Pulse Biosciences, Inc. Announces Successful Treatment of Patients in First-in-Human Study With Its Nano-PFA Cardiac Surgery System
Pulse Biosciences, Inc. Announces Successful Treatment of Patients in First-in-Human Study With Its Nano-PFA Cardiac Surgery System
Company's proprietary system used in study for patients with atrial fibrillation
公司專有的系統用於治療心房顫動患者的研究
Cardiac Surgery System enrolled in the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP)*
心臟手術系統加入FDA的全產品生命週期(TPLC)諮詢計劃(TAP)*
MIAMI--(BUSINESS WIRE)--Aug. 8, 2024--Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology, today announced treatment of the first two patients in the first-in-human feasibility study using its novel Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation.
2024年8月8日,Pulse Biosciences,Inc。(納斯達克:PLSE)(「公司」或「脈衝生物科技」),該公司利用其新穎且專有的納秒脈衝場消融(nsPFA)技術,今天宣佈使用其新型心臟手術系統治療心房顫動的人體可行性研究中的前兩名患者。
Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital, used the Company's Cardiac Surgery System to successfully treat two patients with atrial fibrillation at St. Antonius Hospital, Nieuwegein, The Netherlands. Dr. Van Putte was joined by colleagues and Pulse Biosciences' Chief Medical Officer, Cardiac Surgery, Dr. Gan Dunnington and Chief Science Officer, Cardiac Surgery, Dr. Niv Ad during the concomitant procedure. The first-in-human feasibility study is a multicenter study of up to 30 patients that will include an endocardial catheter-based remapping to confirm chronic isolation at approximately three months post treatment.
St. Antonius醫院的心血管外科醫生Bart Van Putte博士使用公司的心臟手術系統在荷蘭的Nieuwegein的St. Antonius醫院成功治療了兩名心房顫動患者。在聯合手術期間,Van Putte博士與同事以及脈衝生物科技的首席醫療官心臟外科Gan Dunnington博士和首席科學官心臟外科Niv Ad博士一起進行手術。這個人體可行性研究是一個多中心研究,最多可以包括30名患者,其中將包括基於內膜心導管去除術後規劃再次檢查,以在術後約三個月左右確認是否可以持續避孕。
"We are honored to partner with Pulse Biosciences and to be the first team to use this next-generation nano-PFA technology for the treatment of atrial fibrillation in cardiac surgery. The initial procedure results showed effective pulmonary vein and 'box' isolation with Pulse's Cardiac Surgery System," said Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital. "We were impressed by how rapidly and effectively we were able to produce linear ablations in a fraction of the time it takes with the current thermal modalities we use, such as radiofrequency or cryoablation."
「我們很榮幸與Pulse生物科技合作,成爲第一個使用這種心房顫動的下一代納米PFA技術的團隊。最初的手術結果顯示,使用Pulse的心臟手術系統實現了有效的肺靜脈和「盒子」隔離,」St. Antonius醫院的心血管外科醫生Bart Van Putte博士說。「我們對如何快速有效地產生線性消融的速度非常印象深刻,而這要花費目前使用的熱力療法所需的時間的一小部分,例如射頻或低溫消融。」
"These initial treatment results confirm our preclinical work with the cardiac surgical system. The patients tolerated our procedure well. We are pleased to see how the intuitive design of the device facilitates an efficient procedure where surgeons can create controlled lesions with adequate depth very rapidly," added Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences. "We are excited to continue enrollment in this feasibility clinical study, which is intended to demonstrate the device's safety, effectiveness and durability profile."
「這些初始治療結果證實了我們使用心臟外科系統進行的臨床前工作。患者很好地耐受了我們的程序。我們很高興看到設備的直觀設計如何促進外科醫生快速地產生深度足夠的控制性病變,」Pulse生物科技的心臟外科首席醫療官Gan Dunnington博士補充道。「我們很高興能夠繼續招募這項可行性臨床研究,旨在證明該設備的安全性,有效性和持久性特徵。」
Pulse's Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous, transmural, ablation lesions during cardiac surgery procedures for the treatment of atrial fibrillation. The bipolar clamp utilizes the Company's proprietary nanosecond PFA technology. Based on pre-clinical studies, a single application of less than two seconds with the Surgical Clamp creates a consistent, transmural, durable ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation.
Pulse的心臟手術系統與外科夾鉗旨在在心臟外科手術過程中產生持久的連續的穿透性消融病變,用於治療心房顫動。雙極夾具利用公司的專有納秒PFA技術。根據臨床前研究,使用手術夾具小於兩秒的單次應用創建一致的穿透性持久的消融,其速度明顯更快,大約需要目前可用的熱消融技術的1/20的時間。另外,由於nano-PFA的非熱機理作用,不存在可能導致不希望的周圍組織損傷的熱擴散風險,這與熱射頻消融相比具有明顯優勢。
The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in early July 2024. Recently the device was enrolled in the FDA's TAP program. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP program to help generate more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. TAP's primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices of public health importance. According to its website, the FDA has enrolled 46 devices in the TAP program to date, while there have been over 900 Breakthrough Device Designations granted.
nano-PFA心臟外科系統在2024年7月初獲得了FDA突破性設備指定。最近,該設備已加入FDA的TAP計劃。FDA的醫療器械與放射衛生中心(CDRH)啓動了TAP計劃,以幫助更快地開發對公衆健康至關重要的高質量,安全,有效和創新的醫療器械。 TAP的主要目標是通過爲醫療器械開發者提供早期,頻繁和戰略性的與FDA的溝通以及促進與其他關鍵方的接觸,加快患者獲得創新醫療器械的速度。根據其網站,FDA已將46個設備納入TAP計劃,同時已授予900多項突破性設備指定。
"We continue to make great strides on the development of our current nano-PFA devices, three of which have now been used in patients with initial promising results. We are grateful for all the key opinion leader clinicians who have partnered with us to advance nano-PFA technology for the benefit of patients and clinicians worldwide," stated President and Chief Executive Officer Burke T. Barrett. "These initial clinical results with the Cardiac Surgical System will inform the next steps of our clinical and regulatory strategy. We are excited to continue the momentum with the System following its Breakthrough Device Designation and recent enrollment into the prestigious TAP program. Moving forward, we intend to submit for IDE approval from the FDA to begin U.S. clinical work."
