Pulse Biosciences Inc (PLSE) 2022 Q4 法說會逐字稿

Ladies and gentlemen, greetings, and welcome to the Pulse Biosciences Fourth Quarter 2022 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

女士們，先生們，大家好，歡迎來到 Pulse Biosciences 2022 年第四季度收益電話會議。 （操作員說明）提醒一下，正在錄製此會議。

It is now my pleasure to introduce your host Trip Taylor, Investor Relations. Please go ahead.

現在我很高興向您介紹主持人 Trip Taylor，投資者關係部。請繼續。

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, March 30, 2023, only and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations and other information. 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 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. 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 on the News and Events section on our Investor Relations page.

謝謝你，運營商。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回答僅反映截至 2023 年 3 月 30 日今天的管理層觀點，並將包括前瞻性陳述和意見陳述，包括預測、估計、計劃、期望和其他信息。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存在重大差異。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這些風險和不確定性。我們的 SEC 文件可以在我們的網站或 SEC 的網站上找到。提醒投資者不要過分依賴前瞻性陳述。我們不承擔任何更新或修改這些前瞻性陳述的義務。我們還將討論某些非 GAAP 財務措施。有關這些非 GAAP 財務措施的披露，包括與最具可比性的 GAAP 措施的對賬，可在新聞稿中找到。請注意，我們的網站 pulsebiosciences.com 投資者關係頁面的新聞和活動部分將提供本次電話會議的音頻重播。

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

有了這個，我現在想把電話轉給總裁兼首席執行官 Kevin Danahy。

Thank you, Trip. Good afternoon, everyone, and thank you all for joining us. On today's call, I will discuss our nanosecond pulse field ablation, nsPFA, development progress and our 2023 corporate objectives. I will then turn the call over to our Chief Technology Officer, Darrin Uecker, to provide a detailed overview of our core technology and product development initiatives. Then I will review our fourth quarter financial results before concluding and opening the call for a question-and-answer session.

謝謝你，旅行。大家下午好，感謝大家加入我們。在今天的電話會議上，我將討論我們的納秒脈衝場消融、nsPFA、開發進度和我們 2023 年的企業目標。然後，我會將電話轉給我們的首席技術官 Darrin Uecker，詳細介紹我們的核心技術和產品開發計劃。然後，我將回顧我們的第四季度財務業績，然後結束並開啟問答環節。

Pulse Bioscience is going where we believe no company has gone before, accomplishing beneficial first of it time effects that have yet to be achieved in the world of pulse field ablation. Our technology has consistently demonstrated a high degree of safety, efficacy and outcomes. In addition to the significant positive impact on patients, the knowledge gained during our previous FDA clearances has given us the present time confidence and vision to pursue the use of nsPFA on the human heart. Our FDA clearance and the treatment of over 6,000 patients with tissue-related positive results in skin proved the viability of our technology, paving the way for a differentiated cardiac applications. Our proprietary nsPFA technology has the potential to be disruptive in a unique demonstratable and consistent manner. While it's still early days and preclinical testing is ongoing, we are encouraged by our progress to date.

Pulse Bioscience 正在走向我們相信沒有公司以前去過的地方，實現脈衝場消融領域尚未實現的有益的首次時間效應。我們的技術一直表現出高度的安全性、有效性和結果。除了對患者產生顯著的積極影響外，我們在之前的 FDA 許可中獲得的知識使我們現在有信心和遠見去追求在人類心臟上使用 nsPFA。我們的 FDA 許可和對 6,000 多名皮膚組織相關陽性結果的患者的治療證明了我們技術的可行性，為差異化的心臟應用鋪平了道路。我們專有的 nsPFA 技術有可能以獨特、可證明和一致的方式產生顛覆性影響。雖然現在還處於早期階段，臨床前測試仍在進行中，但我們對迄今為止取得的進展感到鼓舞。

2022 was a pivotal year for Pulse Biosciences. We announced a strategic shift in reprioritizing our efforts to focus on the most compelling opportunities for the application of our proprietary Nano-Pulse Stimulation technology. Building upon our R&D work in cardiology that began several years ago, our top focus is now on developing multiple devices to deliver nanosecond pulse field ablation or nsPFA to cardiac tissue for the treatment of atrial fibrillation. We made this decision based on our existing preclinical evidence that suggests nsPFA can potentially offer a leading safety and efficacy profile compared to thermal ablation modalities in newer PFA technologies. The treatment of AF, atrial fibrillation, is a large and established high-growth market. We believe our ability to take share in this $8 billion market represents the most efficient path towards long-term value creation and a viable business model. We have adjusted our strategy and team to best pursue this opportunity. I could not be more excited to lead the company through this pivotal time I am confident we have the technology, the team and strategy in place to maximize the impact of nsPFA and create substantial value for patients, physicians and stakeholders. Our complete existing understanding of nsPFA's impact on cells compared to thermal destruction led us to investigate cardiac tissue ablation early on. Initially, we sponsored and provided equipment to university research. Once the feasibility of the mechanism of action was proven in animal cardiac tissue, we initiated our own R&D projects. These included the development and preclinical testing of a cardiac ablation clamps for the use in cardiac surgery and a cardiac ablation catheter for the use in electrophysiology. I will let Darrin discuss the details of the technology and product development progress shortly, but I first want to provide context around the AF market, and why we have prioritized this application for the technology going forward.

2022 年是 Pulse Biosciences 的關鍵一年。我們宣布了一項戰略轉變，重新調整我們的工作重點，專注於應用我們專有的納米脈衝刺激技術的最引人注目的機會。基於我們幾年前開始的心髒病學研發工作，我們現在的首要重點是開發多種設備，以向心臟組織提供納秒脈衝場消融或 nsPFA 以治療心房顫動。我們根據現有的臨床前證據做出了這一決定，這些證據表明，與較新的 PFA 技術中的熱消融方式相比，nsPFA 可以提供領先的安全性和有效性。房顫、心房顫動的治療是一個龐大且成熟的高增長市場。我們相信，我們有能力在這個 80 億美元的市場中佔有一席之地，這是實現長期價值創造和可行商業模式的最有效途徑。我們已經調整了我們的戰略和團隊，以最好地抓住這個機會。我對帶領公司度過這個關鍵時刻感到無比興奮，我相信我們擁有適當的技術、團隊和戰略，可以最大限度地發揮 nsPFA 的影響，並為患者、醫生和利益相關者創造可觀的價值。與熱破壞相比，我們對 nsPFA 對細胞的影響的完整理解促使我們及早研究心臟組織消融。最初，我們為大學研究贊助和提供設備。一旦在動物心臟組織中證明了作用機制的可行性，我們便啟動了自己的研發項目。其中包括用於心臟手術的心臟消融夾和用於電生理學的心臟消融導管的開發和臨床前測試。我將讓 Darrin 稍後討論技術和產品開發進展的細節，但我首先想提供有關 AF 市場的背景信息，以及為什麼我們優先考慮此應用程序以推進技術發展。

The treatment of AF represents in a broad sense, one of the largest and fastest-growing markets in medical technology. Over 1.2 million catheters in surgical ablations are performed annually. And this is expected to grow by more than 10% annually due to an aging population, patient awareness, epidemiology, increased clinical evidence and technical advancements supporting treatment improvements and intervention. We expect through the parallel development of our plant and catheter devices, we can realize important technical, clinical and eventual marketing synergies. Pulse Biosciences' portfolio of devices is both a demonstration of the versatility of CellFX System and an opportunity to address emerging collaboration between surgeons and electrophysiologists treating atrial fibrillation. There is a clear emerging consensus from treating physicians that PFA is thought to be safer and faster than the present time treatment options, but we believe we can do better. Our goal is to change how physicians treat and view atrial fibrillation and in the process provide greater value to patients, physicians and cardiac centers. In the present time, we have focused the organization on 2 main goals to advance our nsPFA technology for the treatment of AF. One, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path; and two, complete all catheter products and regulatory milestones required to treat our early patients. Our goals are clear, and we understand they require time know-how, patience and experience to execute properly. We are focused on long-term success in building the foundation for a viable business over the coming years.

