What is the expected timeline for additional data releases or potential FDA clearance for the nsPFA™ system in thyroid indications?

Expected timeline

Pulse Biosciences has only reported that the first successful procedures in the PRECISE‑BTN study have now been completed. The trial is multicenter, IRB‑approved and still early in enrollment, so the company will need to collect procedural safety and 12‑month nodule‑size reduction data before it can consider a regulatory filing. In the industry, a Phase 2‑type PFA study that follows a 12‑month primary‑endpoint typically releases its first pooled efficacy read‑out about 6–9 months after the initial procedure. Given that the first procedures were performed in early May 2024, we can expect the initial efficacy data set to be disclosed in Q4 2024 (approximately September‑December 2024).

Assuming the data meet the usual safety‑efficacy thresholds, Pulse would likely pursue a de novo or 510(k) submission to the FDA in early 2025. For a novel ablation platform, the FDA’s review cycle averages 3–4 months, so potential clearance could arrive by mid‑2025 (June‑August 2025). Until then, the market will remain driven by incremental updates from the PRECISE‑BTN study rather than a definitive clearance date.

Trading implication

The stock is poised for a catalyst‑driven move once the Q4 2024 data are released—a “pre‑clearance” rally if the outcomes are positive. In the near term, the price will likely reflect the classic “trial‑news” pattern: modest upside on the upcoming September‑December 2024 data release followed by a more pronounced run‑up if a mid‑2025 FDA clearance is confirmed. Traders should consider buying on any pull‑back after the Q4 data if results are solid, and positioning for a larger upside as the mid‑2025 clearance window approaches. Conversely, a delayed enrollment pace or a negative safety signal could keep the stock compressed until the next data milestone.