ENDRA Life Sciences Inc (NDRA) 2023 Q2 法說會逐字稿

Good day, and welcome to the ENDRA Life Sciences second quarter 2023 financial results conference call. All participants will be in listen-only mode. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

美好的一天，歡迎參加 ENDRA 生命科學 2023 年第二季度財務業績電話會議。所有參與者都將處於僅聽模式。 （操作員說明）請注意此事件正在被記錄。我現在想把會議交給伊馮·布里格斯。請繼續。

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon, and welcome to ENDRA's second quarter 2023 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic and also issued a news release announcing the submission of a de novo request for its TAEUS system to the US FDA, both of which are available in the Investors section of ENDRA's website.

謝謝你，接線員。我是 LHA 的伊馮·布里格斯 (Yvonne Briggs)。下午好，歡迎參加 ENDRA 2023 年第二季度業務更新和財務業績電話會議。今天早些時候，ENDRA 就該主題發布了一份新聞稿，並發布了一份新聞稿，宣布向美國FDA 提交其TAEUS 系統的從頭請求，這兩項請求均可在ENDRA 網站的投資者部分找到。

Before we begin, please note that today's discussion will include forward-looking statements. All statements by management other than statements of historical facts include statements regarding the company's strategies, financial condition, operations, costs, plans and objectives, as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities and expectations regarding regulatory processes, receipt of required regulatory clearances, and product launches are forward-looking statements.

在我們開始之前，請注意，今天的討論將包括前瞻性陳述。除歷史事實陳述外，管理層的所有陳述包括有關公司戰略、財務狀況、運營、成本、計劃和目標的陳述，以及開發和商業化工作的預期結果、臨床研究的時間安排、潛在的合作機會和期望有關監管流程、獲得所需監管許可以及產品發布的信息均為前瞻性陳述。

Except as required by federal securities laws, the company disclaims any obligation to update or revise any forward-looking statements. Please refer to the company's Form 10-K for the 2022 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.

除聯邦證券法要求外，該公司不承擔更新或修改任何前瞻性陳述的義務。請參閱該公司 2022 財年的 10-K 表格以及隨後向 SEC 提交的文件，了解有關前瞻性陳述相關風險和不確定性的更多信息。

In terms of the structure of today's call, Francois Michelon, Chairman and Chief Executive Officer, will begin the prepared remarks followed by Michael Thornton, ENDRA's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the second quarter financial results.

就今天電話會議的結構而言，董事長兼首席執行官 Francois Michelon 將開始準備好的講話，隨後 ENDRA 首席技術官 Michael Thornton 致辭。 Thornton 先生將由高級財務總監 Irina Pestrikova 負責審查第二季度的財務業績。

With that said, I will now turn the call over to Francois Michelon. Francois?

話雖如此，我現在將把電話轉給弗朗索瓦·米其隆。弗朗索瓦？

Thank you, Yvonne, and good afternoon, everyone. And thanks for joining us today to discuss ENDRA's second quarter 2023 financial results and business highlights. As we announced earlier today, I'm extremely pleased that ENDRA submitted its de novo request to the US FDA for the Thermo Acoustic Enhanced Ultrasound liver system, known as TAEUS.

謝謝伊馮，大家下午好。感謝您今天加入我們討論 ENDRA 2023 年第二季度的財務業績和業務亮點。正如我們今天早些時候宣布的那樣，我非常高興 ENDRA 向美國 FDA 提交了熱聲增強超聲肝臟系統（稱為 TAEUS）的從頭請求。

Our de novo submission is a pivotal milestone for ENDRA, highlighting our team's commitment alongside our clinical partners to offer a non-invasive and cost-effective solution for measuring liver fat, which is the root cause of a disease affecting over 1 billion people worldwide. We see the de novo process as a gateway to establish a new regulatory standard, highlighting TAEUS's groundbreaking capabilities, and we look forward to collaborating with the FDA during the review process.

我們的從頭提交是ENDRA 的一個關鍵里程碑，突顯了我們的團隊與臨床合作夥伴的承諾，為測量肝臟脂肪提供非侵入性且具有成本效益的解決方案，肝臟脂肪是影響全球超過10 億人的疾病的根本原因。我們將 de novo 過程視為建立新監管標準的門戶，凸顯了 TAEUS 的突破性能力，我們期待在審查過程中與 FDA 合作。

Gathering and analyzing the scan data along with assembling the submission itself was an enormous task, especially for a company the size of ENDRA. The process has taken a bit longer than we originally expected, [but] we're delighted to have made what we consider to be a first-rate submission to the FDA.