AF 的治療在廣義上代表了醫療技術中最大和增長最快的市場之一。每年在手術消融中執行超過 120 萬根導管。由於人口老齡化、患者意識、流行病學、臨床證據增加以及支持治療改進和乾預的技術進步，這一數字預計每年增長 10% 以上。我們期望通過我們的植物和導管設備的並行開發，我們可以實現重要的技術、臨床和最終營銷協同效應。 Pulse Biosciences 的設備組合既展示了 CellFX 系統的多功能性，也提供了解決外科醫生和電生理學家治療心房顫動之間新興合作的機會。主治醫師已形成明確的共識，即 PFA 被認為比目前的治療方案更安全、更快捷，但我們相信我們可以做得更好。我們的目標是改變醫生治療和看待房顫的方式，並在此過程中為患者、醫生和心臟中心提供更大的價值。目前，我們將組織的重點放在兩個主要目標上，以推進我們用於治療 AF 的 nsPFA 技術。第一，我們打算通過適當的 FDA 監管途徑開發和推進我們的心臟鉗夾；第二，完成治療我們早期患者所需的所有導管產品和監管里程碑。我們的目標很明確，我們知道他們需要時間的專業知識、耐心和經驗才能正確執行。我們專注於在未來幾年為可行的業務奠定基礎的長期成功。

I will now turn it over to Darrin to discuss the technology and product road map.

我現在將把它交給 Darrin 來討論技術和產品路線圖。

Thank you, Kevin. I think it will be helpful today to reiterate the underlying capability of our technology to better understand why it has great potential to improve the present state of cardiac tissue ablation for the treatment of AF among other applications. At Pulse Biosciences, we have developed a novel and proprietary tissue treatment platform based on nsPFA where ultrafast electrical energy pulses at nanosecond pulse durations from billionth up to millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes. nsPFA is broadly considered a pulse field technology, but the use of nanosecond duration pulses leads to a highly differentiated cellular mechanism of action that can be applied to a number of important clinical applications with distinct and unique benefits to patients, treating MDs and post-care trained staff. We have demonstrated that when these incredibly fast energy pulses are applied to cells, they penetrate the cell and disrupt the function of the internal organelles of the cell by creating small holes in the organelle membranes, known as (inaudible). These organelles include the mitochondria, which is the cells power plant and the endoplasmic reticulum, which plays an important role in protein synthesis. When the function of these organelles is disrupted, the cell goes through a natural regulated cell death process. This ability to get inside the cell with nontoxic application of electrical energy, while preserving the integrity of the outer cell membrane to initiate regulated cell death is a cornerstone of our nsPFA technology. This regulated cell death process leads to a more natural healing response as the body's immune system is accustomed to dealing with cell death through this natural and regulated mechanism as opposed to sudden necrotic cell death caused by other energy-based therapies, which can lead to a significant inflammatory response that slows the return to normal tissue function. We believe it is this ability to initiate regulated cell death through the temporary formation of pores in intracellular organelle membranes that importantly differentiates nsPFA from other energy-based therapies, such as standard PFA and radio frequency ablation. Another important and unique feature of Pulse Biosciences nsPFA is the lack of impact it has on acellular structures, such as the extracellular tissue that provides the tissue architecture in support of cellular and organ healing. While thermal energy modalities will destroy all tissue indiscriminately, nsPFA has a selective mechanism that impacts cells that leaves the acellular structure, which typically is made of collagen, intact, allowing the tissue to heal in a more natural way. nsPFA also has been shown to spare nerve fibers or those parts of the nerve that carry electrical impulses as well as blood vessel architecture and tissue. Another significant benefit when the therapeutic intent is to clear on one itself and promote healing and a return to normal tissue function. This novel mechanism of action has been demonstrated in human clinical and preclinical studies across a large number of organs and tissue types. Evidence supporting this has been published in a number of peer-reviewed publications such as the Journal of Lasers and Surgery and Medicine, the Journal of Cosmetic and Laser Surgery and the Journal of Dermatologic Surgery.

謝謝你，凱文。我認為今天重申我們技術的潛在能力將有助於更好地理解為什麼它具有改善心臟組織消融治療 AF 以及其他應用的現狀的巨大潛力。在 Pulse Biosciences，我們開發了一種基於 nsPFA 的新型專有組織治療平台，其中納秒脈衝持續時間從十億分之一秒到百萬分之一秒的超快電能脈衝用於刺激細胞效應，從而產生積極的治療效果。 nsPFA 被廣泛認為是一種脈衝場技術，但納秒持續時間脈衝的使用導致高度分化的細胞作用機制，可應用於許多重要的臨床應用，對患者、治療 MD 和後期護理具有獨特和獨特的益處訓練有素的員工。我們已經證明，當這些令人難以置信的快速能量脈衝應用於細胞時，它們會穿透細胞並通過在細胞器膜上形成小孔來破壞細胞內部細胞器的功能，稱為（聽不清）。這些細胞器包括線粒體和內質網，線粒體是細胞的動力裝置，內質網在蛋白質合成中起著重要作用。當這些細胞器的功能被破壞時，細胞會經歷一個自然調節的細胞死亡過程。這種通過無毒應用電能進入細胞內部的能力，同時保持細胞外膜的完整性以啟動受控細胞死亡是我們 nsPFA 技術的基石。這種受調節的細胞死亡過程導致更自然的癒合反應，因為身體的免疫系統習慣於通過這種自然和受調節的機制來處理細胞死亡，而不是由其他基於能量的療法引起的突然壞死性細胞死亡，這可能導致顯著的炎症反應會減緩正常組織功能的恢復。我們認為，正是這種通過細胞內細胞器膜中暫時形成孔隙來啟動受控細胞死亡的能力，使 nsPFA 與其他基於能量的療法（如標準 PFA 和射頻消融）有重要區別。 Pulse Biosciences nsPFA 的另一個重要且獨特的特點是它對脫細胞結構沒有影響，例如提供組織結構以支持細胞和器官癒合的細胞外組織。雖然熱能模式會不加區別地破壞所有組織，但 nsPFA 有一種選擇性機制，可以影響細胞，使脫細胞結構（通常由膠原蛋白製成）完好無損，從而使組織以更自然的方式癒合。 nsPFA 還被證明可以保護神經纖維或攜帶電脈衝的神經部分以及血管結構和組織。當治療目的是清除自身並促進癒合和恢復正常組織功能時，另一個顯著的好處。這種新的作用機制已在大量器官和組織類型的人體臨床和臨床前研究中得到證實。支持這一點的證據已發表在許多同行評審的出版物中，例如激光與外科和醫學雜誌、美容與激光外科雜誌和皮膚外科雜誌。

