Avinger Inc (AVGR) 2016 Q1 法說會逐字稿

(technical difficulty) quarter ended March 31, 2016. Before we begin, I would like to remind you that management will make statements during this call that includes forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 examination] of historical operating trends and our future financial expectations are based upon our current estimates and various assumptions.

（技術困難）截至 2016 年 3 月 31 日的季度。在我們開始之前，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，這些聲明是根據安全法做出的1995 年《私人證券訴訟改革法案》的港灣條款。本次電話會議中包含的任何不屬於歷史事實陳述的陳述均應視為前瞻性陳述。所有前瞻性陳述，包括但不限於 [我們對歷史經營趨勢的檢查] 和我們未來的財務預期，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 differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list of description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. Avinger disclaims 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. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 4, 2016.

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預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的描述列表，請參閱我們向美國證券交易委員會提交的文件。 Avinger 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新信息、未來事件或其他原因。此電話會議包含時間敏感信息，僅截至 2016 年 5 月 4 日今天的現場直播準確無誤。

I would now like to turn the call over to Jeff.

我現在想把電話轉給傑夫。

Thanks, [Mark]. Good afternoon, and thank you all for joining us. I am very pleased with our first-quarter results, led by our early success in the US launch of our Pantheris image guided atherectomy system. We received [510K] clearance on March 1, and by the end of the first quarter had already sold Pantheris into approximately 60% of our Luba vascular accounts. This is a good indication of how much enthusiasm there is for Pantheris in the marketplace as well as the great work by our sales and training teams preparing preparing the market for launch.

謝謝，[馬克]。下午好，感謝大家加入我們。我對我們第一季度的業績感到非常滿意，這得益於我們在美國推出我們的 Pantheris 圖像引導動脈粥樣硬化切除術系統的早期成功。我們在 3 月 1 日收到了 [510K] 的許可，到第一季度末，我們已經將 Pantheris 出售給我們大約 60% 的 Luba 血管賬戶。這很好地表明了市場對 Pantheris 的熱情以及我們的銷售和培訓團隊為上市做準備的出色工作。

Overall, we're encouraged by the early commercial uptake of Pantheris and I will turn the call over to Doctor Simpson shortly to provide some highlights on what he has seen in the field. But, first, I would like to update you on our operational achievements of the quarter. The US commercial launch of Pantheris in March drove the highest quarterly sales results in Avinger history with total revenue of $4.5 million in the first quarter. We also significantly expanded our installed base of lumivascular accounts. During the quarter, we added 12 new accounts, reaching a total of 107 at the end of the quarter. We sold five Lightboxes during the quarter, including three to new accounts and two conversions of existing placement to purchase accounts.

總體而言，我們對 Pantheris 的早期商業採用感到鼓舞，我將很快將電話轉給辛普森醫生，以提供他在該領域所見所聞的一些亮點。但是，首先，我想向您介紹我們本季度的運營成就。 Pantheris 於 3 月在美國上市，第一季度的總收入為 450 萬美元，創下了 Avinger 歷史上最高的季度銷售業績。我們還顯著擴大了我們的 lumivascular 客戶群。本季度，我們新增了 12 個賬戶，本季度末總數達到 107 個。我們在本季度售出了五個燈箱，其中三個是新帳戶，兩個是將現有展示位置轉換為購買帳戶。

This continued strong growth in new accounts speaks to the appeal of our lumivascular platform and provides further validation that our more flexible capital acquisition model, including our placement to purchase initiative, is working.

新客戶的這種持續強勁增長說明了我們 lumivascular 平台的吸引力，並進一步證明我們更靈活的資本收購模式（包括我們的配售計劃）正在發揮作用。

We continue to evaluate the most effective programs to grow our installed base and remain comfortable that we will achieve our goal of approximately 150 lumivascular accounts by the end of the year.

我們將繼續評估最有效的計劃來擴大我們的安裝基礎，並對我們將在年底前實現大約 150 個 lumivascular 客戶的目標感到滿意。

Turning to sales and marketing, we continue to strategically build our field sales force and ended the quarter with total headcount of 62 sales professionals. We continue to expect to reach our goal of 70 salespeople by the end of 2016, and are encouraged by the high levels of talent, experience, and enthusiasm we are seeing in both our recent hires and in the candidates in our recruiting pipeline.

在銷售和市場營銷方面，我們繼續戰略性地建設我們的現場銷售隊伍，並在本季度結束時擁有 62 名銷售專業人員。我們繼續期望到 2016 年底達到 70 名銷售人員的目標，並且我們在最近招聘的人員和招聘渠道中的候選人中看到的高水平人才、經驗和熱情讓我們感到鼓舞。

I would now like to ask Dr. Simpson to share some of his recent case experiences and feedback from physicians who have used Pantheris. Following Dr. Simpson's remarks, Matt will review our first-quarter financial results and review guidance for 2016. I will then close with comments on our clinical and product development plan for 2016 and then we will open the call for questions. John?

我現在想請辛普森醫生分享他最近的一些病例經驗和使用過Pantheris的醫生的反饋。在 Simpson 博士發表講話後，Matt 將回顧我們第一季度的財務業績並回顧 2016 年的指導意見。然後我將對我們 2016 年的臨床和產品開發計劃發表評論，然後我們將開始提問。約翰？

Thanks, Jeff. Thanks to everyone. I want to add my welcome to everybody, very sincere. I know you all have incredibly busy schedules so we are thrilled that you are on the call. I want to compliment Jeff for summarizing the status of Avinger in four paragraphs. That is a profoundly daunting task. But I think everything that he summarized is really to be taken to heart, if you will.

謝謝，傑夫。謝謝大家。我想對大家表示歡迎，非常真誠。我知道你們的日程安排都非常繁忙，所以我們很高興你們能接聽電話。我要稱讚 Jeff，他用四段話總結了 Avinger 的狀態。這是一項極其艱鉅的任務。但我認為，如果你願意的話，他總結的一切都應該牢記在心。

And so from what Jeff said and from what I will say, I hope it is clear that we understand the magnitude of this opportunity and we are prepared in working hard to show the [interventional] world -- the interventional world is very complicated in that interventional cardiologists, radiologists, and surgeons, so we are intent on showing the entire world the advantages associated with the lumivascular treatment.

因此，根據 Jeff 所說的和我將要說的，我希望我們清楚地了解這個機會的重要性，並且我們準備好努力工作以展示 [干預] 世界 - 干預世界非常複雜介入心髒病專家、放射科醫生和外科醫生，因此我們致力於向全世界展示與 lumivascular 治療相關的優勢。

This treatment, now available in over 100 hospitals nationwide, it still has these three [thieves] that dominate and remain very consistent to all of our previous presentations. In the first is the outstanding safety profile.

