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Pulse Biosciences Gets FDA IDE Nod for Atrial Fibrillation Study
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Key Takeaways
Pulse Biosciences secured FDA IDE clearance to start its NANOCLAMP AF atrial fibrillation study.
The trial will test its nsPFA Cardiac Surgical System in up to 136 patients at 20 global sites.
Early EU data show rapid, consistent ablation, with FDA Breakthrough Device status supporting progress.
Pulse Biosciences (PLSE - Free Report) recently reached a key milestone with the FDA’s approval of its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, evaluating its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF). This marks the first time pulsed field ablation technology is advancing into the cardiac surgical field, opening the door to a potentially safer, faster, and more effective alternative to thermal ablation methods.
For Pulse Biosciences, the IDE approval represents a significant growth catalyst, validating its technology and strengthening its pathway toward broader clinical adoption. The milestone reinforces the company’s position in the cardiac ablation market and provides a clear opportunity to expand its long-term commercial potential.
Likely Trend of PLSE Stock Following the News
Following the announcement, the company's shares closed flat at yesterday’s market closing. Shares of the company have lost 15.2% in the year-to-date period compared with the industry’s 10.9% decline. The S&P 500 has gained 11.9% in the same time frame.
The NANOCLAMP AF study positions Pulse Biosciences to establish its nsPFA technology as a differentiated solution in the large and growing atrial fibrillation market, creating a pathway to future regulatory approvals, wider adoption in cardiac surgery and potential expansion into adjacent indications, ultimately strengthening the company’s revenue prospects and long-term market presence.
PLSE currently has a market capitalization of $1.01 billion.
Image Source: Zacks Investment Research
More on PLSE’s NANOCLAMP AF Data
Pulse Biosciences is likely to initiate its NANOCLAMP AF study soon after receiving FDA approval for its IDE. This single-arm, prospective study is designed to evaluate the effectiveness of the company’s nsPFA Cardiac Surgical System in treating atrial fibrillation during concomitant cardiac surgeries. The study will enrol up to 136 patients across as many as 20 sites, including two outside the United States.
The nsPFA Cardiac Clamp at the center of this study is designed to deliver continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device leverages the company’s proprietary nonthermal nsPFA technology, which early clinical data suggest may offer safety and performance advantages over traditional thermal ablation methods. Unlike thermal approaches, nsPFA energy minimizes the risk of collateral tissue damage due to its nonthermal mechanism of action.
The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA’s Total Product Life Cycle Advisory Program. The company’s 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. Surgeons have reported rapid ablation times, as short as 2.5 seconds, along with consistent, contiguous and fully transmural lesions. The company expects to add additional sites to this study throughout 2025.
Favorable Industry Prospects for PLSE
Per a report by Grand View Research, the global atrial fibrillation market size was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, registering a CAGR of 10.44% from 2025 to 2033.
The atrial fibrillation market is driven by a growing disease burden, rapid technological evolution in treatment and diagnostics and the shift toward remote patient monitoring.
PLSE’s Zacks Rank & Key Picks
Currently, PLSE carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. (WST - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Envista (NVST - Free Report) .
West Pharmaceutical reported second-quarter 2025 adjusted EPS of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.
Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).
Envista has a long-term estimated growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.50%.
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Pulse Biosciences Gets FDA IDE Nod for Atrial Fibrillation Study
Key Takeaways
Pulse Biosciences (PLSE - Free Report) recently reached a key milestone with the FDA’s approval of its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, evaluating its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF). This marks the first time pulsed field ablation technology is advancing into the cardiac surgical field, opening the door to a potentially safer, faster, and more effective alternative to thermal ablation methods.
For Pulse Biosciences, the IDE approval represents a significant growth catalyst, validating its technology and strengthening its pathway toward broader clinical adoption. The milestone reinforces the company’s position in the cardiac ablation market and provides a clear opportunity to expand its long-term commercial potential.
Likely Trend of PLSE Stock Following the News
Following the announcement, the company's shares closed flat at yesterday’s market closing. Shares of the company have lost 15.2% in the year-to-date period compared with the industry’s 10.9% decline. The S&P 500 has gained 11.9% in the same time frame.
The NANOCLAMP AF study positions Pulse Biosciences to establish its nsPFA technology as a differentiated solution in the large and growing atrial fibrillation market, creating a pathway to future regulatory approvals, wider adoption in cardiac surgery and potential expansion into adjacent indications, ultimately strengthening the company’s revenue prospects and long-term market presence.
PLSE currently has a market capitalization of $1.01 billion.
Image Source: Zacks Investment Research
More on PLSE’s NANOCLAMP AF Data
Pulse Biosciences is likely to initiate its NANOCLAMP AF study soon after receiving FDA approval for its IDE. This single-arm, prospective study is designed to evaluate the effectiveness of the company’s nsPFA Cardiac Surgical System in treating atrial fibrillation during concomitant cardiac surgeries. The study will enrol up to 136 patients across as many as 20 sites, including two outside the United States.
The nsPFA Cardiac Clamp at the center of this study is designed to deliver continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device leverages the company’s proprietary nonthermal nsPFA technology, which early clinical data suggest may offer safety and performance advantages over traditional thermal ablation methods. Unlike thermal approaches, nsPFA energy minimizes the risk of collateral tissue damage due to its nonthermal mechanism of action.
The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024 and is enrolled in the FDA’s Total Product Life Cycle Advisory Program. The company’s 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. Surgeons have reported rapid ablation times, as short as 2.5 seconds, along with consistent, contiguous and fully transmural lesions. The company expects to add additional sites to this study throughout 2025.
Favorable Industry Prospects for PLSE
Per a report by Grand View Research, the global atrial fibrillation market size was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, registering a CAGR of 10.44% from 2025 to 2033.
The atrial fibrillation market is driven by a growing disease burden, rapid technological evolution in treatment and diagnostics and the shift toward remote patient monitoring.
PLSE’s Zacks Rank & Key Picks
Currently, PLSE carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. (WST - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Envista (NVST - Free Report) .
West Pharmaceutical reported second-quarter 2025 adjusted EPS of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.
Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).
Envista has a long-term estimated growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.50%.