Pulse Biosciences Announces Late-Breaking Data from its Nanosecond PFA 360° Cardiac Catheter System First-In-Human Feasibility Study Presented at the AF Symposium
Pulse Biosciences (PLSE) presented late-breaking data from its Nanosecond PFA 360° Cardiac Catheter System first-in-human feasibility study at the AF Symposium 2025. The study, evaluating the system's safety and efficacy in treating atrial fibrillation, has treated 77 patients to date by six investigators.
Initial results from the first 30 patients showed a 92.4% success rate for pulmonary vein isolation (PVI) at ~3 months post-procedure. Key metrics include: total PVI ablation time of 11.6±4.5 minutes, procedure time of 88.3±30.1 minutes, and fluoroscopy time of 6.9±2.4 minutes. The study reported one primary SAE (cardiac perforation) and two AEs (vertigo and creatinine elevation), all resolved without sequelae.
The company remains on track to begin an IDE study this year for clinical validation, aiming for commercial approval.
Pulse Biosciences (PLSE) ha presentato dati d'avanguardia dal suo studio di fattibilità sul sistema di cateterismo cardiaco Nanosecond PFA 360° durante il Simposio AF 2025. Lo studio, che valuta la sicurezza e l'efficacia del sistema nel trattamento della fibrillazione atriale, ha trattato finora 77 pazienti da parte di sei investigatori.
I risultati iniziali dei primi 30 pazienti hanno mostrato un tasso di successo del 92,4% per l'isolamento delle vene polmonari (PVI) a circa 3 mesi dopo la procedura. Le metriche chiave includono: tempo totale di ablazione PVI di 11.6±4.5 minuti, tempo di procedura di 88.3±30.1 minuti e tempo di fluoroscopia di 6.9±2.4 minuti. Lo studio ha riportato un evento avverso grave primario (perforazione cardiaca) e due eventi avversi (vertigini ed elevazione della creatinina), tutti risolti senza sequel.
L'azienda rimane in linea per iniziare uno studio IDE quest'anno per la validazione clinica, puntando all'approvazione commerciale.
Pulse Biosciences (PLSE) presentó datos de última hora de su estudio de viabilidad del sistema de catéter cardíaco Nanosecond PFA 360° en el Simposio AF 2025. El estudio, que evalúa la seguridad y eficacia del sistema en el tratamiento de la fibrilación auricular, ha tratado hasta la fecha a 77 pacientes por parte de seis investigadores.
Los resultados iniciales de los primeros 30 pacientes mostraron una tasa de éxito del 92,4% para el aislamiento de la vena pulmonar (PVI) aproximadamente a los 3 meses después del procedimiento. Las métricas clave incluyen: tiempo total de ablación PVI de 11.6±4.5 minutos, tiempo de procedimiento de 88.3±30.1 minutos y tiempo de fluoroscopia de 6.9±2.4 minutos. El estudio reportó un evento adverso grave primario (perforación cardíaca) y dos eventos adversos (vértigo y elevación de creatinina), todos resueltos sin secuelas.
La empresa se encuentra en camino de comenzar un estudio IDE este año para la validación clínica, con el objetivo de obtener la aprobación comercial.
펄스 바이오사이언스(PLSE)는 AF 심포지엄 2025에서 인간을 대상으로 한 나노초 PFA 360° 심장 카테터 시스템의 연구 결과를 발표했습니다. 이 연구는 심방 세동 치료에 있어 시스템의 안전성과 효능을 평가하며, 현재까지 6명의 연구자에 의해 77명의 환자를 치료했습니다.
처음 30명의 환자에서 초기 결과는 시술 후 약 3개월 만에 폐정맥 차단(PVI)에 대한 92.4%의 성공률을 보였습니다. 주요 지표는 PVI 절제 총 소요 시간 11.6±4.5분, 시술 시간 88.3±30.1분, 방사선 노출 시간 6.9±2.4분입니다. 이 연구는 1건의 주요 중대한 이상사례(심장 천공)와 2건의 이상사례(현기증 및 크레아티닌 상승)를 보고하였으며, 모두 후유증 없이 해결되었습니다.
회사는 상업적 승인을 목표로 올해 임상 검증을 위한 IDE 연구를 시작할 계획입니다.
Pulse Biosciences (PLSE) a présenté des données de pointe concernant son étude de faisabilité sur le système de cathéter cardiaque Nanosecond PFA 360° lors du Symposium AF 2025. L'étude, qui évalue la sécurité et l'efficacité du système dans le traitement de la fibrillation atriale, a traité à ce jour 77 patients par six chercheurs.
Les premiers résultats des 30 premiers patients ont montré un taux de succès de 92,4% pour l'isolement des veines pulmonaires (PVI) environ 3 mois après la procédure. Les indicateurs clés incluent : temps total d'ablation PVI de 11.6±4.5 minutes, temps de procédure de 88.3±30.1 minutes et temps de fluoroscopie de 6.9±2.4 minutes. L'étude a signalé un événement indésirable grave principal (perforation cardiaque) et deux événements indésirables (vertiges et élévation de la créatinine), tous résolus sans séquelles.
L'entreprise est en voie de commencer cette année une étude IDE pour la validation clinique, visant une approbation commerciale.
Pulse Biosciences (PLSE) stellte auf dem AF Symposium 2025 aktuelle Daten aus seiner Machbarkeitsstudie zum Nanosecond PFA 360° Herzkathetersystem vor. Die Studie, die die Sicherheit und Wirksamkeit des Systems bei der Behandlung von Vorhofflimmern bewertet, hat bislang 77 Patienten durch sechs Prüfer behandelt.
