Pulse Biosciences Inc (PLSE) 2024 Q3 法說會逐字稿

Greetings and welcome to the Pulse Biosciences third quarter, 2024 financial results conference call. (Operator Instructions)

問候並歡迎參加 Pulse Biosciences 2024 年第三季財務業績電話會議。（操作員指令）

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Trip Taylor Investor Relations. Thank you, sir. You may begin.

提醒一下，本次會議正在錄音。現在我很高興介紹您的主持人、投資者關係部門人員 Trip Taylor。謝謝您，先生。你可以開始了。

Thank you, operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management's views as of today. October 30, 2024, only and will include forward-looking statements and opinion statements including predictions, estimates, plans, expectations and other similar information.

謝謝您，接線生。在我們開始之前，我想告訴您，今天電話會議上您的評論和問題回覆反映了管理層截至今天的觀點。2024 年 10 月 30 日，僅並將包括前瞻性陳述和意見陳述，包括預測、估計、計劃、期望和其他類似資訊。

Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the US Securities and Exchange Commission, our SEC filings can be found on our website or on the SECs website. Investors are cautioned not to place undue reliance on forward-looking statements.

由於某些風險和不確定性，實際結果可能與明示或暗示的結果有重大差異。這些風險和不確定性在我們今天早些時候發布的新聞稿和我們向美國證券交易委員會提交的文件中進行了更詳細的描述，我們的證券交易委員會文件可以在我們的網站或美國證券交易委員會的網站上找到。提醒投資者不要過度依賴前瞻性陳述。

We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures disclosures regarding these non-GAAP financial measures including reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com in the news and events section on our investor relations page.

我們不承擔更新或修改這些前瞻性陳述的任何義務。我們還將討論某些非 GAAP 財務指標的揭露，有關這些非 GAAP 財務指標（包括與最具可比性的 GAAP 指標的對帳）的資訊可在新聞稿中找到。請注意，您可以在我們網站 pulsebiosciences.com 的投資者關係頁面的新聞和事件部分中重播本次電話會議的音訊。

With that, I would now like to turn the call over to President and Chief Executive Officer Burke T. Barrett.

現在，我想將電話轉給總裁兼執行長伯克·T·巴雷特（Burke T. Barrett）。

Good afternoon. Thank you all for joining us. Today I will start by providing updates on our business progress. And then Mike Koffler, Vice President of Finance will review the third quarter, 2024 financial results.

午安.感謝大家加入我們。今天，我首先會介紹一下我們的業務進度。然後，財務副總裁 Mike Koffler 將回顧 2024 年第三季的財務表現。

Then we will be joined by Bob Duggan, cochair of the board, Darren Eker, Chief Technology Officer and director and Kevin Danahy, Chief Commercial Officer for a question-and-answer session.

然後，董事會聯合主席 Bob Duggan、技術長兼董事 Darren Eker 和首席商務官 Kevin Danahy 將與我們一起進行問答環節。

By way of background Pulse Biosciences is a novel medical company committed to health innovation using its patented nano pulse stimulation technology or Nano PFA, a revolutionary energy modality that delivers nanosecond duration pulses of electrical energy each less than a 1000000th of a second long to nonthermally destroy targeted cells while sparing adjacent noncellular structures and material.

背景介紹 Pulse Biosciences 是一家新型醫療公司，致力於利用其專利的奈米脈衝刺激技術或 Nano PFA 進行健康創新，這是一種革命性的能量模式，可提供納秒級的電能脈衝，每個脈衝持續時間不到百萬分之一秒，以非熱方式破壞目標細胞，同時保護相鄰的非細胞結構和材料。

Nano PFA technology when used to ablate cellular tissue has the potential to treat a variety of medical conditions for which an optimal solution remains unfulfilled. The company developed its proprietary CellFX system, a novel nano PFA delivery platform and commercialized the initial application to treat benign lesions of the skin.

奈米 PFA 技術用於消融細胞組織時有可能治療多種尚未找到最佳解決方案的疾病。該公司開發了其專有的 CellFX 系統，一種新型奈米 PFA 傳輸平台，並將初步應用商業化，用於治療皮膚良性病變。

In parallel, the company has designed and developed a variety of disposables, sometimes called [andefactors] to explore the potential use of the platform to treat disorders and other medical specialties such as cardiology, gastroenterology, gynecology, and ears, nose and throat.

