expected to accelerate regulatory submission review times.
- The company anticipates launching IDE studies for both cardiac clamp and 360 catheter in the next few months, with rapid site expansion planned for clinical trial enrollment.
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