ENDRA Life Sciences Inc (NDRA) 2023 Q3 法說會逐字稿

Good day, and welcome to the ENDRA Life Sciences third-quarter 2023 financial results conference call. (Operator Instructions)

美好的一天，歡迎參加 ENDRA 生命科學 2023 年第三季財務業績電話會議。 （操作員說明）

Please note this event is being recorded.

請注意此事件正在被記錄。

I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

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 third-quarter 2023 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic, which is available in the Investors section of ENDRA's website.

謝謝你，接線生。我是 LHA 的伊馮布里格斯 (Yvonne Briggs)。下午好，歡迎參加 ENDRA 2023 年第三季業務更新和財務業績電話會議。今天早些時候，ENDRA 發布了有關此主題的新聞稿，可在 ENDRA 網站的投資者部分獲取該新聞稿。

Before we begin, please note that today's discussion will include forward-looking statements. All statements by management other than statements of historical facts, including 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，包括有關公司策略、財務狀況、營運、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；有關監管流程的潛在合作機會和期望；收到所需的監管許可和產品發布均屬於前瞻性聲明。

Except as required by 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.

除證券法要求外，本公司不承擔更新或修改任何前瞻性聲明的義務。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，以了解有關前瞻性陳述相關風險和不確定性的更多資訊。

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 third-quarter financial results.

就今天電話會議的結構而言，董事長兼執行長 Franois Michelon 將開始準備好的演講；其次是 ENDRA 技術長 Michael Thornton。 Thornton 先生將由資深財務長 Irina Pestrikova 負責審查第三季的財務表現。

With that said, I'll now turn the call over to Francois Michelin. Francois?

話雖如此，我現在將把電話轉給弗朗索瓦·米其林。弗朗索瓦？

Thank you, Yvonne, and good afternoon, everyone, and thanks for joining us today to discuss ENDRA's third quarter 2023 financial results and business highlights. I'm delighted by the momentum that's building for our Thermo Acoustic Enhanced Ultrasound liver system known as TAEUS. This momentum checks a number of boxes, including clinical, regulatory and commercial, along with the convergence of a number of factors that put ENDRA in the right place at the right time.

謝謝 Yvonne，大家下午好，感謝您今天加入我們討論 ENDRA 2023 年第三季的財務業績和業務亮點。我對我們的熱聲增強超音波肝臟系統（TAEUS）正在形成的勢頭感到高興。這種勢頭檢查了許多方面，包括臨床、監管和商業，以及使 ENDRA 在正確的時間出現在正確的地點的許多因素的融合。

I spent the last few days at The Liver Meeting held by the American Association for Study of Liver Diseases where we interacted with experts in the field, clinical users, prospective customers, and partners. Steatotic liver disease, known as SLD, is the umbrella term for a multifaceted metabolic disorder, resulting in too much fat in the liver.

過去幾天，我參加了美國肝病研究協會舉辦的肝臟會議，我們與該領域的專家、臨床使用者、潛在客戶和合作夥伴進行了互動。脂肪性肝病（稱為 SLD）是多方面代謝紊亂的總稱，會導致肝臟中脂肪過多。

Anything over 5% liver fat is of clinical significance, and this fat can irritate an inflamed liver then scar it, and ultimately, lead to irreversible end-stage liver disease. Steatotic liver disease is estimated to affect more than 2 billion people worldwide and is predicted to become the leading root cause of liver transplant in the US by 2030.

任何超過 5% 的肝臟脂肪都具有臨床意義，這種脂肪會刺激發炎的肝臟，然後使其留下疤痕，最終導致不可逆轉的終末期肝病。據估計，脂肪肝病將影響全球超過 20 億人，預計到 2030 年將成為美國肝臟移植的主要原因。

The American Association of Clinical Endocrinology and the American Diabetes Association have updated their guidelines over the past 18 months to include the screening for fatty liver in adults with obesity, pre-diabetes, and type 2 diabetes.

美國臨床內分泌協會和美國糖尿病協會在過去 18 個月更新了其指南，納入了肥胖、糖尿病前期和 2 型糖尿病成人的脂肪肝篩檢。

The good news is that the new GLP-1 obesity drugs have demonstrated clinically significant reductions in liver fat and a rich pipeline of targeted therapies to treat SLD in both obese and non-obese patients is approaching commercialization, with the first drug approvals expected in early 2024. This intersection of variables -- a heavy public health burden, a lack of practical diagnostic tools, and the near-term availability of the first treatments -- creates an opportunity to address the large unmet clinical need for a non-invasive cost effective tool to assist in identifying and monitoring patients. That's where ENDRA intends to lead.

