Profound Medical Corp (PROF) 2025 Q2 法說會逐字稿

Good day, everyone, and thank you for standing by.

大家好，感謝大家的支持。

Welcome to the Profound Medical second-quarter 2025 financial results conference call. (Operator Instructions) Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Stephen Kilmer, Head of Investor Relations.

歡迎參加 Profound Medical 2025 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。現在，我將會議交給演講主持人、投資人關係主管 Stephen Kilmer。

Please go ahead.

請繼續。

Thank you.

謝謝。

Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws in the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions and expectations and relate to, among other things, any expressed or implied statements regarding future financial performance and position and expectations regarding the efficacy of Profound's technologies in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.

大家下午好。首先我要指出的是，本次電話會議將包括美國和加拿大適用證券法所定義的前瞻性陳述。所有前瞻性陳述均基於 Profound 當前的信念、假設和期望，並涉及有關未來財務業績和狀況的任何明示或暗示的陳述以及對 Profound 技術在治療前列腺癌、良性前列腺增生、子宮肌瘤、姑息性疼痛治療​​和骨樣骨瘤方面的療效的期望。此類陳述涉及已知和未知的風險、不確定性和其他因素，可能導致實際結果、績效或成就與此類陳述所暗示的結果、績效或成就有重大差異。

No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statement as a result of -- whether as a result of new information, future events or otherwise, other than as required by law. Representing the company today are Dr. Arun Menawat, Profound's Chief Executive Officer; Rashed Dewan, the company's Chief Financial Officer; Dr. Mathieu Burtnyk, Profound's President; and Tom Tamberrino, our Chief Commercial Officer.

不能保證任何前瞻性陳述。敬請聽眾不要過度依賴這些前瞻性陳述，這些陳述僅代表本次電話會議召開之日的觀點。除非法律要求，Profound 不承擔因新資訊、未來事件或其他原因而公開更新或修改任何前瞻性聲明的義務。今天代表公司的有 Profound 執行長 Arun Menawat 博士、公司財務長 Rashed Dewan、Profound 總裁 Mathieu Burtnyk 博士和商務長 Tom Tamberrino。

With that said, I'll now turn the call over to Rashed.

話雖如此，我現在將電話轉給拉希德。

Good afternoon, everyone, and welcome to our second-quarter 2025 conference call.

大家下午好，歡迎參加我們 2025 年的第二季電話會議。

On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Tom in a moment to provide commercial updates. However, before I do, I would like to provide a brief summary of our second quarter 2025 financial results.

我謹代表管理團隊和 Profound 的全體員工感謝您對我們公司的持續關注。對於那些股東，我們感謝你們一直以來的關注與支持。我稍後會將電話轉給湯姆，以提供商業更新。不過，在此之前，我想先簡單概述我們 2025 年第二季的財務表現。

To streamline things, all of the numbers I will refer to have been rounded, so they are approximate. For the 3-month period ended June 30, 2025, the company received total orders of over $3 million and recorded revenue of $2.2 million with $1.6 million coming from recurring revenue and $650,000 from onetime sale of capital equipment. Second quarter 2025 revenue was essentially unchanged from the same period in 2024. Gross margin in Q2 2025 was 73% compared to 64% in Q2 2024. Total operating expenses in the 2025 second quarter, which consists of R&D and SG&A expenses were $15.4 million compared with $9.3 million in the second quarter of 2024.

為了簡化事情，我將引用的所有數字都經過了四捨五入，因此它們只是近似值。截至 2025 年 6 月 30 日的 3 個月期間，該公司收到的訂單總額超過 300 萬美元，收入為 220 萬美元，其中 160 萬美元來自經常性收入，65 萬美元來自一次性銷售資本設備。2025 年第二季的營收與 2024 年同期基本保持不變。2025 年第二季的毛利率為 73%，而 2024 年第二季的毛利率為 64%。2025 年第二季的總營運費用（包括研發和銷售、一般及行政費用）為 1,540 萬美元，而 2024 年第二季為 930 萬美元。

Overall, the company recorded a second quarter 2025 net loss of $15.7 million or $0.52 per common share compared to a net loss of $6.9 million or $0.28 per common share for the same 3-month period in 2024. As of June 30, 2025, Profound had cash of $35.2 million.

整體而言，該公司 2025 年第二季淨虧損 1,570 萬美元，即每股普通股 0.52 美元，而 2024 年同期淨虧損 690 萬美元，即每股普通股 0.28 美元。截至 2025 年 6 月 30 日，Profound 擁有現金 3,520 萬美元。

With that, I will now turn the call over to Tom.

說完這些，我現在將電話轉給湯姆。

Thank you, Rashed.

謝謝你，拉希德。

There is no sugarcoating the fact that while the orders that we received are up, the final Q2 revenues were below our expectations. The shortfall was largely due to what we believe are short-term delays in completing a few TULSA-PRO capital sales, and we continue to believe we will be able to deliver 70% to 75% growth in 2025 compared to 2024. As I said on our last call, the transition from a placement model, which was the focus through the end of 2024 to a capital model here in 2025 would lend us all to know that it's going to be a back-end loaded operation. Let me provide some color on our pipeline to help illustrate that.

毫無疑問，儘管我們收到的訂單有所增加，但第二季的最終收入低於我們的預期。我們認為，出現這一缺口主要是因為一些 TULSA-PRO 資本銷售的完成出現了短期延遲，我們仍然相信，與 2024 年相比，我們將能夠在 2025 年實現 70% 至 75% 的成長。正如我在上次電話會議上所說的那樣，從 2024 年底的重點投放模式到 2025 年的資本模式的轉變將讓我們所有人都知道這將是一個後端加載的操作。讓我提供一些有關我們管道的顏色來幫助說明這一點。

Today, at the top of the TULSA-PRO sales funnel, there are close to 500 prospects sitting in the targeting stage. Of those 500, there are 100-plus leads in the engaged stage. And of those 100-plus leads, so far, 80 have been qualified. By that, I mean they are within the verify, negotiate and contracting stages. Digging a bit deeper still, 39 are in verify, 27 in negotiate and 14 in contracting.

如今，在 TULSA-PRO 銷售漏斗的頂端，有近 500 個潛在客戶處於定位階段。在這 500 個潛在客戶中，有 100 多個處於參與階段。到目前為止，在這 100 多條線索中，已有 80 條符合資格。我的意思是，他們正處於核實、談判和簽約階段。進一步深入挖掘，有 39 個正在核實中，27 個正在談判中，14 個正在簽約中。

While we obviously can't guarantee all the qualified leads, even those at the last contracting stage will result in final installs before the end of the year, reasonable assumptions and basic math drive our confidence that the second half of the year will be significantly and materially better than the first. We aren't relying on hope and probability models. We are proactively refining our sales team and processes as we grow. A few updates on our sales organization since our last call. This is an organizational sale to organizational buyers, in particular in the UK, where our immediate target customers are corporatized bureaucratic hospitals.

雖然我們顯然無法保證所有合格的潛在客戶，即使處於最後簽約階段的潛在客戶也將在年底前完成最終安裝，但合理的假設和基本的數學計算使我們相信，今年下半年將比上半年有顯著且實質性的改善。我們並不依賴希望和機率模型。隨著我們的發展，我們正在積極完善我們的銷售團隊和流程。自從上次通話以來，我們的銷售組織有一些更新。這是針對組織買家的組織銷售，特別是在英國，我們的直接目標客戶是公司化的官僚醫院。

We have learned that capital reps with experience is not a statistically significant indicator of success. The intangibles of grit, perseverance and resiliency will more than likely prove out to an R squared equaling one as it relates to success in sales, business development or any other role here at Profound for that matter. With that in mind, the UK sales team has been streamlined. The director sales level was eliminated and the regional business director team and capital sales executive team were honed to create a tight knit team for the aforementioned intangible attributes.

我們了解到，具有經驗的資本代表並不是成功的統計顯著指標。勇氣、毅力和韌性等無形因素很可能證明 R 平方等於 1，因為它與銷售、業務開發或 Profound 的任何其他角色的成功有關。考慮到這一點，英國銷售團隊已經精簡。取消了銷售總監級別，對區域業務總監團隊和資本銷售執行團隊進行了磨練，打造了一支針對上述無形屬性的緊密團隊。

There are 3 regional business directors who report directly to the Vice President of Sales. Each regional business director has a team of 3 to 4 capital sales executives. The clinical and service teams play an integral role in the sales process, and we are now offloading items that were previously bucketed for sales to organize, coordinate and execute onto these teams to free up the sales team to build a bigger funnel. Profound organizational leverage is required as this is an organizational sale and an organizational purchase across several specialties and administrative verticals. Thank you for your time.