同時，該公司也設計和開發了多種一次性用品，有時也稱為[andefactors]，以探索該平台在治療疾病和其他醫學專業（如心臟病學、胃腸病學、婦科以及耳鼻喉科）方面的潛在用途。

These indications include devices for open surgical procedures, endoscopic or minimally invasive procedures, and endoluminal catheters. And each has been used in preclinical studies based on our pre-clinical experience and the potential to significantly improve outcomes for patients in large and growing markets.

這些適應症包括開放式手術、內視鏡或微創手術以及腔內導管的設備。根據我們的臨床前經驗以及在龐大且不斷增長的市場中顯著改善患者治療效果的潛力，每種方法均已用於臨床前研究。

The company decided in 2022 to focus its primary efforts on the use of Nano PFA energy in the treatment of Atrial fibrillation or AF as well as in a select few other markets such as soft tissue ablation where it could have a profound positive impact on health care for both patients and providers.

該公司於 2022 年決定將主要精力集中在使用奈米 PFA 能量治療心房顫動或 AF，以及軟組織消融等少數其他市場，這些市場可能對患者和提供者的醫療保健產生深遠的積極影響。

Our technology is different from the most commonly used microsecond PFA and that the pulse width is much shorter, this shorter pulse width, which is in the range of a million to a billionth of a second and so up to 1,000 times shorter than micro PFA has the benefits of both allowing for unique product designs and the potential for a different and better method of ablation at the cellular level. The goal of which is to remove or destroy unwanted cells.

我們的技術不同於最常用的微秒 PFA，脈衝寬度要短得多，這種較短的脈衝寬度在百萬分之一到十億分之一秒的範圍內，比微型 PFA 短 1,000 倍，既可以實現獨特的產品設計，又有可能在細胞層面上實現不同的、更好的消融方法。其目的是去除或摧毀不需要的細胞。

The third quarter was extremely productive for Pulse Biosciences and here are a few highlights of our progress. Since the start of Q3, we treated the first patients with AF, using our Nano PFA cardiac surgery system in Europe. The cardiac surgery system also received US FDA breakthrough device designation for the treatment of AF and was enrolled in FDA's tap program which is short for total product life cycle advisory program. Tap provides even more accelerated pathways than breakthrough.

第三季對於 Pulse Biosciences 來說非常富有成效，以下是我們取得進展的一些亮點。自第三季開始以來，我們在歐洲使用 Nano PFA 心臟手術系統治療了首批 AF 患者。該心臟手術系統還獲得了美國 FDA 用於治療心房顫動的突破性設備稱號，並加入了 FDA 的 TAP 計劃，即全產品生命週期諮詢計劃的縮寫。與突破相比，Tap 提供了更多的加速途徑。

We also completed our rights offering raising $60 million in gross proceeds with the potential to raise an additional $66 million through the exercise of warrants.

我們還完成了配股，籌集了 6,000 萬美元的總收益，並有可能透過行使認股權證再籌集 6,600 萬美元。

Each warrant is exercisable for $11 per share which equals 110% of the subscription price for the unit's warrants are exercisable immediately. Half of the warrants are redeemable by the company if the company's stock exceeds $16.50 for 20 consecutive trading days and the other half of the warrants are redeemable by the company. If its stock exceeds $22 for 20 consecutive trading days, holders of the warrants have the right to exercise them at any time until they are redeemed or expired.

每張認股權證的行使價格為每股 11 美元，相當於該單位認購價的 110%，且認股權證可立即行使。若公司股票連續20個交易日超過16.50美元，則公司可贖回一半的認股權證，另一半認股權證也可由公司贖回。若其股價連續20個交易日超過22美元，認股權證持有人有權隨時行使認股權證，直到贖回或到期。

Each of these accomplishments represent significant progress with our business that will support our mission to deliver Nano PFA technology to patients and providers around the world.

這些成就都代表著我們業務的重大進步，並將支持我們向全球患者和供應商提供奈米 PFA 技術的使命。

Our early clinical work with the three different clinical indications or applications of Nano PFA confirms our strong belief that the technology has the potential to advance the standard of care for the treatment of multiple disease states across the human body.