這種治療，現在在全國 100 多家醫院都可以使用，它仍然有這三個 [竊賊] 占主導地位，並且與我們之前的所有介紹保持非常一致。首先是出色的安全性。

Overall, it is so reassuring to the physicians and better outcomes for the patient when they can see what they are doing. They get to see from inside the artery while they are working on it. And, of course, this leads to the number of second [pharma], which would be great clinical outcomes. And then, number three, not the least of which, would be this new definition of the [typhoo] and the variability of lesions being crossed with the Ocelot and treated with the Pantheris catheter.

總的來說，當醫生可以看到他們在做什麼時，他們會感到非常安心，並為患者帶來更好的結果。當他們在動脈上工作時，他們可以從動脈內部看到。而且，當然，這會導致第二 [pharma] 的數量，這將是很好的臨床結果。然後，第三點，也是其中最重要的一點，就是 [typho] 的新定義以及與 Ocelot 交叉並用 Pantheris 導管治療的病變的可變性。

We are seeing a really unique distribution and composition of plaque and it varies dramatically from patient to patient, which I'm sure is no real surprise, particularly not a surprise to the surgeons. But what really happens what really happens to a vessel when it is treated with existing technologies now really clear as we image imenities or at least while we're working on them. And this always happens with new technologies, particularly the ones that I've introduced, which also helps explain all this gray hair.

我們看到了真正獨特的斑塊分佈和組成，並且它因患者而異，我敢肯定這並不令人驚訝，尤其是外科醫生。但是，當我們用現有技術處理船隻時，真正發生了什麼，當我們想像便利設施時，或者至少在我們處理它們的時候，它現在真的很清楚。這總是發生在新技術上，尤其是我介紹的那些，這也有助於解釋所有這些白髮。

We see areas for improvement in both Ocelot and Pantheris, primarily focused on making both more robust and smaller as both are being used increasingly difficult anatomies and also in smaller vessels. So while we continue to improve our catheters, we are also designing trials to expand the clinical evidence to help support lumivascular -- the concept of lumivascular and keep the physicians focused on the advantages that they can bring to the patients.

我們看到 Ocelot 和 Pantheris 都有待改進的地方，主要集中在使它們更堅固和更小，因為它們都被用於越來越困難的解剖結構以及更小的血管中。因此，在我們繼續改進我們的導管的同時，我們還在設計試驗以擴大臨床證據以幫助支持 lumivascular - lumivascular 的概念並讓醫生專注於他們可以為患者帶來的優勢。

So the first of the trials that we are setting up, the first trial is really focused on radiation reduction opportunity and will be a randomized trial comparing Pantheris to Ocelot outcomes to traditional therapies, while (inaudible) exposure to the docs, the patient, and the staff. I frequently talk about measure reading measuring the radiation exposure to the patient, but it is really the physician that sees the majority of the exposure and that is really where we will focus a lot of our attention.

因此，我們正在開展的第一項試驗，第一項試驗真正關注的是減少輻射的機會，並將是一項隨機試驗，將 Pantheris 和 Ocelot 的結果與傳統療法進行比較，同時（聽不清）接觸醫生、患者和員工。我經常談論測量讀數測量患者的輻射暴露，但實際上看到大部分暴露的是醫生，這也是我們真正關注的地方。

Our second clinical trial, if you will, will be a registry to compare the safety and efficacy of Pantheris, Ocelot outcomes to a large, existing database of a large healthcare insurer provider by now. With the procedures that in this trial will be performed actually by the physicians from the provider, from the large insurer, if you will.

我們的第二個臨床試驗，如果你願意的話，將是一個登記處，用於將 Pantheris、Ocelot 結果的安全性和有效性與目前大型醫療保險公司的大型現有數據庫進行比較。如果您願意，本試驗中的程序將由來自提供者、來自大型保險公司的醫生實際執行。

So a third would be an independent core lab adjudicated perspective, randomized trial, which is the trial that will allow us to compare the safety and efficacy of the Pantheris and Ocelot through other leading treatments for PAD. The exact structure of these trials is evolving, but the current proposed enrollment timelines will be presented by Jeff in his closing remarks.

因此，第三項將是獨立核心實驗室裁定的隨機試驗，該試驗將使我們能夠通過其他領先的 PAD 療法來比較 Pantheris 和 Ocelot 的安全性和有效性。這些試驗的確切結構正在演變，但 Jeff 將在其結束語中介紹當前擬議的入組時間表。

As we are making progress in all these areas, it will be shocking to you that I want it to go faster. Committed to making that happen and I am very committed to making that happen, and I will close my remarks by thanking all of the docs and patients who have been involved in our trials, but also in our commercial launch and all the Avinger employees whose tireless efforts have made this possible.

當我們在所有這些領域取得進展時，如果我希望它進展得更快，你會感到震驚。致力於實現這一目標，我非常致力於實現這一目標，我將通過感謝所有參與我們試驗的醫生和患者，以及參與我們的商業發布的所有 Avinger 員工和不懈努力的所有 Avinger 員工來結束我的發言努力使這成為可能。

So with this, then, I will turn the call over to Matt for the financials.

因此，有了這個，我將把電話轉給馬特來處理財務問題。

Thanks, John. Total revenue was $4.5 million for the first quarter ended March 31, 2016. That is 117% increase from the first quarter of 2015 and a 59% increase from the fourth quarter of 2015. Revenue related to our Lightbox imaging consuls was $1.2 million and 100% increase compared to the first quarter of last year. And consistent with the fourth quarter.

謝謝，約翰。截至 2016 年 3 月 31 日的第一季度總收入為 450 萬美元。與 2015 年第一季度相比增長 117%，與 2015 年第四季度相比增長 59%。與我們的燈箱成像顧問相關的收入為 120 萬美元和 100與去年第一季度相比增加了 %。與第四季度一致。

Revenues from disposable devices were $3.3 million, a 125% increase compared to the first quarter of 2015 and a 105% increase from the fourth quarter. A strong revenue results in the first quarter of 2016 were primarily driven by the US launch of Pantheris in the beginning of March.

一次性設備的收入為 330 萬美元，比 2015 年第一季度增長 125%，比第四季度增長 105%。 2016 年第一季度強勁的收入業績主要得益於 Pantheris 於 3 月初在美國上市。

Gross margin for the first quarter of 2016 was 26%, down from 38% in the comparable quarter of 2015. The decrease was primarily attributable to costs associated with initial manufacturing of Pantheris and anticipation of its commercial launch as well as some increased reserves against inventory and warranty accruals as a result of the modifications to Pantheris that we have made to address the early learnings from the commercial launch. Operating expenses for the first quarter of 2016 were $16.2 million compared to $10.2 million in the first quarter of last year. This growth was primarily attributable to the expansion of the Company's commercial organization and marketing expenses associated with the launch of Pantheris.

2016 年第一季度的毛利率為 26%，低於 2015 年同期的 38%。下降的主要原因是與 Pantheris 的初始製造相關的成本和對其商業發布的預期以及一些庫存儲備增加由於我們為解決從商業發布中獲得的早期經驗而對 Pantheris 進行了修改，因此產生了保修和應計費用。 2016 年第一季度的運營費用為 1620 萬美元，而去年第一季度為 1020 萬美元。這一增長主要歸因於公司商業組織的擴張以及與 Pantheris 上市相關的營銷費用。

We do not expect those marketing launch expenses to continue at the same level through the remainder of the year and, as a result, we expect that the overall operating expenses will also declined slightly in the second quarter relative to Q1.