有 3 位區域業務總監直接向銷售副總裁報告。每個區域業務總監都擁有一個由3至4名資本銷售主管組成的團隊。臨床和服務團隊在銷售過程中發揮著不可或缺的作用，我們現在將以前由銷售團隊組織、協調和執行的專案轉移到這些團隊，以便讓銷售團隊能夠建立更大的銷售管道。由於這是一次跨多個專業和行政垂直領域的組織銷售和組織採購，因此需要強大的組織槓桿。感謝您抽出時間。

I will now turn the call over to Mathieu.

現在我將把電話轉給 Mathieu。

Thank you, Tom, and good afternoon. During the second quarter of this year, two important company objectives were achieved. We believe these milestones are catalysts that will drive adoption and utilization of the TULSA procedure in the United States and also globally. The first of these achievements is the CAPTAIN trial is fully recruited and all patient treatments are complete. The CAPTAN randomized controlled trial is decisive and foundational because it is designed to be a key driver towards gaining favorable recommendation from the relevant professional society treatment guidelines and ultimately to positive reimbursement coverage from private payers.

謝謝你，湯姆，下午好。今年第二季度，公司實現了兩個重要目標。我們相信這些里程碑將成為推動美國乃至全球採用和利用 TULSA 程序的催化劑。其中第一項成就是 CAPTAIN 試驗已完全招募完畢，所有患者治療都已完成。CAPTAN 隨機對照試驗具有決定性和基礎性，因為它旨在成為獲得相關專業協會治療指南的有利推薦並最終獲得私人付款人的積極報銷覆蓋的關鍵驅動力。

Inclusion in society guidelines means eligible prostate cancer patients will have to be presented TULSA as a treatment option. Compare that to today, where most patients who are treated with TULSA are those who either asked for it directly by name or ask for alternatives to today's standards, robotic surgery or radiation. And we know that once patients are presented TULSA as a treatment option, they choose TULSA. The CAPTAIN trial initial target enrollment of 201 patients was surpassed with a total of 212 patients treated. The reason for this increase was to compensate for patients who dropped out of the study disproportionately after being randomized to robotic radical prostatectomy.

納入社會指南意味著符合條件的前列腺癌患者必須接受 TULSA 作為治療選擇。與此相比，今天大多數接受 TULSA 治療的患者要么是直接指名要求接受治療，要么是要求採用當今標準的替代方案，即機器人手術或放射治療。我們知道，一旦患者獲得 TULSA 作為治療選擇，他們就會選擇 TULSA。CAPTAIN 試驗最初招募 201 名患者，目前已累積治療 212 名患者，超出目標。增加的原因是為了補償那些在隨機接受機器人根治性前列腺切除術後不成比例地退出研究的患者。

Already, the initial perioperative outcomes demonstrate conclusively that TULSA provides a superior patient experience compared to robotic surgery. These outcomes were presented during this year's AUA Annual Meeting or that of the American Urological Association, which is at the end of April in Las Vegas. These outcomes were summarized during our last quarter's investor call. Briefly, TULSA provides patients, surgeons and hospitals with no procedural blood loss and no overnight stay, nearly a full 24 hours less than robotic surgery. Compared to robotic surgery, patients treated with TULSA have statistically and clinically significant less pain during the first week after the procedure, and they're in better overall health every day for the first 30 days of their recovery.

初步圍手術期結果已確鑿地表明，與機器人手術相比，TULSA 提供了更優質的患者體驗。這些結果是在今年四月底於拉斯維加斯舉行的美國泌尿外科協會 (AUA) 年會或美國泌尿外科協會年會上發表的。這些結果在我們上個季度的投資者電話會議上進行了總結。簡而言之，TULSA 為患者、外科醫生和醫院提供了無手術失血和無需過夜的體驗，比機器人手術減少了近 24 小時。與機器人手術相比，接受 TULSA 治療的患者在手術後第一週內疼痛明顯減輕，且在康復後的前 30 天內，他們的整體健康狀況每天都更好。

To put this into context, robotic prostatectomy patients take more than 2 weeks, almost 3 weeks of recovery on average to feel like a TULSA patient does the very next day after their procedure. TULSA is giving 2 weeks back to the patient. These perioperative outcomes are meaningful beyond what they mean clinically and operationally for patients, surgeons, hospitals and also payers. They are a window into what we might expect through additional short, medium and long-term study endpoints. In essence, superior perioperative outcomes provide us with the confidence that CAPTAIN will continue to demonstrate favorable TULSA outcomes via its primary endpoints of safety at 1 year and efficacy at 3 years.

具體來說，機器人前列腺切除術患者平均需要 2 週以上、近 3 週的恢復時間才能感覺像塔爾薩患者在手術後第二天的感覺。塔爾薩將給予患者兩週的恢復時間。這些圍手術期結果的意義超越了對病人、外科醫生、醫院和付款人的臨床和操作意義。它們為我們提供了一個窗口，讓我們可以透過額外的短期、中期和長期研究終點來了解我們可能期待的結果。本質上，優異的圍手術期結果讓我們有信心，CAPTAIN 將繼續透過其 1 年安全性和 3 年有效性的主要終點展示良好的 TULSA 結果。

The final preoperative results are on track to be announced at this year's Annual Meeting of the RSNA or the Radiological Society of North America as well as at the SUO or the Society of Urological Oncology, both in early December. We also expect that the data will be mature enough to provide the first subset of 1-year outcome data at these two meetings before announcing more complete results at AUA in 2026. The second seminal achievement this quarter is the pilot release of the new TULSA-AI volume reduction software.

最終的術前結果預計將於今年 12 月初在北美放射學會 (RSNA) 年會以及泌尿腫瘤學會 (SUO) 年會上公佈。我們也預計，這些數據將足夠成熟，能夠在這兩次會議上提供第一組 1 年結果數據，然後在 2026 年的 AUA 上宣布更完整的結果。本季的第二項重大成就是新 TULSA-AI 體積縮減軟體的試點發布。

Using the same TULSA hardware, the same indication for use and the same reimbursement codes, the new software module designed for BPH procedures offers fast intelligent workflows that will provide surgeons with an estimated total procedure time of 60 to 90 minutes regardless of prostate shape or size. The first commercial BPH procedure with the new TULSA-AI volume reduction software was performed in June, and we remain on track with the full commercial launch in the back half of this year.

使用相同的 TULSA 硬體、相同的使用指徵和相同的報銷代碼，專為 BPH 手術設計的新軟體模組提供了快速智慧的工作流程，無論前列腺的形狀或大小如何，都能為外科醫生提供 60 至 90 分鐘的預計總手術時間。第一個使用新型 TULSA-AI 減容軟體的商業化 BPH 手術已於 6 月完成，我們將繼續按計畫在今年下半年全面投入商業化營運。

We believe this new software will help move TULSA from niche to mainstream within the BPH treatment options. Whether prostate cancer, BPH or patients with both cancer and BPH, surgeons and facilities will be able to stack cases, creating predictable and efficient TULSA dates, all with no overnight stay, no blood loss, no fulguration, no Grade 4 adverse events and no need for patients to discontinue their anticoagulant therapy. Coinciding with the TULSA-AI volume reduction pilot release was the publication of 12-month outcomes from a Phase II trial evaluating TULSA for the treatment of men with BPH. The prospective 30-patient study by Dr. Viitala and his team at Turku University Hospital in Finland was published in BJU International.

我們相信這款新軟體將有助於將 TULSA 從 BPH 治療方案中的小眾領域推向主流。無論是前列腺癌、良性前列腺增生或同時患有癌症和良性前列腺增生症的患者，外科醫生和醫療機構都能夠堆疊病例，創建可預測且高效的塔爾薩日期，所有治療均無需過夜、不會失血、不會電灼、不會發生 4 級不良事件，也無需患者停止抗凝血治療。與 TULSA-AI 減容試驗發布同時發布的是評估 TULSA 治療男性 BPH 療效的 II 期試驗的 12 個月結果。芬蘭圖爾庫大學醫院的 Viitala 博士及其團隊進行的一項前瞻性 30 名患者的研究發表在 BJU International 上。

The study demonstrates significant BPH symptoms relief on par or better than modern treatment. The IPSS or International Prostate Symptom Score decreased 76% from 17 to 4. After TULSA, all quality of life measures improved, urine incontinence scores improved, even sexual function scores remained stable or improved in all patients. 96% of patients discontinued their BPH medication and none of the patients had to discontinue or bridge their anticoagulant therapy. These outstanding clinical results speak to the precision achieved using state-of-the-art real-time MRI and true personalized treatment plans offered by AI-powered TULSA-PRO.