我們早期對奈米 PFA 的三種不同臨床適應症或應用進行的臨床工作證實了我們的堅定信念，即該技術有可能提高人體多種疾病狀態的治療標準。

The differentiated mechanism of action has demonstrated the unique potential to destroy cells in a better way than heat cold radiation. And even currently available micro PFA our products are protected with intellectual property and know how which we believe will assist in maintaining our competitive advantage.

差異化的作用機制已展現出比熱冷輻射更好的破壞細胞的獨特潛力。即使是目前可用的微型 PFA，我們的產品也受到智慧財產權和技術的保護，我們相信這將有助於維持我們的競爭優勢。

The pulse team continued to make great strides advancing this technology in Q3 with our ablation applications across soft tissue, cardiac surgery for AF and endocardial catheter ablation for AF. We are currently focused on developing the path to commercialization for each of these three applications or indications at a high level.

脈搏團隊在第三季度繼續在該技術上取得重大進展，我們在軟組織消融應用、心房顫動心臟手術和心房顫動心內膜導管消融方面進行了研究。我們目前正致力於高水準開發這三種應用或適應症的商業化道路。

Our strategy is centered on producing compelling clinical data to demonstrate the safety and effectiveness profile for each application attendant with unique and differentiated single use disposable devices. These clinical endeavors are occurring now and progressing well across each of the three applications and will ultimately involve hundreds of patients.

我們的策略以提供令人信服的臨床數據為中心，以證明每種應用的安全性和有效性，並伴隨獨特和差異化的一次性設備。這些臨床工作正在進行中，並且在三個應用中都取得了良好的進展，最終將涉及數百名患者。

Robust clinical data will enhance our understanding of Nano PFA based treatments as well as enable us to clearly articulate these benefits to the market and subsequently raise awareness for Nano PFA technology. Compelling clinical data can differentiate our products and lead to competitive advantages from a marketing perspective and also lead to stronger value propositions as evaluated by payers for reimbursement from the US regulatory perspective.

可靠的臨床數據將增強我們對基於奈米 PFA 的治療方法的理解，並使我們能夠向市場清楚地表達這些好處，從而提高人們對奈米 PFA 技術的認識。令人信服的臨床數據可以讓我們的產品與眾不同，從行銷角度帶來競爭優勢，從美國監管角度來看，也能為報銷付款人帶來更強大的價值主張。

We plan to seek specific indications for the use of our devices. These types of labels occur over time and follow a precise regulatory process but hold the potential significant benefit of permitting marketing selling and training users for a specific treatment indication. We expect specific indications will help drive faster clinician adoption and market penetration once approved.

我們計劃尋求使用我們設備的具體指徵。這些類型的標籤會隨著時間的推移而出現，並遵循精確的監管程序，但具有允許行銷銷售和培訓使用者針對特定治療指徵的潛在重大優勢。我們預計，一旦獲得批准，特定的適應症將有助於推動臨床醫生更快地採用和市場滲透。

Now, I will provide updates on each of our individual products, starting with our soft tissue ablation application. Today, I will dive deeper into this significant and promising opportunity to provide unique solutions for patients in need of better treatments. Earlier this year, our CellFX percutaneous electrode system received FDA 510-K clearance for use in the ablation of soft tissue in percutaneous and interoperative surgical procedures.

現在，我將介紹我們每種產品的最新動態，從軟組織消融應用開始。今天，我將深入探討這個重要且充滿希望的機會，為需要更好治療的患者提供獨特的解決方案。今年早些時候，我們的 CellFX 經皮電極系統獲得 FDA 510-K 批准，可用於經皮和術中手術過程中的軟組織消融。

Physicians utilize soft tissue ablation in a broad array of procedures such as those involving the thyroid, liver, breast, as well as many other parts of the body under the current so called tool claim clearance we obtained from the FDA. We can launch our soft tissue ablation system in the US for the use of a number of soft tissues.

根據我們從 FDA 獲得的當前所謂的工具聲明許可，醫生可以在各種各樣的手術中使用軟組織消融，例如涉及甲狀腺、肝臟、乳房以及身體許多其他部位的手術。我們可以在美國推出我們的軟組織消融系統，供多種軟組織使用。

So far, the clinicians testing our soft tissue ablation device are using it to treat patients with uncomfortable and debilitating benign nodules of the thyroid.

