Edap Tms SA (EDAP) 2024 Q3 法說會逐字稿

Future sales as we are currently in discussions with multiple hospitals within the HCA group, we also continue to experience strong growth in US focal one HIFU procedures during the quarter US procedures grew 34% on a year over year basis, which reflects continued adoption by urologists who see focal one as an important treatment option for delivering targeted focal therapy in earlier stage prostate cancer patients.

未來銷售由於我們目前正在與 HCA 集團內的多家醫院進行討論，我們在本季度還繼續經歷美國局部一 HIFU 手術的強勁增長，美國手術量同比增長 34%，這反映了泌尿科醫生的持續採用，他們將局部一視為在早期前列腺癌患者中進行靶向局部治療的重要治療選擇。

As mentioned during our last call, we believe that as the results from the groundbreaking HIFI study become more widely disseminated demand for the focal one platform will continue to grow.

正如我們上次電話會議中提到的那樣，我們相信隨著開創性的 HIFI 研究成果得到更廣泛的傳播，對焦點平台的需求將繼續增長。

The Hi fi study presents clear and compelling evidence that robotic HIFU therapy delivered by EDAP's proprietary technology is as effective as radical prostatectomy as a frontline treatment for the management of localized prostate cancer. While additionally offering patients better functional outcomes with respect to preservation of urinary continence and sexual function.

Hi fi 研究提供了明確而令人信服的證據，表明採用 EDAP 專有技術進行的機器人 HIFU 治療作為局部前列腺癌的一線治療方法與根治性前列腺切除術一樣有效。同時也保留尿失禁和性功能方面為患者提供更好的功能結果。

As a reminder, EDAP technology was used exclusively to treat all patients receiving HIFU therapy in this study including 90% with the focal one platform.

提醒一下，本研究中所有接受 HIFU 治療的患者均使用了 EDAP 技術進行治療，其中 90% 的患者使用了 Focus One 平台治療。

We anticipate the publication of the HIFI study results in a high impact peer-reviewed medical journal which will provide focal one HIFU with important visibility to aid in accelerating market adoption.

我們期待 HIFI 研究結果發表在具有高影響力的同行評審醫學期刊上，這將為焦點 HIFU 提供重要的知名度，有助於加速市場採用。

I will now provide a brief update on focal one reimbursement.

我現在將簡要介紹焦點一報銷的最新情況。

The Center for Medicare and Medicaid Services CMS just released the final payment rules for 2025 on November 2nd.

醫療保險和醫療補助服務中心 CMS 剛剛在 11 月 2 日發布了 2025 年的最終支付規則。

The HIFU procedure continues to be supported with favorable reimbursement with CMS finalizing a Medicare hospital payment rate of $9247 as a national average per the adjusted corresponding local wage index factor.

HIFU 手術繼續得到優惠的報銷支持，CMS 最終根據調整後的相應當地工資指數因素確定了 Medicare 醫院支付率為 9247 美元，為全國平均水平。

This rate will become effective on January 1, 2025, and represents a 5.4% increase over the 2024 payment.

該費率將於 2025 年 1 月 1 日生效，比 2024 年的支付金額增加 5.4%。

These reimbursement levels continue to support the favorable strategic business case for hospitals to both invest and integrate focal one HIFU while providing greater patient access to this valuable noninvasive treatment option.

這些報銷水準繼續支持醫院有利的策略性商業案例，既可以投資和整合焦點 HIFU，又可以讓更多患者獲得這種寶貴的非侵入性治療選擇。

CMS also released the physician fee schedule for 2025 which continues to provide strong physician reimbursement for HIFU with 17.73 work relative value units or work our views and 29.41 total [RVS.]

CMS 也發布了 2025 年的醫師費用表，該表繼續為 HIFU 提供強有力的醫師報銷，其中 17.73 個工作相對價值單位或工作我們的觀點和 29.41 個總[右轉。

These figures are significantly higher than any other prostate ablation procedure.

這些數字明顯高於任何其他前列腺消融手術。

Additionally, it provides physicians with a level of reimbursement that is more than 80% of the payment for performing surgery including robotic radical prostatectomy.

此外，它還為醫生提供超過手術費用 80% 的報銷金額，包括機器人根治性攝護腺切除術。

In conclusion, we are pleased with the continued support of the defined reimbursement levels for the use of HIFU, which provides a financially sound and sustainable economic offering for both the hospital and the physician.

總而言之，我們很高興能夠繼續支持使用 HIFU 的明確報銷水平，這為醫院和醫生提供了財務上合理且可持續的經濟效益。

I would now like to briefly discuss some of our recent strategic collaborative activities. On September 19th we announced a very exciting collaboration with the [VDA] Health for the purpose of launching the world's first AI assisted Focal one robotic HIFU procedures.

現在我想簡單談談我們最近的一些策略合作活動。9 月 19 日，我們宣布與 [VDA] Health 進行一項非常令人興奮的合作，目的是推出世界上第一個 AI 輔助的 Focal one 機器人 HIFU 程式。

[Aveda's] FDA cleared [UNFI] AI technology builds 3D patient specific cancer maps that reveal the extent of the tumor boundaries while enabling physicians to deliver more precise and tailored treatments by leveraging unfold. Ais's planning. With the focal one robotic HIFU platform, we believe that urologists can provide a more customized patients specific HIFU ablation procedure for treating prostate cancer.