好消息是，新的GLP-1 肥胖藥物已在臨床上證明可以顯著減少肝臟脂肪，並且用於治療肥胖和非肥胖患者的SLD 的豐富的標靶治療藥物正在接近商業化，首批藥物預計將於年初獲得批准。2024 年。這些變數的交叉——沉重的公共衛生負擔、缺乏實用的診斷工具以及近期可獲得的第一種治療方法——創造了一個機會來解決對非侵入性成本效益的大量未滿足的臨床需求。幫助識別和監測患者的工具。這就是 ENDRA 打算引領的方向。

As discussed on our last conference call, we submitted the TAEUS de novo request to the FDA on August 14 of this year. And since then, the submission has entered the substantive review period. The de novo submission was a significant milestone for ENDRA as this regulatory pathway should strengthen our competitive position with distinctive patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of liver fat.

正如我們在上次電話會議上討論的那樣，我們在今年 8 月 14 日向 FDA 提交了 TAEUS de novo 請求。自此，該意見書進入實質審查期。從頭提交對於 ENDRA 來說是一個重要的里程碑，因為這一監管途徑應透過獨特的專利保護功能作為一種非侵入性護理點工具來幫助表徵肝臟脂肪，從而加強我們的競爭地位。

We look forward to working with the FDA during the review process and the FDA's published goal to make a decision on a de novo requests within 150 review days.

我們期待在審查過程中與 FDA 合作，FDA 公佈的目標是在 150 審查天內就 de novo 請求做出決定。

Since our FDA submission. We've had our second positive clinical dataset reviewed and accepted for presentation by the European Association for Study of the Liver. These clinical abstracts are available on ENDRA's website under the tab Research and Media.

自從我們向 FDA 提交以來。我們的第二個陽性臨床數據集已被歐洲肝臟研究協會審查並接受提交。這些臨床摘要可在 ENDRA 網站的「研究和媒體」標籤下找到。

The most recent abstract includes 45 subjects comparing ENDRA's TAEUS liver measurements to MRI, and we're very pleased with the results. We believe the data in these published abstracts and related presentations are crucial to building awareness of the TAEUS system and its capabilities with clinical users and to supporting commercial adoption of our new technology. The clinical data is the most critical element for getting commercial traction with clinical customers. Mike Thornton will provide more detail on our clinical data in a moment.

最新摘要包括 45 名受試者，將 ENDRA 的 TAEUS 肝臟測量結果與 MRI 進行比較，我們對結果非常滿意。我們相信，這些已發表的摘要和相關簡報中的數據對於提高臨床使用者對 TAEUS 系統及其功能的認識以及支持我們新技術的商業採用至關重要。臨床數據是獲得臨床客戶商業吸引力的最關鍵要素。麥克桑頓稍後將提供有關我們臨床數據的更多詳細資訊。

In terms of commercial activities, we've been actively showcasing our TAEUS liver system at the key clinical conferences in hepatology, endocrinology, and radiology in our target markets of the UK, Germany, France and the US. We've participated in eight clinical conferences this year, including five since September, namely the British Association for Study of the Liver, European Association for the Study of Diabetes, French Society for Hepatology, (inaudible), which is the annual meeting of the ultrasound societies in Germany, Austria, and Switzerland. And I've just returned with Mike Thornton from the American Association for the Study of Liver Diseases in Boston, which is the preeminent liver meeting in the US.

在商業活動方面，我們一直在英國、德國、法國和美國目標市場的肝病學、內分泌學和放射學重要臨床會議上積極展示我們的 TAEUS 肝臟系統。今年我們參加了八次臨床會議，其中五次是從九月開始的，分別是英國肝臟研究協會、歐洲糖尿病研究協會、法國肝病學會（聽不清楚），這是肝臟研究協會的年會。德國、奧地利和瑞士的超音波學會。我剛剛與波士頓美國肝病研究協會的 Mike Thornton 一起回來，該協會是美國最重要的肝臟會議。

We also sponsored a great multidisciplinary panel discussion on liver disease, while at AASLD from the perspective of a hepatologist, the liver experts; and endocrinologists, the metabolic obesity and diabetes experts; and a radiologist, the imaging experts. Steatotic liver disease resonates with each of these specialties and there's a growing interest in the primary care arena as well.