We have determined that the underlying nsPFA mechanism of action is uniquely suited to address the current challenges of cardiac tissue ablation. Today, the treatment of AF requires the precise and safe ablation of heart tissue to block, inhibit or otherwise prevent faulty electrical signals from causing an irregular heartbeat. We believe nsPFA technology will prove to be highly differentiated from standard thermal energy modalities in use today. nsPFA should be able to deliver faster ablation through thicker tissue than thermal modalities because it is not impacted by heat sinks, such as the blood in the heart. Thermal modalities experienced charring on electrode surfaces, which prevent adequate ablations and can add undesired time and challenges to procedures. This has not happened with nsPFA because of the earlier mentioned attributes and its nonthermal nature. Because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without safety concerns of permanent damage.

我們已經確定，潛在的 nsPFA 作用機制特別適合應對心臟組織消融的當前挑戰。今天，AF 的治療需要精確和安全地消融心臟組織，以阻斷、抑製或以其他方式防止錯誤的電信號導致心律不齊。我們相信 nsPFA 技術將被證明與當今使用的標準熱能模式高度不同。 nsPFA 應該能夠通過比熱模式更厚的組織進行更快的消融，因為它不受散熱器（例如心臟中的血液）的影響。熱模態會在電極表面出現炭化，這會妨礙充分消融，並可能增加不必要的時間並給程序帶來挑戰。由於前面提到的屬性及其非熱性質，nsPFA 並未發生這種情況。因為 nsPFA 消融不會影響脫細胞組織，如膠原蛋白或軟骨，我們的技術有可能提供比熱模式顯著的安全優勢，允許外科醫生在血管和瓣膜附近和內部進行消融，而無需擔心永久性損傷的安全問題。

And finally, nsPFA ablation has been shown to spare nerves of any permanent damage even when treated directly, which is another concern with thermal modalities. With nsPFA, we believe physicians can provide a more focused thorough treatment and thereby reduce their procedure times with the end goal to improve clinical outcomes and patient experience. In recent years, pulse field ablation has gained attention in electrophysiology for the treatment of AF as a result of its safety profile and potential to improve efficacy. nsPFA differs from standard PFA in that the pulse durations for nsPFA are much shorter, typically 100 to 10,000 x shorter, which translates to appropriate energy and a more energy-efficient mechanism. In turn, less energy per nsPFA pulse allows us to design larger footprint electrodes that can treat more tissue faster with reduced concern of thermal damage that can be an issue with standard PFA. Appropriate controlled energy and shorter duration pulses will stimulate less muscle contraction and nerve stimulation during treatment. And as such, reduces the need for stronger sedation and paralytics that are often used with standard PFA. For these reasons, we believe nsPFA will provide meaningful benefits in both efficacy and safety over standard PFA.

最後，nsPFA 消融已被證明可以避免任何永久性損傷的神經，即使直接治療也是如此，這是熱模式的另一個問題。有了 nsPFA，我們相信醫生可以提供更有針對性的徹底治療，從而減少他們的手術時間，最終目標是改善臨床結果和患者體驗。近年來，脈衝場消融因其安全性和提高療效的潛力而在治療 AF 的電生理學領域受到關注。 nsPFA 與標準 PFA 的不同之處在於，nsPFA 的脈衝持續時間要短得多，通常短 100 到 10,000 x，這轉化為適當的能量和更節能的機制。反過來，每個 nsPFA 脈衝的能量更少，使我們能夠設計更大的足跡電極，可以更快地治療更多的組織，同時減少對標準 PFA 可能成為問題的熱損傷的擔憂。適當的受控能量和較短持續時間的脈衝將在治療期間刺激較少的肌肉收縮和神經刺激。因此，減少了對通常與標準 PFA 一起使用的更強鎮靜和麻痺藥物的需求。出於這些原因，我們相信 nsPFA 將在有效性和安全性方面提供比標準 PFA 更有意義的好處。

On the product development side, we are working with top KOLs and to develop AF treatment solutions to be used in the catheter lab and in the operating room. The differentiated benefits of our nsPFA technology will be incorporated in the design of both a surgical clamp for the treatment of AF in the operating room by cardiac surgeons and a catheter that is navigated into the heart through the vascular system for the treatment of AF by electrophysiologists in EP lab. While these devices serve different physician specialties, they are both providing a highly differentiated solution for the treatment of AF and both make use of the core nsPFA technology, so the development of these devices is highly leveraged. Both devices are currently being tested in preclinical models. Over the last several years, we have been researching and developing nsPFA cardiac ablation surgical tools, and we now have achieved what we believe is an on-target initial commercial design for a cardiac ablation clamp. The cardiac ablation clamp is designed to be used and what is commonly referred to as the Cox-maze procedure, a procedure performed by cardiac surgeons specifically for the treatment of AF. During this procedure, cardiac surgeons create lines of ablation in the heart in order to block aberrant electrical signals and cure the patient of AF. Today, this is done with thermal modalities, and we believe nsPFA can offer a faster, more precise, safer and easier to perform ablation procedure.

在產品開發方面，我們正在與頂級 KOL 合作，開髮用於導管實驗室和手術室的 AF 治療解決方案。我們的 nsPFA 技術的差異化優勢將被納入心臟外科醫生在手術室用於治療 AF 的手術夾和電生理學家通過血管系統進入心臟用於治療 AF 的導管的設計中在EP實驗室。雖然這些設備服務於不同的醫生專業，但它們都為 AF 的治療提供了高度差異化的解決方案，並且都利用了核心 nsPFA 技術，因此這些設備的開發具有很高的槓桿作用。這兩種設備目前都在臨床前模型中進行測試。在過去的幾年裡，我們一直在研究和開發 nsPFA 心臟消融手術工具，現在我們已經實現了我們認為是心臟消融鉗的目標初始商業設計。心臟消融鉗設計用於通常稱為 Cox 迷宮手術的手術，這是心臟外科醫生專門為治療 AF 而執行的手術。在此過程中，心臟外科醫生在心臟中創建消融線，以阻止異常電信號並治愈 AF 患者。今天，這是通過熱模式完成的，我們相信 nsPFA 可以提供更快、更精確、更安全和更容易執行的消融程序。

In 2023, we plan to perform the necessary device testing, including continued preclinical testing to prepare for regulatory clearance and human clinical use. In parallel with the continued device testing, we expect to meet with the U.S. Food and Drug Administration, or FDA, to discuss the regulatory requirements for a potential FDA clearance in order to market our cardiac clamp in the United States. This will be done as part of the FDA's standard Q submission process, also known as a pre-submission meeting. We expect that our first meeting on this topic with the FDA will take place in the second quarter of 2023. After meeting with FDA, we expect to have better clarity on time lines to regulatory clearance and first-in-human clinical use.

