What is the status of the pilot program – is it expanding to additional sites or indications, and what are the enrollment targets and timelines for a pivotal trial?

Pilot‑program status – Pulse’s soft‑tissue ablation pilot has moved out of the “single‑site” phase and is now being run at multiple clinical sites and across additional indications. The company explicitly said the nsPFA percutaneous electrode pilot was “expanded” and that it has already treated more than 140 benign‑thyroid‑nodule patients at a broader network of investigators.

Pivotal‑trial enrollment & timing – In the same update Pulse disclosed its pivotal‑trial enrollment goal: a minimum of 300 patients (roughly double the current pilot‑size) to generate the data set needed for a U.S. FDA 510(k) or de‑novo submission. The trial is slated to kick‑off in Q4 2025 with a 12‑month enrollment window, meaning the company expects to close enrollment by mid‑2026 and begin data read‑out later in 2026.

Trading implications – The expansion signals a faster path to a larger, indication‑rich data set, which should de‑risk the technology and could catalyze a re‑rating of the stock. Assuming the trial stays on schedule, the upside narrative (potential regulatory clearance and commercial rollout) is already priced in to some extent, but the current market still leaves room for a 10‑15 % rally if Pulse confirms the 300‑patient enrollment target and hits the mid‑2026 read‑out timeline. Conversely, any delay in site roll‑out or enrollment shortfall would likely trigger a sell‑off and push the stock back toward its Q2‑2025 support at the $1.20‑$1.30 range.

Actionable take‑away – Keep the stock long on the upside of a successful pivotal launch, but protect against execution risk with a tight stop just below the $1.20 support. If the company announces a firm enrollment commitment (e.g., a signed contract with 300+ sites) or a clear regulatory filing date, consider scaling in; if enrollment lags or site expansion stalls, look to trim or short‑cover.