「我們在開發我們當前的nano-PFA設備方面取得了巨大的進展,其中有三種設備現已用於患者,並取得了初步的有希望的結果。我們感激與我們合作推進nano-PFA技術以造福全球患者和臨床醫生的所有關鍵意見領袖臨床醫生,」Burke t. Barrett總裁兼首席執行官說。「這個心臟手術系統的初步臨床結果將指導我們的臨床和監管策略的下一步。在獲得突破性設備指定和最近進入著名的TAP計劃之後,我們很高興能夠繼續該系統的發展勢頭。未來,我們打算向FDA提交IDE批准,以開始美國的臨床工作。」
The Company plans to pursue FDA premarket approval (PMA) to commercialize its nano-PFA Cardiac Surgical System in the United States as a treatment for atrial fibrillation. If granted by the FDA, a specific treatment indication would permit direct marketing of the device's treatment benefits. The Company intends to begin its pivotal clinical study of its nano-PFA Cardiac Surgical System as a treatment for atrial fibrillation in early 2025 and will provide additional details on the study and its regulatory and commercial implications later this year.
該公司計劃追求FDA預先市場批准(PMA),以在美國商業化其nano-PFA心臟外科系統,作爲治療心房顫動的方法。如果FDA授予,特定的治療適應症將允許直接營銷該設備的治療效果。該公司計劃於2025年初開始其關鍵性的nano-PFA心臟外科系統臨床研究,並將於今年晚些時候提供有關該研究以及其監管和商業影響的其他詳細信息。
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About Pulse Biosciences
關於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 Miami, Florida and maintains its office in Hayward, California.
pulse biosciences是一家新型生物電醫藥公司,致力於健康創新,具有改善患者生活質量的潛力。該公司專有的CellFX nsPFA技術將納秒脈衝電能傳遞到非熱清晰細胞中,同時保護相鄰的非細胞組織。該公司正積極開發其CellFX nsPFA技術,用於治療心房顫動和其他少數市場,在這些市場上,它可能對患者和醫療提供者的醫療保健產生深遠的積極影響。pulse biosciences現總部設在佛羅里達州的邁阿密,並在加利福尼亞州的海沃德維持其辦公室。
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 the United States and other countries.
Pulse Biosciences,CellFX,Nano-Pulse Stimulation,NPS,nsPFA,CellFX nsPFA以及這些圖標都是Pulse Biosciences,Inc.在美國和其他國家/地區的商標和/或註冊商標。
Forward-Looking Statements
前瞻性聲明
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 create consistent, transmural, durable ablations in cardiac tissue in approximately one-twentieth the time of currently available thermal ablation technologies, statements concerning the Company's expected product development efforts and future clinical studies and regulatory submissions and whether breakthrough designation or enrollment in the FDA's TAP program can accelerate regulatory approval to market the Company's Cardiac Surgery System in the United States, statements concerning whether any clinical study will show that the Company's novel nsPFA mechanism of action will deliver fast and precise ablations in cardiac tissue, statements concerning early clinical successes and whether they are predictive of the safety and efficacy of any medical device such as the CellFX nsPFA Cardiac Surgery 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 atrial fibrillation or any other medical condition, 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.
本新聞稿中的所有非歷史性陳述均爲前瞻性陳述,其中包括有關公司的CellFX nsPFA技術和CellFX系統將能夠創造出持久,持續的消融病變,使用目前可用的熱消融技術所需的約20倍時間的效果,與公司預期的產品開發努力和未來臨床研究以及監管提交有關的陳述,以及突破性指標或在FDA的TAP計劃中註冊是否可以加速通過任何臨床研究展示其新穎的nsPFA機制是否將爲快速精確消融心臟組織提供可靠性,並且靜脈形態學和循環系統外科醫師是否最終對Pulse生物科技公司的CellFX nsPFA系統的未來是否會提供具有顛覆性,優越和持久的治療選擇等,以及其他未來事件。這些陳述不是歷史事實,而是基於脈衝生物科學目前對脈衝生物科學業務,運營和其他類似或相關因素的期望,估計和投射。使用「可能」,「將」,「可能」,「可以」,「應該」,「預測」,「潛在的」,「繼續」,「期望」,「打算」,「計劃」,「項目」,「相信」,「估計」等類似或相關表達式,用於識別這些前瞻性陳述,但並不是所有前瞻性陳述都包含這些語言。您不應過度依賴前瞻性陳述,因爲它們涉及已知和未知的風險,不確定性和假設,這些風險,不確定性和假設在某些情況下超出了Pulse Biosciences的控制範圍。由於許多因素的原因,實際結果可能與前瞻性陳述中的結果有所不同,包括Pulse Biosciences的證券交易委員會的記錄中描述的因素。即使有新信息可用,Pulse Biosciences也不承諾更新本發佈中的信息以反映未來的事件或情況。
View source version on businesswire.com:
請查看商業線(businesswire.com)的源版本。
Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
投資者:
脈衝生物科學公司
巴克·T·巴雷特總裁兼首席執行官
IR@pulsebiosciences.com
Or
或者
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
吉爾馬汀集團
菲利普·特里普·泰勒
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
來源:Pulse Biosciences, Inc.