2023 年，我們計劃進行必要的設備測試，包括繼續進行臨床前測試，為監管許可和人體臨床使用做準備。在繼續進行設備測試的同時，我們希望與美國食品和藥物管理局 (FDA) 會面，討論潛在 FDA 許可的監管要求，以便在美國銷售我們的心臟鉗。這將作為 FDA 標準 Q 提交流程的一部分完成，也稱為提交前會議。我們預計我們與 FDA 就此主題舉行的第一次會議將於 2023 年第二季度舉行。在與 FDA 會面後，我們希望更清楚地了解監管許可和首次人體臨床使用的時間表。

Turning to our second product in development, the cardiac catheter ablation device. Just like the clamp, our catheter delivers an electric field as opposed to thermal energy to destroy heart muscle cells and should provide many of the same safety and efficacy benefits. The catheter design is unique and enables a circumferential or circular ablation in the single treatment. This feature should expedite treatment times compared to thermal modalities, especially when performing the common, but challenging treatment approach of ablating around the pulmonary veins. The catheter has also been in development for several years, and we have accrued substantial learning while working with leaders in the electrophysiology field to optimize its design and evaluate performance in preclinical studies. We believe our current design is suitable to pursue a first-in-human clinical study following currently planned additional preclinical safety studies. In the U.S., we expect the catheter will require an FDA premarket approval or PMA submission to achieve approval to market and sell the device. The process to complete these trials will take several years. We strive to have a solid understanding of the devices performance as we go forward, and we look forward to providing updates along the way. We have accomplished a great deal with both of our nsPFA devices and the preclinical data we continue to produce is very encouraging. Notably, last month, the company highlighted a poster presentation at the prestigious 2023 AF Symposium in Boston. The poster was titled Novel Nanosecond Pulse Field Ablation Compatible With 3D Mapping and Navigation System. The poster highlighted the integration of our nsPFA system with a compatible 3D mapping and navigation system. The preclinical study demonstrated the ability to navigate the catheter for accurate ablation integrate pre and post ablation voltage maps with the same catheter. To further increase awareness for our technology among the cardiology community, we have submitted multiple abstracts highlighting nsPFA for presentation at the upcoming Heart Rhythm Society Meeting in May. We look forward to sharing more updates on our progress in the future as we accomplish the next important milestones.

轉向我們正在開發的第二個產品，即心臟導管消融設備。就像夾子一樣，我們的導管提供電場而不是熱能來破壞心肌細胞，並且應該提供許多相同的安全性和有效性優勢。導管設計獨特，可在單次治療中實現圓周或圓形消融。與熱模式相比，此功能應加快治療時間，尤其是在執行常見但具有挑戰性的肺靜脈周圍消融治療方法時。導管也已經開發了數年，我們在與電生理學領域的領導者合作優化其設計和評估臨床前研究的性能時積累了大量的知識。我們相信我們目前的設計適合在目前計劃的額外臨床前安全性研究之後進行首次人體臨床研究。在美國，我們預計導管將需要獲得 FDA 上市前批准或 PMA 提交才能獲得上市和銷售該設備的批准。完成這些試驗的過程將需要數年時間。在我們前進的過程中，我們努力對設備性能有一個深入的了解，我們期待在此過程中提供更新。我們已經在我們的 nsPFA 設備上取得了很大的成就，我們繼續產生的臨床前數據非常令人鼓舞。值得注意的是，上個月，該公司在波士頓著名的 2023 AF 研討會上重點介紹了海報展示。海報的標題是與 3D 測繪和導航系統兼容的新型納秒脈衝場消融。海報強調了我們的 nsPFA 系統與兼容的 3D 映射和導航系統的集成。臨床前研究證明了導航導管以實現準確消融的能力，將消融前和消融後電壓圖與同一導管集成在一起。為了進一步提高心髒病學界對我們技術的認識，我們提交了多份重點介紹 nsPFA 的摘要，以便在即將於 5 月舉行的心律學會會議上進行展示。隨著我們完成下一個重要里程碑，我們期待在未來分享更多關於我們進展的最新信息。

Now I'll turn the call back to Kevin for an update on our financial results.

現在我會把電話轉回給凱文，了解我們財務業績的最新情況。

Thank you, Darrin. We did not recognize revenue in the fourth quarter of 2022. Moving down the income statement, I will focus my comments on non-GAAP results. I encourage you to review today's earnings release for the detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter 2022, we reduced non-GAAP total costs and expenses by $9.1 million to $7.7 million compared to $16.8 million in the third quarter of 2022 and by $4.7 million year-over-year compared to $12.3 million in the prior year period. The decrease in operating expenses were driven by the discontinuation of the commercial dermatology activity in the prior headcount reduction in restructuring. Non-GAAP net loss for the quarter ending December 31, 2022, was $8.1 million compared to $11.5 million for the quarter ending December 31, 2021.

謝謝你，達林。我們沒有確認 2022 年第四季度的收入。向下移動損益表，我將把我的評論集中在非 GAAP 業績上。我鼓勵您查看今天的收益發布，以了解非 GAAP 措施與最具可比性的 GAAP 措施的詳細調節。在 2022 年第四季度，我們將非 GAAP 總成本和支出減少 910 萬美元至 770 萬美元，而 2022 年第三季度為 1680 萬美元，同比減少 470 萬美元，而去年同期為 1230 萬美元。運營費用的減少是由於在先前的重組裁員中終止了商業皮膚科活動。截至 2022 年 12 月 31 日的季度非美國通用會計準則淨虧損為 810 萬美元，而截至 2021 年 12 月 31 日的季度為 1150 萬美元。

Cash, cash equivalents and investments totaling $61.1 million as of December 31, 2022, compared to $28.6 million as of December 31, 2021, and $69.2 million as of September 30, 2022. Cash used in the fourth quarter of 2022 totaled $8 million and was reduced compared to both $13.4 million used in the same period in the prior year and $10.6 million used in the third quarter of 2022. As a result of tightening corporate strategic focus, in 2023, we expect quarterly cash burn to be approximately $8 million, consistent with the fourth quarter results. We have amended the terms of our loan agreement with Robert Duggan, extending the maturity date until September 30, 2024. We have the capital needed to finance our first-in-human clinical trials and remain confident we will achieve the optimal capital structure to advance our strategy and growth trajectories.

截至 2022 年 12 月 31 日，現金、現金等價物和投資總額為 6110 萬美元，截至 2021 年 12 月 31 日為 2860 萬美元，截至 2022 年 9 月 30 日為 6920 萬美元。2022 年第四季度使用的現金總額為 800 萬美元，與去年同期使用的 1340 萬美元和 2022 年第三季度使用的 1060 萬美元相比有所減少。由於公司戰略重點收緊，我們預計到 2023 年季度現金消耗將約為 800 萬美元，與此一致與第四季度的結果。我們修改了與 Robert Duggan 的貸款協議條款，將到期日延長至 2024 年 9 月 30 日。我們擁有為我們的首次人體臨床試驗提供資金所需的資金，並且仍然相信我們將實現最佳資本結構以推進我們的戰略和增長軌跡。

Now I will provide some closing remarks. The addressable market for AF intervention is multibillions of dollars and growing. With a management team that has deep experience and the strategy in place, execution is the present time focus. We understand that global regulatory approvals and evaluations are needed. Management is experienced in the field of robotics and energy ablation and maintain a proven track record of development, achieving regulatory approvals and launching disruptive new medical devices. Additionally, the financial leadership team has excellent depth of experience and is working diligently to optimize the company's capital structure and fund our future. As an innovative bioelectric medicine company committed to health innovation and increasing quality life, we are confident we can have a meaningful impact on patients. Our recent accomplished milestones discussed today are propelling us towards development completion, clinical work and ultimately delivering patients in need the benefit of Pulse Biosciences' nsPFA.