[Aveda 的] FDA 批准的 [UNFI] AI 技術可構建 3D 患者特定癌症地圖，揭示腫瘤邊界的範圍，同時使醫生能夠透過利用展開來提供更精確和更有針對性的治療。艾絲的計劃。借助焦點機器人 HIFU 平台，我們相信泌尿科醫師可以為患者提供更個人化的 HIFU 消融手術來治療攝護腺癌。

The first series of these focal one AI assisted procedures have already been conducted by Dr. Wayne Brisbane, Assistant Professor of Urology at the University of California, Los Angeles David Geffen School of Medicine.

加州大學洛杉磯分校大衛格芬醫學院泌尿科助理教授 Wayne Brisbane 博士已經進行了首批此類局部 AI 輔助手術。

Thus far, we have received overwhelmingly positive feedback with respect to the combination of these two groundbreaking technologies AI represents an important and strategic next step and step in the evolution of the focal one platform and will help us remain at the forefront of delivering the most advanced focal therapy treatment solutions for patients diagnosed with prostate cancer.

到目前為止，我們收到了關於這兩項突破性技術結合的壓倒性積極反饋，人工智慧代表了焦點平台發展中重要且具有戰略意義的下一步，並將幫助我們始終站在最前沿，為前列腺癌患者提供最先進的局部治療方案。

During the quarter, we had a notable presence at several strategically important neurology focused scientific meetings.

在本季度，我們在幾次具有重要戰略意義的神經病學科學會議上表現出色。

We conducted numerous focal one simulated procedures at the 2024 joint meeting of the Focal Therapy Society and Society of Urologic Robotic Surgeons which took place from September 19th through the 21st in Washington DC.

我們在 9 月 19 日至 21 日在華盛頓特區舉行的局部治療協會和泌尿機器人外科醫生協會 2024 年聯合會議上進行了許多局部一模擬程序。

During this scientific meeting, there was significant interest surrounding our focal one technology and this meeting serves as an important venue for building our relationships with the leading neurologists in the United States.

在這次科學會議期間，人們對我們的焦點技術產生了濃厚的興趣，這次會議成為我們與美國頂尖神經學家建立關係的重要場所。

We also had a major presence at the 2024 focal plus annual meeting which took place from October 17th through the 19th in San Diego, California.

我們也在 10 月 17 日至 19 日於加州聖地牙哥舉行的 2024 年焦點年會上發揮了重要作用。

The focal median is particularly relevant to our business as the majority of attendees have a growing interest in utilizing focal therapy for prostate cancer.

局部中位數與我們的業務特別相關，因為大多數與會者對利用局部治療前列腺癌的興趣日益濃厚。

There were numerous presentations highlighting focal one HIFU at the meeting and we continue to see strong interest amongst urologists who recognize the need to offer a suitable treatment option between active surveillance and radical therapy.

會議上有許多演講強調了焦點一 HIFU，我們繼續看到泌尿科醫生的濃厚興趣，他們認識到需要在主動監測和根治性治療之間提供合適的治療選擇。

Early in the third quarter, we attended the 41st World Congress of Endourology and EUR Technology meeting which took place in Seoul, South Korea from August 12th through the 16th.

第三季初，我們參加了 8 月 12 日至 16 日在韓國首爾舉行的第 41 屆世界腔內泌尿外科大會和 EUR 技術會議。

During this meeting, we provided dozens of hands-on focal one simulations which garnered strong engagement from the intending urologist to quote Dr. Inderberg Gill, addressing a large audience of urologists at the meeting. Going forward, If you don't offer focal therapy, your prostate cancer practice will start shrinking.

在這次會議上，我們提供了數十個實際操作的焦點一模擬，這些模擬獲得了有意向的泌尿科醫生的強烈參與，引用 Inderberg Gill 博士在會上向大量泌尿科醫生發表的講話。展望未來，如果您不提供局部治療，您的前列腺癌治療實踐將開始減少。

Dr. Gill is a pioneer in robotic surgery and world-renowned expert on neurological disease and Chairman of urology at the University of Southern California Tech School of Medicine.

Gill 博士是機器人手術的先驅，也是世界知名的神經系統疾病專家，也是南加州大學理工醫學院泌尿科主任。

The [WC] scientific media also featured a semi live moderated focal one clinical procedure conducted by Dr. Tarek Benede Clinical Assistant Professor at the University of Florida, which demonstrated numerous benefits of the focal one robotic platform.

[WC] 科學媒體也展示了由佛羅裡達大學臨床助理教授塔里克·貝內德博士主持的半現場焦點一臨床程序，該程序展示了焦點一機器人平台的諸多優勢。

I will now briefly touch on our clinical development programs and BPH and endometriosis.

現在我將簡要介紹我們的臨床開發計劃以及 BPH 和子宮內膜異位症。

On October 1st, we announced that the first patients were treated in our in our combined phase one two study evaluating focal one robotic HIFU for the treatment of benign prostatic hyperplasia or BPH.