收集和分析掃描數據以及組裝提交本身是一項艱鉅的任務，特別是對於 ENDRA 這樣規模的公司而言。這個過程比我們最初預期的要長一些，[但是]我們很高興向 FDA 提交了我們認為是一流的材料。

Mike Thornton will provide more detail on our clinical and regulatory progress shortly. But before turning over to Mike, I'd like to mention a few other highlights from the second quarter.

Mike Thornton 將很快提供有關我們的臨床和監管進展的更多詳細信息。但在轉向邁克之前，我想提一下第二季度的其他一些亮點。

We showcased the TAEUS liver system at two major European clinical conferences. ENDRA participated in the German Diabetes Association's 57th DDG Annual Meeting in Berlin, which underscored the role of liver health in managing type two diabetes. Additionally, the company shared study findings in a peer reviewed clinical abstract titled, Thermoacoustic assessment of fatty liver disease - an early clinical feasibility study, at the esteemed European Association for the Study of the Liver Congress in Vienna, commonly known as EASL.

我們在兩個主要的歐洲臨床會議上展示了 TAEUS 肝臟系統。 ENDRA 參加了在柏林舉行的德國糖尿病協會第 57 屆 DDG 年會，該會議強調了肝臟健康在管理二型糖尿病中的作用。此外，該公司還在維也納著名的歐洲肝臟研究協會（通常稱為EASL）上分享了一份題為“脂肪肝疾病熱聲評估——一項早期臨床可行性研究”的同行評審臨床摘要中的研究結果。

This presentation served to elevate TAEUS profile amongst potential clinical users to support commercial adoption. At both conferences, in light of approaching commercial drug therapies targeting liver disease, we heard a lot of discussions about the clinical need for a safe and cost-effective way to suitably identify and monitor patients for their drug response, and this is where ENDRA intends to lead.

本次演示旨在提升潛在臨床用戶對 TAEUS 的了解，以支持商業採用。在這兩次會議上，鑑於針對肝病的商業藥物療法的接近，我們聽到了很多關於臨床需要一種安全且具有成本效益的方法來適當識別和監測患者藥物反應的討論，而這正是ENDRA 的目的領導。

In the second quarter, we also expanded our intellectual property portfolio to 64 issued patents globally. During the second quarter, ENDRA secured four additional patents, including one in the US and three in China. These newly issued patents not only reinforce ENDRA's unique position in assessing liver fat but also open the doors for other potential applications of our thermoacoustic technology.

第二季度，我們還將全球授權專利擴大至 64 項。第二季度，ENDRA 又獲得了四項專利，其中一項在美國，三項在中國。這些新頒發的專利不僅鞏固了 ENDRA 在評估肝臟脂肪方面的獨特地位，而且還為我們的熱聲技術的其他潛在應用打開了大門。

The company is actively exploring licensing opportunities in non-core indications to augment the value of our growing IP portfolio. Finally, in May of this year we raised approximately $4.7 million through an underwritten public offering. Management believes that ENDRA has sufficient cash to fund operations through several important milestones expected in 2023, including supporting commercial activities in Europe.

該公司正在積極探索非核心適應症的許可機會，以增加我們不斷增長的知識產權組合的價值。最後，今年 5 月，我們通過承銷公開發行籌集了約 470 萬美元。管理層認為，ENDRA 擁有足夠的現金來為預計在 2023 年實現幾個重要里程碑的運營提供資金，包括支持歐洲的商業活動。

Okay. Over to Mike Thornton for more detail on our clinical and regulatory progress. Mike?

好的。請聯繫 Mike Thornton，了解有關我們臨床和監管進展的更多詳細信息。麥克風？

Thank you, Francois. We're extremely pleased to have submitted our de novo request to the US FDA for the Thermo Acoustic Enhanced Ultrasound liver system, known as TAEUS. The clinical data submitted as part of our de novo application compared TAEUS estimates of liver fat fraction in 24 subjects to MRI liver fat fraction scores, also known as MRI-PDFF scores, in those same subjects.