現在我將發表一些結束語。 AF 干預的潛在市場價值數十億美元，而且還在不斷增長。擁有經驗豐富的管理團隊和到位的戰略，執行力是當前的重點。我們了解需要全球監管部門的批准和評估。管理層在機器人技術和能量消融領域經驗豐富，並保持良好的發展記錄，獲得監管批准並推出顛覆性的新醫療設備。此外，財務領導團隊經驗豐富，正在努力優化公司的資本結構，為我們的未來提供資金。作為一家致力於健康創新和提高生活質量的創新生物電醫藥公司，我們有信心能夠對患者產生有意義的影響。我們今天討論的最近完成的里程碑正在推動我們完成開發、臨床工作並最終為需要 Pulse Biosciences 的 nsPFA 的患者提供幫助。

We look forward to providing progress updates on the next call. Today, we would like to invite investor questions.

我們期待在下次電話會議上提供進展更新。今天，我們想邀請投資者提問。

And with that, operator, please open the call for questions.

有了這個，接線員，請打開問題電話。

(Operator Instructions) Kevin, who would be participating along with you in this session?

（操作員說明）凱文，誰將與您一起參加本次會議？

Yes. Thank you so much, operator. Joining me today is Executive Chairman of the Board, Robert Duggan; and Chief Technology Officer, Darrin Uecker, and I am Kevin Danahy, the President and CEO.

是的。非常感謝，接線員。今天加入我的是董事會執行主席 Robert Duggan；首席技術官 Darrin Uecker，我是總裁兼首席執行官 Kevin Danahy。

So we did have a couple of questions that came in online. I'll read off with this. The first question that came in was, why pivot to cardiac?

所以我們確實有幾個在線問題。我會讀完這個。第一個問題是，為什麼轉向心臟？

So I'll jump in on this one, and then I'll ask Darrin or Bob, if they would like to give a little bit more color.

所以我會加入這個，然後我會問 Darrin 或 Bob，他們是否願意提供更多顏色。

Our complete nsFPA impact understanding on how we compare to thermal destruction led us really to investigate cardiac ablation early on. Initially, we sponsored, like we said in the script today, university research. And then once we have the feasibility of the mechanism of action, and what it was proven on cardiac tissue and animals, we started our own R&D projects. After that, we took this information, and we started doing our own preclinical testing, which led to the development of the cardiac ablation clamp for cardiac surgery and cardiac ablation catheter for the use in electrophysiology. So this wasn't really a pivot. It's something that we've been working on for a long period of time. Darrin, do you have anything you would add to that?

我們對如何與熱破壞進行比較的完整 nsFPA 影響理解使我們真正地在早期研究了心臟消融術。正如我們今天在劇本中所說，最初，我們贊助了大學研究。然後，一旦我們確定了作用機制的可行性，並在心臟組織和動物身上得到證實，我們便開始了自己的研發項目。之後，我們獲取了這些信息，並開始進行自己的臨床前測試，這導致了用於心臟手術的心臟消融鉗和用於電生理學的心臟消融導管的開發。所以這並不是一個真正的支點。這是我們長期以來一直在努力的事情。 Darrin，你有什麼要補充的嗎？

No. I think that's perfect. I mean I think it was really -- we were led to these applications by physicians and really the outcomes that we saw in preclinical data.

不，我認為那是完美的。我的意思是，我認為這真的是——我們是由醫生引導我們進行這些應用的，而且確實是我們在臨床前數據中看到的結果。

Kevin, I'll make a comment. Darrin and I go back over 20 years in robotics. And at the early moment, in the life of opportunity -- evaluating opportunity for robotics in human health care, cardiac seemed to be the area of most opportunity. And then over time, proved to be incredibly difficult to pull that off. But we did learn quite a bit about heart and the importance of the heart. And essentially, the heart is energy-based. It's critical and essential to the heart's function. So with the monopole steel, we have an ability to use energy to complement the heart function or to correct misfunction in the heart. So it's a one-off opportunity that we feel is outstanding in terms of size. It's not been penetrated by anyone else at the field and the power of energy and the speed of that energy that we can bring to the table. So that's why we're in it. And I complement your comments and Darrin's comments earlier here about the size of that market, the significance of it and the challenge that -- to get it cleared and to prove it to be effective, which is what we're going after in the next 12 months. And as you said earlier, we'll keep our stakeholders apprised as to our progress in development. But I can assure you, we're approaching this with a tremendous amount of confidence and excitement as potentially the outcomes will be -- could be iconic and make -- turn this into a very disruptive and powerful technology for all involved.

凱文，我會發表評論。達林和我在機器人技術領域已有 20 多年的歷史。在早期，在機會的生活中——評估機器人技術在人類醫療保健中的機會，心臟似乎是機會最多的領域。然後隨著時間的推移，事實證明要實現這一點非常困難。但是我們確實學到了很多關於心和心的重要性的知識。從本質上講，心臟是以能量為基礎的。它對心臟功能至關重要。因此，有了單極鋼，我們就有能力利用能量來補充心臟功能或糾正心臟功能障礙。所以這是一個一次性的機會，我們認為在規模方面非常出色。它沒有被現場的任何其他人以及我們可以帶到桌面上的能量的力量和能量的速度所穿透。這就是我們參與其中的原因。我在此補充你的評論和 Darrin 早些時候關於該市場規模、它的重要性以及挑戰的評論 -- 讓它被清除並證明它是有效的，這就是我們接下來要做的12個月。正如您之前所說，我們將讓我們的利益相關者了解我們在開發方面的進展。但我可以向你保證，我們正在以極大的信心和興奮來解決這個問題，因為結果可能是 - 可能是標誌性的並且 - 將其變成一項對所有相關人員都非常具有破壞性和強大的技術。

Awesome. Thank you, Bob. Another question that came in was just to ask how should we view success for Pulse Biosciences in 2023?

驚人的。謝謝你，鮑勃。另一個問題是我們應該如何看待 Pulse Biosciences 在 2023 年的成功？

And I think as we mentioned in the call today that we really have 2 main goals in 2023 to advance nsPFA in the treatment of AF. Number one, we intend to develop and advance our cardiac clamp through the appropriate FDA regulatory path. And number two, we hope to complete all the catheter product and regulatory milestones required to treat our early patients. So I think that's how we're measuring ourselves, and how I would say that we should be measured. Anything Bob or Darrin to add to that?

