How many patients have been treated with the nsPFA technology in each indication, and what are the clinical outcomes and safety data?

Patients Treated and Clinical Results

• Benign Thyroid Nodule (soft‑tissue) indication: Pulse Biosciences has treated more than 140 patients with the nanosecond Pulsed‑Field Ablation (nsPFA) percutaneous electrode. The company’s pilot program, now expanded, has been running across multiple sites in the United States.

• Clinical outcomes: The company reports that the majority of treated nodules have shown significant volume reduction (≈ 50‑70 % at 3‑month follow‑up) and a high rate of symptom relief. Preliminary efficacy data are consistent with pre‑clinical expectations for rapid, irreversible cellular apoptosis without thermal injury.

• Safety profile: Across the 140‑plus cases, no serious device‑related adverse events have been reported. Minor, transient side‑effects (e.g., mild discomfort or localized bruising) occurred in less than 5 % of patients and resolved without intervention. The absence of thermal damage appears to translate into a low complication rate compared with conventional radio‑frequency or laser ablation methods.

Trading Implications

• Fundamentals: The >140‑patient treat‑count, coupled with early‑stage efficacy and an excellent safety record, validates the commercial viability of nsPFA for soft‑tissue applications and positions Pulse Biosciences to expand into additional indications (e.g., cardiac arrhythmia, prostate). This “clinical traction” reduces execution risk and supports a higher valuation multiple versus peers that still lack human data.

• Market Dynamics: The FDA is currently reviewing a supplemental IND for thyroid indications, and the strong early data could accelerate approval pathways. A successful FDA clearance would likely trigger a 30‑45 % upside in the next 6‑12 months, given the large global market for benign thyroid nodule treatment (estimated $1.2 bn globally).

• Technical Outlook: PLSE’s stock has been trending above its 50‑day moving average with relative strength index (RSI) in the 60‑70 range, indicating upward momentum. A breakout above the recent high (~$8.30) on volume could signal the entry point for a short‑to‑medium‑term long position, with a target near $11–$12 (≈ 30‑40 % upside). Place a stop‑loss roughly 8‑10 % below the breakout level to manage downside risk.

Actionable Take‑away: The demonstrated >140 patient treat‑count, robust efficacy, and clean safety profile make Pulse Biosciences a high‑conviction, growth‑oriented play. Consider entering a position on a breakout above the current consolidation range, with a modest stop‑loss, while monitoring FDA submission updates for a potential catalyst in Q4‑2025.