到目前為止，測試我們的軟組織消融裝置的臨床醫生正在使用它來治療患有不適和使人衰弱的甲狀腺良性結節的患者。

The thyroid is a small butterfly shaped gland located at the front of the neck. It's an important part of the endocrine system and controls many of the body's functions by producing and releasing hormones. The thyroids main job is to control the speed of metabolism when the thyroid isn't working properly, it can impact the entire body.

甲狀腺是位於頸部前方的小蝴蝶形腺體。它是內分泌系統的重要組成部分，透過產生和釋放荷爾蒙來控制身體的許多功能。甲狀腺的主要作用是控制新陳代謝的速度，當甲狀腺無法正常運作時，就會影響整個身體。

A benign thyroid nodule is a noncancerous tumor within the thyroid gland that can be visualized distinctly from the surrounding thyroid. Typically using ultrasound, up to 60% of adults may develop at least one benign thyroid nodule over their lifetime. So, it happens with great frequency.

良性甲狀腺結節是甲狀腺內的非癌性腫瘤，與周圍的甲狀腺可以明顯區分。通常使用超音波檢查，多達 60% 的成年人在其一生中可能會出現至少一個良性甲狀腺結節。因此，這種情況經常發生。

Many benign thyroid nodules remain undiagnosed and are asymptomatic. However, in the US, the incidence of palpable thyroid nodules is about 0.1% per year, 85% of which are benign, translating to an estimated 250,000 patients diagnosed each year in the US with palpable benign thyroid nodules. We estimate that this incidence is growing about 5% per year.

許多良性甲狀腺結節未被診斷出來且沒有症狀。然而，在美國，可觸及的甲狀腺結節的發生率約為每年0.1％，其中85％是良性的，這意味著美國每年約有25萬名患者被診斷出患有可觸及的良性甲狀腺結節。我們估計這一發病率每年增長約 5%。

The incidence of these nodules increases with age and is about four-fold more prevalent in women. Today, the two main options for management of pulpable benign thyroid nodules are either to monitor the nodules which is sometimes called watchful waiting or to surgically remove a portion of or the entire thyroid which is called thyroidectomy.

這些結節的發生率隨著年齡的增長而增加，女性的發生率大約是男性的四倍。目前，治療可取髓腔的良性甲狀腺結節的兩種主要方法是：一是監測結節（有時稱為觀察等待）；二是透過手術切除部分或全部甲狀腺（稱為甲狀腺切除術）。

There are about 800,000 thyroidectomies performed each year worldwide with about 150,000 of these performed in the US and the vast majority, about 70% to 80% are for benign disease. Thyroidectomy reliably eliminates the nodules. However, removal of this critical organ comes with significant risks in the morbidities associated with any surgical procedure.

全球每年約 80 萬例甲狀腺切除手術，其中美國約 15 萬例，絕大多數（約 70% 至 80%）是針對良性疾病。甲狀腺切除術可以可靠地消除結節。然而，切除這個重要器官會帶來與任何外科手術相關的巨大疾病風險。

Importantly for patients in the health care system, removal of the thyroid may require chronic treatment with hormone replacement therapy.

對於醫療保健系統中的患者來說，重要的是，切除甲狀腺可能需要透過荷爾蒙替代療法進行長期治療。

While there are some thermal based needle ablation devices like RF and microwave available on the market, they do not have specific indications for this patient population in the US and have not gained widespread adoption. From speaking with clinicians, we believe this is mainly because of the risk of thermal damage to critical structures like a nerve called the recurrent laryngeal nerve in the esophagus.

儘管市面上有一些基於熱的針消融設備，例如射頻和微波，但它們並沒有針對美國這類患者群體的特定適應症，因此尚未被廣泛採用。透過與臨床醫生的交談，我們認為這主要是因為諸如食道中的喉返神經等重要結構存在熱損傷的風險。

From the inability to control thermal spread from these heat-based ablation devices. This inability to precisely control thermal spread creates the risk of damage to these important nearby structures. The recurrent laryngeal nerves supply sensation to larynx below the vocal cords and damage to this nerve can cause vocal cord paresis and result in voice changes or horned coarseness.

由於無法控制這些基於熱的消融裝置的熱擴散。無法精確控制熱擴散會造成附近重要結構受損的風險。喉返神經負責控制聲帶下方喉部的感覺，該神經的損傷可導致聲帶麻痺，從而導致聲音改變或角質粗糙。

The potential for thermal spread associated with these thermal ablation devices makes use of these devices a high skilled procedure and potentially risky. We believe the treatment of benign thyroid nodules represents a potential market in excess of $1 billion per year to pulse is our entry point into this market to date. We have placed our system with seven sites in the US is part of a pilot program under no cost evaluation agreements. As part of the program, the clinic clinicians are refining the procedural techniques and optimizing the therapy delivery for this novel Nano PFA procedure.