謝謝你，弗朗索瓦。我們非常高興向美國 FDA 提交熱聲增強超聲肝臟系統（稱為 TAEUS）的從頭請求。作為我們從頭申請的一部分提交的臨床數據將 24 名受試者的 TAEUS 肝臟脂肪分數估計值與這些受試者的 MRI 肝臟脂肪分數分數（也稱為 MRI-PDFF 分數）進行了比較。

The study data submitted was consistent with our study design and only included study participants where the TAEUS ultrasound and MRI data was obtained successfully. Data was collected at a US site and involved volunteers with liver fat fraction ranging from healthy normal to severe fatty liver disease. The BMI of the subjects ranged from 24, which is normal, to 42, which is severely obese.

提交的研究數據與我們的研究設計一致，並且僅包括成功獲得 TAEUS 超聲和 MRI 數據的研究參與者。數據是在美國的一個網站收集的，涉及肝臟脂肪分數範圍從健康正常到嚴重脂肪肝疾病的志願者。受試者的BMI範圍為24（正常）到42（嚴重肥胖）。

It is significant to note that no subjects were excluded because of high BMI or liver fibrosis. TAEUS estimates of liver fat fraction were highly correlated to MRI-PDFF scores of liver fat fraction within our value of 0.78. The sensitivity of the TAEUS FLIP system in detecting fatty liver disease was 90% with specificity of 71%. To provide some reference of performance, the sensitivity of x-ray mammography in detecting breast cancer is approximately 87% with a specificity of 88%.

值得注意的是，沒有受試者因高 BMI 或肝纖維化而被排除。 TAEUS 對肝臟脂肪分數的估計與肝臟脂肪分數的 MRI-PDFF 評分高度相關，在我們的值 0.78 內。 TAEUS FLIP 系統檢測脂肪肝的敏感性為 90%，特異性為 71%。為了提供一些性能參考，X 射線乳房 X 線攝影檢測乳腺癌的敏感性約為 87%，特異性為 88%。

The negative predictive value, which is the probability of a negative test being correct, was 91%. Negative predictive value is an important measure of TAEUS performance because in a low cost -- in a cost constrained healthcare environment, it's often as important to correctly identify healthy subjects as it is to correctly identify those with the disease. We believe the submitted data with 24 subjects sufficiently supports our de novo application.

陰性預測值為 91%，即陰性測試正確的概率。陰性預測值是 TAEUS 性能的重要衡量標準，因為在低成本的情況下——在成本受限的醫療保健環境中，正確識別健康受試者通常與正確識別患有疾病的受試者一樣重要。我們相信提交的 24 名受試者數據足以支持我們的從頭申請。

In an additional submitted study of intra and inter-operator variability, no statistical significant differences were found between operators in estimating liver fat fraction with the TAEUS FLIP system for either an individual with normal liver fat fraction or an individual with moderate fatty liver disease. All operators demonstrated a highly statistically significant difference in comparing a healthy individual to an individual with moderate fatty liver disease using the TAEUS FLIP system. This is extremely encouraging and we're very happy to submit this data. This is an incredibly important technology milestone for ENDRA.

在另一項提交的操作者內部和操作者間變異性研究中，對於肝臟脂肪分數正常的個體或患有中度脂肪肝疾病的個體，使用TAEUS FLIP 系統估算肝臟脂肪分數時，操作者之間沒有發現顯著差異。所有操作員在使用 TAEUS FLIP 系統比較健康個體與患有中度脂肪肝疾病的個體時都表現出高度統計顯著差異。這是非常令人鼓舞的，我們很高興提交這些數據。對於 ENDRA 來說，這是一個極其重要的技術里程碑。

In terms of growing interest in point-of-care quantitative measures of liver fat fraction among clinicians, quantitative attenuation and backscatter applications for estimating fat fraction are now available from several vendors of premium diagnostic ultrasound systems.

鑑於臨床醫生對肝臟脂肪分數的即時定量測量越來越感興趣，目前多家優質診斷超聲系統供應商都提供用於估計脂肪分數的定量衰減和反向散射應用。

Although their use is largely limited to liver imaging in radiology, the interest in these quantitative measures goes far beyond radiology. ENDRA's thermoacoustic based approach to estimating liver fat leverages unique capabilities that potentially provide four significant advantages when compared to conventional ultrasound-based point-of-care approaches for assessing liver fat fraction.