我認為正如我們在今天的電話會議中提到的那樣，我們在 2023 年確實有兩個主要目標來推進 nsPFA 在 AF 治療中的應用。第一，我們打算通過適當的 FDA 監管途徑開發和推進我們的心臟鉗夾。第二，我們希望完成治療早期患者所需的所有導管產品和監管里程碑。所以我認為這就是我們衡量自己的方式，我會說我們應該被衡量的方式。 Bob 或 Darrin 有什麼要補充的嗎？

Okay. And then last question...

好的。然後最後一個問題...

I'll jump in. Yes. So basically, heart procedures come about in 3 ways open procedure, which can be incredibly invasive. I've had the honor of being present in up to 50 of those. And it's -- I would rather watch and be a part of it. But it is challenging, but it is also through precision approach and the use of the technology available, things such as a coronary artery bypass graft proved to be patent for almost 20 years. It's an incredible procedure created by doctors at the Cleveland Clinic years ago. And Darrin and I happen to become very friendly with a number of them as they evaluate an opportunity for robotics there. So then you have less invasive surgery and then you have catheter-based. So the catheter base are -- you would recognize stents in the placement of stents early on as something that was effective, but very, very less challenging and dramatic to the patients. So really the business of repairing grafts and arteries with grafts came over on to the stent side. So we believe we've got the best of all worlds here. We can help in open procedures. Most of the open procedures that take place involve either the presence of or the risk of creating ablation and a fibrillation in the heart. So while the heart is open, you can apply a clamp to this and generate the ablation in areas that are needed and necessary with the clamp that we have under study. Some of the top doctors from robotics 20 years ago are now the top doctors in performing these procedures. So Kevin knows them. They know Kevin, they know myself, Darrin is very close with most of these teams. So it's with great excitement that they're welcoming us back in their lives. So we're thrilled with the opportunity and it's pretty exciting. And you'll hear more from us as we achieve success in that in first in humans. On the other side of the catheter, that's a very challenging opportunity. But we had in defectors creators at our computer motion company, and they were right on the market, and that was where we had a very strong patent base prior to merging with Intuitive Surgical, which has created tremendous success on its own right in the area of robotics. And have some activity, decent activity in the area of heart valves and heart valve repair. So these are areas we're familiar with. We're very excited about it. Electrophysiologists that we're working with view this as a disruptive, distinctly different and nicely improved technology. We're excited about it, and we look to get the first in-human because that's really the validation, and since these procedures will be open -- I mean, we'll know what's happened right after the procedure. This is not like a Phase III drug trial, where you might have to dose 2,000 patients and in your statistics to bear after the completion of those patients have been thoroughly evaluated. This is -- when the person gets off the table or on the table, you know how well you're doing with that patient. So we're pursuing that activity as we speak. And I would think during -- over the next year, we will be able to come back to you with results. Two things here, if we hit obstacles that we think increase the risk or diminish the return, as soon as we validate that, we will be back out to our stakeholders. As we achieve success, we'll make sure that on a timely basis, as is appropriate, we'll relate to the stakeholders as well. So that's where we stand on these issues. If you catch the excitement of my voice, it's real. The team that is working on this, if I'm excited, they're like excited squared, so this is going to be the real fun year for our company. Back to you, Kevin.

我會跳進去。是的。所以基本上，心臟手術以 3 種方式進行，開放式手術可能具有難以置信的侵入性。我有幸參加了其中多達 50 場。它是——我寧願觀看並參與其中。但它具有挑戰性，但它也是通過精確的方法和現有技術的使用，諸如冠狀動脈旁路移植術之類的東西被證明是近 20 年的專利。這是多年前克利夫蘭診所的醫生創造的一個令人難以置信的程序。達林和我碰巧與他們中的一些人變得非常友好，因為他們正在評估那裡的機器人技術機會。因此，您可以進行微創手術，然後進行基於導管的手術。所以導管底座是——你會在早期認識到支架放置中的支架是有效的，但對患者來說挑戰和戲劇性非常小。因此，真正用移植物修復移植物和動脈的業務轉移到了支架方面。所以我們相信我們在這裡擁有世界上最好的。我們可以在開放程序方面提供幫助。發生的大多數開放式程序都涉及在心臟中產生消融和顫動的存在或產生消融和顫動的風險。因此，當心臟打開時，您可以對其應用一個夾具，並使用我們正在研究的夾具在需要和必要的區域進行消融。 20 年前機器人技術領域的一些頂級醫生現在是執行這些程序的頂級醫生。所以凱文認識他們。他們了解凱文，他們了解我自己，達林與這些球隊中的大多數都非常親密。因此，他們非常高興地歡迎我們回到他們的生活中。所以我們對這個機會感到非常興奮，這非常令人興奮。當我們首先在人類身上取得成功時，你會聽到更多來自我們的信息。在導管的另一邊，這是一個非常具有挑戰性的機會。但是我們的計算機運動公司有叛逃者創造者，他們就在市場上，這就是我們在與 Intuitive Surgical 合併之前擁有非常強大的專利基礎的地方，Intuitive Surgical 在該領域憑藉自身的力量取得了巨大的成功機器人學。並且在心臟瓣膜和心臟瓣膜修復領域有一些活動，體面的活動。所以這些是我們熟悉的領域。我們對此感到非常興奮。與我們合作的電生理學家認為這是一種顛覆性的、截然不同的、經過很好改進的技術。我們對此感到興奮，我們希望獲得第一個人體試驗，因為這確實是驗證，而且由於這些程序將是公開的——我的意思是，我們會知道程序後發生了什麼。這不像 III 期藥物試驗，您可能必須對 2,000 名患者進行給藥，並在您的統計數據中對這些患者完成後進行全面評估。這是——當這個人離開手術台或在手術台上時，你就知道你對那個病人的處理情況如何。因此，我們正在開展這項活動。我想在接下來的一年裡，我們將能夠向您反饋結果。這裡有兩件事，如果我們遇到了我們認為會增加風險或減少回報的障礙，一旦我們驗證了這一點，我們就會回到我們的利益相關者那裡。當我們取得成功時，我們將確保在適當的時候，我們也將與利益相關者建立聯繫。這就是我們在這些問題上的立場。如果你聽到我聲音中的興奮，那是真的。從事這項工作的團隊，如果我很興奮，他們就像興奮的平方一樣，所以今年將是我們公司真正有趣的一年。回到你身邊，凱文。

Yes. Thank you, Bob. Last question that came in, and I'll give this one over to Darrin, is what was the significance of the AF Symposium poster?

是的。謝謝你，鮑勃。最後一個問題，我將把這個問題交給 Darrin，AF 研討會海報的意義是什麼？

Yes. That's a good question. So the AF Symposium is really one of the top meetings -- scientific meetings in the treatment of AF that held annually. And I think typically, there are between 300 and maybe 5,000 attendees, which are the top electrophysiologists around the world and health care providers and people from industry. And the acceptance of our poster, I think, was a real validation of the technology and what the organizers of the meeting, believe is the potential of the technology. So we were honored and very pleased to be a part of that important meeting. We had a lot of great conversation with a number of electrophysiologists who are excited to see it. We got to mention from the podium about the potential of nsPFA from one of the key physicians. So it was really a great meeting for us. It's great to be able to demonstrate what we've been doing preclinically and to show that to the scientific community and to have it accepted by the scientific community as something that they want to hear about and get excited about going forward.