研究表明，BPH 症狀的緩解效果與現代治療方法相當甚至更好。IPSS 或國際前列腺症狀評分從 17 下降到 4，下降了 76%。接受 TULSA 治療後，所有患者的生活品質指標均得到改善，尿失禁評分也得到改善，甚至性功能評分也保持穩定或改善。 96% 的患者停止了 BPH 藥物治療，沒有患者需要停止或銜接抗凝血治療。這些出色的臨床結果證明了使用最先進的即時 MRI 和 AI 驅動的 TULSA-PRO 提供的真正個​​人化治療計劃所實現的精確度。

With that, I'll now turn the call over to Arun.

說完這些，我現在將電話轉給阿倫。

Thanks, Mathieu, and good afternoon, everyone.

謝謝，馬修，大家下午好。

To summarize what you just heard, our sales team has been stabilized. That, combined with our large and growing TULSA-PRO pipeline, continues to drive our confidence in our ability to deliver full year revenue growth of approximately 70% to 75% in 2025 over 2024. The new TULSA-AI volume reduction module to treat patients with BPH symptoms is significantly reducing the procedure time, making it very competitive with other BPH treatment technologies. Adding the BPH module also enables physicians to create a full TULSA day during which both of these prostate cancer and/or BPH patients can be treated.

總結一下大家剛才聽到的，我們的銷售團隊已經穩定下來了。再加上我們龐大且不斷成長的 TULSA-PRO 管道，我們繼續對 2025 年實現全年收入較 2024 年增長約 70% 至 75% 的能力充滿信心。用於治療 BPH 症狀患者的新型 TULSA-AI 體積縮減模組顯著縮短了手術時間，使其與其他 BPH 治療技術相比極具競爭力。添加 BPH 模組還使醫生能夠創建一個完整的 TULSA 日，在此期間可以同時治療前列腺癌和/或 BPH 患者。

From the perspective of ease of scheduling and creating a TULSA program, this ability is important. And finally, the initial clinical outcomes data from CAPTAIN will be presented in December. We continue to believe that as more data is published, it will most likely lead to new guidelines from relevant cancer societies that will effectively require that patients be made aware of TULSA as an option along with radical prostatectomy and radiation therapy. This ends our prepared remarks for today. With that, we're happy to take any questions you might have.

從便於安排和創建 TULSA 計劃的角度來看，這種能力非常重要。最後，CAPTAIN 的初步臨床結果數據將於 12 月公佈。我們仍然相信，隨著更多數據的公佈，相關癌症協會很可能會出台新的指導方針，有效地要求患者了解 TULSA 是除根治性前列腺切除術和放射治療之外的一種選擇。我們今天的準備演講到此結束。因此，我們很樂意回答您可能提出的任何問題。

Operator.

操作員。

(Operator Instructions) Rick Wise, Stifel.

（操作員指示） Rick Wise，Stifel。

This is John on for Rick.

這是約翰，代替瑞克。

Just wanted to start off with the guidance. Good to hear that you're reiterating the prior range. Just want to get a better understanding of the ramp. And then within that, what the -- how to think about the sales contribution from a recurring and capital perspective.

只是想從指導開始。很高興聽到您重申之前的範圍。只是想更了解坡道。然後在此範圍內，如何從經常性和資本角度考慮銷售貢獻。

So if you could just offer some color on how that builds throughout the third and fourth quarter and whether this mix of 80 systems in the pipeline fits more into the capital structure or more into the prior pay-per-use structure that you were using?

那麼，您能否提供一些關於第三季度和第四季度發展情況的詳細信息，以及正在籌備的 80 個系統組合是否更適合資本結構，還是更適合您之前使用的按使用付費結構？

Yes.

是的。

Let me just sort of share that a little bit high level and I'll turn it over to Tom to give you more color. So what I've been saying is that we -- you heard that in our Q1, we have been switching to this standard, what I call the standard med tech model. And what you will see at the high level is that our next goal is to really increase the number of sites in the United States and capital revenue will more likely dominate the total numbers. Up till now, recurring revenue has been dominating because that's been the model we've been using.

讓我稍微分享一下高層次的內容，然後我會把它交給湯姆來給你更多的細節。所以我一直在說的是，您聽說我們在第一季已經轉向這個標準，我稱之為標準醫療技術模型。從高層次來看，我們下一個目標是真正增加美國的站點數量，而資本收入更有可能在總數中占主導地位。到目前為止，經常性收入一直占主導地位，因為這是我們一直在使用的模式。

And so I think over the next few quarters, you will see that the mix of revenue will switch from recurring revenue to capital revenue. But as the installed base grows, over the long haul, we see ourselves as a recurring revenue dominant company where I think over the long haul, it will still be about 70% recurring revenue and 30% capital revenue. One more quick color. If you -- in our press release, we said we are certainly seeing an increase in same-store procedures or in normal terms, you would call it same-store sales. So between Q1 to Q2, we saw an increase in utilization in the same stores by about 10%, which I'm very happy to see.

因此我認為在接下來的幾個季度裡，你會看到收入結構將從經常性收入轉變為資本收入。但隨著安裝基數的成長，從長遠來看，我們將自己視為一家以經常性收入為主的公司，我認為從長遠來看，我們仍然會有大約 70% 的經常性收入和 30% 的資本收入。再來一種快速上色。如果您 - 在我們的新聞稿中，我們說我們確實看到同店程序的成長，或者在正常情況下，您會稱之為同店銷售額的成長。因此，在第一季至第二季之間，我們看到同一家商店的利用率增加了約 10%，我很高興看到這一點。

And at this stage, the whole impact of reimbursement hasn't really hit. I think we are starting to see it now coming in. But Q2 -- Q1, certainly, there wasn't much. Q2, we were starting to see it, and you can see the increase. But in Q3, Q4, you will see that as well.

而在現階段，報銷的整體影響尚未真正顯現。我認為我們現在開始看到它的出現。但 Q2 和 Q1 之間肯定沒有太大差異。Q2，我們開始看到它，您可以看到成長。但在第三、第四季，你也會看到這種情況。

With that, Tom, you might want to provide a little more color on the capital sales part in particular.

湯姆，你可能想特別提供更多有關資本銷售部分的細節。

Yes, happy to, and thank you for the question, John.

是的，很高興，謝謝你的提問，約翰。

So building off Arun's statements and your preliminary question specific to the 80 systems that we've referenced, the capital model is obviously our preferred methodology to introduce the technology into the commercial realm now that Medicare reimbursement is live as of January 1 of this year. So there's a mixture of new capital. There's still some remaining placements from the previous model prior to reimbursement being live on January 1. So converting those placements is absolutely part of the strategy.

因此，根據 Arun 的陳述以及您針對我們提到的 80 個系統提出的初步問題，既然醫療保險報銷已於今年 1 月 1 日生效，那麼資本模型顯然是我們將這項技術引入商業領域的首選方法。因此存在各種新資本。在 1 月 1 日開始報銷之前，先前模型中仍有一些剩餘的安置。因此，轉換這些位置絕對是策略的一部分。

And then last but certainly not least, capital cycles can be quite interesting given the bureaucratic corporatized nature of American healthcare at this stage of the game. So if it's required to do a placement agreement to stay outside of the capital cycle leading into years from now, in order to get new sites, we are willing to work with customers to do a placement agreement with a significant commitment in terms of the number of cases that they will complete. And there's a delta between the cost per procedure under that model versus the capital model, and it's strategically done so that the capital model is absolutely more attractive in the long run for the hospital. Hopefully that provides a little bit more color to the question that you asked.

最後但同樣重要的一點是，考慮到美國醫療保健在現階段的官僚公司化性質，資本週期可能相當有趣。因此，如果需要簽訂安置協議才能在未來幾年內避開資本週期，為了獲得新站點，我們願意與客戶合作簽訂安置協議，並在他們將完成的案例數量方面做出重大承諾。該模型與資本模型下每個手術的成本之間存在差異，從戰略上講，資本模型從長遠來看對醫院來說絕對更具吸引力。希望這能為您提出的問題提供更多的解釋。

Yes, that's helpful.

是的，這很有幫助。

And just in terms of the CAPTAIN data, I wanted to hear any feedback you're getting from physicians in the field. Is this inspiring greater adoption? Is this helping the pipeline? Just any commentary on CAPTAIN would be helpful.

就 CAPTAIN 數據而言，我想聽聽您從該領域的醫生那裡得到的任何回饋。這是否會激發更廣泛的採用？這對管道有幫助嗎？任何有關 CAPTAIN 的評論都會有幫助。

I mean, John, I think with respect to the feedback, we are getting very, very high positive comments that a company like Profound undertook this level of clinical trial. And I think that comes from people who normally don't like to endorse anything, quite frankly. And so I think that part has not -- that has been really, really pleasing to see. The second place we are getting really good feedback is the fact that the trial is now complete. So now it's like the investment has been made, everything is done.