10 月 1 日，我們宣佈在我們的一二期聯合研究中，首批患者接受了治療，該研究評估了焦點一機器人 HIFU 治療良性前列腺增生 (BPH) 的效果。

As a reminder BPH represents an enormous market opportunity for focal one globally. $94 million prevalent cases of BPH were estimated in 2019 and in the US alone, as many as $15 million men currently have BPH symptoms.

提醒一下，BPH 對全球焦點來說代表著巨大的市場機會。 2019 年估計 BPH 患病人數為 9,400 萬美元，光在美國，目前就有多達 1,500 萬美元的男性患有 BPH 症狀。

The phase one two study of the company sponsored prospective Multicenter clinical trial and is designed in two parts.

該公司資助的一、二期研究為前瞻性多中心臨床試驗，設計分為兩部分。

The first part of the study is taking place at three leading institutions in France with a recognized expertise in the treatment of BPH as well in the as in the use of focal one HIFU technology.

研究的第一部分在法國三個領先的機構進行，這些機構在治療 BPH 以及使用局部 HIFU 技術方面擁有公認的專業知識。

Part one is designed to define the treatment parameters per protocol to effectively treat BPH with the goal of achieving optimal patient outcomes.

第一部分旨在定義每個方案的治療參數，以有效治療 BPH，並達到最佳患者治療效果。

Part two of this study will expand patient enrollment across a larger number of clinical sites in order to validate the safety and efficacy of the parameters as defined in part one of the study, we are particularly excited about this program as the focal one approach. When compared to other treatment options, has the potential to better protect the integrity of the urethra and other critical structures.

研究的第二部分將在更多的臨床站點擴大患者招募範圍，以驗證研究第一部分中定義的參數的安全性和有效性，我們對該計劃作為焦點方法感到特別興奮。與其他治療方案相比，有可能更好地保護尿道和其他重要結構的完整性。

We believe that focal one could become an important, effective and less invasive treatment approach for addressing BPH.

我們相信局部治療可以是治療 BPH 的一種重要、有效且侵入性較小的治療方法。

The ongoing phase one two study will also serve as a foundation for initiating a clinical trial in the United States next year, I'll now provide a brief update on our endometriosis program as previously announced in July interim results from our phase three study evaluating robotic HIFU technology for the treatment of deep infiltrating endometriosis showed that robotic HIFU therapy maintained an excellent safety profile while demonstrating greater reductions in endometriosis lesion volumes. As compared to patients in the Sham arm of the study.

正在進行的一二期研究也將為明年在美國啟動臨床試驗奠定基礎，現在我將簡要介紹我們的子宮內膜異位症計劃，正如我們在 7 月份宣布的那樣，我們第三階段研究的中期結果評估了機器人 HIFU 技術治療深部浸潤型子宮內膜異位症的效果，結果表明，機器人 HIFU 治療保持了出色的子宮內膜體積的安全性病變。與研究中假手術組的患者相比。

Both arms of the study also showed significant improvements in pelvic pain reduction at three months from baseline as measured by the standardized visual analog scale.

透過標準化視覺類比量表測量，研究的兩個部分也顯示，與基線相比，三個月後骨盆疼痛減輕有顯著改善。

As previously reported, the primary endpoint of superior reduction in acute pelvic pain in the HIFU arm compared to the Sham arm was not reached. However, upon further review by the clinical investigators, this outcome was likely attributed to comparing differences in pain scores between the two arms of the study after only three months following the procedure.

如先前報導的那樣，與假手術組相比，HIFU 組並未達到急性骨盆疼痛明顯減輕的主要終點。然而，經過臨床研究人員的進一步審查，這一結果很可能歸因於比較手術後僅三個月內研究中兩組之間的疼痛評分差異。

In our view, a therapeutic benefit favoring robotic HIFU is more likely to be confirmed over a longer period of time. Post procedure as suggested by the stabilization of pain scores at six and 12 months. From our published peer-reviewed phase two study. At present, the study is now unblinded and patients have been allowed to cross over to the HIFU Arm Protocol.

我們認為，機器人 HIFU 的治療優勢更有可能在較長時間內得到證實。術後六個月和十二個月的疼痛評分趨於穩定。來自我們發表的經過同儕審查的第二階段研究。目前，該研究已揭開盲法，患者已獲準轉入 HIFU 組方案。

I'm pleased to report now that 85% of the patients from the Sham arm have already elected to cross over into open label extension arm of the study and thus receive treatment with robotic HIFU.

我很高興地報告，現在 85% 的假手術組患者已經選擇進入研究的開放標籤擴展組，從而接受機器人 HIFU 治療。

This is not surprising as the pain symptoms for these sham patients return back to their high baseline levels after one year post procedure.

這並不奇怪，因為這些假手術患者的疼痛症狀在手術後一年後恢復到其高基線水平。

In contrast, the patients from the HIFU arm who were evaluated one year following robotic HIFU treatment, maintained a similar level of improvement over their baseline pain symptoms as measured at three months post procedure.

相較之下，接受機器人 HIFU 治療一年後進行評估的 HIFU 組患者在治療後三個月測量時，其疼痛症狀與基線相比保持了相似的改善水平。

Importantly, these findings are consistent with the significant reduction in lesion volume as measured by MRI which was observed in the HIFU arm only following the unblinding of the study.