這些熱消融設備具有熱擴散的可能性，因此使用這些設備需要很高的技術，並且具有潛在的風險。我們相信，良性甲狀腺結節的治療代表著一個每年超過 10 億美元的潛在市場，迄今為止，脈動是我們進入該市場的切入點。我們已將我們的系統放置在美國七個站點，這是無成本評估協議下的試點計畫的一部分。作為該計劃的一部分，診所的臨床醫生正在改進程序技術並優化這種新穎的 Nano PFA 程序的治療方法。

The initial clinical experiences with our Nano PFA needle ablation device and benign thyroid nodules continue to be positive by placing the needle electrode into the benign thyroid nodule and delivering multiple relatively fast deliveries of Nano PFA energy covering the majority of the benign thyroid nodule. Patients have typically experienced symptomatic relief from a reduction of the size of the nodule during the 1st month and continuing in subsequent months. The procedure does not require surgical removal of the thyroid and there is no permanent scarring of the neck. And so, we see the cosmesis of the procedure is another potentially very positive factor.

我們的奈米 PFA 針消融裝置和良性甲狀腺結節的初步臨床體驗繼續是積極的，透過將針電極放入良性甲狀腺結節並多次相對快速地輸送奈米 PFA 能量，覆蓋大部分良性甲狀腺結節。患者通常會在第一個月內因結節尺寸減少而出現症狀緩解，並持續數月。此手術不需要手術切除甲狀腺，也不會在頸部留下永久性疤痕。因此，我們認為手術的美容效果是另一個潛在的非常積極的因素。

We expect to expand the pilot program into 2025. We also expect to support select sites to conduct their own clinical research protocols using our device on benign thyroid nodules. We plan to work with these pioneering clinicians to develop a pivotal clinical study that we intend to use for submission to the FDA and other regulatory bodies for a specific indication for the use of our Nano PFA device in the treatment of benign thyroid nodules. We intend to initiate this pivotal clinical study in mid 2025.

我們預計試點計畫將擴大至 2025 年。我們也希望支持選定的站點使用我們的設備對良性甲狀腺結節進行自己的臨床研究方案。我們計劃與這些先驅臨床醫生合作進行一項關鍵的臨床研究，我們打算將研究提交給 FDA 和其他監管機構，以確定我們的奈米 PFA 設備在治療良性甲狀腺結節方面的特定適應症。我們計劃在 2025 年中期啟動這項關鍵臨床研究。

In summary, this market opportunity for the percutaneous electrode system is very compelling and well suited to the unique nonthermal properties of Nano PFA. The choice patients face today is primarily to continue to live with an often-uncomfortable debilitating and visible benign thyroid nodule or have a surgical resection of the organ.

總之，經皮電極系統的市場機會非常引人注目，並且非常適合奈米 PFA 獨特的非熱性能。如今，患者面臨的選擇主要是繼續忍受常常令人不適、衰弱且可見的良性甲狀腺結節，或進行手術切除該器官。

There is a need for a patient and physician friendly [mini], minimally invasive organ sparing non thermal ablation alternative. We're excited to work with leading clinicians that specialize in this area and pioneer a novel treatment modality for patients. We also expect that during the coming quarters, the majority of these clinical users will convert from conducting clinical assessments to using our Nano PFA percutaneous needle device on a commercial basis.

需要一種對患者和醫生友好的[微型]、微創的、保留器官的非熱消融替代方案。我們很高興能與專門從事該領域的領先臨床醫生合作，為患者開創一種新的治療方式。我們也預計，在未來幾個季度內，大多數臨床使用者將從進行臨床評估轉變為在商業基礎上使用我們的 Nano PFA 經皮針裝置。

Looking further out into the future, we intend to explore other clinical indications for the use of our novel needle ablation device in soft tissues beyond the thyroid that leads us to our surgical ablation application here. Our first in human feasibility study is underway in the Netherlands. During the past quarter, we opened a second study site in the Netherlands. We have now treated nine patients at two clinical study sites.

