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COPENHAGEN - Pulse Biosciences, Inc. (NASDAQ:PLSE), a medical device company with a market capitalization of $1.3 billion and trading near its 52-week high of $25, announced positive initial results from its first-in-human feasibility study of the nPulse Cardiac Surgical System for treating atrial fibrillation, according to a press release statement. According to InvestingPro data, the stock has delivered an impressive 24% return over the past six months.
The study, presented at the European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, showed a 94% success rate of pulmonary vein isolation at three-month follow-up across 24 patients who underwent electroanatomical mapping after the procedure. While the company is not yet profitable, InvestingPro analysts forecast profitability this year, with projected earnings per share of $1.71.
The company reported that all posterior box isolations were acutely successful in the high-dose cohort, with an average total ablation time of 50 seconds using an average of 13 applications. No esophageal or phrenic nerve damage was observed, and there were no ablation-related severe or major adverse events.
The feasibility study has treated 44 patients to date at three European medical centers: St. Antonius Hospital Nieuwegein and Amsterdam UMC in the Netherlands, and Maastricht UMC+ in Maastricht.
Dr. Bart van Putte, a cardiothoracic surgeon at St. Antonius Hospital who serves as a consultant to Pulse Biosciences, stated that the early results suggest the system’s "speed, safety and effectiveness" could potentially expand cardiac surgical ablation for atrial fibrillation patients.
The nPulse system uses the company’s proprietary Nanosecond Pulsed Field Ablation technology, which delivers nanosecond pulses of electrical energy to clear cells while sparing adjacent noncellular tissue.
Pulse Biosciences CEO Paul LaViolette said the company plans to initiate an IDE study this year to further validate the system as they work toward commercial approval. With analysts maintaining a Buy rating and a $22 price target, investors seeking deeper insights can access comprehensive analysis and 8 additional ProTips through InvestingPro’s detailed research reports, available for over 1,400 US stocks.
In other recent news, Pulse Biosciences reported its Q2 2025 earnings, which showed a significant rise in costs and expenses, leading to a widened net loss compared to the previous year. However, the company maintained strong cash reserves. In regulatory developments, the U.S. Food and Drug Administration approved Pulse Biosciences’ Investigational Device Exemption application for the NANOCLAMP AF study. This study will assess the company’s nsPFA Cardiac Surgery System for treating atrial fibrillation, involving up to 136 patients across 20 sites. Additionally, a clinical feasibility study published in the Journal Thyroid highlighted the effectiveness of Pulse Biosciences’ nsPFA technology in treating benign thyroid nodules, showing a notable reduction in nodule size. In corporate governance news, stockholders approved amendments to the 2017 Equity Incentive Plan, increasing available common shares by two million and broadening the definition of "Consultant" for equity awards. These developments reflect the company’s ongoing efforts in advancing its medical technologies and corporate structure.
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