Pulse Biosciences Inc (PLSE) 2023 Q3 法說會逐字稿

Greetings, and welcome to the Pulse Biosciences Third Quarter 2023 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎參加 Pulse Biosciences 2023 年第三季財報電話會議。 （操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce Philip Taylor, Investor Relations. Thank you. You may begin.

現在我很高興向大家介紹投資者關係部的菲利普泰勒 (Philip Taylor)。謝謝。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, November 13, 2023, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other similar information.

謝謝你，接線生。在我們開始之前，我想通知您，在今天的電話會議中對您的問題的評論和答复僅反映截至今天（2023 年11 月13 日）的管理層觀點，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. The risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these 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。我們今天早些時候發布的新聞稿以及我們向美國證券交易委員會提交的文件中更全面地描述了風險和不確定性。我們的 SEC 備案文件可以在我們的網站或 SEC 網站上找到。投資者應注意不要過度依賴前瞻性陳述。我們不承擔更新或修改這些前瞻性陳述的義務。

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 & Events section on our Investor Relations page.

我們也將討論某些非公認會計準則財務指標。有關這些非公認會計原則財務指標的揭露，包括與最具可比性的公認會計原則指標的調節表，請參閱新聞稿。請注意，本次電話會議將在我們的網站pulsebiosciences.com、投資者關係頁面的新聞與活動部分提供音訊重播。

With that, I would now like to turn the call over to President and Chief Executive Officer, Kevin Danahy.

現在，我想將電話轉給總裁兼執行長凱文·達納西 (Kevin Danahy)。

Thank you, Trip. Good afternoon, everyone, and thank you all for joining us.

謝謝你，特里普。大家下午好，感謝大家加入我們。

On today's call, I will be joined by Darrin Uecker, Chief Technology Officer and Director; Mitch Levinson, Chief Strategy Officer; and Mike Koffler, Vice President of Finance.

首席技術長兼總監 Darrin Uecker 將出席今天的電話會議。米奇‧萊文森，首席策略長；和財務副總裁 Mike Koffler。

Today, I will start by discussing our progress in advancing our top corporate priority. Then I will hand the call over to Darrin Uecker, to detail our cardiac device development achievement. Mitch Levinson will then describe our extra cardiac business development progress, and then Mike Koffler will review the third quarter financial results before I conclude and open the call for a question-and-answer session.

今天，我將首先討論我們在推動公司首要任務方面所取得的進展。然後我會將電話轉交給 Darrin Uecker，詳細介紹我們的心臟裝置開發成果。然後，米奇·萊文森 (Mitch Levinson) 將介紹我們的額外心臟業務發展進展，邁克·科夫勒 (Mike Koffler) 將在我結束發言並開始問答環節之前回顧第三季度的財務業績。

It was a highly productive third quarter for Pulse Biosciences. In the lab, our CellFX nsPFA technology continues to demonstrate the potential to revolutionize the treatment of atrial fibrillation.

對於 Pulse Biosciences 來說，這是一個高產量的第三季。在實驗室中，我們的 CellFX nsPFA 技術不斷展示出徹底改變心房顫動治療的潛力。

In the clinic, CellFX nsPFA is demonstrating the ability to safely and effectively treat benign thyroid nodules. And at the podium, we are pleased to be seeing increased external validation of our technology and presentations from KOLs at various scientific meetings.

在臨床上，CellFX nsPFA 展現了安全有效治療良性甲狀腺結節的能力。在講台上，我們很高興看到我們的技術得到越來越多的外部驗證，以及 KOL 在各種科學會議上的演講。

On the business front, we are excited to have appointed renowned cardiac surgeon, Dr. Niv Ad, as our Chief Science Officer, Cardiac Surgery. Altogether, we've done the work in the lab and it has confirmed our value propositions for CellFX nsPFA. As we share these preclinical results awareness of the benefit of CellFX nsPFA is growing, and attracting industry leaders from across the globe who see the positive impact of their engagement and want to be involved with advancing the technology as quickly as possible, to deliver improved clinical outcomes to their patients as well as many others.

在業務方面，我們很高興任命著名的心臟外科醫生 Niv Ad 博士擔任我們心臟外科的首席科學官。總而言之，我們已經在實驗室完成了這項工作，它證實了我們對 CellFX nsPFA 的價值主張。隨著我們分享這些臨床前結果，人們對CellFX nsPFA 益處的認識不斷增強，並吸引了來自全球各地的行業領導者，他們看到了參與的積極影響，並希望盡快參與推進技術發展，以提供改進的臨床服務對他們的患者以及許多其他人的結果。

Our primary focus is on developing a cardiac ablation catheter and a surgical ablation clamp, both utilizing CellFX nsPFA for the treatment of atrial fibrillation or AF. The clamp will be used during open or minimally invasive heart surgery by cardiac surgeon and the catheter will be navigated into the heart using standard minimally invasive catheter techniques through large blood vessels by electrophysiologists in the EP lab.

我們的主要重點是開發心臟消融導管和手術消融夾，兩者均利用 CellFX nsPFA 來治療心房顫動或 AF。心臟外科醫生將在開放式或微創心臟手術期間使用該夾子，而 EP 實驗室的電生理學家將使用標準微創導管技術透過大血管將導管引導到心臟中。

Importantly, we remain on track with the development of both the clamp and the catheter. While we previously guided that our milestones would occur in the first half of 2024, with the excellent progress to date, we now believe that they will occur by the end of the first quarter of 2024. Our preclinical testing results have validated our confidence in our cardiac surgical plan as we prepare to file a 510(k) submission to the FDA by the end of the first quarter 2024, and to begin the clinical feasibility study for our cardiac ablation catheter also by the end of the first quarter in 2024.

重要的是，我們仍然在夾具和導管的開發上保持在正軌上。雖然我們之前預計我們的里程碑將在2024 年上半年實現，但迄今為止取得了出色的進展，我們現在相信它們將在2024 年第一季末實現。我們的臨床前測試結果驗證了我們對我們的信心我們準備在 2024 年第一季末之前向 FDA 提交 510(k) 申請，並在 2024 年第一季末開始我們的心臟消融導管的臨床可行性研究。

As a reminder, globally, over 1.2 million catheter and surgical ablations are performed annually, and this is expected to grow by more than 10% year-over-year. Still there is a significant runway of adoption for both surgical and catheter techniques because of the safety and efficacy limitations of the current technology, Pulse Biosciences has now demonstrated preclinically, with validation by doctors in the lab, the technological advancements needed to accelerate adoption of both the clamp and the catheter ablation procedures with our novel proprietary CellFX nsPFA technology.

需要提醒的是，全球每年進行超過 120 萬例導管和手術消融，預計將年增超過 10%。由於目前技術的安全性和有效性限制，外科手術和導管技術的採用仍有很長的路要走，Pulse Biosciences 現已在臨床前證明，經過實驗室醫生的驗證，加速這兩種技術的採用所需的技術進步使用我們新穎的專有 CellFX nsPFA 技術進行夾鉗和導管消融手術。

This past quarter, we saw a significant extra validation of our novel CellFX proprietary nsPFA technology from predominant cardiac physicians, including Dr. Usman Siddiqui, and Dr. Niv Ad, along with leading thyroid surgeons, Dr. Stefano Spiezia and Dr. Ralph Tufano. We are thrilled that at the Global EP Summit in September, Dr. Siddiqui shows our CellFX nsPFA circumferential catheter system to highlight Pulse Biosciences' highly differentiated and advanced solution for electrophysiologists.