重要的是，這些發現與 MRI 測量的病變體積顯著減少相一致，這一發現是在研究揭盲後在 HIFU 組中觀察到的。

This additional data continues to suggest that HIFU therapy is a safe noninvasive treatment that has significant potential to reduce pain for women suffering from this debilitating condition.

這些額外的數據繼續表明，HIFU 療法是一種安全的非侵入性治療方法，對減輕患有這種使人衰弱的疾病的女性的疼痛具有巨大的潛力。

Between now and year end, we anticipate meeting with the FDA to discuss this additional data while determining the next steps for this program.

從現在到年底，我們預計與 FDA 會面討論這些額外的數據，同時確定該計劃的下一步。

Before handing the call over to Ken to review our third quarter financial results. I want to briefly mention a change to our board of directors.

在將電話交給肯恩來審查我們的第三季財務結果之前。我想簡單提一下我們董事會的變動。

Following the departure of Mark Osowski, we appointed our existing board member, Dr. Lance Willsey to serve as interim board chair, Effective September 30th.

在 Mark Osowski 離職後，我們任命現任董事會成員 Lance Willsey 博士擔任臨時董事會主席，該任命自 9 月 30 日起生效。

Dr. Willsey is playing an active role assisting the executive team while we continue to search for a permanent replacement.

在我們繼續尋找永久替代者的同時，威爾西博士正在積極協助執行團隊。

Dr. Willsey was first appointed to the EDAP Board of Directors in December of 2023 and has since made valuable contributions to help guide our strategic planning as we expand the focal one platform across the global urology market.

Willsey 博士於 2023 年 12 月首次被任命為 EDAP 董事會成員，自此做出了寶貴貢獻，幫助指導我們的策略規劃，使我們在全球泌尿科市場擴展焦點平台。

Dr. Willsey is a trained urologist who has over 35 years of private and public board experience focused in the area of cancer diagnostics and therapeutics.

Willsey 博士是一位訓練有素的泌尿科醫生，擁有超過 35 年的私人和公共委員會經驗，專注於癌症診斷和治療領域。

He completed his surgical and neurology training at the Massachusetts General Hospital and additional postgraduate training in the steel lab at Harvard University and the Dana Farber Cancer Institute.

他在馬薩諸塞州總醫院完成了外科和神經病學培訓，並在哈佛大學鋼鐵實驗室和丹娜法伯癌症研究所完成了額外的研究生培訓。

I will now turn the call over to Ken to review our third quarter financial results.

現在我將把電話轉給肯來審查我們的第三季財務表現。

Thanks Ryan and good morning, everyone. Please note that all figures except for percentages are in EUR. For conversion purposes our average EUR dollar exchange rate was 1.101 for the third quarter of 2024 total worldwide revenue for the third quarter of 2024 was EUR13.1 million.

謝謝 Ryan，大家早安。請注意，除百分比外所有數字均以歐元為單位。為了換算目的，2024 年第三季歐元平均匯率為 1.101，2024 年第三季全球總營收為 1,310 萬歐元。

An increase of 11.6% as compared to total worldwide revenue of EUR11.7 million for the comparable period of 2023. This was a record for third quarter revenue performance. Looking at revenue by division total revenue in the high food business for the third quarter of 2024 was EUR4.5 million compared to EUR3 million for the third quarter of 2023 which represents a growth of 48.2% year over year. We placed three focal one systems in the third quarter and all three placements were cash sales. Third quarter worldwide HIFU disposable revenue grew 35.3% on a year over year basis. Reflecting strong US procedure growth. Total revenue in the distribution business for the third quarter of 2024 was EUR6.6 million as compared to EUR6 million for the third quarter of 2023. Distribution revenue was driven primarily by recurring revenues from laser sales.

與 2023 年同期全球總營收 1,170 萬歐元相比成長 11.6%。這是第三季營收表現的最高紀錄。按部門查看收入，2024 年第三季高級食品業務總收入為 450 萬歐元，而 2023 年第三季為 300 萬歐元，較去年同期成長 48.2%。我們在第三季投放了三個焦點系統，所有三個系統都是現金銷售。第三季全球 HIFU 一次性治療設備營收年增 35.3%。反映了美國程序的強勁成長。2024 年第三季分銷業務總收入為 660 萬歐元，而 2023 年第三季為 600 萬歐元。分銷收入主要來自雷射銷售的經常性收入。

Total revenue in the litho business for the third quarter of 2024 was EUR2 million as compared to EUR2.7 million for the same period in 2023. The decrease in [lial] revenue was due to selling three lithotripsy units in the third quarter as compared to seven units sold in the third quarter of 2023.

2024 年第三季光刻業務總營收為 200 萬歐元，而 2023 年同期為 270 萬歐元。[lial] 收入的下降是由於第三季度銷售了 3 台碎石機，而 2023 年第三季銷售了 7 台。

Gross profit for the third quarter of 2024 was EUR5.2 million compared to EUR4.2 million for the year ago period. Gross profit margin on net sales was 39.4% in the third quarter compared to 35.5% in the year ago period. The increase in gross profit margin year over year was due to a favorable shift in focal one product mix and positive absorption in the factory. Operating expenses were EUR11 million for the third quarter compared to EUR9.7 million for the same period in 2023. Operating expenses increased primarily due to investments made to support focal one commercial operations globally. Operating loss for the third quarter of 2024 was EUR5.8 million which was relatively flat compared to an operating loss of EUR5.6 million in the third quarter of 2023. Net loss for the third quarter of 2024 was EUR6.4 million or EUR0.17 per diluted share as compared to net loss of EUR3.9 million or EUR0.11 per diluted share in the year ago period.