儘管它們的用途主要限於放射學中的肝臟成像，但對這些定量測量的興趣遠遠超出了放射學。 ENDRA 基於熱聲的肝臟脂肪估計方法利用了獨特的功能，與傳統的基於超聲的現場護理方法評估肝臟脂肪分數相比，該方法可能具有四個顯著優勢。

The first of these advantages is molecular signal contrast. Unlike ultrasound approaches that are sensitive to structural changes in tissue, both TAEUS and MRI are sensitive to chemistry when differentiating fat from lean tissue. That means the thermoacoustic signal is directly related to the accumulation of fat molecules in liver cells that underlies the progression of fatty liver disease.

第一個優點是分子信號對比度。與對組織結構變化敏感的超聲方法不同，TAEUS 和 MRI 在區分脂肪和瘦組織時對化學反應敏感。這意味著熱聲信號與肝細胞中脂肪分子的積累直接相關，而肝細胞中的脂肪分子是脂肪肝疾病進展的基礎。

The second advantage of our approach is its insensitivity to fibrosis. Fibrosis is an excessive accumulation of extracellular proteins that is a common co-morbidity of fatty liver disease. Fibrosis is a significant confounding factor for ultrasound-based techniques and hinders their ability to estimate fat fraction accurately.

我們方法的第二個優點是它對纖維化不敏感。纖維化是細胞外蛋白質的過度積累，是脂肪肝疾病的常見並發症。纖維化是超聲技術的一個重要混雜因素，阻礙了它們準確估計脂肪分數的能力。

In contrast, thermoacoustic signal generation is relatively insensitive to the addition of extracellular proteins to lean tissue. And thus, the presence of fibrosis is largely inconsequential for thermoacoustics. In our clinical studies, we did not exclude any TAEUS exams with fibrosis.

相反，熱聲信號的產生對於向瘦組織中添加細胞外蛋白相對不敏感。因此，纖維化的存在對於熱聲學來說基本上是無關緊要的。在我們的臨床研究中，我們沒有排除任何伴有纖維化的 TAEUS 檢查。

The third advantage of TAEUS is tissue depth penetration. The loss of signal in obese patients is significantly lower for thermoacoustic signals than that of conventional ultrasound for two reasons. First, the distance thermoacoustic signals travel is half the distance of that conventional ultrasound pulse travels. And secondly, thermoacoustic signal detected with the TAEUS FLIP system are much lower in frequency than the standardized 3.5 megahertz transmit receive signal in conventional ultrasound approaches to estimating live fat fraction.

TAEUS 的第三個優點是組織深度穿​​透。肥胖患者的熱聲信號損失明顯低於傳統超聲，原因有二。首先，熱聲信號傳播的距離是傳統超聲波脈衝傳播距離的一半。其次，使用 TAEUS FLIP 系統檢測到的熱聲信號的頻率遠低於估計活體脂肪分數的傳統超聲方法中的標準化 3.5 兆赫發射接收信號。

Thus, the difficult to image patients, large or obese patients, conventional signal attenuation in ultrasound can be many orders of magnitude greater than thermoacoustic. As a result, thermoacoustic method are potentially more effective than ultrasound-based approaches to quantifying fat fraction in high BMI subjects. We excluded no subjects from our FDA submission for reasons of high BMI.

因此，對於難以成像的患者、體型較大或肥胖的患者，超聲中的傳統信號衰減可能比熱聲信號衰減大許多數量級。因此，在量化高 BMI 受試者的脂肪分數方面，熱聲方法可能比基於超聲的方法更有效。我們沒有因高 BMI 原因將受試者排除在 FDA 提交文件之外。

And the fourth advantage of TAEUS is within image calibration. ENDRA's TAEUS approach to estimating liver fat fraction is unique in that each measurement has its own integral calibration data derived from the individual's own fat and muscle that is contained in each measurement. That ensures measurement uniformity across individuals and across devices. Several other point of care devices in the market require periodic calibration and have varying efficacy across patient size that should not be present with the TAEUS device.

TAEUS 的第四個優勢在於圖像校準。 ENDRA 估算肝臟脂肪分數的 TAEUS 方法的獨特之處在於，每次測量都有自己的積分校準數據，這些數據源自每次測量中包含的個人自身脂肪和肌肉。這確保了個人和設備之間的測量一致性。市場上的其他幾種護理點設備需要定期校準，並且根據患者體型的不同而具有不同的功效，而 TAEUS 設備不應該出現這種情況。

In terms of next steps and timeframes for the FDA review process going forward, there are a number of elements that should be considered. First, ENDRA submitted its de novo request via the FDA's electronic Submission Template and Resource tool, known as eSTAR, which guides applicants through the submission process with a standardized online format, ensuring the submission is complete and structured in a way that facilitates efficient review by the FDA.