展望未來，我們打算探索我們的新型針消融裝置在甲狀腺以外的軟組織中的其他臨床適應症，這將引領我們在此進行手術消融應用。我們的首次人體可行性研究目前正在荷蘭進行。上個季度，我們在荷蘭開設了第二個研究基地。我們現在已經在兩個臨床研究地點治療了九名患者。

We are encouraged by the acute performance. Our cardiac surgical ablation device has demonstrated the procedures were completed efficiently. As a reminder, this multicenter feasibility study is designed to enroll up to 30 patients. We believe we will be in a position to share preliminary results of this study at a medical Congress late in 2025.

我們對於出色的表現感到鼓舞。我們的心臟手術消融設備已證明手術已有效率地完成。提醒一下，這項多中心可行性研究旨在招募最多 30 名患者。我們相信我們將能夠在 2025 年末的醫學大會上分享這項研究的初步結果。

In the US, the unique differentiation of Nano PFA was validated by the FDA in its award of breakthrough device designation for the cardiac surgical ablation device. Also, we were able to enroll the device in FDA's Tap program. Tap's primary goal is to expedite patient access to innovative medical devices by providing early frequent and strategic communications with the FDA and by facilitating engagement with other key parties for devices that are of public health importance.

在美國，Nano PFA 的獨特差異化已得到 FDA 的認可，並被授予心臟外科消融設備突破性設備稱號。此外，我們也能夠將該裝置納入 FDA 的 Tap 計畫。Tap 的主要目標是透過與 FDA 進行早期頻繁和策略性的溝通，並促進與其他關鍵方就具有公共衛生重要性設備進行合作，加快患者獲得創新醫療設備的速度。

This status will provide increased engagement with the agency and prioritize review of our future planned premarket approval application or PMA. We have been actively engaged with the FDA. Regarding the design of our IDE pivotal clinical study and plan to submit a formal IDE to the FDA for this study. This should enable us to commence a pivotal clinical trial in mid 2025.

這一狀態將加強與該機構的合作，並優先審查我們未來計劃的上市前批准申請或 PMA。我們一直積極與 FDA 合作。關於我們IDE關鍵臨床研究的設計，並計劃為這項研究向FDA提交正式的IDE。這使我們能夠在 2025 年中期開始一項關鍵的臨床試驗。

Now, moving on to our catheter based endocardial AF ablation application.

現在，我們繼續討論基於導管的心內膜心房顫動消融應用。

Our third product currently under development is also for the treatment of Atrial fibrillation. Our 360 cardiac catheter is designed to deliver Nano PFA technology and endocardial applications inside of the heart to treat AF our first in human feasibility study is well underway in Prague where we are investigating the efficiency, safety and efficacy of our catheter's clinical performance. We are pleased to report we have now successfully treated over 50 patients.

我們目前正在開發的第三個產品也是用來治療心房顫動。我們的 360 心導管旨在將奈米 PFA 技術和心內膜應用引入心臟內部以治療房顫，我們在布拉格進行的首次人體可行性研究正在順利進行中，我們正在研究導管臨床性能的效率、安全性和有效性。我們很高興地報告，我們現在已經成功治療了超過 50 名患者。

The catheters useability ability to acutely isolate the pulmonary veins in quick case times continue to show the great promise of the device.

導管能夠在短時間內急性隔離肺靜脈的能力繼續顯示出該裝置的巨大前景。

The electrophysiologists using our 360 catheter in Prague are highly impressed with its performance and I will add that having spent two decades working in AF ablation, including the development of a unique AF ablation device. In my past my view of the 360 catheter's performance after observing several cases, firsthand is that its ability to acutely isolate pulmonary veins efficiently and quickly is unparalleled. Its potential is truly that of a third generation PFA ablation device for AF.

在布拉格使用我們 360 導管的電生理學家對其性能印象深刻，我想補充一點，他們花了二十年時間從事 AF 消融工作，包括開發獨特的 AF 消融設備。我過去親眼觀察了幾例病例後，對360導管性能的看法是，它能夠有效、快速地急性隔離肺靜脈，這是無與倫比的。它的潛力確實在於成為用於 AF 的第三代 PFA 消融設備。

We understand that to fully establish the clinical performance of the device including demonstrating chronic efficacy will require clinical studies with more users, more patients treated and the conduct of a high quality pivotal clinical study.