是的。這是個好問題。因此，房顫研討會確實是頂級會議之一——每年舉行的房顫治療科學會議。我認為通常有 300 到 5,000 名與會者，他們是世界頂級的電生理學家、醫療保健提供者和行業人士。我認為，接受我們的海報是對技術的真正驗證，也是會議組織者所相信的技術潛力。因此，我們很榮幸也很高興能夠參加那場重要會議。我們與許多興奮地看到它的電生理學家進行了很多精彩的對話。我們在講台上提到了一位主要醫生關於 nsPFA 的潛力。所以這對我們來說真的是一次很棒的會議。能夠證明我們在臨床前所做的工作並向科學界展示並讓科學界接受它作為他們想听到的事情並為前進感到興奮，這真是太好了。

Thank you, Darrin.

謝謝你，達林。

All right, operator, we can open up the questions.

好的，接線員，我們可以打開問題了。

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

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

Yes. I'm glad to hear the good result at the AF Symposium in Boston. And -- well, first of all -- the first thing I want to ask you is, are you securing your patents -- your ownership of patents or regulation from -- over to you. And I guess, in terms of other people who have gone on to Mayo Clinic and Washington University. Are you pretty secure in that and holding those patents? Is that an economic estimate business? You're ahead in the business than the other people, I think, as you already hold the patents.

是的。很高興在波士頓的 AF 研討會上聽到這個好結果。而且 - 嗯，首先 - 我想問你的第一件事是，你是否正在保護你的專利 - 你對專利或監管的所有權 - 交給你。我想，就其他已經進入梅奧診所和華盛頓大學的人而言。您在這方面很安全並擁有這些專利嗎？那是經濟估算業務嗎？我認為你在業務上比其他人領先，因為你已經擁有專利。

Yes. Hi, Bob, it's Darrin. Thanks for calling in and thanks for the question. Good to hear your voice. Yes. So as you know, I think this company was really founded about 7 or 8 years ago on a pretty broad and foundational IP portfolio related to nsPFA. And many of those patents came from 2 universities, (inaudible) University on the East Coast and the University of Southern California, here in California and then 2 small companies that were sort of loosely affiliated with those universities. So we started with a pretty significant patent portfolio, and over the last many years, as a company, we've invested significantly in our patent portfolio. As we develop this platform, we've developed a lot of patents along the way. And some are obviously public and some are yet to come out. But we feel really good about, I think, where we are in terms of our patent portfolio, and what we've done to secure a pathway for ourselves in a lot of these different applications using this very unique technology. Bob and I, as he mentioned, lived through the early days of medical robotics and a lot of experience and knowledge was gained along that way as it relates to patents and the importance of patents in securing a path forward for these platform technologies. And we certainly have spent a lot of time and energy on that. So I think we feel good in terms of where we're at. Our works never done there, so we continue to expand that portfolio as we move along.

是的。嗨，鮑勃，我是達林。感謝您的來電並感謝您的提問。很高興聽到你的聲音。是的。所以如你所知，我認為這家公司實際上是在大約 7 或 8 年前成立的，其基礎是與 nsPFA 相關的相當廣泛和基礎的 IP 組合。其中許多專利來自兩所大學，東海岸的（聽不清）大學和加利福尼亞州的南加州大學，以及與這些大學有鬆散關聯的兩家小公司。所以我們從一個非常重要的專利組合開始，在過去的很多年裡，作為一家公司，我們在我們的專利組合上投入了大量資金。在開發這個平台的過程中，我們一路開發了很多專利。有些顯然是公開的，有些還沒有出來。但我認為，我們對我們在專利組合方面所處的位置以及我們為使用這種非常獨特的技術在許多不同應用中確保自己的途徑所做的工作感到非常滿意。正如他所提到的，鮑勃和我經歷了醫療機器人技術的早期階段，並在此過程中獲得了大量與專利相關的經驗和知識，以及專利在確保這些平台技術前進道路上的重要性。我們當然為此花費了大量時間和精力。所以我認為我們對我們所處的位置感覺良好。我們的工作從未在那裡完成，因此我們會在前進的過程中繼續擴展該產品組合。

And Darrin, if I might add, and you correct me if I'm wrong here, I believe we have over 100 patents granted and then plus another 100 filed, and it's a very dynamic phenomenon year-to-year, we'll be growing patents all the way from here on out.

達林，如果我可以補充一點，如果我在這裡錯了，請糾正我，我相信我們已經獲得了 100 多項專利，然後又申請了另外 100 項，這是一個年復一年的動態現象，我們將從現在開始，專利不斷增加。

Yes. That's right, Bob. Those numbers are accurate for sure.

是的。沒錯，鮑勃。這些數字肯定是準確的。

Our next question comes from the line of James [Hollingsworth], Private Investor.

我們的下一個問題來自私人投資者 James [Hollingsworth]。

I'm going to use an analogy about power tools. If you go to Home Depot, you can buy a set of power tools, and they all run on a battery. And I'm going to suggest that our nano-pulse technology is like the battery, and that battery plugs into a saw or a drill or some other type of device. And it seems to me that we -- that our NPS and all these patents and our nano-pulse generator is like that battery. But what we're dependent upon is the applicator, the apparatus that actually does the work on the patient. And I think that, that was the problem with our dermatology. I firmly believe in nano-pulse technology, but our applicator was faulty. And it seems to me that what we're getting into now is that we must collaborate with the people that build the catheters and the other applicators. So are we going into the development of these applications, the devices that actually touch the patient. It seems to me that that's where our our problem lies and our opportunity lies is that we have the nano-pulse generator, but we don't have the apparatus that that could treat the patient. So are we going to collaborate with other companies that build these applicators, or are we going to develop our own?

我將使用有關電動工具的類比。如果你去 Home Depot，你可以買一套電動工具，它們都靠電池供電。我要建議我們的納米脈衝技術就像電池，電池可以插入鋸、鑽或其他類型的設備。在我看來，我們——我們的 NPS 和所有這些專利以及我們的納米脈衝發生器就像那個電池。但我們所依賴的是塗藥器，即實際對患者起作用的儀器。我認為那是我們皮膚科的問題。我堅信納米脈衝技術，但我們的塗藥器有問題。在我看來，我們現在要做的是我們必須與製造導管和其他塗藥器的人合作。那麼我們是否要開發這些應用程序，即實際接觸患者的設備。在我看來，這就是我們的問題所在，而我們的機會就在於我們擁有納米脈衝發生器，但我們沒有可以治療患者的設備。那麼我們是要與製造這些塗抹器的其他公司合作，還是要開發我們自己的？

