Pulse Biosciences’ Nanosecond PFA Technology to be Featured in Multiple Presentations at the AF Symposium
Pulse Biosciences (PLSE) announced that its Nanosecond Pulsed Field Ablation (nsPFA) technology will be featured at the 30th Annual AF Symposium 2025 in Boston. The presentations include a late-breaking science session and a live case transmission featuring the nsPFA 360° cardiac catheter mapped with Abbott's Ensite X 3D Mapping System.
Dr. Vivek Reddy will present clinical data from the first 30 patients treated in a feasibility study using the nsPFA 360° Cardiac Catheter at Na Homolce Hospital. Additionally, Dr. Petr Neuzil will conduct a live case transmission from Prague demonstrating the catheter's workflow efficiency for pulmonary vein isolation.
The company plans to initiate a U.S. IDE pivotal clinical study for the catheter in mid-2025.
Pulse Biosciences (PLSE) ha annunciato che la sua tecnologia di Ablazione a Campo Pulsato Nanosecondico (nsPFA) sarà presentata al 30° Simposio Annuale AF 2025 a Boston. Le presentazioni includono una sessione scientifica di rilascio tardivo e una trasmissione di un caso dal vivo con il catetere cardiaco nsPFA 360°, mappato con il Sistema di Mappatura 3D Ensite X di Abbott.
Il Dr. Vivek Reddy presenterà dati clinici provenienti dai primi 30 pazienti trattati in uno studio di fattibilità utilizzando il Catetere Cardiaco nsPFA 360° presso l'Ospedale Na Homolce. Inoltre, il Dr. Petr Neuzil condurrà una trasmissione di un caso dal vivo da Praga dimostrando l'efficienza del flusso di lavoro del catetere per l'isolamento delle vene polmonari.
L'azienda prevede di avviare uno studio clinico pivotale IDE negli Stati Uniti per il catetere a metà del 2025.
Pulse Biosciences (PLSE) anunció que su tecnología de Ablación por Campo Pulsado Nanosegundo (nsPFA) será presentada en el 30° Simposio Anual de AF 2025 en Boston. Las presentaciones incluyen una sesión de ciencia de última hora y una transmisión de un caso en vivo que presenta el catéter cardíaco nsPFA 360° mapeado con el Sistema de Mapeo 3D Ensite X de Abbott.
El Dr. Vivek Reddy presentará datos clínicos de los primeros 30 pacientes tratados en un estudio de viabilidad utilizando el Catéter Cardíaco nsPFA 360° en el Hospital Na Homolce. Además, el Dr. Petr Neuzil realizará una transmisión en vivo desde Praga que demostrará la eficiencia del flujo de trabajo del catéter para la aislamiento de las venas pulmonares.
La empresa planea iniciar un estudio clínico pivotal IDE en EE. UU. para el catéter a mediados de 2025.
펄스 바이오사이언스(PLSE)는 자사의 나노초 펄스 필드 절제(nsPFA) 기술이 2025년 보스턴에서 열리는 제30회 AF 심포지엄에서 소개될 것이라고 발표했습니다. 발표에는 늦은 속보 세션과 Abbott의 Ensite X 3D 맵핑 시스템으로 맵핑된 nsPFA 360° 심장 카테터를 포함한 라이브 사례 전송이 포함됩니다.
Vivek Reddy 박사가 Na Homolce 병원에서 nsPFA 360° 심장 카테터를 사용하여 치료한 첫 30명의 환자에 대한 임상 데이터를 발표할 것입니다. 또한 Petr Neuzil 박사가 프라하에서 카테터의 폐정맥 절제 효율성을 보여주는 라이브 사례 전송을 진행할 것입니다.
회사는 2025년 중반에 카테터에 대한 미국 IDE 주요 임상 연구를 시작할 계획입니다.
Pulse Biosciences (PLSE) a annoncé que sa technologie d'Ablation par Champ Pulsé Nanoseconde (nsPFA) sera présentée lors du 30e Symposium Annuel AF 2025 à Boston. Les présentations incluent une session de science tardive et une transmission en direct d'un cas mettant en avant le cathéter cardiaque nsPFA 360° cartographié avec le Système de Cartographie 3D Ensite X d'Abbott.
Le Dr Vivek Reddy présentera des données cliniques des 30 premiers patients traités dans une étude de faisabilité utilisant le Cathéter Cardiaque nsPFA 360° à l'Hôpital Na Homolce. De plus, le Dr Petr Neuzil effectuera une transmission en direct de Prague démontrant l'efficacité du flux de travail du cathéter pour l'isolement des veines pulmonaires.
