Pulse Biosciences announced on April 7, 2026, that it had enrolled and treated the first seven patients in its NANOPULSE-AF IDE pivotal clinical study evaluating the nPulse Cardiac Catheter System (using nsPFA nanosecond pulsed field ablation) for drug-resistant, symptomatic paroxysmal atrial fibrillation. The prospective, multicenter trial plans to enroll approximately 215 patients across up to 30 U.S. and European sites, with primary safety and effectiveness endpoints assessed at 6 and 12 months. This builds directly on positive first-in-human feasibility data showing 100% acute success and 96% freedom from arrhythmia at 12 months (without anti-arrhythmic drugs), which exceeded typical benchmarks in the field. Physicians quoted in the release, including investigators Devi Nair, MD, and Vivek Reddy, MD, highlighted the system’s efficiency, workflow advantages (e.g., integrated Abbott EnSite X mapping, short procedure times), and potential for precise, non-thermal lesions. The stock fell sharply from a prior close of $22.94 (April 6), trading as low as $19.81 intraday and around $20.31 mid-morning, aligning with the reported ≈15% decline. This appears to reflect profit-taking after a recent run-up, as pivotal data remains many months away and the expanded trial will increase cash burn for a development-stage company. No concurrent offering, negative data, or adverse regulatory update was disclosed. Broader market weakness on geopolitical headlines existed but does not explain the outsized move.
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