我們預計這些營銷啟動費用在今年剩餘時間內不會繼續保持在同一水平，因此，我們預計第二季度的整體運營費用也將相對於第一季度略有下降。

Loss from operations for the first quarter of 2016 was $15.0 million compared to $9.4 million for the first quarter of 2015. That loss for the first quarter of 2016 was $16.2 million compared to $10.4 million in the first quarter of 2015. Adjusted EBITDA, which is a non-GAAP measure, was a loss of $12.7 million for the first quarter of 2016 compared to a $7.9 million loss for the first quarter of the previous year.

2016 年第一季度的運營虧損為 1500 萬美元，而 2015 年第一季度為 940 萬美元。2016 年第一季度的虧損為 1620 萬美元，而 2015 年第一季度為 1040 萬美元。調整後的 EBITDA，即根據非美國通用會計準則衡量，2016 年第一季度虧損 1270 萬美元，而去年第一季度虧損 790 萬美元。

Turning to our balance sheet, cash and cash equivalents totaled $26.9 million as of March 31, 2016 compared to $43.1 million as of the year-end 2015. Total debt at quarter end was $30.0 million. In addition to the cash currently on our balance sheet, we also have immediate access to an additional $10 million through our existing debt facility and $10 million beyond that will become available based on achievement of $25 million in trailing 12-month revenue by the end of this year.

轉向我們的資產負債表，截至 2016 年 3 月 31 日，現金和現金等價物總計 2690 萬美元，而截至 2015 年底為 4310 萬美元。季度末的總債務為 3000 萬美元。除了我們資產負債表上目前的現金外，我們還可以通過現有的債務安排立即獲得額外的 1000 萬美元，而超過 1000 萬美元的資金將基於截至 2018 年底的過去 12 個月收入達到 2500 萬美元而可用。今年。

Turning now to our financial guidance for 2016, we continue to expect 2016 revenue to be in the range of $25 million to $30 million, representing year-over-year growth ranging from 134% to 180%. We also continue to expect adjusted EBITDA for 2016 to be a loss of $40 million to $43 million, representing an increased loss of approximately 19% to 28% over 2015 as the Company continues to expand its commercial infrastructure related to the launch of Pantheris, and invest in the further development of the lumivascular platform product.

現在轉向我們 2016 年的財務指引，我們繼續預計 2016 年的收入將在 2500 萬美元至 3000 萬美元之間，同比增長 134% 至 180%。我們還繼續預計 2016 年調整後的 EBITDA 將虧損 4000 萬至 4300 萬美元，比 2015 年虧損增加約 19% 至 28%，因為公司繼續擴大與 Pantheris 推出相關的商業基礎設施，以及投資進一步開發 lumivascular 平台產品。

We also continue to expect net loss per share for 2016 to be in the range of $4.35 to $4.55, and that assumes a weighted average share count of 12.8 million shares. At this point, I would like to turn the call back to Jeff.

我們還繼續預計 2016 年每股淨虧損將在 4.35 美元至 4.55 美元之間，假設加權平均股數為 1280 萬股。在這一點上，我想把電話轉回傑夫。

Thanks, Matt. Well, our primary focus for this year remains continuing to execute on the successful launch of Pantheris, expanding the base of lumivascular accounts, and driving utilization in existing accounts as Dr. Simpson discussed we are also making good progress on the clinical and product development fronts.

謝謝，馬特。好吧，我們今年的主要重點仍然是繼續成功推出 Pantheris，擴大 lumivascular 賬戶的基礎，並推動現有賬戶的利用率，正如 Simpson 博士所討論的那樣，我們在臨床和產品開發方面也取得了良好進展.

For our clinical study focused on the radiation reduction benefits of OCT guided atherectomy, we expect to finalize the protocol this quarter and initiate enrollment in the third quarter. Our second study will be conducted in a large, Blue owned hospital system and will compare clinical outcomes, quality metrics, and help economic measures associated with the lumivascular treatment of PAD against the matched historical cohort of endovascular treatments.

對於我們專注於 OCT 引導的粥樣斑塊切除術減少輻射益處的臨床研究，我們預計將在本季度完成協議並在第三季度開始註冊。我們的第二項研究將在 Blue 擁有的一家大型醫院系統中進行，並將比較臨床結果、質量指標和幫助與 PAD 的 lumivascular 治療相關的經濟措施與匹配的血管內治療的歷史隊列。

Enrollment for this study has been approved by the relevant institutional review boards and is expected to also begin in the third quarter.

這項研究的招募已獲得相關機構審查委員會的批准，預計也將於第三季度開始。

As Dr. Simpson mentioned, our third study will be a randomized controlled trial comparing Pantheris safety and efficacy to other leading PAD treatments, and is expected to track longer-term outcomes. We plan to refine the details of this study as we gain more commercial experience with Pantheris and will likely have the protocol defined and the site selected by year-end with enrollment anticipated to commence early in 2017.

正如 Simpson 博士所提到的，我們的第三項研究將是一項隨機對照試驗，將 Pantheris 的安全性和有效性與其他領先的 PAD 治療進行比較，並有望追踪長期結果。隨著我們獲得更多關於 Pantheris 的商業經驗，我們計劃完善這項研究的細節，並且可能會在年底前定義協議和選擇站點，預計將於 2017 年初開始招募。

Avinger is committed to real-world long-term comparative data, proving out the clinical efficacy and safety benefits of our lumivascular platform. We are excited about the body of data that will be created by these studies and look forward to sharing more details of the individual studies over the next couple of quarters. We have a philosophy of continuous product improvement at Avinger. We have already been making some minor product modifications to Pantheris, based on our early field experience. At the same time, we are making substantial progress on extending our lumivascular platform with Pantheris product line extensions that increase the range of anatomies and lesion types we can treat.

Avinger 致力於真實世界的長期比較數據，證明我們的 lumivascular 平台的臨床療效和安全性優勢。我們對這些研究將創建的數據主體感到興奮，並期待在接下來的幾個季度中分享個別研究的更多細節。在 Avinger，我們有持續改進產品的理念。根據我們早期的現場經驗，我們已經對 Pantheris 進行了一些小的產品修改。與此同時，我們在擴展我們的 lumivascular 平台方面取得了實質性進展，擴展了 Pantheris 產品線，增加了我們可以治療的解剖結構和病變類型的範圍。

Pantheris is configured today as best suited to address PAD treatment in the larger vessels above or behind the knees, such as the SFA and [popliteal]. We estimate that the market currently available to us represents approximately 50% of the overall PAD market. We have active R&D programs underway to develop a lower profile device for use in smaller vessels as well as enhanced cutting mechanisms that will allow us to address most lesions typically encountered in vessels from the hip to the ankle.

