Avinger Inc (AVGR) 2024 Q3 法說會逐字稿

Good day and welcome to the Avinger third quarter, 2024 results conference call.

美好的一天，歡迎參加 Avinger 2024 年第三季業績電話會議。

(Operator Instructions).

（操作員說明）。

I would now like to turn the call over to Matt Kreps, Investor Relations for Avinger.

我現在想將電話轉給 Avinger 投資者關係部的 Matt Kreps。

The floor is yours.

地板是你的。

Thank you, Kelly.

謝謝你，凱利。

And thank you everyone for participating in today's call.

感謝大家參加今天的電話會議。

I would like to welcome you to Avinger third quarter. 2024 conference call.

歡迎您來到 Avinger 第三季。 2024 年電話會議。

Joining us today are Avinger CEO Jeff Soinski, and Principal Financial Officer Nabeel Subainati.

今天加入我們的還有 Avinger 執行長 Jeff Soinski 和財務長 Nabeel Subainati。

Earlier today we released the financial results for the quarter ended September 30, 2024.

今天早些時候，我們發布了截至 2024 年 9 月 30 日的季度財務業績。

A copy of the release is posted on the Avinger website under Investor Relations.

新聞稿的副本發佈在 Avinger 網站的投資者關係欄位下。

Before we begin.

在我們開始之前。

I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws which are made pursuant to the safe harbour for the vision of the private securities Litigation Reform Act of 1995.

我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據 1995 年私人證券訴訟改革法案願景的安全港而製定的。

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements, all forward-looking statements including without limitation our future financial expectations expected timing for commercial launch of products status of our clinical sites, the expected benefits of our products Filings with the FDA and regulatory filings in China and the anticipated timing of Zylox full manufacturing scale of our devices are based upon our current estimates and various assumptions.

本次電話會議中包含的任何非歷史事實陳述的陳述均應被視為前瞻性陳述，所有前瞻性陳述包括但不限於我們未來的財務預期、產品商業推出的預期時間、我們臨床站點的狀態、預期的我們產品的優勢向 FDA 提交的文件和在中國的監管文件以及我們設備的 Zylox 全面生產規模的預期時間均基於我們當前的估計和各種假設。

These statements involve material risks and uncertainties that could cause actual results or events to materially different from those anticipated or implied by these forward-looking statements accordingly.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述相應預期或暗示的結果或事件有重大差異。

You should not place undue reliance on these statements for a list and description of the risks and uncertainties associated with our business.

您不應過度依賴這些聲明來取得與我們業務相關的風險和不確定性的清單和描述。

Please see our Form 10-K files with the Securities and Exchange commission.

請參閱我們向美國證券交易委員會提交的 10-K 表格文件。

Avenger disclose any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

Avenger 揭露任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。

Today's presentation will also include reference to non-GAAP financial measures such as adjusted EBITDA, a reconciliation of these non-GAAP financial measures to the most comparable GAAP financial measures is available within the earnings release, which can be found on Avenger's website.

今天的演示還將提及非GAAP 財務指標，例如調整後的EBITDA，這些非GAAP 財務指標與最具可比性的GAAP 財務指標的調節表可在收益報告中找到，該報告可以在Avenger 的網站上找到。

And with that, I'd like to now turn the call over to Jeff.

現在我想把電話轉給傑夫。

Thank you, Matt, good afternoon and thank you all for joining us in the third quarter.

謝謝馬特，下午好，感謝大家在第三季加入我們。

We achieved notable improvements in operating efficiency and made meaningful strides toward our strategic objectives.

我們的營運效率顯著提高，並在實現策略目標方面取得了有意義的進展。

This progress highlights our dedicated efforts to streamline our peripheral operations, focusing on high value accounts and channelling resources into what we believe could be a groundbreaking advancement in the treatment of coronary artery disease.

這項進展凸顯了我們為簡化外圍業務、專注於高價值客戶並將資源投入到我們認為可能在冠狀動脈疾病治療方面取得突破性進展的努力。

In June, we implemented a cost savings program that reduced our overall head count by 24% including a one-third reduction in our commercial team.