我們也贊助了一場關於肝病的大型多學科小組討論，在 AASLD 上從肝病專家、肝臟專家的角度進行了討論；內分泌學家、代謝性肥胖和糖尿病專家；以及放射科醫師、影像專家。脂肪肝疾病與這些專業產生共鳴，人們對初級保健領域的興趣也越來越大。

Turning to intellectual property, we continued to bolster our portfolio and recently achieved a great new milestone of 70 issued patents with three additional patents issued during the third quarter and three more patents issued in Q4 thus far.

談到智慧財產權，我們繼續加強我們的產品組合，最近實現了 70 項已發布專利的新里程碑，其中第三季又發布了三項專利，第四季迄今又發布了三項專利。

A portfolio with 70 issued patents and no in-licensing dependencies is a remarkable achievement for a company of our size and a testament to the innovation of ENDRA and the proprietary nature of our technology. These newly issued patents protect and further differentiate ENDRA's Thermo Acoustic systems in areas of high unmet clinical need, such as the early detection of steatotic liver disease. The company is also actively exploring licensing opportunities in non-core indications with outside partners to augment the value of our growing intellectual property portfolio.

擁有 70 項已發布專利且不存在許可依賴關係的產品組合對於我們這樣規模的公司來說是一項了不起的成就，也證明了 ENDRA 的創新和我們技術的專有性質。這些新頒發的專利保護了 ENDRA 的 Thermo Acoustic 系統，使其在臨床需求未得到高度滿足的領域（例如脂肪肝病的早期檢測）進一步脫穎而出。該公司也積極與外部合作夥伴探索非核心適應症的授權機會，以增加我們不斷增長的智慧財產權組合的價值。

With that update, I'll turn the call over to Mike Thornton for more details on our clinical and regulatory progress. Michael?

更新後，我將把電話轉給 Mike Thornton，以了解有關我們臨床和監管進展的更多詳細資訊。麥可？

Thank you, Francois. We're very pleased to have submitted a de novo request to the FDA for our TAEUS system in August and to report that our file has advanced the substantive review stage. At this point, we're engaged with the FDA in addressing their questions in a timely and complete manner to keep advancing the process. As we noted earlier, if there are any significant updates, we'll share those with shareholders as we've always done.

謝謝你，弗朗索瓦。我們很高興在 8 月向 FDA 提交了對我們的 TAEUS 系統的重新請求，並報告說我們的文件已進入實質審查階段。目前，我們正在與 FDA 合作，及時、完整地解決他們的問題，以繼續推進這一進程。正如我們之前指出的，如果有任何重大更新，我們將像往常一樣與股東分享。

As Francois mentioned, our clinical study activities support both our regulatory and early commercialization efforts. Our second presentation of clinical data was presented at the recent European Association for the Study of Liver Diseases, Steatotic Liver Disease Summit in September.

正如弗朗索瓦所提到的，我們的臨床研究活動支持我們的監管和早期商業化工作。我們的第二次臨床數據展示是在最近於 9 月舉行的歐洲肝病研究協會脂肪肝病高峰會上進行的。

The clinical study that was presented included 45 study participants exams comparing TAEUS' estimates of liver fat fraction to the established gold standard, MRI measurements, of liver fat fraction. The study cohort included a wide range of body size with body mass index ranging from 24, that is normal, to 45, which is classified as Class III obesity.

所提交的臨床研究包括 45 名研究參與者的檢查，將 TAEUS 的肝臟脂肪分數估計值與既定的肝臟脂肪分數黃金標準 MRI 測量值進行比較。研究族群包括各種體型，體重指數範圍從 24（正常）到 45（被歸類為 III 級肥胖）。

The cohort included four study participants with confirmed fibrosis. No study subjects were excluded due to high body mass index or liver fibrosis. This is a key point. Conventional quantitative ultrasound methods are not able to accurately estimate the liver fat fraction in individuals with high body mass index, and often, overestimate liver fat fraction in subjects with confirmed liver fibrosis.

