Pulse Biosciences (Nasdaq: PLSE) has announced a pivotal regulatory milestone, securing FDA investigational device exemption (IDE) approval for its pulsed field ablation (PFA) system. The approval clears the company to move forward with its NANOCLAMP AF clinical study, a multi-center trial designed to evaluate the safety and effectiveness of its nanosecond PFA (nsPFA) Cardiac Surgery System in the treatment of atrial fibrillation (AFib).

The IDE clearance is a critical step for Pulse, positioning it as the first company to advance PFA into the cardiac surgical field. This not only validates years of preclinical and clinical research but also sets the stage for what could become a transformative new therapy in the management of AFib during concomitant cardiac procedures.

Inside the NANOCLAMP AF study

According to Pulse, the NANOCLAMP AF study will enroll up to 136 patients across 20 sites, including two outside the U.S. The trial is designed to demonstrate the primary effectiveness of nsPFA for AFib in patients undergoing concomitant cardiac surgeries, such as valve repair or coronary artery bypass grafting (CABG).

The focus is on proving that nsPFA can consistently achieve durable, transmural, linear ablations—a benchmark that has been difficult to guarantee with conventional thermal approaches like radiofrequency or cryoablation. By building on its robust preclinical dataset, Pulse aims to show that its technology can become the new standard of care for surgical AFib ablation.

Technology designed to minimize collateral damage

Based in Hayward, California, Pulse Biosciences has engineered its nsPFA system with a bipolar cardiac clamp. This device is designed to deliver continuous, nonthermal electrical energy in nanosecond pulses, disrupting myocardial tissue at the cellular level without generating the heat associated with thermal ablation.

This distinction is critical: traditional thermal ablation carries risks of collateral damage to nearby structures such as the esophagus, phrenic nerve, or coronary arteries. By eliminating heat, nsPFA theoretically reduces these risks while maintaining efficacy in creating contiguous, full-thickness lesions. Faster ablation times also mean shorter procedural durations, an important factor in complex open-heart surgeries.

Pulse positions its system as a replacement for conventional radiofrequency ablation devices, with advantages in safety, speed, and consistency. The technology holds FDA breakthrough device designation, granted last year, underscoring the agency’s recognition of its potential to address an unmet clinical need.

Atrial fibrillation and surgical ablation

Atrial fibrillation (AFib) remains the most common sustained cardiac arrhythmia, affecting more than 33 million people worldwide. Among patients undergoing cardiac surgery, particularly valve or bypass procedures, concomitant AFib is highly prevalent. Left untreated, AFib increases the risk of stroke, heart failure, and reduced survival.

For years, surgical ablation has been performed during open-heart procedures to restore sinus rhythm, but conventional tools have faced limitations in efficacy and safety. Achieving durable, transmural lesions has been technically challenging, and the risk of damaging surrounding tissue has slowed adoption. This has created demand for next-generation technologies that can overcome these hurdles while fitting seamlessly into existing surgical workflows.

Pulse believes its nsPFA platform represents that breakthrough. By providing surgeons with a clamp-based, nonthermal solution, the company aims to deliver a reliable and reproducible method for ablation that reduces risks and improves long-term outcomes.

Leadership perspective

Calling the FDA’s approval a “major milestone,” Paul LaViolette, co-chair and CEO of Pulse Biosciences, emphasized the significance of the achievement.

“This FDA IDE approval is a major milestone for Pulse Biosciences. The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology. Pulse Biosciences is the first company to advance PFA into the cardiac surgical field for the treatment of AFib.”

LaViolette’s comments highlight not only the regulatory validation but also the strategic positioning of Pulse as a first mover in this space. With competitors largely focused on catheter-based PFA for electrophysiology, Pulse has carved out a distinct role by targeting the cardiac surgery market, where ablation is often performed alongside major surgical interventions.

Broader implications

The IDE approval represents more than regulatory progress; it signals growing confidence in the role of PFA as a next-generation modality in cardiac rhythm management. With industry attention centered on nonthermal energy delivery as a safer, more efficient alternative, Pulse’s entrance into surgical AFib treatment could have ripple effects across the broader electrophysiology and cardiac surgery landscape.

The company’s ability to demonstrate durable outcomes in NANOCLAMP AF could reshape practice guidelines, influence surgical decision-making, and expand adoption of AFib treatment during procedures where it has historically been underutilized.