6 月份，我們實施了一項成本節約計劃，將我們的總人數減少了 24%，其中商業團隊減少了三分之一。

The September quarter marks the first full operating period, reflecting these savings with a direct reduction in operating costs and cash needs as well as improved efficiency and gross margin and revenue per sales head.

九月季度標誌著第一個完整的營運期，反映了這些節省，營運成本和現金需求的直接降低，以及效率、毛利率和人均收入的提高。

Our field sales team now comprising 16 professionals is focused on supporting our most active peripheral clinical sites.

我們的現場銷售團隊現在由 16 名專業人員組成，致力於支援我們最活躍的外圍臨床中心。

These sites demonstrate steady case activity and a strong commitment to utilizing our best in class technology to achieve superior patient outcomes, especially for complex peripheral artery disease or PAD.

這些站點展示了穩定的病例活動，並堅定地致力於利用我們一流的技術來實現卓越的患者治療效果，特別是對於複雜的周邊動脈疾病或 PAD。

Despite a much leaner sales team, we maintained approximately 90% of revenue in the third quarter compared to both the prior quarter and the same period.

儘管銷售團隊精簡得多，但與上一季和同期相比，我們第三季的收入仍保持在約 90% 左右。

Last year, we remain dedicated to supporting our user sites and expanding the tools available to provide the best therapeutic solutions for patients.

去年，我們仍然致力於支援我們的用戶網站並擴展可用的工具，為患者提供最佳的治療解決方案。

This includes the ongoing commercialization of our Tigereye crossing catheter and the full commercial launch of our new Pantheris LV, large vessel, peripheral atherectomy, catheter, Pantheris LV is designed to streamline the costly procedure and paired with our portable lightbox three imaging console.

這包括我們的Tigereye 交叉導管的持續商業化以及我們新的Pantheris LV、大血管、外周斑塊旋切術、導管的全面商業化推出，Pantheris LV 旨在簡化昂貴的手術，並與我們的便攜式燈箱三成像控制台配對。

Expand the mainstream appeal of our image guided platform in August.

八月擴大我們影像引導平台的主流吸引力。

We announced the appointment of Dr, Tom Davis, a highly experienced interventional cardiologist and Director of cardiovascular Research at St. John Hospital and Medical Centre in Detroit.

我們宣布任命 Tom Davis 博士，他是一位經驗豐富的介入性心臟病專家，也是底特律聖約翰醫院和醫療中心的心血管研究主任。

As our Chief Medical Officer joined by key opinion leaders in vascular intervention.

作為我們的首席醫療官，血管介入領域的關鍵意見領袖加入其中。

Dr, Davis hosted a physician focused webinar in October titled new approaches to treating peripheral artery disease below the knee and promising new BTK data.

Davis 博士於 10 月主持了一場以醫生為中心的網路研討會，題為治療膝蓋以下週邊動脈疾病的新方法，並承諾提供新的 BTK 數據。

During the session, Dr Davis presented updated interim data from the image BTK post market study which evaluates the use of pantheris SV for treating advanced disease in the smaller vessels below the knee.

在會議期間，戴維斯博士介紹了圖像 BTK 上市後研究的最新中期數據，該研究評估了 pantheris SV 治療膝蓋以下較小血管晚期疾病的用途。

The study continues to demonstrate exceptional clinical outcomes in this challenging patient population showing 100% freedom from major adverse events at 30 days. 97% freedom from target lesion revascularization, an indicator of restenosis and 94% primary patency as assessed by duplex ultrasound at 12 months.

該研究繼續證明了這一具有挑戰性的患者群體的卓越臨床結果，顯示 30 天時 100% 無重大不良事件。 12 個月時以雙功能超音波評估，97% 的患者無需進行目標病灶血管重建（再狹窄指標），且初級通暢率達 94%。

Turning to our coronary program, we've made substantial progress on developing our first coronary product application, an image guided CTO crossing system based on our proprietary optical coherence tomography or OCT guided platform.