該隊列包括四名已確診纖維化的研究參與者。沒有研究對象因高體重指數或肝纖維化而被排除。這是一個關鍵點。傳統的定量超音波方法無法準確估計高體重指數個體的肝臟脂肪分數，並且常常高估已確診肝纖維化受試者的肝臟脂肪分數。

In other wards, conventional tools for the assessment of stereotactic liver disease are not capable of accurately assessing the wide range of possible patient body size and medical conditions, which creates an urgent market need for a device like TAEUS.

在其他病房，用於評估立體定位肝病的傳統工具無法準確評估各種可能的患者體型和醫療狀況，這對 TAEUS 等設備產生了迫切的市場需求。

The TAEUS system estimates of liver fat fraction in this study were highly correlated to MRI-PDFF scores of liver fat fraction with a correlation coefficient r-value of 0.87. In biology and medicine, two variables are considered to be strongly correlated if the Pearson correlation coefficient is greater than 0.8 and that a large part of the measurement variation in the gold standard measurement can be explained by the new measurement method.

本研究中 TAEUS 系統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，相關係數 r 值為 0.87。在生物學和醫學中，如果皮爾森相關係數大於0.8，則兩個變數被認為是強相關的，並且金標準測量中的很大一部分測量變異可以透過新的測量方法來解釋。

The sensitivity of TAEUS in detecting fatty liver disease was 95% with a specificity of 77%. The negative predictive value, which is the probability that a negative test result is correct, was 95%. Negative predictive value is an important measure of test performance. Because in a cost constrained healthcare environment, it is often important to correctly identify healthy subjects and preclude additional costs as it is to identify those individuals with the disease.

TAEUS 檢測脂肪肝的敏感性為 95%，特異性為 77%。陰性預測值為 95%，即陰性檢測結果正確的機率。陰性預測值是測試表現的重要衡量標準。因為在成本有限的醫療保健環境中，正確識別健康受試者並排除額外費用通常很重要，因為它是識別患有疾病的個體。

We're excited by the performance of the system, and our aim is to continue to expand the collection of clinical data and to publish results from our clinical collaborations. In support of this effort, we have recently deployed a TAEUS flip system to a new US clinical collaborator site and are scheduling a European study site deployment in the next few weeks.

我們對該系統的表現感到興奮，我們的目標是繼續擴大臨床數據的收集並發布我們臨床合作的結果。為了支持這項工作，我們最近在一個新的美國臨床合作中心部署了 TAEUS 翻轉系統，並計劃在未來幾週內在歐洲研究中心進行部署。

These new clinical study sites, along with the authorization for new studies at past clinical collaborator sites, will drive our goal of obtaining several hundreds of study participant exams with our approach to estimating liver fat fraction.

這些新的臨床研究地點，以及過去臨床合作地點的新研究授權，將推動我們的目標，即透過我們估計肝臟脂肪分數的方法獲得數百名研究參與者的檢查。

As Francois mentioned, we recently participated in the American Association for the Study of Liver Disease Annual Meeting in Boston, where we showcased the TAEUS system and highlight its capabilities. Our system generated a great deal of interest from both healthcare providers and industry attendees.

正如 Francois 所提到的，我們最近參加了在波士頓舉行的美國肝病研究協會年會，我們在會議上展示了 TAEUS 系統並強調了其功能。我們的系統引起了醫療保健提供者和行業參與者的極大興趣。

During the conference, we also hosted a panel discussion of multidisciplinary experts in the fields of hepatology, endocrinology, and radiology, and a discussion of the multidisciplinary nature of the diagnosis, treatment, and management of metabolic-associated steatotic liver disease.

會議期間，我們還主辦了肝病學、內分泌學和放射學領域多學科專家的小組討論，並討論了代謝相關脂肪性肝病的診斷、治療和管理的多學科性質。

The discussion highlighted the importance of liver fat fraction as a biomarker of diseases that expand beyond the liver namely hypertension, diabetes, cardiovascular disease, and the increased risk of cancer that will drive interest in our technology beyond hepatology. To further upside the relationship between steatotic liver disease and the complex of diseases that makeup metabolic syndrome, recent GLP-1 obesity drug studies have illustrated the relationship between weight loss, a reduction in liver fat fraction, and cardiovascular disease risk.