就 FDA 審查流程的後續步驟和時間表而言，有許多因素需要考慮。首先，ENDRA 通過 FDA 的電子提交模板和資源工具（稱為 eSTAR）提交了從頭請求，該工具以標準化的在線格式指導申請人完成提交流程，確保提交的完整性和結構性，以促進高效審查。 FDA。

Second, we can expect back-and-forth dialogue with the FDA. The FDA's published goal is to make a decision within 150 days of submission. Investors should remember that the FDA routinely engages in interactive discussions with companies in seeking additional information or clarification.

其次，我們可以期待與 FDA 的反復對話。 FDA 公佈的目標是在提交後 150 天內做出決定。投資者應該記住，FDA 經常與公司進行互動討論，以尋求更多信息或澄清。

One factor that may benefit ENDRA during the review process is the FDA's familiarity with our previous 510(k) submission and our interactions in that review process that details our technology's principle of operation and safety profile. Naturally, ENDRA will keep investors informed of material updates as we advance through the FDA process.

在審查過程中可能使 ENDRA 受益的一個因素是 FDA 熟悉我們之前提交的 510(k) 申請以及我們在審查過程中的互動，其中詳細介紹了我們技術的操作原理和安全概況。當然，隨著 FDA 流程的進展，ENDRA 會隨時向投資者通報材料更新。

Now, I'd like to turn the call over to Irina to review the financial results for the second quarter of 2023. Irina?

現在，我想將電話轉給 Irina，審核 2023 年第二季度的財務業績。Irina？

Thank you, Mike. For the quarter ended June 30, 2023, our operating expenses decreased to $3 million from $3.6 million for the same period in 2022. The decrease was mainly due to a decrease in research and development and sales and marketing expenses. Our research and development expenses decreased year over year by approximately $450,000 as we completed the development of our initial TAEUS products.

謝謝你，邁克。截至2023年6月30日的季度，我們的運營費用從2022年同期的360萬美元減少至300萬美元。減少的主要原因是研發以及銷售和營銷費用的減少。隨著我們完成了最初的 TAEUS 產品的開發，我們的研發費用同比減少了約 450,000 美元。

Our sales and marketing expenses decreased by approximately $95,000 for the quarter, mainly due to the departure of our Chief Commercial Officer. General and administrative expenses decreased by approximately $35,000 due to decreased spending on professional fees.

本季度我們的銷售和營銷費用減少了約 95,000 美元，主要是由於我們的首席商務官的離職。由於專業費用支出減少，一般和行政費用減少了約 35,000 美元。

Net loss per share in the second quarter of 2023 was $0.43 per share compared with a net loss of $1.17 per share in the second quarter of 2022. Cash and cash equivalents were $4.8 million as of June 30, 2023.

2023 年第二季度每股淨虧損為 0.43 美元，而 2022 年第二季度每股淨虧損為 1.17 美元。截至 2023 年 6 月 30 日，現金和現金等價物為 480 萬美元。

During the second quarter of 2023, the company raised approximately $4.7 million in net proceeds through an underwritten public offering. We believe our current capital position provides a runway into the fourth quarter of 2023.

2023 年第二季度，該公司通過承銷公開發行籌集了約 470 萬美元的淨收益。我們相信，我們目前的資本狀況為 2023 年第四季度提供了基礎。

We maintain our asset-light operating model with prudent hires in our operations and commercial team in anticipation of future growth. As we execute our regulatory and commercial strategy for TAEUS, we plan to adjust our expense structure accordingly in support of these activities.

我們維持輕資產運營模式，謹慎招聘運營和商業團隊，以應對未來的增長。當我們執行 TAEUS 的監管和商業策略時，我們計劃相應地調整我們的費用結構以支持這些活動。

Now, I'll turn the call back to Francois.