Pantheris 今天的配置最適合解決膝蓋上方或後方較大血管的 PAD 治療，例如 SFA 和 [膕窩]。我們估計我們目前可用的市場約佔整個 PAD 市場的 50%。我們正在進行積極的研發計劃，以開髮用於較小血管的低剖面設備以及增強的切割機制，這將使我們能夠解決從臀部到腳踝的血管中通常遇到的大多數病變。

Our goal is to file a 510(k) for the devices with the enhanced cutting capability in the third quarter of this year, and to have FDA clearance by the end of this year. We anticipate that we will be in a position to file a 510(k) for the lower profile device early in 2017 and expect both of these new products to contribute to incremental revenue growth next year.

我們的目標是在今年第三季度為具有增強切割能力的設備提交 510(k)，並在今年年底前獲得 FDA 批准。我們預計我們將能夠在 2017 年初為低端設備提交 510(k) 申請，並預計這兩種新產品將在明年為增量收入增長做出貢獻。

In summary, we are pleased with our early momentum in 2016 and excited about our prospects going forward.

總而言之，我們對 2016 年的早期勢頭感到滿意，並對我們未來的前景感到興奮。

With that, we would like to open the call to your questions.

有了這個，我們想打開您的問題的電話。

(Operator Instructions) Jason Milles, Canaccord Genuity.

（操作員說明）Jason Milles，Canaccord Genuity。

Jeff, Matt, and John, congrats on a good start to the Pantheris era.

Jeff、Matt 和 John，祝賀 Pantheris 時代有了一個良好的開端。

Thank you, Jason. Appreciate it.

謝謝你，傑森。欣賞它。

Super. So I wanted to start there with Pantheris. You didn't break out specifically the Pantheris revenue -- catheter revenue in the quarter. But if we assume that the run rate for Ocelot improved modestly, would it be fair to assume that Pantheris catheter revenue was above $1 million or $1.31 million or $1.34 million? Am I in the ballpark there, just as a start?

極好的。所以我想從 Pantheris 開始。你沒有具體列出 Pantheris 的收入——本季度的導管收入。但是，如果我們假設 Ocelot 的運行率略有提高，那麼假設 Pantheris 導管收入超過 100 萬美元、131 萬美元或 134 萬美元是否公平？我在球場上嗎，只是作為一個開始？

Yes. I think you're in the right ballpark. We haven't broken out the individual products, but I think if you were to look at the historical trend for our disposable devices, which we have provided in past quarters, that we are very much in that same range for Ocelot sales and then the incremental disposable revenue that we generated in Q1 really was attributed to Pantheris.

是的。我認為你是在正確的球場。我們還沒有對個別產品進行細分，但我想如果你看一下我們在過去幾個季度提供的一次性設備的歷史趨勢，我們的 Ocelot 銷售額幾乎處於同一範圍內，然後是我們在第一季度產生的增量可支配收入確實歸因於 Pantheris。

And then, of course, the Lightbox revenue has bounced around a bit from quarter to quarter, but we did provide that number. So I hope that helps.

然後，當然，Lightbox 收入每個季度都有所反彈，但我們確實提供了這個數字。所以我希望能有所幫助。

You broke that out. So that was a known. So that leads to my second question which is, the run rate in just a month, obviously, you only had it for a month, was better than what we had modeled. And you also David detail, Jeff, that you penetrated 60% of the accounts. Now, correct my assumption, if you might, but I am assuming that the Lightbox placements are in those facilities that planned to use it -- use Pantheris, in addition to Ocelot.

你把它弄壞了。所以這是眾所周知的。所以這就引出了我的第二個問題，即一個月內的運行率，顯然，你只有一個月的運行率，比我們建模的要好。大衛，傑夫，你還詳細說明你滲透了 60% 的賬戶。現在，請糾正我的假設，如果可以的話，但我假設燈箱展示位置是在那些計劃使用它的設施中——除了 Ocelot 之外，還使用 Pantheris。

So eventually that gets to 100%, but given that you were in 60% this quarter for just a month, it would imply that, if we are calculating the ESP correctly, that your quarterly utilization rate in those 60% of accounts was north of 20 units per quarter.

所以最終達到 100%，但考慮到您本季度僅一個月處於 60%，這意味著，如果我們正確計算 ESP，您在這 60% 的賬戶中的季度利用率高於每季度 20 個單元。

Was there any stocking or anything that would result in that utilization rate that I mentioned being wrong? And that certainly portends positively as we look at what we had modeled previously for the rest of the year. And, obviously, makes your guidance look imminently doable. Could you comment on those numbers and perhaps just give qualitative overview of the thoughts for the ramp through the rest of the year? Sorry for that long question, but (multiple speakers).

是否有任何庫存或任何會導致我提到的利用率錯誤的東西？當我們查看我們之前為今年剩餘時間建模的內容時，這肯定預示著積極的跡象。而且，顯然，使您的指導看起來迫在眉睫。您能否對這些數字發表評論，也許只是對今年餘下時間的增長想法進行定性概述？很抱歉問了這麼長的問題，但是（多位發言者）。

Appreciate the question, Jason. So really, we are just looking at one month as you know with the approval on March 1 of Pantheris revenue. And, really, what we are seeing in that month are the initial orders of Pantheris.

感謝這個問題，傑森。所以真的，我們只關注 3 月 1 日 Pantheris 收入批准的一個月。而且，實際上，我們在那個月看到的是 Pantheris 的初始訂單。

And so it is, I think, too early to project utilization or reorder rates based on a single end month quarter. I think our second-quarter revenue -- I think you are exactly right. We will now be focused on, of course, getting the initial orders in the remaining accounts, continuing to add new accounts, and, very importantly, driving utilization in our existing accounts.

因此，我認為，基於單個月底季度來預測利用率或再訂購率還為時過早。我認為我們的第二季度收入——我認為你是完全正確的。當然，我們現在將專注於在剩餘賬戶中獲得初始訂單，繼續添加新賬戶，並且非常重要的是，推動我們現有賬戶的利用率。

But I wouldn't project too much about utilization rates, based on the one month of revenue and based on the vast majority of those orders being initial orders and accounts. I will also say, though, that we are really pleased with how rapidly we were able to penetrate such a large percentage of our accounts. And I think that does speak to -- and we have talked about on past calls -- our efforts with [fact] committees, with physician training, with training of our sales force in advance of the actual approval of the commercial or enhanced version of Pantheris, where we were really answering Dr. Simpson's call to not squander the opportunity of the early clinical approval in the fourth quarter of last year of the clinical device.