討論強調了肝臟脂肪分數作為肝臟以外疾病（即高血壓、糖尿病、心血管疾病）的生物標記的重要性，以及癌症風險的增加，這將引起人們對肝病學以外的技術的興趣。為了進一步闡明脂肪肝病與代謝症候群的複雜疾病之間的關係，最近的 GLP-1 肥胖藥物研究闡明了體重減輕、肝臟脂肪分數減少和心血管疾病風險之間的關係。

Overall, the discussion with clinicians and the focus on issues directly addressed by TAEUS during the panel discussion demonstrates not only a clear market need for our system, but also an awareness and urgency from practitioners, which we are hopeful will soon translate into our first sales.

總體而言，與臨床醫生的討論以及小組討論期間對TAEUS 直接解決的問題的關注不僅表明了我們系統的明確市場需求，而且表明了從業者的意識和緊迫性，我們希望這將很快轉化為我們的第一筆銷售。

Now I'd like to turn the call over to Irina to review our financial results for the third quarter of 2023.

現在我想將電話轉給 Irina，讓她審查我們 2023 年第三季的財務表現。

Irina?

伊琳娜？

Thank you, Mike. For the quarter ended September 30, 2023, our operating expenses decreased to $3.1 million from $3.4 million for the same period in 2022. The decrease was mainly due to a decrease in research and development and sales and marketing expenses.

謝謝你，麥克。截至2023年9月30日的季度，我們的營運費用從2022年同期的340萬美元減少至310萬美元。減少的主要原因是研發以及銷售和行銷費用的減少。

Our research and development expenses decreased year over year by approximately $197,000 as we completed the development of our initial TAEUS product. Our sales and marketing expenses decreased by approximately $177,000, mainly due to the departure of our Chief Commercial Officer.

隨著我們完成了最初的 TAEUS 產品的開發，我們的研發費用比去年同期減少了約 197,000 美元。我們的銷售和行銷費用減少了約 177,000 美元，主要是由於我們的首席商務官的離職。

General administrative expenses increased by approximately $86,000 due to higher spending on professional fees. Net loss in the third quarter of 2023 was $3.1 million or $0.4 per share. And this compares with a net loss of $3.4 million or $1.9 per share in the third quarter of 2022.

由於專業費用支出增加，一般管理費用增加了約 86,000 美元。 2023 年第三季淨虧損為 310 萬美元，即每股 0.4 美元。相比之下，2022 年第三季淨虧損為 340 萬美元，即每股淨虧損 1.9 美元。

Cash and cash equivalents were $3.3 million as of September 30, 2023. In the third quarter, we raised a total of $1.2 million in gross proceeds from the sale of common stock through our ATM facility. We believe our current capital position provides a runway into the first quarter of 2024, and we are currently evaluating alternatives to raise capital to provide for our future funding needs.

截至 2023 年 9 月 30 日，現金和現金等價物為 330 萬美元。第三季度，我們透過 ATM 設施出售普通股籌集了總計 120 萬美元的總收益。我們相信，我們目前的資本狀況為 2024 年第一季提供了一條通道，我們目前正在評估籌集資金的替代方案，以滿足我們未來的融資需求。

We'll maintain our asset-light operating model with further 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.

我們將維持輕資產營運模式，並進一步招募營運和商業團隊，以應對未來的成長。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, we remain very excited about the value proposition for TAEUS as a non-invasive cost effective tool to assess liver fat, especially as the clinical community prepares for the near-term arrival of the first treatments targeting the disease, which affects 2 billion people worldwide.

非常感謝，伊琳娜和麥克。最後，我們對TAEUS 作為評估肝臟脂肪的非侵入性成本有效工具的價值主張感到非常興奮，特別是當臨床界正在為第一批針對該疾病的治療方法近期到來做準備時，該疾病影響了20億人世界各地的人們。

ENDRA's near-term focus is on the following four value-added catalysts: number one, securing the first commercial orders for our TAEUS technology in Europe, where we have the CE mark; second, supporting the FDA through their review process with a goal of achieving a favorable de novo decision for ENDRA; third, commercializing in the US market upon FDA approval along with our Vietnam distribution agreement that is tied to the FDA approval; and fourth, continuing to grow and diversify our base of clinical evidence at clinical study partner sites in our target markets in Europe and the US to support commercial adoption of our technology.

ENDRA 的近期重點是以下四個增值催化劑：第一，在歐洲獲得 TAEUS 技術的第一批商業訂單，我們在歐洲擁有 CE 標誌；其次，支持 FDA 完成審查流程，目標是為 ENDRA 做出有利的從頭決定；第三，在 FDA 批准後在美國市場商業化，以及與 FDA 批准相關的越南分銷協議；第四，繼續擴大我們在歐洲和美國目標市場的臨床研究合作夥伴站點的臨床證據基礎並使其多樣化，以支持我們技術的商業採用。

With that overview of our business and recent financial performance, I'd like to now open the call for questions. Operator?