上個季度，我們看到主要心臟病醫生（包括 Usman Siddiqui 博士和 Niv Ad 博士）以及領先的甲狀腺外科醫生 Stefano Spiezia 博士和 Ralph Tufano 博士對我們的新型 CellFX 專有 nsPFA 技術進行了重大額外驗證。我們很高興在 9 月的全球 EP 高峰會上，Siddiqui 博士展示了我們的 CellFX nsPFA 環形導管系統，以突出 Pulse Biosciences 為電生理學家提供的高度差異化和先進的解決方案。

In addition to our cardiac ablation catheter validation, I am pleased that Dr. Spiezia and Dr. Tufano presented two posters at the American Thyroid Association Annual Meeting, detailing the early results of our clinical study for the treatment of benign thyroid nodules.

除了我們的心臟消融導管驗證之外，我很高興 Spiezia 博士和 Tufano 博士在美國甲狀腺協會年會上展示了兩張海報，詳細介紹了我們治療良性甲狀腺結節的臨床研究的早期結果。

Specifically, Dr. Spiezia, highlighted his participation in our first-in-human surgical procedures and observations of complete ablation of the cellular tissue without evidence of thermal necrosis or damaged to non-cellulose structures. Dr. Ralph Tufano found the results extremely compelling and suggested that CellFX nsPFA could be a significant advancement in the treatment of symptomatic benign thyroid nodules. This further validates our believe that CellFX nsPFA is a platform technology that will make a significant impact on patient care.

具體來說，Spiezia 博士強調了他參與了我們的首次人體外科手術，並觀察到細胞組織完全消融，沒有熱壞死或非纖維素結構損壞的證據。 Ralph Tufano 博士發現結果非常引人注目，並表明 CellFX nsPFA 可能是治療有症狀的良性甲狀腺結節的重大進步。這進一步證實了我們的信念：CellFX nsPFA 是一項將對病患照護產生重大影響的平台技術。

As an additional point of external validation we received in the quarter, we have had multiple surgeons volunteering to join our studies with the purpose of advancing CellFX nsPFA and our novel endofunctors in the areas where they are well respected. We view this positive reception from the medical leaders as confirmation that our CellFX nsPFA technology can have a significant clinical impact in cardiology.

作為我們在本季度收到的外部驗證的另一點，我們有多名外科醫生自願加入我們的研究，目的是在備受推崇的領域推進 CellFX nsPFA 和我們的新型內視鏡。我們認為醫學界領導者的正面評價證實了我們的 CellFX nsPFA 技術可以對心臟病學產生重大的臨床影響。

We are also encouraged by recent comments and earnings conference calls from companies in the cardiac surgery market and industry analyst, as to the size and growth of the cardiac ablation market, and we believe our highly differentiated solution can capture a large portion of this expanding opportunity. Doc Ad's quote says what we all believe, that CelFX-NSPFA has the potential to not only replace all other energy modalities in cardiac ablation, including radio frequency and cryo, but due to the speed, safety and ablation performance of the system, it has the potential to significantly expand the number of patients we treat in cardiac surgery.

我們也對心臟手術市場公司和行業分析師最近對心臟消融市場的規模和增長發表的評論和財報電話會議感到鼓舞，我們相信我們高度差異化的解決方案可以抓住這一不斷擴大的機會的很大一部分。 Ad 博士的引言說出了我們都相信的，CelFX-NSPFA 不僅有潛力取代心臟消融中的所有其他能量方式，包括射頻和冷凍，而且由於系統的速度、安全性和消融性能，它已經有可能顯著增加我們在心臟手術中治療的患者數量。

As awareness of our novel technology sits throughout the industry, we are also incredibly excited to have Dr. Niv Ad, joining our team as Chief Science Officer, Cardiac Surgery. Dr. Ad is extremely well-respected cardiothoracic surgeon and will aid us in bringing CellFX nsPFA from the lab to the clinic, with his years of clinical and leadership roles in cardiothoracic surgery. Dr. Ad brings unparalleled academic experience, helping to launch new medical technologies, which we believe complement very well the clinical experience of our Chief Medical Officer for Cardiac Surgery, Dr. Gan Dunnington. Dr. Ad's experience paired with Dr. Dunnington's industry-leading minimally invasive approach further validates our CellFX nsPFA technology and overall mission to further improve the lives of patients and physicians.

隨著整個行業對我們的新技術的認識，我們也非常高興 Niv Ad 博士加入我們的團隊，擔任心臟外科首席科學官。 Ad 博士是一位備受尊敬的心胸外科醫生，憑藉他在心胸外科領域多年的臨床和領導作用，他將幫助我們將 CellFX nsPFA 從實驗室帶到臨床。 Ad 博士帶來了無與倫比的學術經驗，幫助推出新的醫療技術，我們相信這可以很好地補充我們心臟外科首席醫療官 Gan Dunnington 博士的臨床經驗。 Ad 博士的經驗與 Dunnington 博士領先業界的微創方法相結合，進一步驗證了我們的 CellFX nsPFA 技術和進一步改善患者和醫生生活的整體使命。

Overall, awareness of our preclinical and clinical achievements is leading to external interest in the opportunity to further develop and eventually commercialize our CellFX nsPFA technology platform. These opportunities are only being considered if they align with our business goals, to create value by accelerating our timelines to market and facilitating health innovation that has the potential to significantly improve the quality of life for patients.

總體而言，對我們的臨床前和臨床成就的認識正在引起外部對進一步開發並最終將我們的 CellFX nsPFA 技術平台商業化的機會的興趣。只有當這些機會符合我們的業務目標時，我們才會考慮這些機會，即透過加快上市時間並促進有潛力顯著改善患者生活品質的健康創新來創造價值。

I will now hand the call over to Darrin to provide updates for our cardiac device development and preclinical performance.

我現在將把電話轉交給達林，為我們的心臟設備開發和臨床前性能提供最新資訊。

Thank you, Kevin. We are making significant progress advancing our feasibility and preclinical studies for cardiac ablation clamp and catheter programs. Our progress is garnering the attention of KOLs who are actively reaching out to participate in our CellFX nsPFA studies. We are excited to leverage this shared interest to continue our momentum into the clinic and view this external interest as a testament to the immense potential of CellFX nsPFA and future cardiac ablation market adoption.

謝謝你，凱文。我們在推進心臟消融鉗和導管計畫的可行性和臨床前研究方面取得了重大進展。我們的進展引起了 KOL 的關注，他們積極參與我們的 CellFX nsPFA 研究。我們很高興能夠利用這種共同的興趣繼續我們進入臨床的動力，並將這種外部興趣視為 CellFX nsPFA 和未來心臟消融市場採用的巨大潛力的證明。

As a reminder, our core technology, Nanosecond Pulsed Field Ablation, integrated into our CellFX platform, is fundamentally different from standard PFA. We believe CellFX nsPFA can deliver safer and more effective ablation of cardiac tissue. CellFX controls the delivery of nanosecond duration pulses of electrical energy, that's pulse durations under 1 millionth of a second, to nonthermally cause cells to go through a natural regulated cell death process.

提醒一下，我們的核心技術奈秒脈衝場消融整合到我們的 CellFX 平台中，與標準 PFA 有著根本的不同。我們相信 CellFX nsPFA 可以提供更安全、更有效的心臟組織消融。 CellFX 控制奈秒持續時間的電能脈衝（脈衝持續時間低於百萬分之一秒）的傳遞，以非熱方式導致細胞經歷自然調節的細胞死亡過程。

The CellFX nsPFA energy pulses are uniquely able to penetrate the cell membrane and alter the function of cell organals, leading to regulated cell death rather than immediately destroying cells, like other energy modalities, such as standard PFA, cryo, which uses extreme cold, or radio frequency ablation, which uses extreme heat. The penetration alters does not destroy internal cellular function while sparing noncellular tissue and leading to a more elegant, precise regulated cell death. This differs from current microsecond ablation technologies where physicians may use suboptimal parameters to protect surrounding cellular tissues, and as a result, sacrifice efficacy for safety.