但我不會根據一個月的收入和這些訂單中的絕大多數是初始訂單和賬戶，對利用率做出太多預測。不過，我還要說的是，我們真的很高興能夠如此迅速地滲透到我們如此大比例的賬戶中。我認為這確實說明了——我們在過去的電話會議上也談到了——我們在 [事實] 委員會、醫師培訓以及我們的銷售人員在商業或增強版實際批准之前所做的努力Pantheris，我們真正響應了 Simpson 博士的呼籲，不要浪費去年第四季度臨床設備早期臨床批准的機會。

So, I think it also -- we are, as we said in our press release and also in Matt's comments, we are reaffirming our guidance for the year. Again, we are at the end of the first quarter or just one month into this launch and we don't want to get too far ahead of ourselves here. But, of course, extremely pleased with how quickly we have come out of the gates and doing everything we possibly can to continue that positive momentum.

所以，我認為它也是——正如我們在新聞稿和馬特的評論中所說，我們正在重申我們今年的指導方針。同樣，我們正處於第一季度末或本次發布僅一個月，我們不想在這裡走得太遠。但是，當然，我們對我們走出大門的速度如此之快並儘我們所能繼續保持這種積極勢頭感到非常高興。

That is helpful color, Jeff. I appreciate that. Just -- I have several questions, but I will limit it to one more and then get back into queue.

這是有用的顏色，傑夫。我很感激。只是-- 我有幾個問題，但我會再限制一個，然後再回到隊列中。

With respect to penetration of accounts, your -- 60% of them exiting the quarter, how does it look for you to penetrate the remainder of the 107, at least, let alone any additional accounts that you add here in the June quarter?

關於賬戶滲透率，您的 - 60% 的賬戶退出了本季度，您如何看待您至少滲透 107 個賬戶的其餘部分，更不用說您在 6 月季度在這裡添加的任何其他賬戶了？

Yes. I think you have certainly given the efforts that have started even prior to the approval of Pantheris and our continued efforts and progress and, mostly, the appeal of this lumivascular approach and excitement around Pantheris and as well as the, of course, strong atherectomy reimbursement. We feel our prospects are very good to continue that penetration.

是的。我想你肯定已經給出了在 Pantheris 獲批之前就已經開始的努力以及我們持續的努力和進步，主要是這種 lumivascular 方法的吸引力和 Pantheris 周圍的興奮，當然還有強大的斑塊切除術報銷.我們認為繼續滲透的前景非常好。

Josh Jennings, Cowen and Company.

喬希·詹寧斯、考恩公司。

I would like to second Jason's congratulations on the momentum and the early success with the Pantheris launch.

我想附和 Jason 對 Pantheris 發射的勢頭和早期成功的祝賀。

If I could start off with just a question, maybe for Dr. Simpson and Jeff -- Dr. Simpson, you talked about the safety and efficacy of the Pantheris device. And I was just hoping for some incremental color just on how the Vision trial date data is being digested now that you are officially marketing it with a commercial launch here with the Pantheris.

如果我能從一個問題開始，也許是關於辛普森博士和傑夫——辛普森博士，你談到了 Pantheris 裝置的安全性和有效性。我只是希望在 Vision 試用日期數據如何被消化的情況下獲得一些增量顏色，因為您正在通過在這裡與 Pantheris 一起進行商業發布來正式營銷它。

Yes. So continued excitement that is really amazing because, you know, we had no vascular perforations in the Vision trial and we have had no perforations during the commercial launch either. I don't actually have the numbers or how many cases we have done, but it is a large, noticeable number. And the perforation risk was not really dramatic. They are very totally consistent with Vision. We would know about it by now. And it is actually absolutely consistent with everything we have seen in Vision.

是的。如此持續的興奮真是太棒了，因為，你知道，我們在 Vision 試驗中沒有血管穿孔，在商業發布期間我們也沒有穿孔。我實際上沒有數字或我們已經完成了多少案例，但這是一個很大的、引人注目的數字。而且穿孔風險並不是很嚴重。它們與 Vision 完全一致。我們現在就會知道了。而且它實際上與我們在Vision中看到的一切完全一致。

There have been no surprises in terms of the function of the devices. We are seeing the devices used by new doctors and perhaps they are not quite as gentle with the device, maybe, as I would want them to be, but I just believe that it is -- everything is totally consistent. So for sure, there have been no surprises along those lines. And maybe it is a favorable surprise just to know that we have been able to reconfirm everything that we saw in Vision.

就設備的功能而言，沒有任何驚喜。我們正在看到新醫生使用的設備，也許他們對設備的使用並不像我希望的那樣溫和，但我只是相信它是——一切都完全一致。所以可以肯定的是，在這些方面沒有任何意外。知道我們能夠重新確認我們在 Vision 中看到的一切，這也許是一個驚喜。

Great. And just in terms of how they are perceiving the Vision data well and how competitive it is with other data that are out there, our understanding of the Vision trial was one of the more rigorous data sets for 510(k) approval (multiple speakers) data with the other devices on the market having -- the clinicians having longer experience with those. But, (multiple speakers) this data set resonating with clinicians, is the follow-up there?

偉大的。就他們如何很好地感知 Vision 數據以及它與現有其他數據的競爭力而言，我們對 Vision 試驗的理解是 510(k) 批准的更嚴格的數據集之一（多位發言者）市場上其他設備的數據——臨床醫生對這些設備有更長的經驗。但是，（多位發言者）這個數據集引起了臨床醫生的共鳴，是否有後續行動？

I think for sure, yes, it does resonate with everybody. Everybody wants a larger data set when the process [is innermost] what we were alluding to in the call was all the different trials that we would do to expand that data set.

我肯定地認為，是的，它確實引起了每個人的共鳴。每個人都想要一個更大的數據集，當我們在電話中提到的過程 [是最內在的] 是我們將進行的所有不同試驗以擴展該數據集時。

But to say that you can treat patients with the profoundly low risk of dissection -- vascular perforation or any kind of complication is just really extra --. I don't think anybody now sort of questions the Vision data. I think at one point they might have said, wait a minute, this is just a little bit too good to be true.

但是要說你可以治療夾層風險極低的患者——血管穿孔或任何類型的並發症，這真的是額外的——。我認為現在沒有人質疑 Vision 數據。我想有一次他們可能會說，等一下，這有點太好了，令人難以置信。

But I think it is not -- and obviously, also this will translate into better long-term outcomes. We ought to be able to confirm that we can have due procedure with less radiation. So I think that the Vision -- everything that we have seen so far really is well aligned with all the Vision data, which I think the world is beginning to accept the Vision data as relevant.

但我認為它不是——而且顯然，這也將轉化為更好的長期結果。我們應該能夠確認我們可以在輻射較少的情況下進行適當的程序。所以我認為 Vision——我們到目前為止所看到的一切確實與所有 Vision 數據保持一致，我認為世界正在開始接受 Vision 數據的相關性。

Small trial, but relevant data. I think it would be hard to deny that now.

小試驗，但相關數據。我認為現在很難否認這一點。

Excellent. And then, Jeff, you talked about the pathway for the below the knee device. Any further color you can give us on just what is going to be required to get that -- the regulatory approval and some of the timelines out in the next year?