在概述了我們的業務和最近的財務表現之後，我現在想開始提問。操作員？

(Operator Instructions)

（操作員說明）

Edward Woo, Ascendiant Capital.

吳宇森，Ascendian Capital。

Hi, Ed.

嗨，艾德。

Yeah. Congratulations on the progress. I had a question about the de novo submission. You said that target of 180 days. Does the FDA typically keep it at 180? Or is there a possibility that it could be quicker depending on the review?

是的。祝賀取得的進展。我對從頭提交有疑問。你說的目標是180天。 FDA 通常將其保持在 180 嗎？或者根據審查是否有可能更快？

Yes, it's actually -- I don't know if I misspoke or my voice wasn't clear, it's 150 days of review time. And you know, that includes everything from invasive, higher risk products to a lower risk product. It's a bell curve.

是的，實際上是──不知道是我說錯了還是我的聲音不清楚，現在是150天的審稿時間。你知道，這包括從侵入性、高風險產品到低風險產品的一切。這是一條鐘形曲線。

I don't want to get any more specific than that. But obviously, there is a possibility of being somewhere around that. I just wanted to give what's the official sort of target coming from the FDA. And I hope now that we're past COVID distraction that burdened the FDA for quite a lot of time in '20, '21, '22, that the agency will return to its norms in terms of review cycle. So thanks for that question.

我不想說得更具體。但顯然，有可能達到這個目標。我只是想給出 FDA 的官方目標是什麼。我希望現在我們已經擺脫了新冠疫情帶來的干擾，這種幹擾在 20 年、21 年、22 年相當長的一段時間裡給 FDA 帶來了負擔，該機構將在審查週期方面恢復正常。謝謝你提出這個問題。

Anything else on your mind?

還有什麼想法嗎？

Yeah. Then a follow up on, is it a binary process where you submit the application and you just get a response after 180 days? Or is there a back-and-forth that they have follow-up question or comments?

是的。然後跟進，這是一個二元流程嗎？您提交申請，然後在 180 天後才收到回覆？或是否有反覆表明他們有後續問題或意見？

No, no. Great question, and I may ask Mike to jump in here a little bit. But no, thankfully, it's not a black box. It is quite interactive.

不，不。很好的問題，我可以請麥克插話一下。但不，謝天謝地，它不是一個黑盒子。這是相當互動的。

And because it is a new technology and we're in this de novo category, there are a number of anticipated questions that we've been engaging on with the FDA, and it's quite collaborative so far in tone and cadence.

因為它是一項新技術，而且我們屬於從頭開始的類別，所以我們一直在與 FDA 討論許多預期的問題，並且到目前為止在語氣和節奏上都進行了相當的合作。

Mike, I don't know if you have other ways you might want to characterize our interaction with the FDA thus far.

麥克，我不知道您是否還有其他方式來描述我們迄今為止與 FDA 的互動。

Yeah. We've had a number of interactions with them with some questions that came from the FDA, including two cycles of rapid turnaround responses within a matter of days. So we're continuing that process.

是的。我們就 FDA 提出的一些問題與他們進行了多次互動，包括在幾天內進行兩個週期的快速週轉回應。所以我們正在繼續這個過程。

Those typically are iterative process until the end?

這些通常是迭代過程直到最後？

Yeah, correct. And I think along the way, both parties kind of understand where they're going, address any issues, resolve any questions that may be open.

是的，正確。我認為，在這個過程中，雙方都了解自己的方向，解決任何問題，解決任何可能的問題。

But hopefully, it's not a surprise at the end since we've been engaged along the path. So to be clear, it's not submit it and wait 150 days and get a yes/no. It's submit it, engage, address questions as we've been doing quickly and effectively and collaborate with the agency to bring this to market.

但希望最終結果不會令人意外，因為我們一直在努力。所以需要明確的是，提交後等待 150 天並得到“是”/“否”的答复。就像我們一直在快速有效地做的那樣，提交、參與、解決問題，並與該機構合作將其推向市場。

Yeah, that sounds good and congratulations. Good job. And my last question is just on as you guys get ready for hopefully a successful approval, would you talk about -- can you talk a little bit about the commercialization plans that you guys are having setting up here in the US? Can you start now or do you have to wait until you actually get the final approval to really step on the gas?

