Pulse Biosciences Announces Positive Clinical Data Presented at the American Thyroid Association
Pulse Biosciences (PLSE) announced positive preliminary results from its first-in-human feasibility study using Nanosecond Pulsed Field Ablation (nano-PFA) for treating benign thyroid nodules. The study, presented at the 2024 American Thyroid Association Annual Meeting, showed that nano-PFA treatment reduced nodule sizes by over 50% and provided symptomatic relief within the first month. The company's Percutaneous Electrode System demonstrated effectiveness without residual fibrosis or scarring. The 30-patient clinical trial (NCT06117085) is being conducted in Naples, Italy, with plans for a pivotal trial in mid-2025 to support U.S. commercialization.
Pulse Biosciences (PLSE) ha annunciato risultati preliminari positivi dal suo primo studio di fattibilità su esseri umani utilizzando l'Ablazione a Campo Pulsato di Nanosecondi (nano-PFA) per il trattamento di noduli tiroidei benigni. Lo studio, presentato al 2024 American Thyroid Association Annual Meeting, ha dimostrato che il trattamento nano-PFA ha ridotto le dimensioni dei noduli di oltre 50% e ha fornito un sollievo sintomatico entro il primo mese. Il Sistema di Elettrodo Percutaneo dell'azienda ha mostrato efficacia senza fibrosi residua o cicatrici. Lo studio clinico, che coinvolge 30 pazienti (NCT06117085), è in corso a Napoli, Italia, con piani per uno studio cruciale a metà del 2025 per supportare la commercializzazione negli Stati Uniti.
Pulse Biosciences (PLSE) anunció resultados preliminares positivos de su primer estudio de viabilidad en humanos utilizando Ablación por Campo Pulsado de Nanosegundos (nano-PFA) para tratar nódulos tiroideos benignos. El estudio, presentado en la Reunión Anual de la Asociación Americana de Tiroides de 2024, mostró que el tratamiento con nano-PFA redujo el tamaño de los nódulos en más del 50% y proporcionó alivio sintomático dentro del primer mes. El Sistema de Electrodos Percutáneos de la compañía demostró efectividad sin fibrosis residual ni cicatrices. El ensayo clínico de 30 pacientes (NCT06117085) se está llevando a cabo en Nápoles, Italia, con planes para un ensayo pivotal a mediados de 2025 para apoyar la comercialización en EE. UU.
Pulse Biosciences (PLSE)는 양성 갑상선 결절 치료를 위한 나노초 펄스 필드 절제(nano-PFA)를 사용한 인체에서의 첫 번째 가능성 연구에서 긍정적인 초기 결과를 발표했습니다. 이 연구는 2024년 미국 갑상선 학회 연례 회의에서 발표되었으며, nano-PFA 치료가 결절 크기를 50% 이상 줄였고 첫 번째 달 이내에 증상 완화 효과를 제공했음을 보여주었습니다. 회사의 경피적 전극 시스템은 잔여 섬유증이나 흉터 없이 효과를 나타냈습니다. 30명의 환자가 참여하는 이 임상 시험(NCT06117085)은 이탈리아 나폴리에서 진행 중이며, 미국 상업화를 지원하기 위해 2025년 중반에 주요 시험을 계획하고 있습니다.
Pulse Biosciences (PLSE) a annoncé des résultats préliminaires positifs de sa première étude de faisabilité sur l'homme utilisant l'Ablation par Champ Pulsé de Nanosecondes (nano-PFA) pour le traitement des nodules thyroïdiens bénins. L'étude, présentée lors de la Réunion Annuelle de l'Association Américaine de la Thyroïde en 2024, a montré que le traitement nano-PFA avait réduit la taille des nodules de plus de 50% et avait apporté un soulagement symptomatique dans le premier mois. Le Système d'Électrode Percutanée de l'entreprise a montré son efficacité sans fibrose résiduelle ni cicatrices. L'essai clinique impliquant 30 patients (NCT06117085) est en cours à Naples, en Italie, avec des projets pour un essai pivot à la mi-2025 afin de soutenir la commercialisation aux États-Unis.