談到我們的冠狀動脈項目，我們在開發第一個冠狀動脈產品應用方面取得了實質進展，這是一種基於我們專有的光學相干斷層掃描或 OCT 引導平台的影像引導 CTO 交叉系統。

Since our last earnings call, we have successfully completed all phase three verification and validation testing necessary to support an investigational device exemption or IDE application with the FDA.

自上次財報電話會議以來，我們已成功完成了支持研究設備豁免或向 FDA 提交 IDE 申請所需的所有第三階段驗證和驗證測試。

Working closely with our coronary physician advisers.

與我們的冠心病醫師顧問密切合作。

We've defined the clinical study parameters including inclusion exclusion criteria, study endpoints treatment protocol and patient follow up requirements.

我們定義了臨床研究參數，包括納入排除標準、研究終點治療方案和患者追蹤要求。

We've also completed a biostatistical analysis to determine the optimal sample size for our study targeting 110 patients with a 30 day follow up period to maximize alignment with the FDA.

我們還完成了生物統計分析，以確定針對 110 名患者的研究的最佳樣本量，並進行 30 天的隨訪，以最大限度地與 FDA 保持一致。

We opted to submit a pre submission package in September ahead of the IDE application.

我們選擇在 9 月在 IDE 申請之前提交預提交包。

This approach enables us to seek FDA feedback on our study design target patient population and choice of predicate device for an anticipated 510-K regulatory pathway.

這種方法使我們能夠就我們的研究設計目標患者群體以及預期 510-K 監管途徑的謂詞設備選擇尋求 FDA 的回饋。

Once the pre submission process is complete, which we anticipate in the fourth quarter, we'll be ready to file the IDE.

一旦預提交過程完成（我們預計在第四季度），我們將準備好提交 IDE。

In the meantime, we are actively engaging high volume clinical sites for participation in the trial with five identified and discussions underway with several more.

同時，我們正在積極吸引大量臨床中心參與試驗，已確定五個臨床中心，並正在與更多臨床中心進行討論。

We expect to expand to 10 or more sites ahead of study initiation and are planning to begin patient enrolment upon receiving FDA approval of the IDE which is anticipated in the first half of 2025.

我們預計在研究開始前擴展到 10 個或更多中心，並計劃在 IDE 獲得 FDA 批准後開始患者登記，預計在 2025 年上半年。

We're excited to complete this process and advance this revolutionary new technology through the clinical study and regulatory approval process.

我們很高興能夠完成這個過程，並透過臨床研究和監管審批流程來推進這項革命性的新技術。

We believe our coronary device has the potential to redefine a large and underserved market crossing chronic total occlusions or CTOs and coronary arteries is currently a complex time consuming and costly procedure with a documented high failure rate.

我們相信，我們的冠狀動脈裝置有潛力重新定義一個龐大且服務不足的市場，跨越慢性完全閉塞或 CTO，而冠狀動脈目前是一項複雜的耗時且昂貴的手術，且失敗率很高。

By harnessing our proprietary image guided technology.

透過利用我們專有的影像引導技術。

We aim to provide physicians with a superior streamlined and more effective solution for crossing coronary CTOs.

我們的目標是為醫生提供更優化、更有效的冠狀動脈 CTO 解決方案。

Our technology is deployed within a low profile catheter system, integrating real time OCT guidance with the precise control and steer ability needed for an integrated approach.

我們的技術部署在薄型導管系統中，將即時 OCT 引導與整合方法所需的精確控制和轉向能力相結合。

We expect this to significantly reduce procedure times and improve crossing success rates while remaining within the true lumen similar to our peripheral devices.

我們預計這將顯著減少手術時間並提高穿越成功率，同時保持在與我們的周邊設備類似的真實管腔內。

Our coronary system also incorporates precise vessel measurement capabilities, enabling positions to accurately size balloons or stents prior to placement critical factor for optimal patient outcomes.

我們的冠狀動脈系統還具有精確的血管測量功能，能夠在放置之前準確地確定球囊或支架的尺寸，這是最佳患者治療效果的關鍵因素。

The design of our unique image guided system is expected to allow positions to cross coronary CTOs with less dependence on specialty wires support catheters and re entry devices.

