Gold ticks up but remains pressured by Fed rate caution, easing trade fears
HAYWARD, Calif. - Pulse Biosciences, Inc. (NASDAQ:PLSE), a $1.17 billion market cap medical device company with a FAIR financial health rating according to InvestingPro, has enrolled the first patient in its NANOCLAMP AF Study for the treatment of atrial fibrillation (AF), according to a company press release.
The first procedure using the nPulse Cardiac Surgical System was completed at St. Helena Hospital in California following recent FDA Investigational Device Exemption (IDE) approval. The NANOCLAMP AF is a single-arm, prospective multicenter study designed to evaluate the safety and effectiveness of the system for treating AF during concomitant surgical procedures. While the company currently shows negative earnings, InvestingPro analysts project profitability by year-end, with an EPS forecast of $1.71.
Dr. Gan Dunnington, who performed the first procedure with Dr. Aaron Kime at Adventist Health, noted that his team was impressed by the device’s ease of use and treatment speed.
The nPulse Cardiac Surgical System is designed to create continuous, full-thickness ablation lines during concomitant cardiac procedures using nanosecond Pulsed Field Ablation technology. The system utilizes a nonthermal energy modality that the company states may provide safety and procedural advantages over conventional thermal ablation methods.
Dr. Matthew Romano, National Principal Investigator and Professor of Cardiac Surgery at the University of Michigan, stated that the technology "has the potential to revolutionize how we approach concomitant ablation procedures."
The system received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA’s Total Product Life Cycle Advisory Program.
Multiple sites, including two outside the United States, are planned for patient enrollment in the study, which aims to demonstrate the benefits of nanosecond PFA for treating atrial fibrillation during other cardiac surgical procedures. The company maintains a strong financial position with a current ratio of 12.05 and minimal debt-to-equity of 0.08. Get access to 10+ additional exclusive InvestingPro Tips and comprehensive analysis in our Pro Research Report, helping you make informed investment decisions.
In other recent news, Pulse Biosciences reported its Q2 2025 earnings, which highlighted a significant increase in costs and expenses, resulting in a widened net loss compared to the previous year. Despite these financial challenges, the company maintained strong cash reserves. Additionally, the U.S. Food and Drug Administration approved Pulse Biosciences’ Investigational Device Exemption application for the NANOCLAMP AF study, which will assess the effectiveness of its nanosecond Pulsed Field Ablation technology for atrial fibrillation treatment. Meanwhile, the company announced positive results from its first-in-human feasibility study of the nPulse Cardiac Surgical System, showing a 94% success rate in treating atrial fibrillation. In another development, a clinical feasibility study demonstrated the effectiveness of its technology for treating benign thyroid nodules, with a significant reduction in nodule size reported. Moreover, stockholders approved an amendment to the 2017 Equity Incentive Plan, increasing the number of common shares and expanding the definition of "Consultant." These recent developments indicate ongoing advancements and strategic decisions within Pulse Biosciences.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.