2024 年第三季的毛利為 520 萬歐元，而去年同期為 420 萬歐元。第三季淨銷售毛利率為39.4%，去年同期為35.5%。毛利率年增率是由於焦點產品結構的有利轉變和工廠的積極吸收。第三季的營業費用為 1,100 萬歐元，而 2023 年同期為 970 萬歐元。營業費用的增加主要是由於為支持全球焦點商業運營而進行的投資。2024 年第三季的營業虧損為 580 萬歐元，與 2023 年第三季的 560 萬歐元營業虧損相比持平。2024 年第三季淨虧損為 640 萬歐元或每股攤薄虧損 0.17 歐元，而去年同期淨虧損為 390 萬歐元或每股攤薄虧損 0.11 歐元。

Turning to the balance sheet ending inventory was EUR21 million in the third quarter of 2024 as compared to EUR15.1 million at the end of the fourth quarter in 2023. As I mentioned last quarter, we have made advanced purchasing decisions related to ultrasound technology and we have built additional focal one and [exac] inventory in anticipation of higher demand. Also, as a result of new medical device requirements. Under [Cemar], multiple ESWL units had to be manufactured in advance of these new requirements becoming effective. We anticipate selling the ESWL inventory down by the first half of calendar year, 2025 total cash and cash equivalents at the end of the third quarter was EUR25.5 million as compared to EUR43.5 million at the end of the fourth quarter of 2023. The EUR80 million decrease in cash and cash equivalents on a year-to-date basis was attributed to spending on operating activities including of inventory investments. As I described earlier, capital investments to help grow the high food business and pay down of long-term borrowings. We remain focused on optimizing our investments from both an operating and cash resource perspective so that we can effectively manage and grow our focal one business in the long term. Those are our key financial highlights for the third quarter of 2024 and with that, I would like to turn the call back to Ryan.

轉向資產負債表，2024 年第三季的期末庫存為 2,100 萬歐元，而 2023 年第四季末的期末庫存為 1,510 萬歐元。正如我在上個季度提到的，我們已經做出了與超音波技術相關的提前採購決策，為了滿足更高的需求，我們已經建立了額外的焦點和[exac]庫存。此外，由於新的醫療器材需求。根據 [Cemar] 的規定，必須在這些新要求生效之前製造多個 ESWL 裝置。我們預計將在上半年出售 ESWL 庫存，2025 年第三季末的總現金和現金等價物為 2,550 萬歐元，而 2023 年第四季末的總現金和現金等價物為 4,350 萬歐元。年初至今現金和現金等價物減少 8,000 萬歐元，原因是包括庫存投資在內的營運活動支出。正如我之前所描述的，資本投資有助於發展高端食品業務並償還長期借款。我們仍然致力於從營運和現金資源角度優化我們的投資，以便我們能夠長期有效地管理和發展我們的重點業務。這些是我們 2024 年第三季的主要財務亮點，現在我想把電話轉回給 Ryan。

Thanks Ken.

謝謝肯。

As we look outward, we are making significant investments to capitalize on the growing focal therapy market opportunity with the most advanced technology platform and a growing install base of focal one systems at leading institutions and hospitals.

放眼未來，我們正在進行大量投資，利用最先進的技術平台和領先機構和醫院不斷增長的局部治療系統安裝基礎，抓住不斷增長的局部治療市場機會。

We are achieving this strategic objective as we build an important new treatment category for prostate cancer that lies between active surveillance and radical therapy.

我們正在實現這一策略目標，因為我們正在為前列腺癌建立一個介於主動監測和根治性治療之間的重要的新治療類別。

While building a new treatment category takes time and effort. There is no question that this paradigm shift in the treatment of prostate cancer is taking place and we believe focal one is fast becoming the leading technology platform that will dominate this new treatment category for years to come.

而建立一個新的治療類別需要時間和精力。毫無疑問，前列腺癌治療的範式轉變正在發生，我們相信 Focal One 將迅速成為領先的技術平台，並將在未來幾年主導這一新的治療類別。

As we grow, we continue to deploy our talent and capital in a highly strategic manner for the purpose of building relationships across a continuum of stakeholders including all the urology, major practices, large hospital networks and urology fellowship programs.

隨著我們的成長，我們繼續以高度策略性的方式部署我們的人才和資本，目的是與包括所有泌尿科、主要診所、大型醫院網絡和泌尿科研究金項目在內的一系列利益相關者建立關係。

Through these efforts, we are creating world class robotic HIFU treatment programs to ensure that focal one is being fully utilized and that more urologists are being trained early in their careers to use this important technology.

透過這些努力，我們正在創建世界一流的機器人 HIFU 治療方案，以確保局部治療得到充分利用，並確保更多的泌尿科醫生在職業生涯早期接受使用這項重要技術的培訓。

As discussed in my prior comments, we are also attending the most relevant urology focused scientific conferences around the world and integrating cutting edge new technologies such as AI to further extend our market and technology leading position.

