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Stock impact report

PLSE Wins FDA IDE Approval to Launch nPulse AF Ablation Study Trial [Yahoo! Finance]

Pulse Biosciences, Inc (PLSE) 
Last pulse biosciences, inc earnings: 11/7 03:42 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.pulsebiosciences.com
Company Research Source: Yahoo! Finance
Catheter Ablation System study for the treatment of paroxysmal atrial fibrillation. The approval allows PLSE to begin a multicenter clinical trial evaluating its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology, marking an important regulatory milestone for the cardiac portfolio. For investors, the IDE clearance de-risks the clinical pathway, builds on encouraging European feasibility data and positions PLSE to generate meaningful U.S. clinical evidence that could support broader adoption and future commercialization. Following the announcement, the company's shares closed flat at yesterday's market closing. Shares of the company have lost 4.5% in the year-to-date period compared with the industry's 16.4% growth. The S&P 500 has gained 14.8% in the same time frame. Over the long run, the FDA IDE approval strengthens PLSE's business by advancing its nPulse system toward U.S. commercialization in the fast-growing AF ablation market, while validating its differentiat Show less Read more
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