我們獨特的影像引導系統的設計預計將允許位置穿過冠狀動脈 CTO，而減少對專用線支撐導管和再進入裝置的依賴。

Use of real time OCT imaging minimizes X-ray radiation exposure and iodine based contrast eye usage which pose significant health risks to both physicians and patients.

使用即時 OCT 成像可最大限度地減少 X 射線輻射暴露和碘對比眼的使用，這對醫生和患者都構成重大健康風險。

Our extensive animal and cadaver studies along with our experience with OCT guided therapy and peripheral applications support our confidence that this combination of onboard image guidance and vessel specific directional control will deliver a strong safety profile in clinical practice.

我們廣泛的動物和屍體研究以及 OCT 引導治療和外圍應用的經驗支持我們的信心，即機載影像引導和血管特定方向控制的結合將在臨床實踐中提供強大的安全性。

We expect our coronary CTO crossing system to benefit from favourable reimbursement dynamics upon FDA clearance.

我們預計我們的冠狀動脈 CTO 交叉系統在 FDA 批准後將受益於有利的報銷動態。

Our device would immediately qualify for existing high value reimbursement codes for coronary CTO crossing and OCT diagnostic imaging.

我們的設備將立即有資格獲得冠狀動脈 CTO 交叉和 OCT 診斷成像的現有高價值報銷代碼。

This advantage sets it apart from peripheral markets where dedicated reimbursement codes for CTO crossing and diagnostic OCT imaging are not available.

這一優勢使其與外圍市場區分開來，這些市場不提供 CTO 交叉和診斷 OCT 成像的專用報銷代碼。

Additionally, our system is expected to drive substantial cost savings for hospitals by reducing crossing times lowering contrast media usage and minimizing the need for accessory devices.

此外，我們的系統預計將透過減少交叉時間、降低造影劑使用量並最大限度地減少對輔助設備的需求，為醫院節省大量成本。

These benefits enable a more favourable cost profile allowing hospitals to treat more cases or allocate resources more efficiently.

這些好處可以實現更有利的成本狀況，使醫院能夠治療更多病例或更有效地分配資源。

We look forward to sharing our continuing progress in the development of this exciting new clinical and business opportunity in the coming quarters.

我們期待在未來幾季分享我們在開發這一令人興奮的新臨床和商業機會方面的持續進展。

Before I turn the call over to Nabeel, I'd like to take a few minutes to update you on our strategic partnership with Zylox-Tonbridge, a leader in the peripheral vascular and neurovascular markets in China.

在將電話轉給 Nabeel 之前，我想花幾分鐘時間向您介紹我們與中國外周血管和神經血管市場領導者 Zylox-Tonbridge 的戰略合作夥伴關係的最新情況。

This relationship consists of three important components, first investment alignment.

這種關係由三個重要組成部分組成，首先是投資協調。

Earlier this year, Zylox made a substantial equity investment, Avinger aligning their interest with ours as shareholders in our future success.

今年早些時候，Zylox 進行了大量股權投資，Avinger 將他們的利益與我們作為股東的利益結合起來，共同推動我們未來的成功。

Second market access, our agreement has paved the way for introducing our image guided devices to the vast and growing greater China market through Zylox is extensive and well established sales and marketing network and third cost effective manufacturing.

第二個市場准入，我們的協議為透過 Zylox 廣泛且完善的銷售和行銷網路以及第三個具有成本效益的製造將我們的影像引導設備引入廣闊且不斷增長的大中華市場鋪平了道路。

The partnership provides a pathway for lower cost offshore manufacturing of our devices for use in worldwide markets.

該合作夥伴關係為我們在全球市場上使用的設備的低成本離岸製造提供了一條途徑。

We're excited about the rapid progress Zylox is making in expanding access to our proprietary image guided products for the estimated 50 million people in China affected by peripheral artery disease.