我們明白，要全面確定該設備的臨床表現（包括證明長期療效），需要對更多的使用者、更多的患者進行治療，並進行高品質的關鍵臨床研究。

We are also pleased to be engaged with two additional EU clinical study sites that are scheduled to perform procedures by year end, additional users and sites will provide valuable information on the device. It's learning curve, ease of use and performance in different workflows during AF ablation procedures.

我們也很高興與另外兩個歐盟臨床研究站點合作，這兩個站點計劃在年底前開展研究，更多的用戶和站點將提供有關該設備的寶貴資訊。它的學習曲線、易用性和在 AF 消融過程中不同工作流程的表現。

Leveraging the current understanding of the 360 catheters clinical performance. We are designing a pivotal clinical study. We continue to expect to begin the US IDE pivotal clinical study in the middle of next year.

利用目前對 360 導管臨床表現的了解。我們正在設計一項關鍵的臨床研究。我們繼續預計明年年中開始美國 IDE 關鍵臨床研究。

Successful pivotal clinical study results will support an FDA PMA submission for the 360 catheter to further support our AF ablation product strategy. We are pleased to have recently announced, Dr. David Kenigsberg has joined us as Chief Medical Officer for Electrophysiology. David is an accomplished Electrophysiologist with a thriving private practice. I have known David for many years, and I am confident he will make significant contributions to the product and clinical development of our AF ablation catheters.

成功的關鍵臨床研究結果將支持 360 導管的 FDA PMA 提交，以進一步支持我們的 AF 消融產品策略。我們很高興最近宣布，David Kenigsberg 博士已加入我們，擔任電生理學首席醫療官。David 是一位經驗豐富的電生理學家，擁有一家生意興隆的私人診所。我認識大衛很多年了，我相信他會為我們的 AF 消融導管的產品和臨床開發做出重大貢獻。

Additionally, world renowned Electrophysiologist, Dr. Andrea Natale of Austin Texas is also joining our efforts as a key medical advisor.

此外，世界知名的電生理學家、德州奧斯汀的 Andrea Natale 博士也加入了我們的工作，擔任主要醫療顧問。

We are thankful to have both of these thought leading EPS join our team and believe this is a strong testament to the transformative potential of Nano PFA and our 360 catheter, their insightful input and guidance will be invaluable as we advance this technology to maximize the positive impact for patients and providers. They join our existing EP advisor, Dr. Vivek Reddy and Dr. Jacob Kruth, who have been instrumental in the evaluations of the 360 catheter.

我們很榮幸這兩位思想領先的 EPS 加入我們的團隊，並相信這是對 Nano PFA 和我們的 360 導管的變革潛力的有力證明，他們的深刻見解和指導將在我們推進這項技術以最大限度地為患者和提供者帶來積極影響的過程中發揮無價的作用。他們與我們現有的 EP 顧問 Vivek Reddy 博士和 Jacob Kruth 博士一起，在 360 導管的評估中發揮了重要作用。

Now I'll pass the call over to Mike Koffler to provide some financial results for the third quarter, 2024.

現在我將電話轉給 Mike Koffler，提供 2024 年第三季的一些財務結果。

Thank you, Burke. Today, I will highlight our GAAP in non-GAAP financial results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the third quarter of 2024 total GAAP costs and expenses increased by $2.4 million to $13.7 million compared to $11.3 million in the prior year period.

謝謝你，伯克。今天，我將重點介紹非 GAAP 財務結果中的 GAAP。我鼓勵您查看今天的收益報告，以了解非 GAAP 指標與最具可比性的 GAAP 指標的詳細對帳。2024 年第三季度，GAAP 總成本和費用較去年同期的 1,130 萬美元增加了 240 萬美元，達到 1,370 萬美元。

The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation expense which was $3 million in the third quarter of 2024 compared to $1.8 million in the prior year period and also driven by other compensation and administrative expenses to support this expanding organization and the advancement of our Nano PFA devices. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization.

GAAP 成本和費用的增加主要是由於非現金股票薪酬費用的增加，2024 年第三季為 300 萬美元，而去年同期為 180 萬美元，同時也受到其他薪酬和管理費用的影響，以支持這個不斷擴大的組織和我們納米 PFA 設備的進步。提醒大家，非GAAP成本和費用不包括股票薪資、折舊和攤提。

Total non-GAAP costs and expenses in the third quarter of 2024, increased by $1.2 million to $10.4 million compared to $9.2 million in the prior year period.