Competitive landscape and the growing momentum of pulsed field ablation

Pulse Biosciences’ FDA IDE approval for its nanosecond pulsed field ablation (nsPFA) system places it within one of the most dynamic areas of cardiovascular innovation today. Over the past five years, pulsed field ablation (PFA) has emerged as a transformative technology in the treatment of atrial fibrillation (AFib), offering a nonthermal alternative to radiofrequency (RF) and cryoablation methods that have dominated the space for decades.

While most of the attention has focused on catheter-based PFA for electrophysiology labs, Pulse Biosciences is breaking ground by targeting the surgical AFib market. This distinction could prove significant, giving the company first-mover advantage in a segment of cardiac care where consistent lesion formation has historically been difficult to achieve.

The PFA surge in electrophysiology

Major players in electrophysiology have already embraced PFA as the next-generation energy modality for AFib ablation:

• Boston Scientific made headlines with its $1.15 billion acquisition of Farapulse, a pioneer in catheter-based PFA. The deal underscored industry confidence in the safety and efficacy of the approach.

• Medtronic has invested heavily in PFA technology through its PulseSelect system, which gained CE Mark approval in Europe and is progressing through U.S. clinical trials.

• Johnson & Johnson’s Biosense Webster is also pursuing PFA innovations, leveraging its strong foothold in the electrophysiology market.

These developments reflect a growing consensus that PFA could supplant thermal ablation as the dominant approach, thanks to faster procedures, reduced complication rates, and more reproducible outcomes. Clinical data so far suggest PFA offers a favorable safety profile, particularly in minimizing risks of esophageal injury and pulmonary vein stenosis.

Pulse Biosciences’ differentiated strategy

While giants like Boston Scientific, Medtronic, and J&J focus on the catheter-based space, Pulse Biosciences is carving a different path. Its cardiac clamp-based nsPFA system is specifically designed for use in concomitant cardiac surgeries. This creates a unique value proposition:

• 1. Built-in adoption opportunity: Surgeons already perform AFib ablation during open-heart procedures, but existing tools are inconsistent. Pulse’s system could provide a reliable, streamlined alternative.

• 2. Synergy with surgical workflow: Because the clamp is integrated into surgeries already being performed, no additional access or major workflow changes are required.

• 3. Clear differentiation: By focusing on the surgical setting, Pulse avoids direct competition with catheter-based PFA leaders while staking a claim in an underserved niche.

This positioning could allow the company to establish itself as a complementary player in the broader PFA ecosystem, with potential to expand into adjacent applications over time.

Why timing matters?

The IDE approval comes at a critical juncture for both Pulse and the broader PFA field. With catheter-based systems approaching commercialization in the U.S., awareness of PFA’s benefits among clinicians and hospital administrators is at an all-time high. Surgeons familiar with the advantages of PFA in electrophysiology may be more open to adopting it in the surgical setting.

Moreover, healthcare systems face pressure to improve efficiency and outcomes while reducing complications. Surgical AFib treatment has historically been underutilized, in part because of the limitations of thermal tools. If Pulse can demonstrate that nsPFA reliably produces durable lesions without collateral damage, it could help expand adoption of surgical AFib ablation, creating a larger overall market.

Competitive risks and opportunities

Despite its promising positioning, Pulse faces several challenges:

• 1. Resource gap: Competing against multinational MedTech giants requires careful allocation of capital and strategic partnerships. Boston Scientific and Medtronic have far greater commercial infrastructure.

• 2. Clinical validation: While preclinical and early human data are encouraging, large-scale, multi-center studies like NANOCLAMP AF are essential to prove durability and reproducibility in real-world practice.

• 3. Regulatory pathway: The IDE approval is a milestone, but successful trial execution and eventual FDA premarket approval will determine commercialization timelines.

On the opportunity side, Pulse could benefit from first-mover advantage in surgical PFA, establish relationships with leading cardiac surgeons, and potentially position itself as an acquisition target for a larger MedTech player seeking to expand into this niche.

The MedTech race toward innovation

The broader MedTech industry is in the midst of a shift toward precision energy delivery technologies. Whether in oncology, dermatology, or cardiology, nonthermal approaches are gaining traction as safer and more targeted alternatives. Pulse’s expertise in nanosecond energy delivery places it in a strong position to participate in this trend, with potential applications extending beyond cardiology in the future.

From an investor perspective, the company’s Nasdaq listing (PLSE) offers a public market lens on PFA innovation. The FDA’s IDE approval is likely to be viewed as a de-risking milestone, enhancing credibility and potentially attracting strategic interest or partnership opportunities.

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