我們對 Zylox 在為中國大約 5000 萬外周動脈疾病患者擴大使用我們的專有圖像引導產品方面取得的快速進展感到興奮。

Our team has been working closely with Zylox to support their efforts in completing regulatory filings for our high speed peripheral catheters and the Lightbox three imaging console in China.

我們的團隊一直與 Zylox 密切合作，支持他們完成我們的高速外周導管和 Lightbox 3 成像控制台在中國的監管備案。

Before the end of this year, with registration clearance anticipated in 2025 related to these efforts, Zylox recently received the prestigious innovative medical device review designation for our pantheris device in China akin to the breakthrough device designation in the US.

在今年年底之前，這些努力預計將於 2025 年獲得註冊許可，Zylox 最近在中國獲得了著名的創新醫療器材審查稱號，類似於美國的突破性器材稱號。

This recognition enables priority regulatory review and underscores the impact of our technology in this important new market.

這項認可使我們能夠優先進行監管審查，並強調了我們的技術在這個重要的新市場中的影響力。

We are also supporting Zylox professional education initiatives and initial premarket promotion activities in China.

我們也支持 Zylox 在中國的專業教育計畫和初步上市前推廣活動。

Our products were presented for the first time at the China endovascular course, CEC the leading clinical conference for Chinese endovascular surgeons where many physicians expressed strong interest in our image guided technology.

我們的產品首次在中國血管內外科會議（CEC）上首次亮相，這是中國血管內外科醫生的領先臨床會議，許多醫生對我們的影像引導技術表示了濃厚的興趣。

In addition, we are working with Zylox Operations Group to support the development of manufacturing capabilities for Avinger products at their state of the art manufacturing facility in Hangzhou China.

此外，我們也與 Zylox Operations Group 合作，支援其位於中國杭州的先進製造廠開發 Avinger 產品的製造能力。

We anticipate that Zylox will complete its full manufacturing scale up for our devices by mid 2025 which is expected to enhance production efficiency and provide the opportunity for additional cost reductions in the future.

我們預計 Zylox 將在 2025 年中期完成我們設備的全面製造規模，這有望提高生產效率並為未來進一步降低成本提供機會。

As a reminder sales of Avinger products in the Zylox territory will be royalty bearing for Avinger.

謹此提醒，Avinger 產品在 Zylox 地區的銷售將由 Avinger 承擔特許權使用費。

Following regulatory approval, we will sell finished goods to Zylox until their self manufactured products are available for sale in China.

在獲得監管部門批准後，我們將向 Zylox 銷售成品，直至其自行生產的產品可在中國銷售。

We're excited about the potential of this partnership and the positive impact it could have on our growth.

我們對這種合作關係的潛力及其對我們的發展可能產生的積極影響感到興奮。

At this point.

在此刻。

I'd like to turn the call over to Nabeel Subainati, our principal financial officer to take us through the financial results.

我想將電話轉給我們的財務長 Nabeel Subainati，讓我們了解財務表現。

Nabeel.

納比爾.

Thank you, Jeff.

謝謝你，傑夫。

Total revenue for the third quarter of 2024 was $1.7 million down slightly from $1.8 million in both the previous quarter and the same period last year.

2024 年第三季的總收入為 170 萬美元，略低於上一季和去年同期的 180 萬美元。

This aligns with our strategic decision to concentrate field support on higher volume user sites while significantly reducing the peripheral sales team as part of our cost savings initiative.

這符合我們的策略決策，即將現場支援集中在更高容量的用戶站點，同時大幅減少外圍銷售團隊，作為我們成本節約計畫的一部分。

Gross margin for the third quarter of 2024 was 26% increase from 20% in the second quarter of 2024 and 21% in the third quarter of 2023 reflecting improved operating efficiency.

2024 年第三季的毛利率為 26%，較 2024 年第二季的 20% 和 2023 年第三季的 21% 成長，反映出營運效率的提高。

Following our strategic realignment, operating expenses for the third quarter of 2024 declined to $4.1 million compared to $4.5 million in the second quarter of 2024 and $4.4 million.