Die ersten Ergebnisse der ersten 30 Patienten zeigten eine Erfolgsquote von 92,4% für die Isolation der Lungenvenen (PVI) etwa 3 Monate nach dem Eingriff. Wichtige Kennzahlen umfassen: Gesamtablationszeit für PVI von 11,6±4,5 Minuten, Eingriffszeit von 88,3±30,1 Minuten und Fluoroskopiezeit von 6,9±2,4 Minuten. Die Studie berichtete über ein primäres schwerwiegendes unerwünschtes Ereignis (Herzperforation) und zwei unerwünschte Ereignisse (Schwindel und Kreatininerhöhung), die alle ohne Folgen gelöst wurden.
Das Unternehmen bleibt auf Kurs, in diesem Jahr eine IDE-Studie zur klinischen Validierung zu beginnen, mit dem Ziel der kommerziellen Genehmigung.
- High success rate of 92.4% in pulmonary vein isolation at 3-month follow-up
- Efficient procedure metrics with short ablation times (11.6 minutes)
- 100% acute success rate with conduction block
- On track for IDE study initiation in 2025
- One serious adverse event (cardiac perforation) reported
- Two additional adverse events occurred (vertigo and creatinine elevation)
Insights
The clinical trial data for Pulse Biosciences' Nanosecond PFA 360° Cardiac Catheter System reveals compelling efficacy metrics that could position this technology as a significant advancement in atrial fibrillation treatment. The 92.4% success rate for pulmonary vein isolation at 3-month follow-up, combined with notably short procedure times (average 88.3 minutes), demonstrates strong potential for improved clinical workflow efficiency. For context, traditional RF ablation procedures typically take 2-3 hours with success rates around 70-80%.
The safety profile appears promising with only one primary serious adverse event out of 77 patients, though this early data needs validation in larger studies. The 11.6-minute average ablation time is particularly noteworthy, as it suggests significant time savings compared to conventional approaches. The technology's compatibility with Abbott's Ensite X System also indicates strong potential for seamless integration into existing clinical workflows.
This clinical milestone represents a significant value catalyst for PLSE, potentially accelerating their path to commercialization in the $2+ billion global cardiac ablation market. The positive initial data strengthens their competitive position against established players like Medtronic and Boston Scientific. The planned IDE study initiation in 2025 could serve as a major near-term catalyst for the stock.
The technology's demonstrated efficiency improvements - particularly the reduced procedure times - present a compelling economic value proposition for healthcare providers. Shorter procedure times typically translate to higher patient throughput and better resource utilization, which could drive strong market adoption. The successful integration with Abbott's mapping system also suggests potential strategic partnership opportunities that could enhance market penetration.
Successfully treated atrial fibrillation (AF) in initial 30 patients with the Nanosecond PFA 360° Cardiac Catheter
The feasibility study is intended to assess the initial safety and efficacy of the Nanosecond PFA 360° Cardiac Catheter System for the treatment of AF (NCT06696170). To date, 77 patients have been treated by six investigators, including Dr. Vivek Reddy and Prof. Petr Neuzil, in cases performed at Na Holmolce Hospital in
“The remap results for the first 30 patients treated with the Nanosecond PFA 360° Cardiac Catheter demonstrate strong pulmonary vein isolation (PVI) with short case times,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY. “This novel technology offers a unique user experience that has the potential to improve workflow with a pliable catheter for nimble and precise positioning in the anatomy, and combined with the differentiated energy, enables consistent, durable transmural ablations.”
Initial Cohort Study Results
-
All (
100% ) lesions were acutely successful with conduction block. -
Success rate of PVI at ~3 months was
92.4% (109/118). - Total PVI ablation time was 11.6±4.5 minutes.
- Total procedure and fluoroscopy times were 88.3±30.1 and 6.9±2.4 minutes, respectively.
- Left atrial dwell time was 29.6±15.3 minutes.
- 1 Primary SAE (cardiac perforation) and 2 AEs including vertigo (n=1; managed conservatively) and creatinine elevation (n=1; treated with IV saline). All AEs were resolved without sequelae.
Also, at the AF Symposium, a live case transmission highlighted the nsPFA 360° Cardiac Catheter with 3D mapping and navigation on the Abbott Ensite X System. Prof. Petr Neuzil and Drs. Moritoshi Funasako and Jan Petru performed a successful live case highlighting the nsPFA 360° Cardiac Catheters’ ability to rapidly isolate the pulmonary veins with a fast, efficient procedure workflow.
“We appreciate the support of the renowned EPs who are performing the initial clinical work with our catheter ablation system and are presenting its clinical performance to their peers in the scientific community. We believe nanosecond PFA represents the next generation energy modality that will improve the safety, efficacy and efficiency of AF ablation through a more straightforward and clinician-friendly procedure,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “We remain on track to begin an IDE study this year for clinical validation of our devices and look forward to continuing our work with thought leading physicians to achieve commercial approval and deliver this technology to more patients and providers.”
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences is now headquartered in
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in
Note: Dr. Reddy serves as a consultant to Pulse Biosciences (as well as other companies developing pulsed field ablation catheters).
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s CellFX nsPFA technology and CellFX System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company’s expected product development efforts, such as advancement of its nsPFA 360° Cardiac Catheter to treat atrial fibrillation, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action and catheter design will deliver strong pulmonary vein isolation (PVI) or consistent and durable transmural ablations, statements concerning market opportunities, customer adoption and future use of the CellFX System to address a range of conditions such as atrial fibrillation, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the nsPFA 360° Cardiac Catheter, Pulse Biosciences’ expectations, whether stated or implied, regarding its future clinical studies and regulatory submissions, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121586271/en/
Investors:
Pulse Biosciences, Inc.
Darrin Uecker, CTO or Kevin Danahy CCO
IR@pulsebiosciences.com
Or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
FAQ
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