出色的。然後，傑夫，你談到了膝下裝置的通路。你能給我們進一步的顏色來說明實現這一目標所需的條件——監管批准和明年的一些時間表嗎？

Yes. So Jason, -- I'm sorry, Josh. We look at both devices and the enhanced cutting capability as well as the lower profile as 510(k) filings. And we do not anticipate that there will be any clinical studies required. And so, we are well along in development of both products. Very pleased with R&D effort and focus. And are on track. I think this is the first time we have provided specific timelines as to when we will be filing and, of course, we anticipate no surprises in the approval timelines with FDA.

是的。所以傑森，- 對不起，喬希。我們將這兩種設備和增強的切割能力以及較低的配置視為 510(k) 文件。我們預計不需要任何臨床研究。因此，我們在開發這兩種產品方面進展順利。對研發工作和專注度非常滿意。並且走上正軌。我認為這是我們第一次提供關於何時提交申請的具體時間表，當然，我們預計 FDA 的批准時間表不會有任何意外。

Excellent. Just one last follow-up. Vessel prep and followed by drug-coated balloon has garnered some momentum here over the last six to 12 months and understand that longer term the prospects of Pantheris, being a single device solution for a wide variety of lesion sets, is -- again, we understand that. But just in the interim, would you guys ever consider a distribution partner with a company that has a drug-coated balloon, either in international markets as you have CE Mark approval or even domestically? Thanks a lot.

出色的。最後一次跟進。在過去的 6 到 12 個月裡，血管準備和隨後的藥物塗層球囊在這裡獲得了一些動力，並且了解到 Pantheris 的長期前景，作為針對各種病變組的單一設備解決方案，我們再次明白。但在此期間，你們是否會考慮與擁有藥物塗層氣球的公司建立分銷合作夥伴，無論是在獲得 CE 標誌批准的國際市場上，還是在國內？多謝。

Yes. So I think we do see the drug coated balloons being used. They are used for drug delivery. They are not being used for angioplasty effect, which is kind of interesting, used post Pantheris. And I think we would be open to all kinds of considerations.

是的。所以我認為我們確實看到了使用藥物塗層的氣球。它們用於藥物輸送。它們沒有被用於血管成形術效果，這很有趣，在 Pantheris 之後使用。我認為我們會對各種考慮持開放態度。

I think, overall, I personally believe that the majority of the patients could be effectively treated, certainly they do not need additional angioplasty; whether they need drug or not is -- that would be a part of the study to define that. I think probably more people are getting drug than needed so I would really sort of -- my leaning would be toward trying to study that and find out what the real answer is.

我認為，總體而言，我個人認為大多數患者可以得到有效治療，當然他們不需要額外的血管成形術；他們是否需要藥物是——這將是定義這一點的研究的一部分。我認為吸毒的人可能比需要的多，所以我真的有點——我傾向於嘗試研究它並找出真正的答案是什麼。

But, overall, if I can create a pretty much normal artery, then and geographically and by OCT, the OCT images are really dramatic in terms of how big the lumen is you have created -- how big the lumen isn't and what the surface looks like. It is really -- that part is so special and so unique that it is going to drive adoption, I think, in a big-time way.

但是，總的來說，如果我能創造出一條非常正常的動脈，那麼在地理上和通過 OCT，OCT 圖像在你創造的管腔有多大方面確實非常引人注目——管腔有多大，管腔有多大？表面看起來像。它真的——那部分是如此特別和獨特，以至於我認為它將以一種重要的方式推動採用。

I personally think it will drive us away from drug. For sure, it has already driven us away from stent. It's going to drive us away from just balloon angioplasty, I personally believe. And also eventually away from the drug.

我個人認為它會讓我們遠離毒品。可以肯定的是，它已經讓我們遠離了支架。我個人認為，這將使我們遠離球囊血管成形術。也最終遠離毒品。

I would like to build on what Dr. Simpson said around stent usage. One of the things that was so exciting coming out of the Vision data was the very low usage of stents at around 4% across the study. We continue to see in our early clinical experience very, very minimal stent usage in placement. A big part of what we are all about with this technology and this lumivascular platform is to provide information for the physician, so they can decide what is best for their patient.

我想以 Simpson 博士關於支架使用的觀點為基礎。從 Vision 數據中得出的令人興奮的事情之一是整個研究中支架的使用率非常低，約為 4%。在我們的早期臨床經驗中，我們繼續看到在放置過程中支架的使用非常非常少。我們對這項技術和這個 lumivascular 平台所做的很大一部分是為醫生提供信息，這樣他們就可以決定什麼對他們的病人最好。

Now, in some cases, they do decide to use DCVs, they are certainly a factor in the market. But we want to empower them with information. We want to empower them eventually with data to help make those decisions better. Having said that, as you know, there is a large degree of interest in the combination of the significant debulking provided by directional atherectomy, prior to use of a drug-coated balloon. I think we will very much benefit from that, the building body of evidence from other companies as well as the clinical acceptance of the need for this plaque debulking prior to deployment of a drug-coated balloon.

現在，在某些情況下，他們確實決定使用 DCV，這無疑是市場的一個因素。但我們想用信息賦予他們權力。我們希望最終通過數據賦予他們權力，以幫助他們更好地做出這些決定。話雖如此，正如您所知，在使用藥物塗層球囊之前，人們對通過定向旋磨術提供的顯著減瘤組合產生了很大的興趣。我認為我們將從中獲益良多，包括來自其他公司的大量證據以及臨床上對在部署藥物塗層球囊之前需要進行這種斑塊減滅的接受度。

So again, I think that works to our benefit.

因此，我再次認為這對我們有利。

Chris Cooley, Stephens.

克里斯庫利，斯蒂芬斯。

Good afternoon, everyone. Let me just continue the (technical difficulty) (inaudible) of the favorable sentiments. It is a great first start for Pantheris. I know you're very proud of the results.

大家下午好。讓我繼續（技術困難）（聽不清）的好評。對於 Pantheris 來說，這是一個很好的開端。我知道你對結果感到非常自豪。

If I may, could you just maybe remind us a little bit about the sales force. You're clearly expanding the number of reps there. Could you give us some color about the types of adds that you are bringing on and then, additionally, along those same lines, how are they allocating their time? Just trying to

如果可以的話，你能否提醒我們一些關於銷售人員的事情。您顯然正在擴大那裡的代表人數。您能否給我們一些關於您帶來的添加類型的顏色，然後，另外，沿著同樣的思路，他們如何分配時間？只是想

Quarter ended March 31, 2016. Before we begin, I would like to remind you that management will make statements during this call that includes forward-looking statements within the meaning of federal Securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 examination of historical operating trends and our future financial expectations are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list of description of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. Avinger disclaims 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. This conference call contains time sensitive information and is accurate only as of the live broadcast today, May 4, 2016. I would now like to turn the call over to Jeff.