我的意思是，約翰，我認為就回饋而言，我們得到了非常非常積極的評價，像 Profound 這樣的公司進行了這種程度的臨床試驗。坦白說，我認為這是來自那些通常不喜歡支持任何事情的人。所以我認為這部分並沒有——這真的非常令人高興。我們得到的非常好的回饋的第二個事實是試驗現已完成。所以現在就像投資已經完成一樣，一切都完成了。

And the reason that is important is because historically, if you go back 15 years or so, there have been attempts to do Level 1 trials in prostate cancer, but those trials have always never -- they never completed recruitment and thereby they were all shut down before they completed. And so I think the fact that we were able to complete the treatments and the recruitment, I think people are finding that patients obviously are interested in doing this as well. The third thing that we are -- people do ask things like, well, what do you see? Are you seeing anything that could give us some kind of a preliminary indication on outcomes and so on. And I think that there is certainly a very high level of confidence in our team with respect to the outcomes.

這一點很重要，因為從歷史上看，如果回顧 15 年前，人們曾嘗試進行前列腺癌的 1 級試驗，但這些試驗始終未能完成招募，因此在完成之前就全部被關閉了。因此，我認為我們能夠完成治療和招募，我認為人們發現患者顯然也對此感興趣。第三件事是──人們確實會問這樣的問題，那麼，你看到了什麼？您是否看到任何可以為我們提供關於結果等初步跡象的資訊？我認為我們的團隊對於結果肯定非常有信心。

And it's not necessarily divulging any data from the trial, but it's just thinking about the fact that when we look at the results of the TACT trial, they were better than the trials -- any trial in radical prostatectomy. And then since that time, our product has improved, introducing new modules that have improved. And we have multiple hospitals that have done their own trial and their data is actually even better than the TACT trial data. So I think there is sufficient body of evidence that we feel that if the CAPTAIN results are in the same realm and there is no reason to believe they won't be that we should be able to demonstrate statistically at least the non-inferior or better outcomes.

它不一定會洩露任何試驗數據，但只是考慮到當我們查看 TACT 試驗的結果時，它們比根治性前列腺切除術的任何試驗都要好。從那時起，我們的產品得到了改進，並推出了改進的新模組。我們有多家醫院進行了自己的試驗，他們的數據實際上甚至比 TACT 試驗數據更好。因此，我認為有足夠的證據表明，如果 CAPTAIN 的結果處於同一範圍內，並且沒有理由相信它們不會處於同一範圍內，那麼我們應該能夠至少從統計上證明非劣效或更好的結果。

Great, that's helpful.

太好了，很有幫助。

Thank for taking my questions.

感謝您回答我的問題。

Michael Freeman, Raymond James.

麥可弗里曼、雷蒙詹姆斯。

Hi, Arun, Tom, Rashed, Mathieu, thanks very much for taking my call.

嗨，阿倫、湯姆、拉希德、馬修，非常感謝你們接聽我的電話。

I think first, I'd like to ask about the -- there were some news about the proposed rule for reimbursement on BPH treatments during the last several weeks. I wonder if you could shed some light on sort of the relative attractiveness of the codes assigned to the TULSA procedure versus what's currently out there for BPH today.

我想首先，我想問一下——過去幾週有一些關於 BPH 治療報銷擬議規則的消息。我想知道您是否可以解釋一下分配給 TULSA 程式的程式碼與目前 BPH 程式的程式碼的相對吸引力。

Sure. Mathieu, you might as well take this since you're closest to it.

當然。馬修，既然你離它最近，你最好拿著它。

Yes, absolutely.

是的，絕對是。

So thank you, Michael, for the question. The proposed CMS proposed rule did come out in July in reference to the proposed facility payments and physician payments starting in 2026. Of course, it's just a draft guidance until the final rule is out in November. But interestingly, on the BPH side of the equation, there were large adjustments made to the physician RVUs, relative value units, which is the physician payment part of the equation, a downwards adjustment for transurethral resection of the prostate TRP as well as other transurethral resect procedures for BPH.

所以，邁克爾，謝謝你提出這個問題。CMS 提議的規則確實於 7 月出台，其中提到了從 2026 年開始的擬議設施支付和醫生支付。當然，這只是一份指導草案，直到 11 月最終規則出台。但有趣的是，在 BPH 方面，對醫生的 RVUs（相對價值單位）進行了較大的調整，這是等式中醫生支付的部分，對經尿道前列腺切除術 TRP 以及其他 BPH 經尿道切除術進行了下調。

And so from a TULSA perspective, we actually were impacted the least compared to all these other procedures. We maintained our Level 7 facility reimbursement for the hospital, device intensive for the ASCs remain very, very favorable from a facility standpoint. And from a physician payment standpoint, we were impacted the least compared to all the other procedures. And so when you think about -- you can think about these as one BPH procedure versus one TULSA-PRO. And from that perspective, we are quite a bit more favorable than those other procedures.

因此，從塔爾薩的角度來看，與所有其他程序相比，我們受到的影響實際上最小。我們維持了醫院的 7 級設施報銷，從設施角度來看，ASC 的設備密集仍然非常有利。從醫生支付的角度來看，與所有其他程序相比，我們受到的影響最小。因此，當您考慮時——您可以將它們視為一個 BPH 程式與 TULSA-PRO 程式。從這個角度來看，我們比其他程序更有利。

And then on top of that, when you think about it as a per unit time. So per unit time, what are the number of RVUs that the physicians are generating? Well, they're going to start generating fewer RVUs under the adjusted BPH codes. And then with our TULSA-AI volume reduction software, where the goal of that is to streamline the procedure down to about a 60- to 90-minute skin-to-skin time for the physician. From a per unit time perspective, we continue to maintain a very favorable positioning to other BPH procedures.

然後在此基礎上，當你將其視為單位時間。那麼單位時間內醫師產生的 RVU 數量是多少？嗯，根據調整後的 BPH 代碼，他們將開始產生更少的 RVU。然後使用我們的 TULSA-AI 體積縮減軟體，其目標是將手術過程簡化為醫生的皮膚接觸時間約為 60 至 90 分鐘。從單位時間角度來看，我們繼續保持對其他 BPH 手術非常有利的定位。

So from that perspective, we're receiving really great feedback from both facilities as well as physicians in that concept that they can now sort of book a full TULSA day, whether it's once a week or once every 2 weeks and really be able to stack their cases throughout that day and combining both kind of prostate cancer patients as well as BPH patients. So operationally and financially, we're receiving really great feedback from that perspective.

因此，從這個角度來看，我們從醫療機構和醫生那裡得到了非常好的反饋，他們現在可以預訂一整天的塔爾薩診療，無論是每週一次還是每兩週一次，並且能夠在那一天真正堆積他們的病例，並將前列腺癌患者和 BPH 患者結合起來。因此，從營運和財務角度來看，我們收到了非常好的回饋。

Michael, we're -- yes, I mean, if you think about specific numbers, I think a lot of people have Aquablation in their mind, so I might as well address it is that indeed, now they are more in the standard category CPT-1 code. And I think as our BPH module with the volume reduction module demonstrates that it can be done in the 60 to 75 minutes that we've targeted, I think to Mathieu's point, we will -- in absolute dollars, it will pay higher than what these other procedures pay, and it will be relevant. So having said all that, I mean, it is a proposed rule and things do change. And so please keep that in mind. But yes, I think TULSA came -- has effectively come out with no material change in this year's rules.

邁克爾，我們——是的，我的意思是，如果你考慮具體的數字，我認為很多人心裡都有水消融的概念，所以我最好還是說一下，事實上，現在他們更符合標準類別的 CPT-1 代碼。我認為，正如我們的 BPH 模組和體積減少模組所證明的那樣，它可以在我們設定的 60 到 75 分鐘內完成，我認為對於 Mathieu 的觀點，我們將 — — 以絕對美元計算，它的支付將高於其他程式支付的費用，並且它將具有相關性。所以說了這麼多，我的意思是，這是一條擬議的規則，事情確實會改變。所以請記住這一點。但是的，我認為塔爾薩今年的規則實際上沒有任何實質變化。

That's great.

那太棒了。

I appreciate all of that color. Another question, I think and this is probably going to Tom. I really appreciate you laying out what your sales funnel looks like. And I wonder if you could zoom in a bit on that sort of the final segment of Verify negotiating contracting.

我很欣賞所有這些顏色。我認為還有一個問題可能要問湯姆。我非常感謝您闡述您的銷售管道。我想知道您是否可以稍微放大一下驗證談判合約的最後部分。

Could you describe a little bit more about what -- go a little deeper on the definitions of each of these stages? And then specifically on your contracting stage, what would you -- how would you describe the average time between -- I guess, average time between folks being in the contracting stage to installed and the average conversion rate that you've seen historically?