經過策略調整，2024 年第三季的營運費用下降至 410 萬美元，而 2024 年第二季的營運費用為 450 萬美元，2024 年第二季的營運費用為 440 萬美元。

In the third quarter of 2023.

2023年第三季。

In June, we reduced our head count by approximately one-fourth as we streamlined our peripheral operations and directed resources to the development of our coronary artery disease program.

6 月份，我們精簡了外圍業務並將資源用於冠狀動脈疾病計畫的開發，從而減少了約四分之一的員工人數。

Reflective of these actions, selling general administrative expenses decreased by close to $0.6 million or 16% in the third quarter of 2024.

由於這些行動，2024 年第三季銷售一般管理費用減少了近 60 萬美元，即 16%。

While research and development expense increased by approximately $0.2 million or 20%.

而研發費用則增加了約 20 萬美元，即 20%。

Compared to the prior quarter.

與上一季相比。

Net loss and comprehensive loss for the third quarter of 2024 was $3.7 million reflecting a 15% improvement compared to $4.4 million in the second quarter of 2024 and 17% improvement compared to $4.5 million in the third quarter of 2023 adjusted EBITDA as defined under non-GAAP financial measures provided in today's press release was a loss of $3.4 million a 12% improvement compared to a loss of $3.8 million in the second quarter of 2024 and 10% improvement compared to a loss of $3.7 million in the third quarter of 2023.

2024 年第三季的淨虧損和綜合虧損為370 萬美元，與2024 年第二季的440 萬美元相比，改善了15%；與2023 年第三季調整後EBITDA 的450 萬美元相比，改善了17%。美元相比，改善了10%。

For more information regarding non-GAAP financial measures, please see non-GAAP financial measures and the reconciliation of non-GAAP measures to the nearest GAAP measure provided in the tables in today's press release, cash and cash equivalents totalled $5.9 million as of September 30.

有關非 GAAP 財務指標的更多信息，請參閱今天新聞稿表格中提供的非 GAAP 財務指標以及非 GAAP 指標與最接近 GAAP 指標的調整表，截至 9 月 30 日現金和現金等價物總計 590 萬美元。

At this point, I'd like to turn the call back to Jeff for Q&A.

此時，我想將電話轉回傑夫進行問答。

Thanks Nabeel.

謝謝納比爾。

We made significant progress across the company in the third quarter, realizing significant cost savings and improved operating efficiency following our strategic realignment in June, expanding our Pantheris LV large vessel Atherectomy system to full commercial launch, advancing the development of our first coronary product entry, which we believe will be a game changer for the safe and effective treatment of coronary CTOs and supporting Zylox commercialization efforts for entry into the vast and growing greater China market.

第三季度，我們在整個公司取得了重大進展，繼6 月的策略調整後，我們實現了顯著的成本節約並提高了營運效率，將我們的Pantheris LV 大血管斑塊切除術系統擴展到全面商業推出，推進了我們第一個冠狀動脈產品的開發，我們相信，這將改變安全有效治療冠狀動脈 CTO 的遊戲規則，並支持 Zylox 進入廣闊且不斷增長的大中華市場的商業化努力。

We appreciate the commitment of our team as we look forward to achieving critical milestones in these and other areas and remain dedicated to our mission of radically changing the way vascular disease is treated.

我們感謝我們團隊的承諾，因為我們期待在這些和其他領域實現關鍵的里程碑，並繼續致力於從根本上改變血管疾病治療方式的使命。

At this point, we'd like to open the call to your questions.

現在，我們想開始回答您的問題。

Certainly, the floor is now open for questions.

當然，現在可以提問。

(Operator Instructions)

（操作員說明）

Your first question is coming from RK with H.C. Wainwright.

你的第一個問題來自 RK 和 H.C.溫賴特。

Please put your question.

請提出您的問題。

Your line is live.

您的線路已上線。

Thank you.

謝謝。

Good afternoon.

午安.

Jeff and then a deal, a couple of quick questions.

傑夫，然後是一筆交易，幾個簡短的問題。

The first one is from Pantheris.

第一個來自 Pantheris。

I just said this is the first full quarter of commercialization.