截至 2016 年 3 月 31 日的季度。在我們開始之前，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。本次電話會議中包含的任何不屬於歷史事實陳述的陳述均應視為前瞻性陳述。所有前瞻性陳述，包括但不限於我們對歷史經營趨勢的審查和我們未來的財務預期，都是基於我們目前的估計和各種假設。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預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。有關與我們業務相關的風險和不確定性的描述列表，請參閱我們向美國證券交易委員會提交的文件。 Avinger 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新信息、未來事件或其他原因。此電話會議包含時間敏感信息，僅在 2016 年 5 月 4 日今天的現場直播時準確無誤。我現在想將電話轉給 Jeff。

Thanks, Mark. Good afternoon, and thank you all for joining us. I am very pleased with our first quarter results, led by our early success in the US launch of our Pantheris image guided atherectomy system. We received five 10K clearance on March 1, and by the end of the first quarter had already sold Pantheris into approximately 60% of our Luba vascular accounts. This is a good indication of how much enthusiasm there is for Pantheris in the marketplace as well as the great work by our sales and training teams preparing preparing the market for launch. Overall, we're encouraged by the early commercial uptake of Pantheris and I will turn the call over to Dr. Simpson shortly to provide some highlights on what he has seen in the field. But, first, I would like to update you on our operational achievements of the quarter. The US commercial launch of Pantheris in March drove the highest quarterly sales results in Avinger history. With total revenue of $4.5 million in the first quarter. We also significantly expanded our installed base of lumivascular accounts. During the quarter, we added 12 new accounts, reaching a total of 107 at the end of the quarter. We sold five Lightboxes during the quarter, including 32 new accounts and two conversions of existing placement to purchase accounts. This continued strong growth in new accounts speaks to the appeal of our lumivascular platform and provides further validation that our most more flexible capital acquisition model, including our placement to purchase initiative, is working. We continue to evaluate the most effective programs to grow our installed base and remain comfortable that we will achieve our goal of approximately 150 lumivascular accounts by the end of the year. Turning to sales and marketing, we continue to strategically build our field sales force and ended the quarter with total headcount of 62 sales professionals. We continue to expect to reach our goal of 70 salespeople by the end of 2016 and are encouraged by the high levels of talent, experience, and enthusiasm we are seeing in both our recent hires and in the candidates in our recruiting pipeline. I would now like to ask Dr. Simpson to share some of his recent case experiences and feedback from physicians who have used Pantheris. Following Dr. Simpson's remarks, Matt will review our first quarter financial results and review guidance for 2015 2016. I will then close with comments on our clinical and product development plan for 2016 and then we will open the call for questions. John?

謝謝，馬克。下午好，感謝大家加入我們。我對我們第一季度的業績感到非常滿意，這得益於我們在美國推出我們的 Pantheris 圖像引導動脈粥樣硬化切除術系統的早期成功。我們在 3 月 1 日收到了五個 10K 許可，到第一季度末，我們已經將 Pantheris 賣給了我們大約 60% 的 Luba 血管賬戶。這很好地表明了市場對 Pantheris 的熱情以及我們的銷售和培訓團隊為上市做準備的出色工作。總的來說，我們對 Pantheris 的早期商業採用感到鼓舞，我將很快將電話轉給辛普森博士，以提供他在該領域所見的一些亮點。但是，首先，我想向您介紹我們本季度的運營成就。 Pantheris 於 3 月在美國上市，推動了 Avinger 歷史上最高的季度銷售業績。第一季度總收入為 450 萬美元。我們還顯著擴大了我們的 lumivascular 客戶群。本季度，我們新增了 12 個賬戶，本季度末總數達到 107 個。我們在本季度售出了 5 個 Lightbox，包括 32 個新帳戶和兩個將現有展示位置轉換為購買帳戶的帳戶。新客戶的持續強勁增長說明了我們 lumivascular 平台的吸引力，並進一步證明我們最靈活的資本收購模式（包括我們的購買計劃）正在發揮作用。我們將繼續評估最有效的計劃來擴大我們的安裝基礎，並對我們將在年底前實現大約 150 個 lumivascular 客戶的目標感到滿意。在銷售和市場營銷方面，我們繼續戰略性地建設我們的現場銷售隊伍，並在本季度結束時擁有 62 名銷售專業人員。我們繼續期望到 2016 年底達到 70 名銷售人員的目標，並且我們在最近招聘的人員和招聘渠道中的候選人中看到的高水平人才、經驗和熱情讓我們感到鼓舞。我現在想請辛普森醫生分享他最近的一些病例經驗和使用過Pantheris的醫生的反饋。在 Simpson 博士發表講話後，Matt 將回顧我們第一季度的財務業績並回顧 2015 年和 2016 年的指導意見。然後我將以對我們 2016 年臨床和產品開發計劃的評論結束，然後我們將開始提問。約翰？

Thanks, Jeff. Thanks to everyone. I want to add my welcome to everybody very sincere. I know you all have incredibly busy schedules so we are thrilled that you are on the call. I want to compliment Jeff for summarizing the status of Avinger in four paragraphs. That is a profoundly daunting task. But I think everything that he summarized is really to be taken to heart, if you will. And so from what Jeff said and from what I will say, I hope it is clear that we understand the magnitude of this opportunity and we are prepared in working hard to show the (inaudible) world -- the (inaudible) world is very complicated in that interventional cardiologists, radiologists, and surgeons, so we are intent on showing the entire world the advantages associated with the lumivascular treatment. This treatment now available in over 100 hospitals nationwide. It still has these three thieves that dominate and remain very consistent to all of our previous presentations. In the first is the outstanding safety profile. Overall, it is so reassuring to the physicians and better outcomes for the patient when they can see what they are doing. They get to see from inside the artery while they are working on it. And, of course, this leads to the number of second (inaudible), which would be great clinical outcomes. And then, number three, not the least of which, would be this new definition of the (inaudible) and the variability of lesions being crossed with the Ocelot and treated with Pantheris catheter. We are seeing a really unique distribution and composition of plaque and it varies dramatically from patient to patient, which I'm sure is no real surprise, particularly not a surprise to the surgeons. But rep really happens what really happens to a vessel when it is treating with existing technologies now really clear as we image (inaudible) while we are working on them. And this always happens with new technologies, particularly the ones that I've introduced, which also helps explain all this gray hair. We see areas for improvement in both Ocelot and Pantheris, primarily focused on making both more robust and smaller as both are being used increasingly difficult anatomies and also in smaller vessels. So while we continue to improve our Enters, we are also designing trials to expand the clinical evidence to help support lumivascular -- the concept of lumivascular and keep the physicians focused on the advantages that they can bring to the patients. So the first of the trials that we are setting up, the first trial is really focused on radiation reduction opportunity and will be a randomized trial comparing Pantheris to Ocelot outcomes to traditional therapies, while (inaudible) exposure to the docs, the patient, and the staff. I frequently talk about measure reading measuring the radiation exposure to the patient, but it is really the physician that sees the majority of the exposure and that is really where we will focus a lot of our attention. Our second clinical trial, if you will, will be a registry to compare the safety and efficacy of Pantheris, Ocelot outcomes to a large, existing database of a large healthcare insurer provider by now. With the procedures that in this trial will be performed actually by the physicians from the provider, from the large insurer, if you will. So a third would be an independent core lab adjudicated perspective, randomized trial, which is the trial that will allow us to compare the safety and efficacy of the Pantheris and Ocelot through other leading treatments for PAD. The exact structure of these trials is evolving, but the current proposed enrollment (inaudible) timelines will be presented by Jeff in his closing remarks. As we are making progress in all these areas, it will be shocking to you that I wanted to go faster. Committed to making that happen and I am very committed to making that happen, and I will close my remarks by thanking all of the docs and patients who have been involved in our trials, but also in our commercial launch. And all the Avinger employees whose tireless efforts have made this possible. So with this, then, I will turn the call over to Matt for the financials.