您能否更詳細地描述一下每個階段的定義？然後具體到您的承包階段，您會如何描述平均時間？我想，從承包階段到安裝階段之間的平均時間，以及您歷史上看到的平均轉換率？

Michael, thanks for the question.

邁克爾，謝謝你的提問。

And oh man, do I wish I had very analytical answers to it at this stage of the game. We're working towards that, right, because we just switched to the capital model at the beginning this year. So the point being is that the definition of these stages is to enable us to be able to do just that, right? What is the average time to go from one stage to the next, et cetera, et cetera, so that we can be much more predictive and reliable in our forecasting as an organization.

天哪，我真希望在遊戲的這個階段我能得到非常分析的答案。我們正在朝著這個目標努力，因為我們今年年初才剛轉向資本模式。所以重點是，這些階段的定義是為了讓我們能夠做到這一點，對嗎？從一個階段到下一個階段的平均時間是多少，等等，這樣我們作為一個組織就可以在預測中更具預測性和可靠性。

What I can tell you is that we check all the boxes, right, the clinical value with patients, the clinical value as seen by the physicians. And as you just asked a great question specific to the economics, we check the box there as well. So really, what we've learned how to do is organizational selling. And what do I mean by that is, we've done a much better job here of honing the process such that we include our clinical team for the clinical sale, our health economics and market access team for the economic sale and working very closely, and this is getting back to your original question, with our service team and our engineers as it relates to verifying and confirming magnet compatibility and any potential remediation that may need to take place in order to launch a TULSA program such that we can leverage the other departments outside of sales to work in parallel to the sales process so that we're not doing things in just a 1 block, 2 block, 3-block fashion, but trying to get each of those pathways started and running in parallel as much as humanly possible to compress the time lines of a normal capital sale. So part of the verification is exactly as I just described, specific to confirming magnet compatibility, any potential remediation that needs to take place to launch a TULSA program from a workflow standpoint and the list goes on.

我可以告訴你的是，我們檢查了所有的盒子，對，病人的臨床價值，醫生看到的臨床價值。由於您剛才提出了一個有關經濟學的很好的問題，因此我們也勾選了這個方塊。所以實際上，我們學會如何進行組織銷售。我的意思是，我們在完善流程方面做得更好，包括臨床銷售的臨床團隊、經濟銷售的衛生經濟學和市場准入團隊，我們緊密合作，回到您最初的問題，我們的服務團隊和工程師驗證和確認磁體兼容性以及啟動 TULSA 計劃可能需要採取的任何潛在補救措施，以便我們可以利用銷售以外的其他部門與銷售流程並行工作，這樣我們就不會只以 1 個區塊個區塊的方式做事，而是盡可能地嘗試啟動和並行運行每個途徑，以壓縮正常資本銷售的時間表。因此，驗證的一部分正如我剛才所描述的，具體來說是確認磁鐵相容性，從工作流程的角度啟動 TULSA 程序需要採取的任何潛在補救措施等等。

So we are doing a much better job of ensuring that we are setting up new site launches such that by the time the PO is issued, we've already got a good portion of the launch under our belts so we can get to treating patients faster, which is obviously the goal of everything that we're doing here in the first place.

因此，我們在確保新網站啟動方面做得更好，以便在採購訂單發佈時，我們已經完成了大部分啟動工作，這樣我們就可以更快地治療患者，這顯然是我們在這裡所做的一切的首要目標。

Okay. All right. I appreciate that.

好的。好的。我很感激。

Now one -- maybe we can just zoom in on the contracting stage. What -- then they might infer some things, but I wonder if you could just go over what exactly the activities are that your targets in that stage are engaged in with you? And as many details as you can.

現在——也許我們可以放大收縮階段。什麼——然後他們可能會推斷出一些事情，但我想知道您是否可以詳細回顧一下您的目標在那個階段與您一起從事的活動到底是什麼？並儘可能詳細地說明。

I can give you a little bit of color.

我可以給你一點顏色。

Sure. No, I think -- so I think I understand where you -- what you're really asking. At the moment, because of the newness of the fact that these are capital sales, our contracting phase is slightly more complex than once we get established in hospitals figure out how to acquire the TULSA program. It is a little bit more complex from the perspective that multiple departments are involved generally.

當然。不，我想——所以我想我明白你真正想問的是什麼。目前，由於這些都是資本銷售，因此我們的簽約階段比我們在醫院建立後弄清楚如何獲得 TULSA 計劃要稍微複雜一些。從一般涉及多個部門的角度來看，情況稍微複雜一些。

there's -- certainly, the surgery department is involved always if -- since it is a surgical procedure, urology is involved, radiology is involved to some extent, anesthesia might be involved and so on. So I think those lines of communications, how do you streamline that contracting phase is what Tom is referring to. So it's definitely not a couple of weeks. It's probably not more than 90 days or 3 to 4 months. Unfortunately, we cannot give you more color than this at the moment.

當然，如果這是一個外科手術，外科部門就會參與其中，泌尿科、放射科在某種程度上都會參與其中，麻醉科也可能參與其中等等。所以我認為湯姆所指的就是這些溝通管道，如何簡化簽約階段。所以肯定不是幾週的時間。大概不會超過90天或3到4個月。不幸的是，我們目前無法為您提供更多顏色。

But what Tom has accomplished is the fact that we are now -- we have a very clear idea of what are these departments, how do we go about streamlining them and how do we measure these so that as time goes on, we can contract these time frames. So I think your point is -- your thought process is right, why is it taking long? It's because it is a new process, and it is a little bit more complex than if it was an established product, and we simply had a device that was sold to one department. Is that helpful?

但湯姆所取得的成就是，我們現在非常清楚地知道這些部門是什麼，我們如何精簡它們，以及如何衡量它們，以便隨著時間的推移，我們可以縮短這些時間框架。所以我認為你的觀點是──你的思考過程是正確的，為什麼要花很久？這是因為它是一個新流程，它比成熟產品稍微複雜一些，而且我們只是將一個設備賣給一個部門。這樣有幫助嗎？

Yes. I understand that. Very last question here. You described some streamlining in your sales force. I wonder if that might translate to a reduction in burn going forward?

是的。我明白。這是最後一個問題。您描述了銷售隊伍的一些精簡措施。我想知道這是否意味著今後燒傷的減少？

Yes. Rashed, you might address that.

是的。拉希德，你可以談談這個問題。

Sure.

當然。

So thanks, Michael. So definitely, like I mean, we initially had said, remember last year when we had the analyst call that we'll have a little bit higher cash burn in the Q1 and Q2. And as Tom said, that we already did make the necessary adjustment in the sales team. Also, if you look at our working capital, we have also increased our inventory a little bit to fulfill the orders that's going to come in, in the future.

所以謝謝你，麥可。所以，就像我最初說的，記得去年我們接到分析師電話時說，我們在第一季和第二季的現金消耗會稍微高一點。正如湯姆所說，我們已經對銷售團隊做出了必要的調整。此外，如果您查看我們的營運資金，我們還增加了一些庫存以滿足未來的訂單。

Also, please note that our gross margin has been staying very strong. We've been in the 70-plus percent, right? So in the second half, as the order comes in and we convert the working capital into cash, then we expect that our cash burn in the second half is going to be much lower compared to the first half.

另外，請注意我們的毛利率一直保持很高的水平。我們已經達到 70% 以上了，對吧？因此，在下半年，隨著訂單的到來以及我們將營運資金轉換為現金，我們預計下半年的現金消耗將比上半年低得多。

Scott McAuley, Paradigm Capital.

麥考利 (Scott McAuley)，Paradigm Capital。

Thank you all for taking the questions.

謝謝大家回答問題。

I guess two for me. One, maybe I missed it, but kind of what's the current number of active TULSA placements in the UK? And how many have been added kind of since our last update?

我想對我來說是兩個。第一，也許我錯過了，但目前英國活躍的 TULSA 安置點數量是多少？自上次更新以來，我們增加了多少個？

So we have about 60 active sites. We've added -- we're installing three at the moment. We are pretty confident we'll hit at least 75 by end of this year.

因此，我們有大約 60 個活躍站點。我們已經添加了——目前正在安裝三個。我們非常有信心，到今年年底我們將至少達到 75 個。

That's great. And on the TULSA-PLUS, that was kind of highlighted as part of that investor event during AUA and seemed like an interesting opportunity. Any updates there or any of those numbers that you had highlighted in the pipeline for TULSA-PLUS or are you treating that kind of separately?

那太棒了。在 TULSA-PLUS 上，這在 AUA 期間的投資者活動中得到了重點強調，似乎是一個有趣的機會。有任何更新嗎？或者您在 TULSA-PLUS 管道中強調的任何數字，還是您會單獨處理這些數字？

Yes.