現在，我將把電話轉回給弗朗索瓦。

Thanks very much, Irina and Mike. In closing, during the second quarter and subsequent weeks, ENDRA has made a great amount of important progress. I couldn't be more proud of the business. As we've discussed, we submitted our FDA de novo request for the TAEUS liver application with confidence that our work will set a benchmark for new product class. We had our first TAEUS liver clinical abstract published by the leading European Association for the Study of the Liver. And third, we raised capital with long-term investors to support key milestones throughout the second half of 2023.

非常感謝，伊琳娜和邁克。最後，在第二季度和隨後的幾週內，ENDRA 取得了巨大的重要進展。我對這項業務感到非常自豪。正如我們所討論的，我們向 FDA 提交了 TAEUS 肝臟應用的從頭請求，並相信我們的工作將為新產品類別樹立基準。我們的第一份 TAEUS 肝臟臨床摘要由領先的歐洲肝臟研究協會發表。第三，我們與長期投資者籌集資金，以支持 2023 年下半年的關鍵里程碑。

Mike spoke about the next steps and timetable between ENDRA and the FDA, and I remind listeners that although there are various due dates in place for regulatory reviews and processes, we don't control the FDA process. However, I can assure you we'll do everything necessary to keep things moving along quickly and productively. And we obviously commit to keeping shareholders apprised of developments with the agency during our quarterly conference calls and to make public announcements when there are material developments to report.

Mike 談到了 ENDRA 和 FDA 之間的後續步驟和時間表，我提醒聽眾，儘管監管審查和流程有不同的截止日期，但我們無法控制 FDA 流程。不過，我可以向您保證，我們將採取一切必要措施，讓事情快速有效地進行。我們顯然致力於在季度電話會議期間向股東通報該機構的進展情況，並在有重大進展需要報告時發佈公告。

In closing, I couldn't be more excited about the future of TAEUS and the future of ENDRA. The US represents the largest market opportunity for TAEUS and we're confident that our technology's various advantages along with a price that's 150th the cost of MRI will secure a place for TAEUS in the hands of clinicians.

最後，我對 TAEUS 和 ENDRA 的未來感到非常興奮。美國是 TAEUS 最大的市場機會，我們相信我們的技術的各種優勢以及 MRI 成本 150 倍的價格將為 TAEUS 在臨床醫生手中贏得一席之地。

So with that overview, I'd like to turn the call over for questions. Operator?

有了這個概述，我想轉過來詢問問題。操作員？

Thank you. We will now begin the question-and-answer session. (Operator Instructions) Ed Woo with Ascendiant Capital.

謝謝。我們現在開始問答環節。 （操作員指示）Ed Woo 與 Ascendiant Capital。

Yeah. I wanted to say congratulations for the submission today. It was very good news and I wish you guys all the best in getting your quick approval. My question is you previously had a distribution agreement in Vietnam. Is that still in place? And will you -- I think previously it was, you will recognize revenue as soon as you get US FDA approval. Is that correct?

是的。我想對今天的提交表示祝賀。這是一個非常好的消息，我祝愿你們一切順利，盡快獲得批准。我的問題是你們之前在越南簽訂了分銷協議。那還在嗎？我認為以前是這樣，一旦獲得美國 FDA 的批准，您就會確認收入。那是對的嗎？

Good question. Yeah. So the exclusive distribution agreement with distributor in Vietnam is in place and it takes effect and is activated by the approval -- by the FDA of our application in the US. That will kick off a three-year process with a commitment of 40 systems at an agreed upfront transfer price. So that is a good example of an important but secondary market opportunity that is going to be directly revenue generating in addition to Europe, where we're currently focused, then the US, and then, as you pointed out, other opportunities like Vietnam through partners.

好問題。是的。因此，與越南經銷商的獨家經銷協議已經生效，並在 FDA 批准我們在美國的申請後生效並激活。這將啟動一個為期三年的進程，承諾以商定的預付款轉讓價格購買 40 個系統。因此，這是一個重要但二級市場機會的好例子，除了我們目前關注的歐洲，然後是美國，然後，正如您所指出的，還有越南等其他機會，這些機會將直接產生收入夥伴。

Great. And then my next question is, how much commercialization efforts can you do now in the US before you get approval? Are you able to really get things up and running or do you still have to kind of wait until you get the formal approval?

偉大的。那麼我的下一個問題是，在獲得批准之前，你現在在美國可以做多少商業化努力？您是否能夠真正讓事情啟動並運行，還是仍然需要等到獲得正式批准？

Yeah. Good question. If I might, I'll sort of put it under the broader umbrella of commercialization. And we expect to record our first sales in Europe before the end of the year. But it's important to understand, as you're asking, that we've been putting in place a number of key elements to support a successful commercial ramp, both in international markets as well as the US pending the FDA clearance up.