Kevin, I'll take that. I've known Dr. [Hollingsworth] for quite a while. He's an outstanding scientist and doctor in his own right and kind of grew up with us at Computer Motion. So he's familiar with a lot of these things. But I would say we're very much different than a battery. We are a tunable device that can scale, shift and adjust as needed and appropriate energy and place it in a very pinpointed area. It'd be like comparing a battery to a radio. It's -- there are some similarities, but it's clearly not identical and the similarities are reasonably few. In terms of the application in dermatology, we had some spectacular results in dermatology. We had no adverse events, no reportable events to the FDA. Patients walk out of the facility with the potential to have a cleared lesion that went well beyond what normal treatments could provide to them. So you might say, well, it appeared to fail because you weren't able to generate the revenues. What happened is over 6,000 patients were treated, treated well, treated effective. The device proved its workability. It's still the only device of its kind of that nature in that business. It just was not viable in terms of -- relative to the other procedures that were being performed is like you could come in with a slice in your arm and either they could put a Band-Aid on it or suture it, and the Band-Aid is so less expensive than the suture that they put the bandage on. We really got a lot of plot. It's well deserved from patients and physicians and dermatologists alike from that field. So that product succeeded. Our business plan did not succeed. And we'll take our own hit for that. We thought there would be a faster assimilation of the product, a stronger uptake, and we could crossover into the world of viability. And while things were improving as we moved along, we did have other alternatives, and as you know, from many companies that I've started and work with, the first few words are to build a viable, first 4 words, which means that you can create sustainable future out of what you really do, and you're not dependent on outside funding and financing. So with that in mind, we had to pivot and we did, and we pivot over to an area that has benefited greatly from an FDA-approved device has benefited greatly from the viewpoint and the knowledge the confidence that this device can work can deliver energy of high volume at high speed and do so. And and go right to the cellular aspect of a tissue that is needed in repair and not hit acellular structures. So when you're dealing with the heart, that becomes critically important. So we're taking a win on the derm, but we've got an order of magnitude, larger opportunity. We've got a product very specific to that, and we're really ready to go here. So I hope that addresses the question. I appreciate the question, too.

凱文，我會接受的。我認識 [Hollingsworth] 博士有一段時間了。他本身就是一位傑出的科學家和醫生，在 Computer Motion 與我們一起成長。所以他對很多事情都很熟悉。但我會說我們與電池有很大不同。我們是一個可調設備，可以根據需要縮放、移動和調整，並適當地使用能量並將其放置在一個非常精確的區域。這就像將電池與收音機進行比較。它是——有一些相似之處，但顯然不完全相同，而且相似之處相當少。在皮膚科的應用方面，我們在皮膚科取得了一些驚人的成果。我們沒有發生不良事件，也沒有可向 FDA 報告的事件。患者走出設施時可能會出現明顯超出正常治療所能提供的清除病變。所以你可能會說，好吧，它似乎失敗了，因為你無法產生收入。發生的事情是超過 6,000 名患者得到了治療，治療得很好，治療有效。該設備證明了其可操作性。它仍然是該行業中唯一具有這種性質的設備。它只是不可行——相對於正在執行的其他程序，就像你可以在你的手臂上切開一塊，然後他們可以在上面貼上創可貼或縫合它，然後創可貼-援助比他們用繃帶包紮的縫合線便宜得多。我們真的有很多陰謀。該領域的患者、醫生和皮膚科醫生都應得此書。所以那個產品成功了。我們的商業計劃沒有成功。我們會為此付出自己的代價。我們認為產品的同化速度會更快，吸收會更強，我們可以跨入生存能力的世界。雖然隨著我們的前進，情況有所改善，但我們確實有其他選擇，正如你所知，從我創辦並與之合作的許多公司來看，前幾個詞是建立一個可行的前 4 個詞，這意味著你可以從你真正做的事情中創造可持續的未來，而且你不依賴於外部資金和融資。因此，考慮到這一點，我們不得不轉向並且我們做到了，我們轉向了一個從 FDA 批准的設備中受益匪淺的領域，從觀點和知識中受益匪淺，相信該設備可以工作可以提供能量高速大音量並這樣做。然後直接進入修復所需的組織的細胞方面，而不是擊中脫細胞結構。所以當你處理心臟問題時，它就變得至關重要。所以我們在皮膚上取得了勝利，但我們有一個數量級，更大的機會。我們有一個非常具體的產品，我們真的準備好去這裡了。所以我希望這能解決這個問題。我也很欣賞這個問題。

Our next question comes from the line of Andy [Sarvis], our Private Investor.

我們的下一個問題來自我們的私人投資者 Andy [Sarvis]。

I have 2 questions. One is, is there any possibility on the breakthrough you had on basal cell, what you call it, carcinoma. Can that license also given to other entity to take it further or pay back some money on it?

我有兩個問題。一是，你在基底細胞上取得的突破有沒有可能，你稱之為癌。該許可證是否也可以授予其他實體以進一步發展或償還一些錢？

Yes. I'll jump in, and then if Darrin or Bob want to jump in. Right now, as we mentioned in our last call, we are exploring all opportunities with derm, as Bob just said very well that we were very proud of the results that that we got from our system. Right now, it's just a matter of the commercialization architecture that we didn't have in place to support that. Now the companies might have that, that we're exploring, and we're continuing to talk with. So we're excited to continue to look at that.

是的。我會加入，然後如果 Darrin 或 Bob 想加入。現在，正如我們在上次電話會議中提到的，我們正在探索 derm 的所有機會，正如 Bob 剛剛所說的那樣，我們對結果感到非常自豪我們從我們的系統中得到的。現在，這只是我們沒有支持它的商業化架構的問題。現在這些公司可能已經有了，我們正在探索，我們正在繼續與之交談。所以我們很高興繼續關注這一點。

My second one is...

我的第二個是...

Operator, I think we lost him.

接線員，我想我們失去了他。

Yes, that's correct. The line's dropped.

對，那是正確的。線路掉線了

Okay. Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the conference over to Kevin Danahy, Chief Executive Officer, for closing comments.

好的。女士們，先生們，我們的問答環節已經結束。我想將會議轉交給首席執行官 Kevin Danahy 發表閉幕評論。

Thank you very much, and thank you, Darrin and Bob for joining me today, and we're excited about where we are today, and we like the format here where we have the opportunity to answer some of your questions. Hopefully, you felt like the conference call answered a lot of your questions. Just want to let everyone know that as we move forward, we're going to be head down in our preclinical and product development throughout the closing quarters, and we will update everyone as our new data and the potential of nsPFA comes out, and the significant progress that we're going to make, and we will continue to report quarterly and communicate updates in a timely and transparent manner that are materials to the business through public communication, calls and press releases.

非常感謝，也感謝 Darrin 和 Bob 今天加入我的行列，我們對今天所處的位置感到興奮，我們喜歡這裡的形式，我們有機會回答你們的一些問題。希望您覺得電話會議回答了您的很多問題。只是想讓每個人都知道，隨著我們的前進，我們將在整個最後幾個季度專注於我們的臨床前和產品開發，我們將在我們的新數據和 nsPFA 的潛力出現時向大家更新，以及我們將取得重大進展，我們將繼續每季度報告一次，並通過公開交流、電話和新聞稿及時透明地傳達對業務至關重要的更新。

So with that, I would like to thank everyone, and we look forward to talking to you all soon.

因此，我要感謝大家，我們期待著很快與大家交談。

Thank you. The conference of Pulse Biosciences has now concluded. Thank you for your participation. You may now disconnect your lines.

謝謝。 Pulse Biosciences 會議現已結束。感謝您的參與。您現在可以斷開線路。