是的，聽起來不錯，恭喜你。好工作。我的最後一個問題是在你們準備好希望獲得成功批准時，你們能談談——你們能談談你們在美國製定的商業化計劃嗎？你可以現在就開始，還是必須等到真正獲得最終批准才能真正加速？

So a couple of things. One, our focus right now is Europe because we obviously have regulatory approval there. We have a small cost effective sales team in France, UK, and Germany. And we're building our clinical study sites in those regions in each country, not only to build the base of clinical evidence, as Mike referred, that also to become reference sites in each of those target markets.

有幾件事。第一，我們現在的重點是歐洲，因為我們顯然在那裡得到了監管部門的批准。我們在法國、英國和德國擁有一支具有成本效益的小型銷售團隊。我們正在每個國家的這些地區建立臨床研究中心，正如麥克所提到的那樣，不僅是為了建立臨床證據基礎，也是為了成為每個目標市場的參考中心。

So our first focus and we think our first opportunity is clearly commercially in Europe and those are very large markets. Germany, France, and the UK are the largest healthcare markets. They have a mix of public and private structures, but there's plenty of opportunity for ENDRA there.

因此，我們的第一個重點，我們認為我們的第一個機會顯然是在歐洲進行商業化，這些都是非常大的市場。德國、法國和英國是最大的醫療保健市場。他們混合了公共和私人結構，但 ENDRA 在那裡有很多機會。

And I would say as we get closer to an FDA decision, we would replicate some of that approach and certainly leverage anything we've learned in Europe in terms of clinical and economic value propositions that support the product. But also I think we'll be a little bit ahead because as Mike said, we have sites in the US that are currently scanning patients under what is called an IRB or Institutional Review Board protocol, which is a pre-FDA approval to use this study or use the TAEUS technology on subjects and patients.

我想說，當我們接近 FDA 的決定時，我們將複製其中的一些方法，並且肯定會利用我們在歐洲學到的任何支持該產品的臨床和經濟價值主張。但我也認為我們會領先一點，因為正如邁克所說，我們在美國有一些站點，目前正在根據所謂的 IRB 或機構審查委員會協議對患者進行掃描，該協議是 FDA 批准使用該協議的。受試者和患者研究或使用TAEUS 技術。

And so we're going to be building our base of clinical evidence in the US ahead of getting the FDA approval, which will help us once we have the FDA approval. Then we'll carefully deploy a targeted sales team probably around the reference sites that I mentioned, the clinical sites where we can use and leverage those partnerships to be references for the next wave of adopters.

因此，我們將在獲得 FDA 批准之前在美國建立臨床證據基礎，這將在我們獲得 FDA 批准後對我們有所幫助。然後，我們將仔細部署一個有針對性的銷售團隊，可能圍繞我提到的參考站點，我們可以使用和利用這些合作夥伴關係的臨床站點，為下一波採用者提供參考。

But clearly, the goal is to stay focused on Europe first, get the FDA approval, open up that market, leverage of clinical evidence that's being built around, and then pursue opportunities in Asia. But we have to be as focused and effective and cost effective as possible as well. Hope that's helpful.

但顯然，我們的目標是首先關注歐洲，獲得 FDA 批准，開放該市場，利用正在建立的臨床證據，然後在亞洲尋求機會。但我們也必須盡可能專注、有效且具成本效益。希望有幫助。

Yes, that's very helpful. Thank you. And I wish you guys good luck. Thank you.

是的，這非常有幫助。謝謝。我祝你們好運。謝謝。

Thank you, Ed, very much.

非常感謝你，艾德。

This concludes --

結論是——

Operator -- yeah, I don't see any other questions. Thank you, operator, for facilitating that, and I very much want to thank our listeners, our investors today for joining our call.

接線員——是的，我沒有看到任何其他問題。感謝業者為此事提供的便利，我非常感謝我們的聽眾、投資者今天加入我們的電話會議。

We look forward to keeping you informed of our accomplishments and to speaking with you again when we report our fourth-quarter and full-year financial results. Wish you all a good evening.

我們期待向您通報我們的成就，並在我們報告第四季度和全年財務業績時再次與您交談。祝大家有個美好的夜晚。

The conference has 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。您現在可以斷開連線。