正如我之前的評論中所討論的，我們也參加了世界各地最相關的泌尿科科學會議，並整合了人工智慧等尖端新技術，以進一步擴大我們的市場和技術領先地位。

These combined efforts are translating into commercial success as demonstrated not only by our consistently strong year over year procedure growth in the US, but also by the strong focal one adoption amongst the most well recognized cancer treatment centers.

這些共同的努力正在轉化為商業上的成功，這不僅體現在我們在美國持續強勁的逐年手術成長上，也體現在我們最知名的癌症治療中心大力採用焦點治療法。

In fact, focal one is now installed in over third of the National Cancer Institute designated Comprehensive Cancer Centers and we expect that percentage will continue to grow as more urologists embrace focal one. Higher utilization will lead to more clinical data and this data will gain more attention at upcoming urology meetings.

事實上，目前美國國家癌症研究所指定的綜合癌症中心中超過三分之一都安裝了局部檢查系統，我們預計，隨著越來越多的泌尿科醫生採用局部檢查系統，這一比例將繼續增長。更高的利用率將帶來更多的臨床數據，這些數據將在即將召開的泌尿科會議上受到更多關注。

This data will also lead to more peer review publications which further validates the technology and will provide a basis for expanding robotic HIFU and the treatment guidelines for prostate cancer.

這些數據還將帶來更多的同行評審出版物，進一步驗證該技術，並為擴大機器人 HIFU 和前列腺癌治療指南提供基礎。

As urologists enthusiasm and adoption continues to grow for focal one.

隨著泌尿科醫生對焦點的熱情和採用而不斷增長。

We also see growing demand coming directly from patients who will increasingly seek effective less invasive treatment options that fall between active surveillance and radical therapy patients and their doctors want to address cancer earlier in the course of the disease while also maximizing quality of life outcomes as a noninvasive therapy providing excellent oncological control. Focal one therefore represents an important treatment option for many of these patients.

我們也看到，來自患者的需求日益增長，他們將越來越多地尋求介於主動監測和根治性治療之間的有效、侵入性較小的治療方案，而他們的醫生則希望在疾病早期就治療癌症，同時作為一種提供良好腫瘤控制的非侵入性治療方法，最大限度地提高生活品質。因此，局部治療對於許多此類患者來說是重要的治療選擇。

As we have discussed on past earnings calls. I believe we are in the early stages of an important and positive shift in how prostate cancer is being managed.

正如我們在過去的財報電話會議上所討論的。我相信我們正處於前列腺癌治療方法重要且積極轉變的早期階段。

As noted, we are executing on our strategic goal of establishing focal one as the premier robotic HIFU therapy for prostate cancer, which we believe will generate significant value for our shareholders.

如上所述，我們正在執行我們的策略目標，即將 Focus One 打造為前列腺癌首屈一指的機器人 HIFU 治療方法，我們相信這將為我們的股東創造巨大價值。

With that. I would now like to turn the call back over to the operator for questions, operator.

就這樣。我現在想將電話轉回給接線員，以便回答問題。

At this time. (Operator Instructions)

此時。（操作員指令）

We'll take our first question from Michael Stanton with Jeffries. Please go ahead. Your line is open.

我們將從傑弗里斯的邁克爾·斯坦頓那裡得到第一個問題。請繼續。您的線路已開通。

Good morning and thanks for taking the questions, I guess just to start. Hi, can you, can you elaborate a little more on, what you're seeing just in the among the hospital customers and, and the F one pipeline, you know, three placements this quarter, I think last quarter, you said, you know, you were expecting second half placements to exceed first half. Is that still the case? So yeah, basically the pipeline, what you're seeing in the hospital environment and then two H versus one H placements. Thank you.

早安，感謝您回答這些問題，我想這只是開始。您好，您能否詳細說明您在醫院客戶和 F one 管道中看到的情況，您知道，本季度有三次安置，我想上個季度您說過，您知道，您預計下半年的安置數量將超過上半年。現在還是這樣嗎？是的，基本上就是管道，您在醫院環境中看到的，然後是兩個 H 與一個 H 的位置。謝謝。

That can happen.

這是有可能發生的。

Yes, Michael, we, saw good activity in the third quarter. Of course, we're always building our pipelines. We had a few sales that slipped into Q4. As noted, we are still planning on having a stronger back half of the year. Second half of the year, we continue to see momentum and high level engagement in many of our pipeline customers. And again, you know, coming off of a number of very key scientific meetings and, and some of the engagement we have, there's been very strong clinical interest from many urologists in attendance to those those events. So yes, we do continue to see a strong growth in the second half of the year.

是的，邁克爾，我們看到了第三季的良好表現。當然，我們一直在建造我們的管道。我們的一些銷售量下滑到了第四季。如上所述，我們仍計劃在今年下半年取得更強勁的業績。下半年，我們繼續看到許多管道客戶的發展動能和高水準的參與。而且您知道，在參加了一系列非常重要的科學會議以及我們進行的一些活動之後，許多參加這些活動的泌尿科醫生表現出了非常濃厚的臨床興趣。所以是的，我們確實將繼續看到今年下半年的強勁成長。

Got it. Thank you. And you know, you're still seeing a nice focal one procedure growth in the US year over year. Ryan, I was wondering if you could just maybe elaborate some on how utilization per customer or account has been trending and you know, maybe where that stands today.