CellFX nsPFA 能量脈衝具有獨特的能力，能夠穿透細胞膜並改變細胞器官的功能，從而導致受調節的細胞死亡，而不是像其他能量方式一樣立即破壞細胞，例如標準PFA、冷凍（使用極冷或低溫）射頻消融，使用極高的熱量。滲透改變不會破壞內部細胞功能，同時保留非細胞組織並導致更優雅、更精確的受控細胞死亡。這與目前的微秒消融技術不同，在目前的微秒消融技術中，醫生可能會使用次優參數來保護周圍的細胞組織，從而犧牲療效以換取安全。

Our early data shows that the CellFX nsPFA nonthermal mechanism of action, as opposed to thermal, can lead to beneficial outcomes in the clinical setting where physicians do not need to trade safety for efficacy. An additional benefit of the CellFX nsPFA mechanism of action is that it requires significantly less energy per unit volume to ablate cardiac tissue, sometimes up to 10x less when compared to microsecond pulses or thermal modalities, because CellFX nsPFA generally needs less energy per pulse to ablate tissue, we deliver our treatments through electrodes that have a larger footprint, better treatment coverage, enabling faster, more efficient therapeutic resolution.

我們的早期數據表明，與熱相反，CellFX nsPFA 非熱作用機制可以在臨床環境中帶來有益的結果，醫生無需為了療效而犧牲安全性。 CellFX nsPFA 作用機制的另一個好處是，消融心臟組織時每單位體積所需的能量顯著減少，有時與微秒脈衝或熱模式相比，能量減少多達10 倍，因為CellFX nsPFA 通常每個脈衝消融所需的能量更少組織，我們透過具有更大佔地面積、更好治療覆蓋範圍的電極提供治療，從而實現更快、更有效的治療解決方案。

Due to the patient value for time sensitivity in surgery, particularly in cases where the patient is under general anesthesia, reducing even seconds of treatment time can greatly reduce the risk for a patient during and post procedure.

由於患者對手術時間的敏感性，特別是在患者處於全身麻醉的情況下，減少甚至數秒的治療時間都可以大大降低患者在手術期間和術後的風險。

In present time, we believe our preclinical studies and accelerating first-in-human surgical procedures indicate Pulse Biosciences' CellFX nsPFA devices provide a new and higher standard of safety and efficacy. Our competitive advantage is protected by 148 issued patents globally and 103 pending patent applications worldwide with more on the way each quarter.

目前，我們相信我們的臨床前研究和加速的首次人體外科手術表明 Pulse Biosciences 的 CellFX nsPFA 設備提供了新的更高的安全性和有效性標準。我們的競爭優勢受到全球 148 項已頒發專利和全球 103 項待決專利申請的保護，並且每個季度都會有更多專利申請。

In the lab, we consistently see the clear advantages in our CellFX nsPFA cardiac ablation plant compared to other energy modalities, as evident by a consistency in achieving transmural ablations in 1.25 seconds, independent of tissue type or thickness, which is roughly a 20th of the time it takes for radiofrequency ablation. The results from our preclinical work support our hypothesis that CellFX nsPFA ablation can produce highly differentiated and market-leading safety and efficacy compared to traditional thermal modalities, including cryosurgery and radiofrequency ablation.

在實驗室中，我們始終看到CellFX nsPFA 心臟消融設備與其他能量方式相比具有明顯的優勢，這一點可以從在1.25 秒內實現透壁消融的一致性上看出，與組織類型或厚度無關，這大約是組織類型或厚度的二十分之一。射頻消融所需的時間。我們的臨床前工作結果支持了我們的假設，即與傳統的熱治療方式（包括冷凍手術和射頻消融）相比，CellFX nsPFA 消融可以產生高度差異化且市場領先的安全性和功效。

In addition to the speed and consistency of the ablations created by our CellFX nsPFA cardiac clamp, the preclinical data to date supports our intention that CellFX nsPFA has safety benefits over the extreme heat or cold of thermal modalities due to its nonthermal mechanism of action and the lack of any concern regarding thermal spread that could lead to damage of collateral tissue, which is a concern and has been reported with thermal modalities.

除了我們的 CellFX nsPFA 心臟鉗產生的消融速度和一致性之外，迄今為止的臨床前數據支持我們的意圖，即 CellFX nsPFA 由於其非熱作用機制和沒有任何關於熱擴散可能導致側支組織損傷的擔憂，這是一個令人擔憂的問題，並且已在熱模式中報告過。

With the preclinical data we've generated to date, we retain our belief that the CellFX nsPFA cardiac clamp provides a significant improvement over current thermal modalities and tracks with our expectations to file a 510(k) submission to the FDA by the end of the first quarter of 2024.

根據我們迄今為止產生的臨床前數據，我們仍然相信 CellFX nsPFA 心臟鉗比目前的熱模式提供了顯著的改進，並追蹤我們的預期，即在 2017 年年底之前向 FDA 提交 510(k) 申請。 2024 年第一季。

Dr. Niv Ad, who joined our team in late October, is bolstering our development and clinical programs by bringing many years of experience in the surgical treatment of atrial fibrillation and minimally invasive heart surgery to the Pulse Biosciences team. To date, he's published over 200 peer-reviewed research articles, all while being responsible for in excess of 3,000 minimally invasive cardiac surgical procedures, and we are grateful he has agreed to join our team and to apply his experience and expertise as we move towards the clinic and look to drive adoption of CellFX nsPFA technology in cardiac surgery clinics.

Niv Ad 博士於 10 月底加入我們的團隊，他為 Pulse Biosciences 團隊帶來了房顫外科治療和微創心臟手術方面多年的經驗，以支持我們的開發和臨床項目。迄今為止，他已發表了200 多篇經過同行評審的研究文章，同時負責超過3,000 例微創心臟外科手術，我們很感激他同意加入我們的團隊，並在我們邁向成功的過程中應用他的經驗和專業知識。診所並希望推動 CellFX nsPFA 技術在心臟手術診所的採用。

Specifically, his academic expertise will play a large role in our future trials focused on optimizing study design and parameters. Dr. Niv Ad's background is extremely complementary to that of Dr. Gan Dunnington, our Chief Medical Officer of Cardiac Surgery, and his innovative approach in the clinical setting. We are very fortunate to have two of the preeminent surgeons in the field on our team as we advance our product development and clinical studies.

具體來說，他的學術專業知識將在我們未來專注於優化研究設計和參數的試驗中發揮重要作用。 Niv Ad 博士的背景與我們心臟外科首席醫療官 Gan Dunnington 博士的背景以及他在臨床環境中的創新方法極為互補。我們非常幸運，在我們推進產品開發和臨床研究的過程中，我們的團隊擁有兩位該領域傑出的外科醫生。

Now on to the progress we have made on our CellFX nsPFA cardiac ablation catheter. This past quarter, we achieved and accelerated key internal milestones on the path to first-in-human studies, completing important preclinical safety and performance studies, as well as the required testing of the CellFX system and circumferential catheter.

現在介紹我們在 CellFX nsPFA 心臟消融導管方面的進展。上個季度，我們實現並加速了首次人體研究道路上的關鍵內部里程碑，完成了重要的臨床前安全性和性能研究，以及 CellFX 系統和環形導管所需的測試。

As a reminder, we designed our catheter to create a precisely focused circumstantial ablation targeted for pulmonary vein isolation in a single 5-second application with CellFX nsPFA, without the need for repeated repositioning and treating, which can be required with other technologies. We believe this capability will lead to a procedure that is easier to perform with significantly reduced procedure times.

提醒一下，我們設計的導管是為了在使用 CellFX nsPFA 的 5 秒應用中創建針對肺靜脈隔離的精確聚焦的環境消融，而無需重複重新定位和治療，而這可能是其他技術所需要的。我們相信這種能力將使手術更容易執行，並顯著減少手術時間。

In September, Dr. Usman Siddiqui detailed the benefits of our CellFX nsPFA circumferential catheter, at the Global EP Summit 2023 in Cleveland, Ohio. The presentation outlined the differentiated nature of our circumvential catheter, including performing consistent circumferential ablation of targeted pulmonary veins in a single application in approximately 5 seconds with CellFX nsPFA.