是的。

Scott, that's a very good question also. We remain very bullish on the TULSA-PLUS model. I think the short-term sales that described are related to using existing MRs in existing sites because that still remains the fastest way to drive installations and top line growth. But there are a couple of really good strategic things that are happening.

斯科特，這也是一個很好的問題。我們仍然非常看好 TULSA-PLUS 模式。我認為所描述的短期銷售與在現有站點使用現有 MR 有關，因為這仍然是推動安裝和收入成長的最快方式。但確實有一些非常好的策略性事件正在發生。

One of them is that since we talked last, Cook Medical has now announced a whole new division. It's called IMRI division. So I'm sure you can guess that is for interventional MRs. So they are working closely with Siemens to be able to start installing new interventional MRs at hospitals and the reception seems to be pretty good. We have been also reviewing at number of sites with the economic models and the economics is, frankly, pretty compelling.

其中之一是，自從我們上次談話以來，庫克醫療現已宣布成立一個全新的部門。它被稱為 IMRI 部門。所以我相信您可以猜到這是用於介入性 MR。因此，他們正在與西門子密切合作，以便開始在醫院安裝新的介入性磁振造影，而且效果似乎相當不錯。我們也一直在多個網站上審查經濟模型，坦白說，這些經濟學模型非常引人注目。

So we never thought that it would be a big revenue generator for 2025, as we've said before. But we do think that we are likely to have at least one install by end of the year. The product we have is being -- we are developing the compatibility with the Siemens interventional magnet, and we are on track to have it completed in mid- to late Q4. So we are still very positive on this. We're absolutely delighted that Siemens and a big company like Cook will start to get interventional MRs installed.

因此，正如我們之前所說，我們從未想過它會成為 2025 年的巨大收入來源。但我們確實認為，到今年年底我們可能會至少安裝一次。我們正在開發與西門子介入磁鐵相容的產品，預計將在第四季度中後期完成。所以我們對此仍然非常樂觀。我們非常高興西門子和庫克這樣的大公司將開始安裝介入性磁振造影。

So this whole issue related to the multi-departmental sale and the workflow, all those issues will get resolved as the interventional MRs get installed in the hospital. I can give you a couple of examples. So for example, Johns Hopkins has purchased the TULSA system, and they have purchased an interventional MR. That system should be running later this year. We have other hospitals that have ordered this and will be running by middle of next year that we know about.

因此，與多部門銷售和工作流程相關的整個問題，隨著介入性 MR 在醫院的安裝，所有這些問題都將得到解決。我可以舉幾個例子給你聽。例如，約翰霍普金斯大學購買了TULSA系統，並購買了介入性磁振造影（MR）。該系統預計將於今年稍後投入運作。據我們所知，其他醫院也已訂購此產品，並將於明年年中投入使用。

And we also know that, for example, Invictus interventional MRs for neurosurgery. We have a couple of sites that are now switching from diagnostic MRs to interventional MRs that are normally designed for neuro can now also be used for urology. So Mayo, Jacksonville is a very good example where they've already done that and are very happy with that change. So that transition is most certainly on track, and we're really thrilled with it.

我們也知道，例如，用於神經外科手術的 Invictus 介入 MR。我們有幾個站點現在正在從診斷性 MR 轉換為介入性 MR，這些 MR 通常設計用於神經科，現在也可以用於泌尿科。梅奧和傑克遜維爾就是一個很好的例子，他們已經這樣做了，並且對這種改變感到非常高興。因此，這一轉變肯定是在正確的軌道上進行的，我們對此感到非常興奮。

That's great.

那太棒了。

Very interesting color there. And sorry, one last one for me. I know the past few months has been some new marketing initiatives, hiring the spokesperson, I think kind of increased activity on social media and elsewhere. Are you happy with the results of those initiatives, kind of planned expansion of those for the balance of the year to help get the word out both kind of directly to patients as well as to new physicians?

那裡的顏色非常有趣。抱歉，這是我最後一次了。我知道過去幾個月有一些新的行銷舉措，聘請發言人，我認為社群媒體和其他地方的活動有所增加。您對這些舉措的結果滿意嗎？您是否計劃在今年餘下時間擴大這些措施的覆蓋範圍，以便直接向患者和新醫生宣傳？

Scott, we're -- I'm personally very, very happy with the team that we have. We did make some adjustments in that team also because when you hire all these new people, you have to look at what fits and what doesn't. But at this point, I'm thrilled with where we are. And yes, we are really, really grateful and excited about Leonard joining as our spokesperson. And yes, you will see significant presence as the top line grows, you will see significant presence in the social media from us.

史考特，我個人對我們現有的團隊非常非常滿意。我們確實也對該團隊做了一些調整，因為當你僱用所有這些新人時，你必須考慮哪些適合，哪些不適合。但目前，我對我們所處的狀況感到非常興奮。是的，我們真的非常感激和興奮倫納德加入我們並擔任我們的發言人。是的，隨著收入的成長，您會看到我們在社群媒體上的顯著影響力。

Doug Loe, Leede Financial.

Doug Loe，Leede Financial。

I appreciate all the color on all the blocking and tackling you're doing to drive TULSA-PRO adoption. there's no substitute for this more blocking and tackling on that theme. But just a couple of related questions, if I may. Arun, maybe just with regard to the 60 existing TULSA-PRO active sites that you referred to. Just wondering if you are aware of any longitudinal studies or localized clinical trials that might be relevant in the peer-reviewed medical literature that could sort of drive awareness of TULSA-PRO's utility just from a clinical collaborator perspective?

我非常欣賞您為推動 TULSA-PRO 的採用而採取的所有阻撓和解決措施。沒有什麼可以取代在這主題上採取更多的阻撓和解決措施。但如果可以的話，我只想問幾個相關問題。阿倫，也許只是關於您提到的 60 個現有的 TULSA-PRO 活躍站點。只是想知道您是否知道同儕審查的醫學文獻中可能相關的任何縱向研究或局部臨床試驗，這些研究或試驗可以從臨床合作者的角度提高對 TULSA-PRO 實用性的認識？

So that's the first question. And then second of all, I was just wondering the number of the systemic therapies for targeting prostate cancer that used to target castrate-resistant disease are moving downstream into localized disease, ZYTIGA and XTANDI, specifically the cytochrome inhibitors. I was just wondering if in your discussions with potential customers, if there's any sort of pushback on perhaps some bias toward continuing to use systemic therapies in comparison to a localized ablation therapy like TULSA-PRO, if that's at all relevant to adoption.

這是第一個問題。其次，我只是想知道，用於針對去勢抵抗性疾病的前列腺癌全身療法的數量正在轉向局部疾病，ZYTIGA 和 XTANDI，特別是細胞色素抑製劑。我只是想知道，在您與潛在客戶的討論中，是否存在任何形式的阻力，例如與 TULSA-PRO 等局部消融療法相比，可能存在繼續使用全身療法的偏見，這是否與採用有關。

And I'll leave it with those two questions.

我將留下這兩個問題。

Okay. Doug, how much time do you have?

好的。道格，你有多少時間？

This is about philosophy. But I'll try to address them to the best I can. But Mathieu, with respect to clinical trial, maybe you could provide a little bit of color on how many publications we've had so far and how many presentations and then just a little more color on the ongoing studies, and then I'll come back and answer the question on the other -- the second part of Doug's question.

這是關於哲學的。但我會盡力解決這些問題。但是 Mathieu，關於臨床試驗，也許您可以稍微介紹一下我們迄今為止發表了多少篇出版物、做了多少場演講，然後再稍微介紹一下正在進行的研究，然後我會回來回答另一個問題——Doug 問題的第二部分。

Yes, for sure.

是的，當然。

Thank you, Doug. Of course, Profound has our sponsored studies, CAPTAIN, obviously big news through to the completion of all patient treatments, and we move through into the data readout, which we believe will be important for professional society guidelines, which will be impactful for utilization. But in addition to that, there are a number of other initiatives, both kind of from Profound's perspective and many from the sites themselves. So we do have an international registry.

謝謝你，道格。當然，Profound 有我們贊助的研究，CAPTAIN，顯然是所有患者治療完成的重大新聞，我們進入數據讀數，我們相信這對於專業協會指南很重要，這將對利用率產生影響。但除此之外，還有許多其他舉措，既有從 Profound 的角度提出的，也有從網站本身提出的。所以我們確實有一個國際註冊機構。

So this is a Profound-sponsored registry. It's called the CARE Registry, and it's international, and we invite every TULSA site into this registry. And the protocol is designed such that any patient treated with TULSA-PRO can be put into the registry. So whether they have cancer, whether they have BPH or whether they have certain specific things about their condition, they can all be included in the registry and then we can do some subgroup analysis after the fact. So that is certainly a growing body of evidence, and we've done a number of conference presentations through that.