知道了。謝謝。而且您知道，您仍然看到美國焦點一手術年增長良好。瑞安，我想知道您是否可以詳細說明每個客戶或帳戶的使用率趨勢，以及目前的情況。

Yeah, so as we're adding really a new treatment service line. When we launch our focal one programs, there's a ramp period. So we look at our accounts, you know, objectively as programs. So we build these programs, we launch them and then there's typically a ramp period, there's a training period and onboarding period, we continue to see hospitals, you know, increasing their procedures some faster than others. But, you know, the commitment is there. And as noted, you know, we made an announcement on terms of reimbursement, reimbursement continues to be strong.

是的，我們確實增加了一條新的治療服務線。當我們推出焦點項目時，會有一個上升期。因此，我們客觀地將我們的帳戶視為程序。因此，我們建立了這些項目，並啟動它們，然後通常會有一個提升期、一個培訓期和入職期，我們繼續看到一些醫院比其他醫院更快地增加其程序。但你知道，承諾是存在的。如您所知，我們已經宣布了報銷條款，報銷仍然強勁。

So, there's, you know, there's the economics that support the activity. But I think the real thing we see is increased clinical value demonstrated back from a number of our installed users. The data that's been presented at some of the local scientific meetings in national meetings has been very positive. We continue to see some hospitals now turning on more marketing activity to attract a broader patient population. So again, good healthy growth on procedures is something we pay a lot of attention to. We have a bifurcated sales force, meaning one that focuses on capital and one that focuses on clinical and we continue to continue to monitor adoption at each account and utilization by each urologist trained on use of focal one.

所以，你知道，有經濟因素支撐這項活動。但我認為，我們真正看到的是從許多安裝用戶那裡得到的臨床價值的提升。在一些全國性的地方科學會議上公佈的數據非常積極。我們繼續看到一些醫院正在進行更多的行銷活動來吸引更廣泛的患者群體。所以，我們再次非常關注程序的良好健康發展。我們擁有一支分工明確的銷售隊伍，一支專注於資本，另一支專注於臨床，我們將繼續監控每個帳戶的採用情況以及每位接受過焦點產品使用培訓的泌尿科醫生的使用情況。

Great. Thank you, Ryan.

偉大的。謝謝你，瑞安。

Thank you.

謝謝。

Thank you. (Operator Instructions)

謝謝。（操作員指令）

We'll take our next question from Sean lee with H.C. Wainwright, your line is open.

下一個問題由 H.C. 的 Sean Lee 提出。溫賴特，您的路線已開通。

Hey, good morning, guys. This is Sean here for RK and thanks for taking my questions. I just got two quick ones on the clinical programs. So, we regard regarding the DCH study, when can we expect the initial results from that? And what kind of data would that entail?

嘿，大家早安。我是 RK 的 Sean，感謝您回答我的問題。我剛剛快速得到了兩個關於臨床項目的資訊。那麼，關於 DCH 研究，我們什麼時候可以獲得初步結果？那這會涉及什麼樣的數據？

Well, as noted, we are we on the journey of a phase one, phase two study? So results we would not see until sometime later next year. Again, we are combining these two parts of the study really to accelerate our scientific findings around treatment parameters, etc. So, we've got a well laid out plan. As noted,. We have three sites now that are active, and we have the ability to add additional sites. Once we get through some of the early work we're doing, now we will expand to other sites. So, it won't be until later next year. And we're, we'll be excited to obviously present some of that data and those findings accordingly.

嗯，如同前面提到的，我們是否正在進行第一階段、第二階段的研究？因此我們要到明年晚些時候才能看到結果。再次強調，我們將這兩個部分的研究結合起來，實際上是為了加速我們在治療參數等方面的科學發現。如上所述，。我們目前有三個活躍的站點，並且我們有能力添加其他站點。一旦我們完成了一些早期工作，我們就會擴展到其他網站。因此，要等到明年晚些時候了。我們非常高興能夠展示其中的一些數據和發現。

Great one quick follow up on that. How many patients are expected in the first two parts?

很好的一次快速跟進。前兩部分預計會有多少名患者？

Yeah, it's, well, it's, really, it's truncated on, on the protocol. So, it's broken down in various numbers. You know, we have a subset of 30 to expand above 30 to 60. It's called out directly in the protocol. I think the thing to understand in this study is that we combine both parts of the study, right, the phase one and phase two parts. And as we look at that, our goal is to accelerate to more sites. Once we look at treatment parameters including, you know, volume treatment location and really setting up the procedure for a wider group of participants will be able to, you know, play with those numbers in terms of what we, we would like to see as we move forward and write additional new study protocols. So, that's where we're at with that. We're excited about this program. And, we have other centers that are very eager to participate.

是的，它確實在協議上被截斷了。因此，它被分解成各種數字。您知道，我們有 30 個子集，可以從 30 擴展到 60。它直接在協定中被呼叫。我認為這項研究需要理解的是，我們將研究的兩個部分結合起來，對吧，第一階段和第二階段。我們看到這一點，我們的目標是加速覆蓋更多站點。一旦我們了解了治療參數，包括體積、治療位置，並真正為更廣泛的參與者群體設定程序，我們就可以根據我們希望看到的結果來處理這些數字，並編寫新的研究方案。這就是我們現在的狀況。我們對這個項目感到非常興奮。而且，我們還有其他中心也非常渴望參與。

Great. Thank you for that in the prepared remarks. You mentioned that the company expects to initiated study in the US next year as well. Would that mirror this French study, or would you modify it based on what you see in the this first study?