9 月，Usman Siddiqui 博士在俄亥俄州克利夫蘭舉行的 2023 年全球 EP 高峰會上詳細介紹了我們的 CellFX nsPFA 環形導管的優勢。該演示概述了我們的環繞導管的差異化性質，包括使用 CellFX nsPFA 在大約 5 秒內一次應用對目標肺靜脈進行一致的環繞消融。

We look forward to our first in-human feasibility study with our novel CellFX nsPFA circumstantial catheter integrated with a navigation and mapping visualization system. With the preclinical studies and other testing close to completion and the required regulatory approvals in process, we remain confident that this important milestone will occur by the end of the first quarter 2024.

我們期待利用我們的新型 CellFX nsPFA 環境導管與導航和繪圖視覺化系統進行首次人體可行性研究。隨著臨床前研究和其他測試接近完成以及所需的監管批准正在進行中，我們仍然有信心這一重要的里程碑將在 2024 年第一季末實現。

As a final point, it's important to note that while our cardiac clamp and cardiac catheter both represent significant product opportunities in surgery and electrophysiology, respectively, they also represent a validation of CellFX nsPFA in cardiac ablation, and we believe will be the first of a portfolio of CellFX nsPFA devices in cardiac ablation as we deliver on our goals to provide comprehensive solutions for the treatment of AF and significantly improve the lives of patients.

最後一點，值得注意的是，雖然我們的心臟鉗和心導管分別代表了手術和電生理學領域的重要產品機會，但它們也代表了CellFX nsPFA 在心臟消融方面的驗證，我們相信這將是第一個我們在心臟消融領域推出了 CellFX nsPFA 設備產品組合，以實現為 AF 治療提供全面解決方案並顯著改善患者生活的目標。

I'll now turn to Mitch to outline the additional validation we received recently regarding our continuous work to understand the applications of CellFX nsPFA across the human body. Mitch?

現在，我將請 Mitch 概述我們最近收到的有關我們不斷努力了解 CellFX nsPFA 在人體中應用的額外驗證。米奇？

Thanks, Darrin. The Pulse team continues to explore and develop new clinical areas where our novel technology can have a large positive impact on human health. We continue to explore potential new opportunities while prioritizing cardiac ablation, and we're allocating a large majority of our resources to advancing the treatment of AF.

謝謝，達林。 Pulse 團隊不斷探索和開發新的臨床領域，我們的新技術可以對人類健康產生巨大的正面影響。我們繼續探索潛在的新機會，同時優先考慮心臟消融，我們正在分配大部分資源來推進心房顫動的治療。

As we reported in August, we started our clinical feasibility study for treating benign thyroid tumors or nodules in the second quarter of this year. This study represents the first time our CellFX nsPFA energy was used inside the human body. We intended to assess patient tolerance, safety and tissue response.

正如我們在八月報道的那樣，我們在今年第二季度開始了治療良性甲狀腺腫瘤或結節的臨床可行性研究。這項研究代表我們的 CellFX nsPFA 能量首次在人體內使用。我們打算評估患者的耐受性、安全性和組織反應。

In the fibroid study, benign tumors were treated with our novel CellFX nsPFA percutaneous electrode using ultrasound visualization. Patients were kept conscious under local anesthesia and with the intent to assess tissue response at 90-, 180- and 360-day increments following the procedure. The 90-day evaluation has now been completed, and we're pleased with the positive results. Ultrasound imaging at 90 days has shown complete resorption of the treated volumes with most of the volume reduction occurring by 30 days post treatment with no evidence of fibrosis or scarring, a very positive finding.

在肌瘤研究中，使用我們的新型 CellFX nsPFA 經皮電極利用超音波可視化技術治療良性腫瘤。患者在局部麻醉下保持意識，旨在評估手術後 90 天、180 天和 360 天增量的組織反應。 90 天的評估現已完成，我們對正面的結果感到滿意。 90 天的超音波影像顯示治療體積完全吸收，大部分體積減少發生在治療後 30 天，沒有纖維化或疤痕的證據，這是一個非常積極的發現。

One of the problems with thermal ablation modalities like RF or microwave, is that the treated volume shrinks down into a ball of fibrotic tissue that can persist for a very long time. This means that the tumor volume is not completely eliminated and the residual fibrotic ball can neglect thyroid cancer under follow-on ultrasound imaging, complicating long-term care for the patient.

射頻或微波等熱消融方式的問題之一是，治療區域會縮小成纖維組織球，並且會持續很長時間。這意味著腫瘤體積沒有完全消除，殘留的纖維化球在後續超音波成像下可能會忽略甲狀腺癌，使患者的長期照護變得複雜。

Early results from our study were presented at the American Thyroid Association Annual Meeting in Washington, D.C., in late September. Our principal investigator, Dr. Stefan Spiezia, presented two posters alongside Dr. Ralph Tufano, to their colleagues about histological and ultrasound observations [immediately] post-treatment. The histological assessment findings exemplifies some of the key advantages of CellFX nsPFA technology, including cellular tissue selectivity, well-defined ablation zone margins and the absence of thermally induced necrosis.

我們的研究的早期結果已於 9 月下旬在華盛頓特區舉行的美國甲狀腺協會年會上發表。我們的首席研究員 Stefan Spiezia 博士與 Ralph Tufano 博士一起向他們的同事展示了兩張關於治療後[立即]組織學和超音波觀察的海報。組織學評估結果例證了 CellFX nsPFA 技術的一些關鍵優勢，包括細胞組織選擇性、明確的消融區域邊緣以及不存在熱誘導壞死。

Dr. Spiezia assessed that the treatment times were relatively short, which aligned with our own expectations, both presenting physicians felt that findings provide an early indication that CellFX nsPFA may be safe and effective for the treatment of benign thyroid nodules. The reception among the clinical community is uniformly positive. It's creating enthusiasm for what many are now expecting to be the next breakthrough in the treatment of benign thyroid disease. Based on these very encouraging early findings, we've decided to expand the study to enroll additional subjects.

Spiezia 博士評估認為治療時間相對較短，這與我們自己的預期相符，兩位主講醫生都認為研究結果提供了早期跡象，表明 CellFX nsPFA 對於治療良性甲狀腺結節可能是安全有效的。臨床界的反應一致正面。它激起了人們對良性甲狀腺疾病治療的下一個突破的熱情。基於這些非常令人鼓舞的早期發現，我們決定擴大研究範圍以招募更多受試者。

Treatment of benign thyroid nodules is a large and underserved market, both in the U.S. and abroad, almost 3 million patients worldwide developed a palpable thyroid nodule each year without being treated. There are about 800,000 thyroidectomy each year worldwide, and the vast majority of these are for benign disease, about 70% to 80%. A large percentage of patients with benign thyroid nodules forgo surgery and thermal oblation because of their inherent risks and scarring. We believe the benefits of CellFX technology will improve clinical outcomes for many thyroid disease patients and be much more readily adopted by physicians, increasing the number of patients who can be treated.

良性甲狀腺結節的治療是一個龐大且服務不足的市場，無論是在美國還是在國外，全球每年有近 300 萬名患者在未接受治療的情況下出現可觸及的甲狀腺結節。全球每年約有80萬例甲狀腺切除手術，其中絕大多數是良性疾病，約佔70%至80%。由於固有的風險和疤痕，很大一部分良性甲狀腺結節患者放棄了手術和熱消融術。我們相信 CellFX 技術的優勢將改善許多甲狀腺疾病患者的臨床結果，並且更容易被醫生採用，從而增加可以接受治療的患者數量。

With an optimal clinical solution, we believe the treatment of benign thyroid nodules represents a potential market of well over $1 billion per year. It also will serve as the first foray of CellFX technology into the treatment of solid tumors, potentially opening other critical markets. An FDA cleared product will allow us to validate our value proposition in the important U.S. market. So we're preparing to file a 510(k) submission with the FDA for our proprietary CellFX nsPFA percutaneous electrode by the end of the first quarter 2024. We look forward to sharing updates on our continued progress over the coming months.