所以這是一個由 Profound 贊助的註冊處。它被稱為 CARE Registry，是國際性的，我們邀請每個塔爾薩站點加入這個註冊中心。該協議的設計使得任何接受 TULSA-PRO 治療的患者都可以被納入登記冊。因此，無論他們是否患有癌症，是否患有 BPH，或者他們的病情是否有某些特定情況，都可以納入登記冊，然後我們可以在事後進行一些亞組分析。因此，這無疑是越來越多的證據，我們已經透過此做了許多會議演示。

there's a number of important UK sites in this registry, and we've also expanded it to a few important sites outside the UK So that's ongoing, and we plan to have that as regular updates throughout the year as the years progress. And I think that will provide a lot of real-world evidence as to what kind of patients are treated with TULSA as well as clinical outcomes, which will then again help drive adoption as well as payer coverage. As Arun was sort of alluding to, many of the sites like to revalidate their clinical outcomes once they acquire the TULSA-PRO.

該註冊表中有許多重要的英國站點，我們還將其擴展到英國以外的幾個重要站點，因此這項工作正在進行中，我們計劃隨著時間的推移在全年進行定期更新。我認為這將提供大量現實世界的證據，說明哪些類型的患者接受 TULSA 治療以及臨床結果，這將再次有助於推動採用以及付款人覆蓋。正如阿倫所暗示的那樣，許多站點在獲得 TULSA-PRO 後都喜歡重新驗證其臨床結果。

So they read about our clinical studies, TACT trial, et cetera. They acquire the device, especially academic hospitals. They like to sort of revalidate in their own hands what kind of outcomes are they getting. And so they do their own sort of studies on their own. And as Arun mentioned in his comments, what we see from those studies actually is the outcomes there are actually better than TACT more often than not as they sort of get to use the product without tight clinical trial restrictions, if you want to call them that.

因此他們閱讀了我們的臨床研究、TACT 試驗等。他們購買了該設備，尤其是學術醫院。他們喜歡親自重新驗證他們將會得到什麼樣的結果。因此他們自己進行自己的研究。正如 Arun 在他的評論中提到的那樣，我們從這些研究中實際上看到的是，它們的結果實際上往往比 TACT 更好，因為他們可以在沒有嚴格臨床試驗限制的情況下使用產品，如果你想這樣稱呼它們的話。

So there, we've certainly seen these sites present their data through the conference circuit. Sometimes we even include them in some of our press releases. They include major academic sites in the UK We mentioned Mayo, Florida, UT Southwestern. And I can tell you that sort of so far this year, we've had at least 12 presentations at major society meetings that featured CAPTAIN data, our CARE Registry data, real-world usage of the contouring assistant, AI feature, dose escalation protocols and so on.

因此，我們確實看到這些網站透過會議管道展示他們的數據。有時我們甚至會將它們納入我們的一些新聞稿中。其中包括英國主要的學術場所，我們提到了梅奧、佛羅裡達、德州大學西南醫學中心。我可以告訴您，今年到目前為止，我們已經在主要社會會議上進行了至少 12 次演示，其中介紹了 CAPTAIN 數據、我們的 CARE 註冊數據、輪廓助手的實際使用、AI 功能、劑量遞增協議等。

So I don't know, it's a bit of a long-winded answer to your question, but do you find that helpful?

所以我不知道，這對您的問題來說是一個有點冗長的回答，但您覺得這有幫助嗎？

Yes.

是的。

Yes.

是的。

With respect to your other second question, Doug, prostate is an incredibly dynamic space right now. And there's quite a bit of research going on in not only drug development, but also in better diagnostics. And to the point that you made, can we, in fact, diagnose better and earlier and thereby catch these patients while the disease is confined to the prostate, I think there's quite a bit of work going on. So I'm going to summarize very quickly for you.

關於您的第二個問題，道格，前列腺現在是一個非常活躍的領域。不僅在藥物開發方面，而且在更好的診斷方面也有大量的研究正在進行中。至於您提出的問題，我們能否在疾病局限於前列腺時更好地、更早地進行診斷並發現這些患者，我認為還有很多工作要做。所以我很快就會為你們總結一下。

So number one, on the diagnostics side, the basic conclusion from some of the big studies is if you can visualize the cancer in -- through an MRI, you should treat it. If you cannot visualize the cancer, it is not worth treating. And that has been validated quite a bit through genomics testing and so on. So we're thrilled with that because that kind of gets us to more MR-centric treatment of prostate and catching the disease when it's confined, it means more patients for technologies like ours. The second thing that is really, really important is that a lot of these drugs are basically trying to confine or arrest the disease and they go after the cancer stem cells.

因此，首先，在診斷方面，一些大型研究的基本結論是，如果您可以透過 MRI 看到癌症，就應該對其進行治療。如果您無法看到癌症，那麼就不值得治療。這已經通過基因組學測試等得到了相當多的驗證。因此，我們對此感到非常興奮，因為這使我們能夠以 MR 為中心治療前列腺，並在疾病受到限制時發現它，這意味著更多的患者可以使用像我們這樣的技術。第二件非常非常重要的事情是，許多藥物基本上都試圖限製或阻止疾病，而它們針對的是癌症幹細胞。

So I think what we are seeing is that there is a very good likelihood that TULSA and these drug developments are likely to be very complementary, where you might kill anywhere from 50% to 90% of the prostate where the disease is. It is a diffused multifocal disease. And so you could kill the discernible cancer and then supply some disease to make sure that the cancer stem cells that do remain will not leave. So I'm actually, quite frankly, very bullish about all of this. Hard to talk about it in these forms, but I think that TULSA is going to have a very prominent role as these new technologies come to market.

所以我認為，我們看到的是，TULSA 和這些藥物開發很有可能具有互補性，可能會殺死 50% 到 90% 的攝護腺疾病。這是一種瀰漫性多灶性疾病。因此，你可以殺死可辨識的癌症，然後提供一些疾病以確保殘留的癌症幹細胞不會消失。所以坦白說，我對這一切非常樂觀。很難以這些形式談論它，但我認為隨著這些新技術進入市場，塔爾薩將發揮非常突出的作用。

Ben Haynor, Lake Street Capital Markets.

Ben Haynor，Lake Street Capital Markets。

Good afternoon, gentlemen. Thanks for taking the questions.

先生們，下午好。感謝您回答這些問題。

Just curious on how the soft launch of the volume reduction module for BPH is going. What's kind of been the initial reaction there? Is there any records you can share in terms of fastest procedure time? Or has anyone beat kind of the leader in the clubhouse of, I think, 5 procedures in a day -- TULSA procedures in a day is the highest I've heard, has anyone vested that yet?

只是好奇 BPH 體積縮減模組的試運轉進展如何。那裡最初的反應是什麼樣的？能分享一下最快手術時間的紀錄嗎？或者有沒有人打敗俱樂部裡的領導者，我認為，一天 5 個程序——塔爾薩一天的程序是我聽說過的最高值，有沒有人已經確定了？

Ben, thanks very much for the question.

本，非常感謝你的提問。

I'll take a stab at it to start, and I'd really like Mathieu to chime in as well as he's very close to the launch with his clinical team also. Thus far, the feedback has been great, and we're excited for the full launch coming up in Q4 of that particular software module and upgrade. The whole point of that is to make sure that we streamline a few different things, in particular, the procedure time, as you're alluding to. And so we're looking to get that procedure time in the range of 60 to 90 minutes, of course, depending on the size of the prostate and any other concomitant factors that go into that.

我會嘗試一下，而且我真的很希望 Mathieu 也能參與進來，因為他和他的臨床團隊也已經非常接近啟動了。到目前為止，反饋非常好，我們很高興看到該特定軟體模組和升級將在第四季度全面推出。這樣做的目的是為了確保我們簡化一些不同的事情，特別是程序時間，正如您所提到的。因此，我們希望將手術時間控制在 60 到 90 分鐘之間，當然，這取決於前列腺的大小以及任何其他相關因素。

But on average, 60 to 90 minutes, which is obviously quite different than our current time line as it relates to prostate cancer, where many times it's a whole gland ablation, which, of course, takes more time than just removing a segment of the tissue as you would do in BPH procedures. So very excited about that and very excited about the full launch coming up.

但平均而言，需要 60 到 90 分鐘，這顯然與我們目前治療前列腺癌的時間線有很大不同，前列腺癌很多時候是整個腺體消融，當然，這比在 BPH 手術中僅切除一部分組織需要更多時間。對此我感到非常興奮，對即將全面推出的產品也感到非常興奮。

And I'll let Mathieu chime in as well on anything I may have missed.