L'entreprise prévoit de lancer une étude clinique pivotale IDE aux États-Unis pour le cathéter à la mi-2025.
Pulse Biosciences (PLSE) gab bekannt, dass ihre Technologie der Nanosekunden-Pulsfeld-Ablation (nsPFA) beim 30. jährlichen AF-Symposium 2025 in Boston vorgestellt wird. Zu den Präsentationen gehören eine Spätwissenschaftssitzung und eine Live-Übertragung eines Falls mit dem nsPFA 360° Herzkatheter, das mit dem Ensite X 3D-Mapping-System von Abbott kartiert ist.
Dr. Vivek Reddy wird klinische Daten von den ersten 30 Patienten präsentieren, die in einer Machbarkeitsstudie mit dem nsPFA 360° Herzkatheter im Na Homolce Krankenhaus behandelt wurden. Zudem wird Dr. Petr Neuzil eine Live-Fallübertragung aus Prag durchführen, welche die Effizienz des Arbeitsablaufs des Katheters zur Isolierung der Lungenvenen demonstriert.
Das Unternehmen plant, Mitte 2025 eine entscheidende klinische Studie mit IDE für den Katheter in den USA zu starten.
- Company advancing towards U.S. IDE pivotal clinical study in mid-2025
- Technology selected for presentation at major scientific meeting
- Initial feasibility study data from 30 patients to be presented
- None.
Insights
The upcoming presentations at the AF Symposium represent a technical milestone rather than a market-moving event. While the late-breaking session and live case demonstration will showcase Pulse Biosciences' nanosecond PFA technology, no definitive clinical outcomes or regulatory progress will be announced. The planned U.S. IDE pivotal study initiation in mid-2025 remains the more significant catalyst.
The integration with Abbott's Ensite X 3D Mapping System is technically noteworthy, as compatibility with leading mapping platforms is important for clinical adoption. The feasibility study data from the first 30 patients will provide early insights into the technology's performance, but this small sample size is primarily meant to demonstrate safety and initial efficacy rather than definitive clinical superiority.
For context, the atrial fibrillation ablation market is highly competitive, with established players like Medtronic and Boston Scientific already having PFA systems in development. While Pulse's nanosecond PFA approach is differentiated, market penetration will ultimately depend on pivotal trial results and regulatory approval, neither of which are addressed in these presentations.
Nanosecond PFA 360° Cardiac Catheter for AF ablation to be highlighted in late-breaking clinical science session and in a live case transmission
“Since joining the Company’s Board last year I have seen the team make remarkable strides on the product development and clinical evidence with the proprietary nsPFA 360° Cardiac Catheter device. Having two renowned physicians showcase the clinical benefits of the differentiated mechanism of action and device at this vital AF scientific meeting is a strong testament to the team’s progress and the unique role of nsPFA,” said Paul LaViolette, Co-Chairman of Pulse Biosciences’ Board of Directors. “Pulse Biosciences will continue to advance its nsPFA technology within the clinical community as it drives towards initiating a
Key Nanosecond PFA Scientific Programming
Friday, January 17th
- 5:30-7:00pm, Vivek Reddy, MD – Late Breaking Clinical Science Session
- Title: Pulsed Field Ablation Using a Compliant Circular Catheter Delivering Nanosecond Pulses to Treat Atrial Fibrillation
- Review of the first 30 patients treated in a feasibility study with the nsPFA 360° Cardiac Catheter at Na Homolce Hospital by Drs. Vivek Reddy and Petr Neuzil
Saturday, January 18th
-
7:30-9:30am, Petr Neuzil, MD, PhD (Homolka Hospital,
Prague, Czech Republic ) – Live Case Transmission - Title: Nanosecond Pulsed Field Ablation for Atrial Fibrillation
-
Live case broadcast from Na Homolce Hospital in
Prague , CZ. The live case will highlight the nsPFA 360° Cardiac Catheter workflow efficiency for pulmonary vein isolation, and 3D mapping and navigation with the Abbott Ensite X system as part of a 3D navigation workflow.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20250113481268/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
When will Pulse Biosciences (PLSE) begin its IDE pivotal clinical study for the nsPFA catheter?
How many patients were included in PLSE's initial nsPFA 360° Cardiac Catheter feasibility study?
What mapping system is being used with PLSE's nsPFA 360° Cardiac Catheter?
Where will PLSE's live case transmission of the nsPFA technology take place?