憑藉最佳的臨床解決方案，我們相信良性甲狀腺結節的治療代表著每年遠超過 10 億美元的潛在市場。它還將成為 CellFX 技術首次涉足實體腫瘤治療，有可能打開其他關鍵市場。 FDA 批准的產品將使我們能夠在重要的美國市場驗證我們的價值主張。因此，我們準備在 2024 年第一季末之前向 FDA 提交我們專有的 CellFX nsPFA 經皮電極的 510(k) 申請。我們期待在未來幾個月分享我們持續進展的最新資訊。

Now I'll pass the call over to Mike Koffler for an update on our financial results.

現在我將把電話轉接給邁克·科夫勒 (Mike Koffler)，以了解我們財務表現的最新情況。

Thank you, Mitch. Moving down the income statement, I'll focus my comments on our non-GAAP results. I encourage you to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.

謝謝你，米奇。向下看損益表，我將專注於評論我們的非公認會計準則績效。我鼓勵您查看今天的收益報告，以了解非公認會計準則衡量指標與最具可比性的公認會計準則衡量指標的詳細調節情況。

In the third quarter of 2023, we reduced non-GAAP total cost and expenses by $7.6 million to $9.2 million, compared to $16.8 million in the prior year period. The decrease in total cost and expenses was driven by the prior head count reduction and restructuring, and the $7.2 million inventory reserve related to the dermatology business in the third quarter of 2022, partially offset by an increase of $2.3 million in research and development expenses to support advancement of our CellFX nsPFA cardiology devices.

2023 年第三季度，我們將非 GAAP 總成本和費用減少了 760 萬美元，達到 920 萬美元，而去年同期為 1,680 萬美元。總成本和費用的下降是由於先前的人員減少和重組，以及 2022 年第三季與皮膚科業務相關的 720 萬美元庫存儲備，部分被研發費用增加 230 萬美元所抵消。支持我們的CellFX nsPFA 心臟病學設備的進步。

Non-GAAP net loss for the quarter ended September 30, 2023, was $8.5 million compared to $16.8 million for the quarter ended September 30, 2022. Cash, cash equivalents and investments totaled $50.4 million as of September 30, 2023, compared to $58.7 million as of June 30, 2023. Cash used in the third quarter of 2023 totaled $8.7 million, and was reduced compared to $10.6 million used in the same period in the prior year and $10 million used in the second quarter of 2023. We expect cash usage of approximately $8 million in the fourth quarter of 2023.

截至2023 年9 月30 日的季度的非公認會計原則淨虧損為850 萬美元，而截至2022 年9 月30 日的季度為1,680 萬美元。 截至2023 年9 月30 日，現金、現金等價物和投資總額為5,040 萬美元，而截至2023 年9 月30 日為5,870 萬美元截至2023 年6 月30 日。2023 年第三季度使用的現金總額為870 萬美元，較上年同期使用的1,060 萬美元和2023 年第二季使用的1,000 萬美元有所減少。我們預計現金使用情況2023 年第四季約為 800 萬美元。

I will now turn the call back over to Kevin.

我現在將把電話轉回給凱文。

Thank you, Mike. Now I will provide some closing remarks. Pulse Biosciences is receiving significant support from highly-esteemed physicians in the field of cardiology, who have been impressed with our CellFX nsPFA preclinical study results.

謝謝你，麥克。現在我將發表一些結束語。 Pulse Biosciences 在心臟病學領域獲得了備受尊敬的醫生的大力支持，他們對我們的 CellFX nsPFA 臨床前研究結果印象深刻。

We are excited to further build out our medical network as we deliver our novel cardiac ablation devices to market. Two of the top cardiothoracic surgeons in the world, Dr. Niv Ad and Dr. Gan Dunnington, committed to joining our leadership team as the first-hand experience with our proprietary CellFX nsPFA technology. Their immediate commitment shows how our scientific and engineering expertise is indicative of a strong future market adoption of our technology. We look forward to providing additional updates on the next call.

當我們將新型心臟消融設備推向市場時，我們很高興進一步建立我們的醫療網絡。兩位世界頂級心胸外科醫生 Niv Ad 博士和 Gan Dunnington 博士致力於加入我們的領導團隊，獲得我們專有的 CellFX nsPFA 技術的第一手經驗。他們的立即承諾表明我們的科學和工程專業知識表明未來市場將大力採用我們的技術。我們期待在下次通話中提供更多更新。

Joining me today for a question-and-answer session is our Executive Chairman of the Board, Bob Duggan; Chief Technology Officer and Director, Darrin Uecker; Chief Strategy Officer, Mitch Levinson; and Vice President of Finance, Mike Koffler.

今天與我一起參加問答環節的是我們的董事會執行主席鮑勃·杜根 (Bob Duggan)；首席技術長兼總監 Darrin Uecker；首席策略長米奇‧萊文森；和財務副總裁 Mike Koffler。

Operator, please open the call for questions.

接線員，請打開電話提問。

(Operator Instructions) I'd like to pass it to Philip Taylor for some pre-submitted questions first.

（操作員說明）我想先將其傳遞給 Philip Taylor，並詢問一些預先提交的問題。

Thank you, operator. We're going to start by addressing a few questions we've received over e-mail.

謝謝你，接線生。我們將首先解決透過電子郵件收到的一些問題。

The first question is, in your press release, you noted the cardiac milestones between December and end of Q1 2024. Previously, you stated in the first half of 2024, which I assume is Q1 or Q2. Does this imply that these developments have gone better than planned and are expected to happen soon?

第一個問題是，在你們的新聞稿中，你們提到了12 月到2024 年第一季末之間的心臟里程碑。此前，你們提到了2024 年上半年，我認為是第一季或第二季度。這是否意味著這些進展比計劃的要好並且預計很快就會發生？

Yes. Thanks, Trip. This is Darrin. I'll answer that question. So that's an excellent question. For both the cardiac clamp 510(k) and the first in-human feasibility study for the catheter, there are a number of tasks that have to be completed, including all the preclinical testing, device verification testing, and regulatory safety testing, just to name a few. And for the catheter, there's an extra step, which is a regulatory step to have the study approved, and all of these tasks carry some schedule risk associated with them.

是的。謝謝，特里普。這是達林。我來回答這個問題。這是一個很好的問題。對於心臟鉗 510(k) 和導管的首次人體可行性研究，有許多任務必須完成，包括所有臨床前測試、設備驗證測試和監管安全測試，只是為了舉幾個例子。對於導管來說，還有一個額外的步驟，即研究獲得批准的監管步驟，所有這些任務都會帶來一些與之相關的進度風險。

So as we stated in the prepared remarks, we're encouraged by our progress, and while there are still a number of these items that are outstanding and need to be finished prior to either of these milestones being completed, as of today, we believe they will occur sometime between the beginning of December and the end of Q1 2024. And I'd further add that we have site approval, the clinical site is ready, and we have MD availability. So we're very encouraged by all the progress we're making and look forward to updating as we complete these milestones.

因此，正如我們在準備好的發言中所述，我們對我們的進展感到鼓舞，雖然仍有許多項目尚未完成，需要在完成這些里程碑之前完成，但截至今天，我們相信它們將在12 月初到2024年第一季末之間的某個時間發生。我想進一步補充一點，我們已經獲得了場地批准，臨床場地已經準備就緒，並且我們有MD 可用。因此，我們對所取得的所有進展感到非常鼓舞，並期待在完成這些里程碑時進行更新。

All right. Thank you, Darrin. Here's the next one. I understand from your remarks why nsPFA is potentially superior to PFA. Are you aware of any other companies using nsPFA in cardiac ablation besides Pulse Biosciences? And if not, why do you think that is?