我也會讓 Mathieu 補充我可能遺漏的任何內容。

Yes.

是的。

Thank you, Tom, and thank you, Ben, for the question. We are in a limited -- in a pilot launch. And so we have installed the software at about four to five sites that are participating in this launch so that we can gather the data in time for the full launch. And as Tom mentioned, we are getting a really excellent feedback from the physician users on all the various features, and we are taking that feedback and adjusting our user interface accordingly based upon the feedback from these physicians, and we'll be able to incorporate that for the full launch towards in the back half of this year.

謝謝湯姆，也謝謝本提出這個問題。我們目前處於有限的試點階段。因此，我們在參與此次發射的大約四到五個站點安裝了該軟體，以便我們能夠及時收集全面發射的數據。正如湯姆所提到的，我們從醫生用戶那裡得到了關於各種功能的非常好的反饋，我們正在根據這些醫生的反饋來調整我們的用戶界面，我們將能夠在今年下半年將其融入到全面推出中。

To your question about are we meeting our objectives, certainly, the early data tells us that, yes, we are certainly meeting our objectives of the 60 to 90 minutes. And if anything, it's closer to the 60 than to the 90. So we're delighted to see that. And again, this is with the first version of the software. So I think to give you a comprehensive answer to your question, I'd like to complete the pilot version of the launch and then have our full software released, which will have the full extent of features validated by our clinical users, which should really be the commercial-grade software that we would like to evaluate in market.

對於您關於我們是否達到目標的問題，當然，早期數據告訴我們，是的，我們肯定達到了 60 到 90 分鐘的目標。如果有的話，它更接近 60 而不是 90。所以我們很高興看到這一點。再次強調，這是該軟體的第一個版本。因此，為了全面回答您的問題，我想完成試點版本的發布，然後發布我們的完整軟體，該軟體將具有經過我們臨床用戶驗證的全部功能，這應該是我們真正想要在市場上評估的商業級軟體。

Okay, very helpful.

好的，非常有幫助。

And then on kind of the next slugs of CAPTAIN data that are coming out, I know there's been a little bit of discussion here this afternoon. But what beyond -- what we've already -- not beyond what we've already talked about, but can you kind of summarize what you expect to see here in a couple of few months here at RSNA and SUO, I mean, subset of the one-year outcomes potentially. What else do you think will get people excited?

然後，關於即將發布的下一批 CAPTAIN 數據，我知道今天下午這裡已經有了一些討論。但是除了我們已經討論過的內容之外，您能否總結一下您期望在幾個月後在 RSNA 和 SUO 看到什麼，我的意思是，潛在的一年結果的子集。您認為還有什麼會讓人興奮？

Mathieu, do you want to take that?

馬修，你想拿走這個嗎？

Yes, sure.

是的，當然。

Go ahead and take that. Yes. So I think first and foremost, I mean, not to minimize it, but having the complete data set of the perioperative outcomes will be important because it will sort of be the final data set of those outcomes, and that will also be what we will be publishing in peer-reviewed publications, which is then what professional societies and payers look at. They tend to look at the full peer-reviewed publication rather than sort of conference presentations.

繼續吧，拿著它。是的。因此我認為，首先，我的意思是，不要將其最小化，但擁有完整的圍手術期結果數據集非常重要，因為它將成為這些結果的最終數據集，這也是我們將在同行評審的出版物上發表的內容，然後由專業協會和付款人來審查。他們傾向於閱讀完整的同行評審出版物，而不是某種會議簡報。

So I think that's not to be minimized that at RSNA and SUO, we'll have that in place. We'll have that in the literature, and that will really enable us to start some of these conversations with professional societies who we know we're already supportive of the procedure, right? The professional societies are the ones that sort of took the TULSA procedure to the CPT panel for the CPT Category 1 code. So we already know that there's support of the procedure now with sort of peer-reviewed publications in that randomized context, Level 1 data, it will give us more interactions with them as well as with payers. In addition to that, we will have to check how mature the data set is with respect to all the other either primary or secondary outcomes.

因此我認為，在 RSNA 和 SUO 我們將會實現這一點，這一點不容忽視。我們將在文獻中介紹這一點，這將真正使我們能夠與我們知道已經支持該程序的專業協會展開一些對話，對嗎？專業協會將 TULSA 程序提交給 CPT 小組，以獲得 CPT 類別 1 代碼。因此，我們已經知道，現在有經過同行評審的出版物在隨機環境中支持該程序，即 1 級數據，它將使我們與他們以及付款人進行更多互動。除此之外，我們還必須檢查資料集相對於所有其他主要或次要結果的成熟度。

We do expect that by then, we'll be -- like we'll have certain elements with a strong enough maturity that we'll be able to start to give kind of interim looks at that, whether it's one-year sort of safety outcomes, one-year quality of life outcomes, urinary incontinence, erectile dysfunction and then maybe even some early efficacy outcomes. It's difficult for me to give you exact targets right now because it will depend on the maturity of that data, but that would be sort of what we'd be considering at that point in time, some PSAs, potentially even some histological comparisons of biopsy outcomes to positive surgical margins on the surgery side.

我們確實希望到那時，我們將擁有足夠成熟的某些要素，以便我們能夠開始對其進行中期觀察，無論是一年的安全結果、一年的生活品質結果、尿失禁、勃起功能障礙，甚至可能是一些早期的療效結果。我現在很難給出確切的目標，因為這取決於數據的成熟度，但這將是我們在那個時間點考慮的內容，一些 PSA，甚至可能是活檢結果與手術方面的陽性手術邊緣的一些組織學比較。

Okay, so still quite a bit to see there, obviously. And then you mentioned the conversations with the professional societies of the CAPTAIN data. Any more color you can shine on the conversations with payers on that front?

好的，顯然還有很多東西要看。然後您提到了與 CAPTAIN 資料專業協會的對話。您能就此與付款人進行的對話提供更多細節嗎？

Yes, absolutely. I think to a certain point, the no blood loss and no hospital stay, people knew this before going into the trial. And so from like a physician standpoint, they're not surprised necessarily, but it does give us data to go directly to the patient and do sort of direct-to-patient marketing. And these are also the types of data that are very, very important for kind of hospital administrators as well as payers, right? And so for them to see kind of that 24 hours less length of stay for them that implies very important things from an operational and financial standpoint.

是的，絕對是。我認為，在某種程度上，人們在進行試驗之前就知道了不失血、不住院。因此，從醫生的角度來看，他們不一定會感到驚訝，但它確實為我們提供了直接面向患者並進行直接面向患者的營銷的數據。這些資料類型對於醫院管理人員和付款人來說也非常非常重要，對嗎？因此，對他們來說，住院時間減少 24 小時，從營運和財務的角度來看，這意味著非常重要的事情。

So these are certainly things that they look at. The other set of data, the less pain, the patient better overall health, those endpoints actually were not necessarily -- I speak to a lot of physicians where they were like, I know the company was telling me these patients weren't in pain, but we're still treating their whole prostate. And so they still had some open questions around some of that post-op patient experience. And so the fact that we've been able to demonstrate statistically and clinically significant, less pain for that first week after therapy and better overall health for the full first 30 days after the procedure, that's actually quite impactful for our physicians and our patients. And I think that does start to influence how they sort of present TULSA to their patients.

所以這些肯定是他們關注的事情。另一組數據是，疼痛越少，患者的整體健康狀況越好，這些終點實際上並不一定——我與很多醫生交談過，他們說，我知道公司告訴我這些患者沒有疼痛，但我們仍在治療他們的整個前列腺。因此，他們對術後患者的一些體驗仍然存在一些懸而未決的問題。因此，我們已經能夠從統計和臨床上證明，治療後第一週的疼痛感減輕，以及治療後前 30 天內的整體健康狀況改善，這對我們的醫生和患者來說實際上影響很大。我認為這確實開始影響他們向病人展示塔爾薩的方式。

Okay, great.

好的，太好了。

Well, that's all I have.

嗯，這就是我所知道的全部了。

Thanks for taking the question, gentlemen.

謝謝各位先生提出這個問題。

And there are no further questions in the queue at this time. I will now turn the call back over to Dr. Menawat for any closing remarks.

目前隊列中沒有其他問題。現在我將把電話轉回給梅納瓦特博士，請他做最後發言。

Thank you so much for the colorful questions. We're looking forward to updating you in the Q3 analyst call. Thank you. Have a wonderful day.

非常感謝您提出這些豐富多彩的問題。我們期待在第三季分析師電話會議上向您通報最新情況。謝謝。祝您有美好的一天。

This concludes today's conference call. Thank you for your participation, and you may now disconnect.

今天的電話會議到此結束。感謝您的參與，您現在可以斷開連接。