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HAYWARD, Calif. - Pulse Biosciences, Inc. (NASDAQ:PLSE), a $1.02 billion medical device company currently trading at $15.11, announced Monday that the U.S. Food and Drug Administration has approved its Investigational Device Exemption application for the NANOCLAMP AF study, which will evaluate the company’s nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for treating atrial fibrillation. According to InvestingPro analysis, the company appears slightly overvalued at current levels, though analysts maintain a $22 price target.
The single-arm, prospective study will enroll up to 136 patients across 20 sites, including two outside the United States. The trial aims to demonstrate the effectiveness of the nsPFA technology during concomitant surgical procedures.
The nsPFA Cardiac Clamp is designed to deliver continuous, linear, transmural ablations during cardiac surgeries using the company’s proprietary nonthermal technology. The device received FDA Breakthrough Device Designation in July 2024.
"This FDA IDE approval is a major milestone for Pulse Biosciences," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences, according to the company’s press release.
A first-in-human feasibility study has been underway in the European Union since August 2024, with over 40 patients treated across three sites in The Netherlands. According to the company, surgeons have reported ablation times as short as 2.5 seconds, along with consistent lesions.
The company expects to add more sites to its European study throughout 2025 and plans to present data at the upcoming European Association for Cardio-Thoracic Surgery meeting in Copenhagen, Denmark, October 8-11, 2025.
Pulse Biosciences’ nsPFA technology uses nanosecond pulses of electrical energy to clear cells while sparing adjacent noncellular tissue. The company is developing this technology for atrial fibrillation treatment and other potential applications in surgical soft tissue ablation.
In other recent news, Pulse Biosciences reported its Q2 2025 earnings, highlighting a significant rise in costs and expenses. The company’s net loss expanded compared to the previous year; however, it maintained strong cash reserves. In addition to financial updates, Pulse Biosciences announced promising results from a first-in-human clinical feasibility study using its Nanosecond Pulsed Field Ablation (nsPFA) technology for benign thyroid nodules. Conducted at Ospedale del Mare in Naples, Italy, the study demonstrated a reduction in nodule size by up to 93% after one year. Patients experienced symptom relief and a reduction in nodule size by more than 48% just two weeks post-treatment. These developments showcase the company’s ongoing efforts in medical innovation despite financial hurdles.
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