好的。謝謝你，達林。這是下一篇。從您的評論中我了解到為什麼 nsPFA 可能優於 PFA。除了 Pulse Biosciences 之外，您還知道還有其他公司在心臟消融中使用 nsPFA 嗎？如果不是，你認為這是為什麼？

Yes. Thanks, Trip. I'll take that one again. This is Darrin. Thanks for the question. I'm not aware of any other companies utilizing nsPFA, or specifically pulse field with pulse durations of less than a microsecond, in cardiac ablation. Of course, there are several companies that are using pulses in the tens to hundreds of microseconds as we've noted on previous calls.

是的。謝謝，特里普。我會再拿那個。這是達林。謝謝你的提問。我不知道有任何其他公司在心臟消融中使用 nsPFA，或者特別是脈衝持續時間小於一微秒的脈衝場。當然，正如我們在之前的電話會議中指出的那樣，有幾家公司正在使用數十到數百微秒的脈衝。

So there are 2 important things that I think one should consider when thinking about why we're not aware of other companies using nsPFA.

因此，我認為在思考為什麼我們不知道其他公司使用 nsPFA 時，應該考慮兩件重要的事情。

So the first is, Pulse Biosciences was founded on a large intellectual property and patent portfolio that was acquired from universities that were at the forefront of research and development of nsPFA. These patents include core nanosecond pulse field technology as well as the application of nsPFA into cardiac ablation. So we believe strongly that this IP is very strong. It's likely something that one would consider if they were going to get into the use of nsPFA in cardiac surgery or in any other field, and I think it's also fair to say that pulsing in the -- in the microsecond domain as other companies are doing, has been around for a very long time. And so that technology is readily available, and it's likely that there's less concern about any competitive intellectual property for pulsing in that domain.

首先，Pulse Biosciences 建立在大量智慧財產權和專利組合的基礎上，這些智慧財產權和專利組合是從處於 nsPFA 研發前沿的大學獲得的。這些專利包括核心奈秒脈衝場技術以及 nsPFA 在心臟消融中的應用。所以我們堅信這個IP非常強大。如果他們打算在心臟手術或任何其他領域使用 nsPFA，那麼這可能是人們會考慮的事情，而且我認為公平地說，像其他公司正在做的那樣，在微秒域中進行脈衝，已經存在很長時間了。因此，該技術很容易獲得，並且很可能不太擔心該領域的脈衝的任何競爭性智慧財產權。

Second, we also know, having developed this technology over many years, that it requires unique engineering capabilities with regard to the pulse technology endofunctor development, and I'm not aware of any other company that has developed these kinds of capabilities. So I think -- those are just a couple of reasons why we think it's likely that there are no other companies in cardiac that are using nsPFA.

其次，我們也知道，經過多年開發這項技術，它需要在脈衝技術內函子開發方面具有獨特的工程能力，而且我不知道有任何其他公司已經開發出此類能力。所以我認為，這些只是我們認為心臟領域可能沒有其他公司使用 nsPFA 的幾個原因。

Yes. If you might, you could add to that, the very tightknit Pulse Bioscience team has roughly a decade of experience in CellFX controlled nanosecond pulsed field ablation. If you call it a juggernaut, that would be an appropriate description.

是的。如果可以的話，您可以補充一點，非常緊密的 Pulse Bioscience 團隊在 CellFX 控制的奈秒脈衝場消融方面擁有大約十年的經驗。如果你稱之為主宰者，那將是一個合適的描述。

On top of that, we have our intellectual property patent base and a very dynamic present time IP activities going pedal to the metal. So we're pretty excited about the position we're in. we respect the time it's taken to arrive at this capacity and the opportunity now looks brighter than it ever has in the past.

最重要的是，我們擁有智慧財產權專利基礎和當前非常活躍的智慧財產權活動。因此，我們對目前的處境感到非常興奮。我們尊重達到這項能力所花費的時間，而且現在的機會看起來比過去任何時候都更加光明。

Thank you both. Here's one for Kevin. Why is Pulse pursuing surgical cardiac ablation when the market is relatively small compared to catheter-based cardiac ablation?

謝謝你們倆。這是給凱文的一份。與基於導管的心臟消融相比，市場相對較小，為什麼 Pulse 仍追求外科心臟消融？

Thanks, Trip. This is really a great question. We see this as a huge opportunity in cardiac surgical ablation. There are over 1 million open heart procedures done every year worldwide. And then NIH says it's up to 2 million. So it's probably somewhere between those two numbers.

謝謝，特里普。這確實是一個很好的問題。我們認為這是心臟手術消融的巨大機會。全球每年進行超過 100 萬例心臟直視手術。然後 NIH 說這個數字高達 200 萬。所以它可能介於這兩個數字之間。

And what we see is our world-class physicians, Dr. Gan Dunnington, Dr. Niv Ad, they joined our team because they recognize the quality of our lesions and what we could create with our nsPFA energy in this game-changing applications in cardiac surgery. And they look at this as an opportunity to really impact that larger number. And that's a possibility for us in the future. And that's why we're so excited about it, and we believe that the CellFX nsPFA can accelerate surgeon adoption and finally bridge that gap between safety and efficacy and reduce the OR time significantly. So we see great opportunity for us in the future in this space, and we think this market is ever evolving. Darrin?

And what we see is our world-class physicians, Dr. Gan Dunnington, Dr. Niv Ad, they joined our team because they recognize the quality of our lesions and what we could create with our nsPFA energy in this game-changing applications in cardiac手術.他們認為這是一個真正影響更多人的機會。這對我們來說是未來的一種可能性。這就是為什麼我們對此如此興奮，我們相信 CellFX nsPFA 可以加速外科醫生的採用，最終彌合安全性和有效性之間的差距，並顯著縮短手術時間。因此，我們看到了這個領域未來的巨大機遇，我們認為這個市場正在不斷發展。達林？

Yes, I'll just add a little bit to that. Thanks, Kevin. So today, it's estimated, just to give you a couple more numbers, it's estimated that of the patients undergoing open-heart surgery globally on an annual basis, over 300,000 are potential candidates for surgical ablation. So that's a market opportunity of north of $1 billion. The interesting number is really that there's only about 20% of those patients are being treated for their AF today.

是的，我會補充一點。謝謝，凱文。因此，今天，為了提供大家更多的數字，據估計，全球每年接受心臟直視手術的患者中，有超過 30 萬人是手術消融的潛在候選者。因此，這是一個價值超過 10 億美元的市場機會。有趣的數字是，目前只有大約 20% 的患者正在接受 AF 治療。

So according to our Chief Medical Officer for Cardiac Surgery, Dr. Dunnington, this relatively low penetration rate has everything to do with the current technologies that are being used. And as we've noted before, these are thermal modalities like radiofrequency ablation and cryoablation. These devices have been available for decades, but still have relatively low adoption and penetration. So clearly, there are challenges with their use. And it's Dr. Dunnington's belief and our belief that the speed, lesion quality and inherent safety of CellFX nsPFA-powered cardiac ablation devices, starting with our CellFX nsPFA cardiac clamp, that will enable a simpler, faster, safer and more efficacious procedure that has the potential to both expand adoption and increase procedure growth in this market.