是的。好問題。如果可以的話，我會將其置於更廣泛的商業化保護之下。我們預計將在年底前在歐洲實現首次銷售。但重要的是要了解，正如您所問的那樣，我們已經在國際市場和美國市場上製定了一些關鍵要素來支持成功的商業增長，等待 FDA 的批准。

First, I'd say, we've been building our base of clinical market awareness by participating in key medical conferences and by hosting people in our exhibit and our booth. So as a case in point, although we've been at EASL and focusing on Europe, we are attending and we'll have a booth at the American Association for Study of Liver Disease, which is the preeminent liver society in the US in November being held in Boston.

首先，我想說，我們一直通過參加重要的醫學會議以及在我們的展覽和展位上接待人們來建立我們的臨床市場意識基礎。因此，作為一個恰當的例子，儘管我們參加了 EASL 並專注於歐洲，但我們將參加美國肝病研究協會，並且我們將在 11 月份的美國肝臟疾病研究協會設立一個展位。在波士頓舉行。

And second, we were delighted to have the EASL peer-reviewed abstract publication. And building now on our submission with the FDA, we're going to continue to build our base of clinical evidence and sharing it broadly as it comes in. So that applies and is interesting to clinicians all over the world. We've had the abstract from EASL already translated into multiple languages and it's something that we're sharing that's on our website for US customers along with everyone else.

其次，我們很高興獲得 EASL 同行評審的摘要出版物。現在，在我們向 FDA 提交的文件的基礎上，我們將繼續建立我們的臨床證據基礎，並在收到後廣泛分享。因此，這適用於世界各地的臨床醫生，並且對他們很有趣。我們已經將 EASL 的摘要翻譯成多種語言，並在我們的網站上向美國客戶以及其他所有人分享。

The third and, I'd say, final thing is you've heard a lot this year about how we've been gaining real world clinical user feedback and improving our system through user training, the development of active software guidance, and these are key considerations we're putting in place that are global in nature and that will benefit customers globally. Because learning how they use the product and how we should train them, how we should help them perform their job more effectively and giving them a good experience is really the bedrock of our system.

第三件事，我想說的最後一件事是，今年您已經聽到很多關於我們如何獲得現實世界臨床用戶反饋並通過用戶培訓、開發主動軟件指導來改進我們的系統的信息，這些是我們正在實施的關鍵考慮因素本質上是全球性的，將使全球客戶受益。因為了解他們如何使用產品以及我們應該如何培訓他們，我們應該如何幫助他們更有效地完成工作並為他們提供良好的體驗，這確實是我們系統的基石。

If our system works only in the hands of experts that are highly supervised, that's going to be tough to kind of scale the business. And we feel like these improvements, the clinical data we've supported and built this year is going to be globally valuable, so for the Europe and the US as you were asking. I hope that's helpful.

如果我們的系統只能在受到嚴格監督的專家手中運行，那麼擴展業務將變得困難。我們覺得這些改進，我們今年支持和建立的臨床數據將具有全球價值，所以對於歐洲和美國來說，正如你所問的那樣。我希望這有幫助。

Yeah, that's very helpful. Thank you for answering my questions and I wish you guys good luck. Thank you.

是的，這非常有幫助。感謝您回答我的問題，祝你們好運。謝謝。

Thank you, again, Ed.

再次感謝你，艾德。

This concludes our question-and-answer session. I would like to turn the conference back over to Francois Michelon for any closing remarks.

我們的問答環節到此結束。我想將會議轉回弗朗索瓦·米歇爾 (Francois Michelon) 發表閉幕詞。

Great. Well, at this point, I just want to thank everyone for joining us today. A lot of work, a lot of accomplishments in the quarter through today with the FDA announcement. We look forward to keeping everyone updated on our progress and to speaking with you again on our next quarterly conference call. Have a nice evening.

偉大的。好吧，此時此刻，我只想感謝大家今天加入我們。隨著 FDA 的宣布，截至今天這個季度我們做了很多工作，取得了很多成就。我們期待著向大家通報我們的最新進展，並在下一個季度的電話會議上再次與您交談。祝你今晚愉快。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。