我剛才說這是商業化的第一個完整季度。

So, what are you hearing from the physicians?

那麼，您從醫生那裡聽到了什麼？

How would they like things?

他們會喜歡什麼？

how should we think about the future adoption?

我們該如何考慮未來的採用？

No, Thanks RK.

不，謝謝 RK。

So, first of all, you're referring to the, the full commercial launch of the Pantheris LV in the third quarter and obviously we announced that late in the quarter and so it's still early days.

首先，您指的是第三季 Pantheris LV 的全面商業發布，顯然我們是在本季末宣布的，所以現在還為時過早。

But we're very pleased with the response we're getting in the market from a clinical perspective.

但從臨床角度來看，我們對市場上所得到的反應感到非常滿意。

I think physicians are very pleased with the simplicity of operation.

我認為醫生對操作的簡單性非常滿意。

As you know, we had made changes versus our current large vessel device to simplify and streamline the procedure, to make it easier for new physicians to pick up the device and have success with it more similar to other directional ay products that they may have used before.

如您所知，我們對當前的大血管設備進行了更改，以簡化和簡化程序，使新醫生更容易拿起該設備並取得成功，與他們可能使用過的其他定向產品更相似。

And picking up on a lot of the advances and improvements we made in Pantheris SV, which as you know, is developing.

如您所知，我們正在開發 Pantheris SV，並汲取了我們在 Pantheris SV 中取得的許多進步和改進。

It has been a very strong product for us but is also delivering outstanding clinical data.

它對我們來說是一個非常強大的產品，但也提供了出色的臨床數據。

And one of the primary motivators for Pantheris SV is in combination with our portable Lightbox three imaging console to really broaden the mainstream appeal of our technology.

Pantheris SV 的主要動力之一是與我們的便攜式 Lightbox 三成像控制台相結合，以真正擴大我們技術的主流吸引力。

And so, and maybe as a kind of a more tangible expression of the early success with the product, although we didn't expand until the latter part of the quarter, our Pantheris LV revenue did increase over 20% versus the sales in the second quarter.

And so, and maybe as a kind of a more tangible expression of the early success with the product, although we didn't expand until the latter part of the quarter, our Pantheris LV revenue did increase over 20% versus the sales in the second四分之一.

So a good start.

這是一個好的開始。

We have not seen because we were in limited launch for a pretty significant amount of time, we were able to make some improvements in the product before expanding the full commercial launch.

我們還沒有看到，因為我們在相當長的時間內處於有限的發布狀態，所以我們能夠在擴大全面的商業發布之前對產品進行一些改進。

So, so very pleased with the performance and what we're seeing so far.

所以，對我們目前所看到的表現和所看到的非常滿意。

Good, The other question is on the on your collaboration.

好的，另一個問題是關於你們的合作。

So how sure are you that Zylox could get the approval in time and also how much more additional work do they need to do to get the commercialization going?

那麼，您有多確定 Zylox 能夠及時獲得批准，以及他們還需要做多少額外的工作才能商業化？

Yes.

是的。

So, first of all, we've been very, we have been working very closely with Zylox through this process.

因此，首先，我們在整個過程中一直與 Zylox 非常密切地合作。

And so, we have good visibility on what is happening in China and with their filings to NMPA, one of the major steps in China, first steps is to go through an extensive and rigorous what they call type testing process.

因此，我們對中國正在發生的事情有很好的了解，隨著他們向 NMPA 提交文件，這是中國的主要步驟之一，第一步是透過他們所謂的廣泛而嚴格的型式測試流程。

All of our products have now been through the type testing process successfully in which is a kind of a verification, validation type of testing protocols that are very rigorous.

我們所有的產品現已成功通過型式測試流程，這是非常嚴格的驗證、確認測試協議。

They've all successfully completed that testing and several of the Filings have already been made and we are told and we are confident that the remainder of Filings for our catheters and products will be completed prior to the end of this year.

他們都已成功完成該測試，並且已經進行了一些備案，我們被告知並且我們有信心我們的導管和產品的其餘備案將在今年年底之前完成。

So, we're projecting a regulatory approval in China in the second half of '25.