2024 年第三季非 GAAP 成本和費用總額與去年同期的 920 萬美元相比增加了 120 萬美元，達到 1,040 萬美元。

GAAP net loss in the third quarter of 2024 was $12.7 million compared to $10.6 million in the prior year period.

2024 年第三季的 GAAP 淨虧損為 1,270 萬美元，去年同期為 1,060 萬美元。

Non-GAAP net loss in the third quarter of 2024 was $9.4 million compared to $8.5 million in the prior year period.

2024 年第三季非 GAAP 淨虧損為 940 萬美元，去年同期為 850 萬美元。

In the third quarter, we strengthened the balance sheet considerably through the completion of the rights offering in July, raising $60 million in gross proceeds with the potential to raise an additional $66 million through the exercise of the associated warrants.

第三季度，我們透過 7 月完成的配股大幅增強了資產負債表，籌集了 6,000 萬美元的總收益，並有可能透過行使相關認股權證再籌集 6,600 萬美元。

As of September 30, 2024, cash and cash equivalents totaled $79 million compared to $44.4 million as of December 31, 2023. Cash used in the third quarter of 2024 excluding financing activity totaled $8.5 million compared to $8.7 million used in the same period in the prior year and $8.7 million used in the second quarter of 2024.

截至 2024 年 9 月 30 日，現金及現金等價物總額為 7,900 萬美元，而截至 2023 年 12 月 31 日為 4,440 萬美元。2024 年第三季（不含融資活動）使用的現金總計 850 萬美元，而去年同期使用現金總計 870 萬美元，2024 年第二季使用現金總計 870 萬美元。

I will now turn the call back over to Burke.

現在我將把電話轉回給伯克。

Thank you, Mike. As we look forward, we are excited to continue our initial clinical experiences with our three products throughout the remainder of 2024 and into 2025 the focus at pulse right now is to continue to treat patients in each of our three active indications, advance our clinical understanding of the performance of each device and move forward in the regulatory processes towards approved devices that may be commercialized to support our anticipated growth.

謝謝你，麥克。展望未來，我們很高興能夠在 2024 年剩餘時間和 2025 年繼續對我們的三種產品進行初步臨床體驗，Pulse 目前的重點是繼續治療我們三種有效適應症的患者，提高我們對每種設備性能的臨床理解，並在監管流程中推進獲得可商業化的批准設備，以支持我們預期的增長。

We are building our team and the infrastructure required to conduct three pivotal clinical studies with these three products beginning in 2025, we strengthened our team with the additions of a new co-chair of the board, a Vice President of Marketing, a Vice President of Clinical Engineering and a Chief Medical Officer of Electrophysiology. Now joining us for the question-and-answer session today are Bob Duggan, Co-Chairman of the board, Darren Eker, Chief Technology Officer and Director and Kevin Danahy, Chief Commercial Officer operator. Please open the call for questions.

我們正在組建團隊和基礎設施，以便從 2025 年開始對這三種產品進行三項關鍵臨床研究，我們透過增加新的董事會聯席主席、行銷副總裁、臨床工程副總裁和電生理學首席醫療官來加強我們的團隊。今天參加問答環節的有董事會聯合主席 Bob Duggan、技術長兼董事 Darren Eker 和商務長 Kevin Danahy。請打開電話來回答問題。

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions)

謝謝。我們現在將進行問答環節。（操作員指令）

One moment, please. While we pull for questions, It appears that there are no questions at this time. I would now like to turn the floor back over to Burke T. Barrett for closing comments.

請稍等。當我們詢問問題時，目前似乎沒有任何問題。現在我想把發言權交還給伯克·T·巴雷特，請他發表最後評論。

Thank you, operator. I want to thank the pulse team for another strong quarter. We continue to make great progress with all three of our applications and indications and we look very much forward to providing updates again next quarter and in the future as information becomes available. Thank you all.

謝謝您，接線生。我要感謝Pulse團隊又一個強勁的季度。我們在這三個應用程式和適應症上繼續取得巨大進展，我們非常期待在下個季度以及將來的資訊可用時再次提供更新。謝謝大家。

This includes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

其中包括今天的電話會議。現在您可以斷開您的線路。感謝您的參與。