因此，根據我們心臟外科首席醫療官 Dunnington 博士的說法，這種相對較低的普及率與目前所使用的技術密切相關。正如我們之前指出的，這些都是熱方式，例如射頻消融和冷凍消融。這些設備已經問世了幾十年，但採用率和滲透率仍然相對較低。很明顯，它們的使用有挑戰。 Dunnington 博士和我們都相信，CellFX nsPFA 驅動的心臟消融設備的速度、病變質量和固有安全性（從我們的 CellFX nsPFA 心臟鉗開始）將實現更簡單、更快、更安全和更有效的手術，擴大該市場採用率和增加程序成長的潛力。

It's also true that the catheter market is substantially larger than the surgical market today. But we view this as a single very large opportunity for the treatment of AF where patients will be treated by the EPs, the cardiac surgeons or both. And as the technology and devices evolve, we think it will shift more and more to a hybrid approach which is why we're focused on providing our technology to sell CellFX nsPFA devices to both of these groups. And it's our belief that we'll be able to do this and leverage not only leverage those channels but look for opportunities to create unique synergistic treatment opportunities.

確實，導管市場比當今的外科市場大得多。但我們認為這是治療 AF 的一個非常大的機會，患者將接受 EP、心臟外科醫生或兩者的治療。隨著技術和設備的發展，我們認為它將越來越多地轉向混合方法，這就是為什麼我們專注於提供我們的技術來向這兩個群體銷售 CellFX nsPFA 設備。我們相信，我們將能夠做到這一點，並且不僅利用這些管道，而且尋找機會創造獨特的協同治療機會。

All right. The next question is pretty much the same as the previous question, but for the thyroid market. Mitch, do you want to take this one?

好的。下一個問題與上一個問題幾乎相同，但針對的是甲狀腺市場。米奇，你想要這個嗎？

Yes. Sure, Trip. We've now treated 21 subjects with our benign thyroid nodules with our percutaneous electrode in the clinic, and the early results, they're just super encouraging. And like we said earlier, these clinical results, the safety, the prospect of clearing the entire module without leaving that fibrotic ball. All of that, in our opinion, makes our solution just -- it's just a lot better than surgery or any of the current ablation options, and the thyroid market itself, it's big.

是的。當然，特里普。現在，我們已經在診所用經皮電極治療了 21 名患有良性甲狀腺結節的受試者，早期結果非常令人鼓舞。正如我們之前所說，這些臨床結果、安全性以及清除整個模組而不留下纖維化球的前景。在我們看來，所有這些使得我們的解決方案比手術或任何當前的消融選擇要好得多，而且甲狀腺市場本身很大。

Peer-reviewed articles estimate about 1 in 1,000 people worldwide, that's millions of people each year, suffer from symptomatic thyroid nodules. And most of these go untreated. We welcome all of them to the world of patient and physician-friendly treatment, and that's what we're shooting for with CellFX nsPFA.

同行評審文章估計，全世界大約千分之一（即每年數百萬人）患有有症狀的甲狀腺結節。其中大多數都沒有得到治療。我們歡迎他們所有人來到患者和醫生友好的治療世界，這就是我們 CellFX nsPFA 的目標。

About 800,000 thyroidectomies are done each year, that's where they're getting half or their entire thyroid removed, but most of these patients choose to just live with their condition instead of having surgery for some people, the cure might be worse than the disease. We think that not only are we going to be able to address a lot of these thyroidectomy patients, but because of our better safety, the efficacy and the healing profile, we think we can reach a good number of those 8 million "watchful" waiting patients. And we also think our procedure is going to be just really teachable and reproducible. That's going to allow us to enter the market and grow this new market quickly. And not only do we have this large opportunity for thyroid nodules, but this is also going to open the opportunity for a bunch of other applications, including treating other types of tumors.

每年約有 80 萬例甲狀腺切除術，其中一半或全部甲狀腺被切除，但大多數患者選擇忍受自己的病情，而不是對某些人進行手術，治療可能比疾病本身更糟糕。我們認為，我們不僅能夠解決大量甲狀腺切除術患者的問題，而且由於我們更好的安全性、有效性和治癒情況，我們認為我們可以涵蓋這 800 萬「警惕」等待中的大部分患者患者。我們也認為我們的程式將是真正可教學和可重複的。這將使我們能夠進入市場並快速發展這個新市場。我們不僅在甲狀腺結節方面擁有巨大的機會，而且也將為許多其他應用帶來機會，包括治療其他類型的腫瘤。

All right. That's it for our submitted questions. Operator, we can open up the line.

好的。這就是我們提交的問題。接線員，我們可以開通線路了。

Our first question comes from the line of Robert Lovgren with Medical Hope Productions.

我們的第一個問題來自 Medical Hope Productions 的 Robert Lovgren。

Yes. It's very interesting that you -- all the stuff that talked about here. I got a couple of questions here. First of all, safer and faster. And I guess it's -- what I'm told is, easier to do basically for initial electrophysiologists to do it where they're just starting out.

是的。非常有趣的是你——這裡談論的所有東西。我在這裡有幾個問題。首先，更安全、更快速。我想，據我所知，對於最初的電生理學家來說，基本上在他們剛開始的地方更容易做到這一點。

In addition, have you sort of thought about an Advisory Board, Scientific Advisory Board? And then this papers business is -- they're (inaudible) -- I wished you put those papers up on your website, so we can read some of those papers. And then what about the company that you're in business with they're developing, is that part of the process? I forgot the name of the company, but, hello?

此外，您是否考慮過設立顧問委員會、科學顧問委員會？然後這篇論文的業務是——他們（聽不清楚）——我希望你把這些論文放在你的網站上，這樣我們就可以閱讀其中的一些論文。那麼與你有業務往來的公司呢？他們正在開發，這是這個過程的一部分嗎？我忘了公司的名字，但是，你好？

Bob, this is Darrin. I'll tackle some of these. There -- looks -- I think you have kind of four questions here. So let me see if I can go in order.

鮑勃，這是達林。我將解決其中一些問題。看起來，我想你有四個問題。那麼讓我看看是否可以按順序進行。

So the first one you mentioned is safety and speed. And so I think this is a general capability of nsPFA, both on the catheter side and on the clamp side. And by safety, generally, what we mean by that is our system or this technology is completely nonthermal. So a lot of the safety issues that you see in ablation, in cardiac ablation in particular, have to do with the fact that thermal modalities are used. And when you're using a thermal modality...

所以你提到的第一個就是安全和速度。因此，我認為這是 nsPFA 的一般功能，無論是在導管側還是在夾具側。一般來說，我們所說的安全是指我們的系統或這項技術完全是非熱的。因此，您在消融（尤其是心臟消融）中看到的許多安全問題都與使用熱方式有關。當您使用熱模式時...

Irreversible and reversible, this is reversible. Nanopulse is the only one that's reversible...

不可逆和可逆，這個是可逆的。奈米脈衝是唯一一種可逆的...

Yes. So there is a reversible component to it, but the safety really has to do largely with the fact that we don't have any kind of thermal spread, that thermal spread is something that can -- when you're doing cardiac ablations can reach the esophagus and nerves and other critical structures. And of course, we're nonthermal. So we don't have that aspect.

是的。所以它有一個可逆的組成部分，但安全性實際上很大程度上與我們沒有任何形式的熱擴散有關，當你進行心臟消融時，熱擴散可以達到食道、神經和其他重要結構。當然，我們是非熱能的。所以我們沒有這方面。

And on the speed side, speed has been demonstrated by us and others, it's a very fast technology in terms of the speed required to do the ablation, and substantially faster, many times faster than what you see with radiofrequency ablation or cryosurgery. And really, speed isn't just a convenience. It's also a safety component. So the faster that you can perform these procedures, the sooner the patient gets out of anesthesia and back on their feet. So I think there's a safety component that has also has to do with the speed.

在速度方面，我們和其他人已經證明了速度，就消融所需的速度而言，這是一種非常快的技術，而且比射頻消融或冷凍手術快很多倍。事實上，速度不僅僅是一種便利。它也是一個安全組件。因此，執行這些手術的速度越快，患者就越早擺脫麻醉並重新站起來。所以我認為安全因素也跟速度有關。

You mentioned a question about would we have an Advisory Board, we're starting to build that team. So you've heard about Dr. Dunnington and Dr. Niv ad, and some of the other EPs that we're doing work with. And so we'll certainly over time, build what we believe will be a top-notch Advisory Board, likely both on the catheter side and on the cardiac surgery side. And that will come in time as these things evolve.