Pulse Biosciences (PLSE) gab positive vorläufige Ergebnisse seiner ersten Machbarkeitsstudie an Menschen bekannt, die die Nanosekunden-Pulsfeldablation (nano-PFA) zur Behandlung von benignen Schilddrüsenknoten verwendet. Die Studie, die auf dem Jahresmeeting der American Thyroid Association 2024 vorgestellt wurde, zeigte, dass die nano-PFA-Behandlung die Knotengröße um über 50% reduzierte und innerhalb des ersten Monats symptomatische Linderung bot. Das perkutane Elektroden-System des Unternehmens zeigte Effektivität ohne verbleibende Fibrose oder Narben. Die klinische Studie mit 30 Patienten (NCT06117085) wird in Neapel, Italien durchgeführt, mit Plänen für eine entscheidende Studie Mitte 2025 zur Unterstützung der Kommerzialisierung in den USA.
- Clinical trial showed >50% reduction in thyroid nodule size
- Symptomatic relief achieved within first month of treatment
- No evidence of residual fibrosis or scarring reported
- Treatment demonstrates potential advantages over thermal ablation procedures
- Results are preliminary and from a small feasibility study
- U.S. pivotal trial not starting until mid-2025
- Product not yet approved for commercial use
Insights
The preliminary clinical data for Pulse Biosciences' nano-PFA technology represents a significant breakthrough in thyroid nodule treatment. The >50% reduction in nodule volume and rapid symptom relief within one month is particularly impressive compared to existing treatments. The nonthermal approach addresses a key limitation of current thermal ablation methods by potentially reducing complications.
The 30-patient feasibility study lays important groundwork for the planned pivotal trial in mid-2025. While the sample size is modest, the results are compelling enough to support further development. The technology's ability to achieve results without scarring or fibrosis could position PLSE's system as a preferred minimally invasive alternative to surgery for the large market of benign thyroid nodule patients.
This clinical milestone significantly strengthens PLSE's market position in the
The study's results in Europe also enhance the company's global market potential, particularly important as thyroid nodules affect up to
European feasibility study demonstrates using nano-PFA in benign thyroid nodules reduces nodule volume by greater than
The preliminary data demonstrate that nano-PFA pulses effectively delivered by the Company’s Percutaneous Electrode System reduced nodule sizes on average by over
“I am proud to report that in the treated nodules, we observed significant nodule volume reductions which led to great improvements in symptoms for the patients in our study. We are excited to finish the long-term follow-up, complete the study, and continue the utilization of nano-PFA to advance the standard of care for patients with benign thyroid nodules,” said Dr. Stefano Spiezia, Chief of Endocrine Surgery Division at Napoli Ospedale del Mare and principal investigator of the study and founder of “Save Your Thyroid” institute.
Pulse Biosciences’ nsPFA Percutaneous Electrode System is currently being investigated by Stefano Spiezia, Chief of Endocrine Surgery Division at Napoli Ospedale del Mare,
“These groundbreaking results suggest nano-PFA energy can provide symptomatic relief to patients with benign thyroid nodules across the first month after the treatment,” said Burke T. Barrett, Pulse Biosciences President and Chief Executive Officer. “We would like to thank Dr. Spiezia and his team for all the clinical work they continue to do with the System. This feasibility study and our ongoing
About Percutaneous Electrode System
The Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nano-PFA Console. The proprietary and novel electrode is designed to harness and deliver the key advantages of nano-PFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received
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
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 safely and effectively provide symptomatic relief to patients with benign thyroid nodules or cause significant nodule volume reductions, whether within a month or otherwise, statements concerning the Company’s expected product development efforts and future clinical studies and regulatory submissions and whether the Company might obtain regulatory approval to market and sell the nsPFA Percutaneous Electrode System as a treatment for benign thyroid nodules, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action will deliver fast and precise ablations, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nsPFA Percutaneous Electrode System, and Pulse Biosciences’ expectations, whether stated or implied, regarding whether the Company’s CellFX nsPFA technology will become a disruptive, superior and durable treatment option for treating benign thyroid nodules or any other medical condition or otherwise advance current medical standards of care, 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.
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Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
FAQ
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