因此，我們預計將於 25 年下半年在中國獲得監管部門的批准。

In the meantime, Zylox is developing their own manufacturing capability for our products.

與此同時，Zylox 正在為我們的產品開發自己的製造能力。

We actually have people over in China right now including our CTO helping them establish their manufacturing lines.

實際上，我們現在在中國有人，包括我們的技術官，幫助他們建立生產線。

We've been supplying parts and [jigs] and fixtures and components to help bring their lines up.

我們一直在提供零件和[夾具]以及固定裝置和組件來幫助他們建立生產線。

So again, there again, I believe that they are right on track with their internal plan and right on track with our expectation to have completed their manufacturing scale up process by, the middle of next year and to qualify that facility.

所以，我再次相信，他們的內部計劃是正確的，我們的預期也是正確的，他們將在明年年中之前完成製造規模擴大過程，並獲得該工廠的資格。

That's important for us because it could provide the opportunity for us to source from Zylox following FDA registration of their facility and bring our cost down.

這對我們很重要，因為它可以為我們提供在 FDA 註冊 Zylox 設施後從 Zylox 購買的機會，並降低我們的成本。

Not only on our cost of goods but provide other cost savings opportunities.

不僅在我們的商品成本上，而且還提供其他成本節約機會。

It also would provide a foundation for them to pursue approval for a for a domestically manufactured version of our product.

它還將為他們尋求批准我們產品的國內製造版本奠定基礎。

But the initial regulatory process and pathway as we talked about before will be the first to get our product improved.

但我們之前談到的最初的監管流程和途徑將是我們產品改進的第一個。

As an imported product, we will supply product to Zylox following approval and then when they have their own self manufacturing, self manufactured product, cleared, provide the opportunity for them to, to fulfil their own market needs.

作為進口產品，我們將在獲得批准後向 Zylox 供應產品，然後當他們擁有自己的自行製造、自行製造的產品並清關時，為他們提供機會，以滿足自己的市場需求。

We did have a presentation of the products and demo sessions that were very well attended by physicians that Zylox hosted at the Chinese end of vascular conference.

我們確實進行了產品介紹和演示會議，Zylox 在中國血管會議上主辦的會議吸引了許多醫生的參與。

We also had people in attendance supporting those efforts.

我們也有人出席支持這些努力。

And again, we have been incredibly impressed with the professionalism of their organization, the capabilities of their organization and how well they've embraced us in the process.

我們再次對他們組織的專業、組織能力以及他們在過程中對我們的支持程度印象深刻。

So we have high hopes that this massive market will be unlocked.

所以我們對這個巨大的市場能夠被釋放抱持著很大的希望。

By Zylox with these very innovative products and as we talked about on the call, they've received the innovative medical device designation which should help accelerate their regulatory review and approval process as well.

Zylox 憑藉這些非常創新的產品，正如我們在電話中談到的那樣，他們已經獲得了創新醫療器材稱號，這也將有助於加快他們的監管審查和批准流程。

So, all good things coming out of China over the past several months.

所以，過去幾個月所有的好事都來自中國。

Thank.

感謝。

Alright, thank you RK.

好的，謝謝 RK。

There are no questions in queue at this time.

目前隊列中沒有問題。

I would now like to turn the floor back over to Jeffrey Soinski for any closing remarks.

現在我想請傑弗裡·索因斯基發表結束語。

Well, thank you again for joining our call this afternoon.

好的，再次感謝您今天下午加入我們的電話會議。

We very much appreciate your interest in our company and look forward to reporting our further progress when we present our year end results.

我們非常感謝您對我們公司的興趣，並期待在我們公佈年終業績時報告我們的進一步進展。

Thank you.

謝謝。

Thank you, everyone.

謝謝大家。

This does conclude today's conference call.

今天的電話會議到此結束。

You may disconnect your phone lines at this time and have a wonderful day.

此時您可以斷開電話線並度過美好的一天。

Thank you for your participation.

感謝您的參與。