你提到我們是否有一個顧問委員會的問題，我們正在開始建立這個團隊。您已經聽說過 Dunnington 博士和 Niv 博士的廣告，以及我們正在合作的其他一些 EP。因此，隨著時間的推移，我們肯定會建立一個我們認為一流的諮詢委員會，可能在導管方面和心臟手術方面都是如此。隨著這些事情的發展，這將會及時到來。

You asked about papers and getting the papers posted on our website, which we very often do sometimes, we have to make sure that whatever the society or scientific meeting that, that publication exists in is okay with us publishing it on our website. But when they are -- and we try to make that happen every time, we certainly will do that.

您詢問了有關論文的問題，並將論文發佈在我們的網站上，有時我們經常這樣做，我們必須確保無論該出版物存在於哪個學會或科學會議中，我們都可以將其發佈在我們的網站上。但當它們出現時——而且我們每次都努力做到這一點，我們當然會這麼做。

And lastly, I think you're referring to a partnership that we have ongoing with our catheter to deliver mapping and navigation technology. And we view mapping and navigation as kind of part of the overall system that needs to be delivered into the EP to do these ablations with catheters. And so our first in-human activity, we will have a mapping and navigation partner along with us. We've integrated our technologies together to provide a really physician-friendly and what ends up being a patient-friendly solution. So I think I got through the four questions that you had, but if not, let me know.

最後，我認為您指的是我們與導管正在進行的合作夥伴關係，以提供測繪和導航技術。我們將測繪和導航視為整個系統的一部分，需要將其傳送到 EP 中以使用導管進行這些消融。因此，我們的第一個人類活動將有一個地圖和導航合作夥伴與我們同行。我們將我們的技術整合在一起，提供真正對醫生友好且最終成為對患者友好的解決方案。所以我想我已經回答了你們提出的四個問題，但如果沒有，請告訴我。

Our next question comes from the line of Jason Smith, a private investor.

我們的下一個問題來自私人投資者傑森史密斯。

Congratulations on making fantastic progress on bringing nsPFA to patients. It's just been awesome to watch the evolution of the progress taking place. My question is whether the patents that are originally held by FARAPULSE or other standard PFA patent holders, is broad enough to potentially cause patent infringements by Pulse Biosciences?

恭喜您在將 nsPFA 帶給患者方面取得了巨大進展。目睹所發生的進展的演變真是太棒了。我的問題是 FARAPULSE 或其他標準 PFA 專利持有者最初持有的專利是否廣泛到足以導致 Pulse Biosciences 侵犯專利權？

Yes. Thanks, Jason. I wouldn't want to comment at all on patents by any other patent holders specifically, we spend a lot of our time and energy, and we invest a lot in our patent portfolio. We invest a lot in our product design, and we invest a lot in doing everything we can to ensure that any of these markets are open to our products. And so I think that's the best way for me to handle that.

是的。謝謝，傑森。我不想具體評論任何其他專利持有者的專利，我們花費了大量的時間和精力，並且我們在專利組合上投入了大量資金。我們在產品設計上投入了大量資金，並竭盡全力確保這些市場對我們的產品開放。所以我認為這是我處理這個問題的最佳方式。

Jason, this is Bob Duggan. Just the process of [obtaining] a patent is inclusive of validation of its appropriateness. That doesn't mean after the fact one can't bring that into question. But it's no small task to get through the patent filter. So with 188, 148 in hand, 103 pending and a very rapid set of developments, developments that are application specific to CellFX and the nanosecond pulse, we're in pretty good -- we think we're in a pretty good position, time will tell, but we do not consider our business to have a significant or serious patent risk at all. We think we're very strong in that area.

傑森，這是鮑伯杜根。 [取得]專利的過程就包含了對其適當性的驗證。這並不意味著事後人們不能對此提出質疑。但要通過專利過濾並不是一件容易的事。因此，擁有188 個、148 個在手、103 個待定以及一系列非常快速的開發，這些開發是針對CellFX 和納秒脈衝的應用程序，我們處於非常好的位置- 我們認為我們處於一個非常好的位置，時間會告訴我們，但我們認為我們的業務根本不存在重大或嚴重的專利風險。我們認為我們在該領域非常強大。

Yes. I think the biggest factor is when you touch the patient, is it safe? Patients who are really reluctant to go from a current condition to a surgical procedure, if it's not say, then it comes, is it friendly. But if that -- those two questions are answered positively for the patient that is equally important, if not more important, is it physician-friendly? That's why you see 8,000 procedures today done robotically when we used to celebrate back in the day when we started our company in (inaudible), -- we have one procedure done every other week, times change. But safety, friendliness to both -- friendliness is our true ally to the patient and to the physician and thereby, and therefore, it is scalable.

是的。我認為最大的因素是當你接觸病人時，安全嗎？確實不願意從目前的狀況轉到手術治療的患者，如果不說，那就來了，友好嗎？但是，如果這兩個問題得到了積極的回答，那麼這對患者來說同樣重要，甚至更重要，這對醫生來說是否友善？這就是為什麼今天我們看到 8,000 項手術是由機器人完成的，而我們過去常常慶祝我們公司成立的那一天（聽不清楚）——我們每隔一周完成一次手術，時代在變化。但對雙方來說，安全、友善——友好是我們對病人和醫生的真正盟友，因此，它是可擴展的。

So when you have else coming into the business as they are, (technical difficulty) not to be underestimated how positive that is. So in this case, we've treated over 7,000 lesion. Now we're treating some very specific areas of the heart. And once that's done, you'll see acceleration of our activities, and we await those opportunities and the timing is coming close. I can say that to when that will happen.

因此，當你有其他人進入這個行業時，（技術難度）不要低估它的正面意義。在這個案例中，我們治療了 7,000 多個病變。現在我們正在治療心臟的一些非常特定的區域。一旦完成，您將看到我們活動的加速，我們正在等待這些機會，時機即將到來。我可以說那是什麼時候發生的。

There are no other questions in the queue. I'd like to hand the call back to management for closing remarks.

隊列中沒有其他問題。我想將電話轉交給管理階層以供結束語。

Yes. Thank you. One of the things I just want to close is to say, the past quarter has been outstanding for us. And we've done the work in the lab. We've done the work in the clinic, and we've done the work on the engineering side, and we're extremely excited about where we're going with nsPFA, CellFX, and we're really excited to bring these results to you.

是的。謝謝。我想結束的一件事是，過去的季度對我們來說非常出色。我們已經在實驗室完成了這項工作。我們已經完成了臨床工作，也完成了工程方面的工作，我們對 nsPFA、CellFX 的發展方向感到非常興奮，我們非常高興能夠將這些結果帶給大家你。

So stay tuned, keep watching us. We are really passionate about what we're doing. We think we're highly differentiated. We have a robust IP portfolio strategy. It starts with our energy. It goes from the energy to the console, from the console to the endofunctors, from the end of endofunctors to the patient, and we think that we've done an amazing job there. So continued ask questions, stay engaged, and we will continue to communicate. And we thank you for -- all of you for joining the call.

所以請繼續關注我們。我們對我們正在做的事情充滿熱情。我們認為我們是高度差異化的。我們擁有強大的智慧財產權組合策略。它始於我們的能量。它從能量到控制台，從控制台到endofunctors，從endofunctors的末端到患者，我們認為我們在這方面做得非常出色。因此，繼續提出問題，保持參與，我們將繼續溝通。我們感謝你們所有人加入這次電話會議。

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。此時您可以斷開線路，度過美好的一天。