偉大的。感謝您在準備好的發言中所做的發言。您提到公司預計明年也將在美國啟動研究。這是否與法國的研究相似，或者您會根據第一項研究的結果對其進行修改嗎？

Okay. can you repeat that? I can't, we can't hear you here.

好的。你能重複一遍嗎？我不能，我們這裡聽不到你的聲音。

In the prepared you mentioned. I think you mentioned that the company expects to start US clinical study in BPH as well next year. Would that mirror the first French study or is it, or are you going to modify it based on what you see?

在你所提到的準備中。我記得您提到過，該公司預計明年也將在美國啟動針對 BPH 的臨床研究。這是否反映了第一項法國的研究，或者您是否會根據您所看到的情況對其進行修改？

Yeah. So, I think what we, want to do here is take the results of the combined phase one two study to expand to multiple sites. While we're doing that, we'll be looking at protocol design to get in front of the FDA sometime next year. So again, we're, accelerating this process and look to expand it to additional sites.

是的。因此，我認為我們在這裡要做的是將第一階段和第二階段的綜合研究結果擴展到多個地點。在此過程中，我們將研究協議設計，以便在明年某個時候提交給 FDA。因此，我們再次加速這一進程，並希望將其擴展到更多站點。

And again, you know, we would be working closely with our investigators to develop the right protocol that would suit the needs for the FDA.

再說一次，您知道，我們將與我們的研究人員密切合作，以製定適合 FDA 需求的正確協議。

Thank you for that clarification and my final question on the endometriosis program. So, you mentioned that the longer-term effects are more likely to see a benefit for HIFU. So, how long are you continuing to follow these patients for longer? And when do you expect to release these longer-term results sometime down the line?

感謝您的澄清，這也是我關於子宮內膜異位症計畫的最後一個問題。所以，您提到從長期來看 HIFU 更有可能帶來益處。那麼，您還會繼續追蹤這些患者多久呢？您預計何時發布這些長期結果？

So, we've shown again that we per protocol have the ability to continue to follow these patients and we're, you know, we have the ability to follow outwards of 12 months and beyond. So again, we're continuing to monitor these patients closely. I think what we've shown clearly and commented on is that we've shown high safety in use of the technology. We've showed a reduction in the size of the MRI lesion under MRI visualization, the reduction of lesion size in the in the HAU arm. And then we've shown a crossover rate of 85%. Meaning that patients who were followed in the original study upon being unblinded were returning back to their baseline pain scores. So that's, you know, represents something we've socialized before and made comment to that the follow-up time at three months was probably not adequate to prove the data endpoints that we needed, you know, post treatment. So again, I think what our goal will be is we've got expected meetings with the FDA here before the end of the year and we will be using the latest data analysis and follow up to prepare for that conversation with the FDA.

因此，我們再次表明，我們有能力按照協議繼續追蹤這些患者，而且我們有能力追蹤 12 個月甚至更長。因此，我們將繼續密切監測這些患者。我認為我們已經清楚展示和評論的是，我們在使用該技術時已經表現出很高的安全性。我們已經證明，在 MRI 視覺化下，MRI 病變的大小有所減小，HAU 組的病變尺寸也有所減少。然後我們顯示了 85% 的交叉率。這意味著在原始研究中被追蹤的患者在揭開盲法後疼痛評分會恢復到基線。所以，你知道，這代表了我們之前社交過的事情，並且評論說三個月的追蹤時間可能不足以證明我們治療後所需的數據終點。所以，我再說一遍，我認為我們的目標是在年底之前與 FDA 舉行預期會議，我們將使用最新的數據分析和後續行動為與 FDA 的對話做準備。

We're excited about some of the findings we've had recently as we, you know, uncovered more of this. But clearly, we have high belief in the procedure, and we will continue to look positively outward.

我們對最近的一些發現感到非常興奮，因為我們發現了更多這樣的資訊。但顯然，我們對這項程序充滿信心，我們將繼續保持積極的態度。

Great. Thanks again for taking my questions.

偉大的。再次感謝您回答我的問題。

Thank you.

謝謝。

Thank you. (Operator Instructions)

謝謝。（操作員指令）

I will turn the program back over to Ryan Rhodes for International remarks.

我將把節目交還給 Ryan Rhodes，請他發表國際評論。

I want to thank everyone again for joining us on our today's call and we look forward to seeing you at the upcoming Jeffreys London Healthcare conference on November 19th and the following month at the Piper Sandler Health Care Conference in New York City.

我想再次感謝大家參加我們今天的電話會議，我們期待在 11 月 19 日即將舉行的 Jeffreys London Healthcare 會議和下個月在紐約市舉行的 Piper Sandler Health Care 會議上見到大家。

Thank you.

謝謝。

This does include today's conference. Thank you for your participation. You may disconnect at any time.

這確實包括今天的會議。感謝您的參與。您可以隨時斷開連線。