謝謝，傑夫。謝謝大家。我想對大家表示非常誠摯的歡迎。我知道你們的日程安排都非常繁忙，所以我們很高興你們能接聽電話。我要稱讚 Jeff，他用四段話總結了 Avinger 的狀態。這是一項極其艱鉅的任務。但我認為，如果你願意的話，他總結的一切都應該牢記在心。因此，根據 Jeff 所說的和我將要說的，我希望我們清楚地了解這個機會的重要性，並且我們準備好努力工作來展示（聽不清）世界——（聽不清）世界非常複雜在介入心髒病專家、放射科醫生和外科醫生中，我們致力於向全世界展示與 lumivascular 治療相關的優勢。目前，該療法已在全國 100 多家醫院提供。它仍然有這三個盜賊，它們佔據主導地位並且與我們之前的所有演示文稿保持非常一致。首先是出色的安全性。總的來說，當醫生可以看到他們在做什麼時，他們會感到非常安心，並為患者帶來更好的結果。當他們在動脈上工作時，他們可以從動脈內部看到。當然，這會導致秒數（聽不清），這將是很好的臨床結果。然後，第三個，而不是其中最重要的一個，就是這個（聽不清）的新定義以及與 Ocelot 交叉並用 Pantheris 導管治療的病變的可變性。我們看到了真正獨特的斑塊分佈和組成，並且它因患者而異，我敢肯定這並不令人驚訝，尤其是外科醫生。但是當我們使用現有技術處理船隻時，rep 確實發生了真正發生的事情，現在我們在處理它們時想像（聽不清）時非常清楚。這總是發生在新技術上，尤其是我介紹的那些，這也有助於解釋所有這些白髮。我們看到 Ocelot 和 Pantheris 都有待改進的地方，主要集中在使它們更堅固和更小，因為它們都被用於越來越困難的解剖結構以及更小的血管中。因此，在我們繼續改進我們的 Enters 的同時，我們還在設計試驗以擴大臨床證據，以幫助支持 lumivascular——lumivascular 的概念，並讓醫生專注於他們可以為患者帶來的優勢。因此，我們正在開展的第一項試驗，第一項試驗真正關注的是減少輻射的機會，並將是一項隨機試驗，將 Pantheris 和 Ocelot 的結果與傳統療法進行比較，同時（聽不清）接觸醫生、患者和員工。我經常談論測量讀數測量患者的輻射暴露，但實際上看到大部分暴露的是醫生，這也是我們真正關注的地方。我們的第二個臨床試驗，如果你願意的話，將是一個登記處，用於將 Pantheris、Ocelot 結果的安全性和有效性與目前大型醫療保險公司的大型現有數據庫進行比較。如果您願意，本試驗中的程序將由來自提供者、來自大型保險公司的醫生實際執行。因此，第三項將是獨立核心實驗室裁定的隨機試驗，該試驗將使我們能夠通過其他領先的 PAD 療法來比較 Pantheris 和 Ocelot 的安全性和有效性。這些試驗的確切結構正在演變，但 Jeff 將在他的結束語中介紹當前提議的註冊（聽不清）時間表。當我們在所有這些領域取得進展時，您會驚訝於我想走得更快。致力於實現這一目標，我非常致力於實現這一目標，我將通過感謝所有參與我們的試驗以及我們的商業發布的醫生和患者來結束我的發言。以及所有 Avinger 員工的不懈努力使這成為可能。因此，有了這個，我將把電話轉給馬特來處理財務問題。

Thanks, John. Total revenue was $4.5 million for the first quarter ended March 31, 2016. That is 117% increase on the first quarter of 2015 and a 59% increase from the fourth quarter of 2015. Revenue related to our Lightbox imaging consuls was $1.2 million and 100% increase compared to the first quarter of last year. And consistent with the fourth quarter. Revenues from disposable devices were $3.3 million, a 20 -- a 125% increase compared to the first quarter of 2015 and a 100 and *C* 105% increase from the fourth quarter. A strong revenue results in the first quarter of 2016 were primarily driven by the US launch of Pantheris in the beginning of March. Gross margin for the first quarter 2016 was 26%, down from 38% in the comparable quarter of 2015. The decrease was primarily attributable to costs associated with initial manufacturing of Pantheris and anticipation of its commercial launch as well as some increased reserves against inventory and warranty accruals as a result of the modifications to Pantheris that we have made to address the early learnings from the commercial launch. Operating expenses for the first quarter of 2016 were $16.2 million compared to $10.2 million in the first quarter of last year. This growth was primarily attributable to the expansion of the company's commercial organization and marketing expenses associated with the launch of Pantheris. We do not expect those marketing launch expenses to continue at the same level through the remainder of the year and, as a result, we expect that the overall operating expenses will also declined slightly in the second quarter relative to Q1. Loss from operations for the first quarter of 2016 was $15.0 million compared to $9.4 million for the first quarter of 2015. That loss net for the first quarter of 2016 was $16.2 million compared to $10.4 million in the first quarter of 2015. Adjusted EBITDA, which is a non-GAAP measures, was a loss of $12.7 million for the first quarter of 2016 compared to a $7.9 million loss for the first quarter of the previous year. Turning to our balance sheet, cash and cash equivalents totaled $26.9 million as of March 31, 2016 compared to $43.1 million as of the year-end 2015. Total debt at quarter end was $30.0 million. In addition to the cash currently on our balance sheet, we also have immediate access to an additional $10 million through our existing debt facility and $10 million beyond that will become available based on achievement of $25 million in trailing 12-month revenue by the end of this year. Turning out to our financial guidance for 2016, we continue to expect 2016 revenue to be in the range of $25 million to $30 million, representing year-over-year growth ranging from $134 million space *C* 134% to 180%. We also continue to expect adjusted EBITDA for 2016 to be a loss of $40 million to $43 million, representing an increased loss of approximately 19% to 28% over 2015. If the company continues to expand its commercial infrastructure related to the launch of Pantheris, and invest in the further development of the lumivascular platform product. We also continue to expect net loss per share for 2016 to be in the range of $4.35 to $4.55, and that assumes a weighted average share count of 12.8 million shares. At this point, I would like to turn the call back to Jeff.

謝謝，約翰。截至 2016 年 3 月 31 日的第一季度總收入為 450 萬美元。與 2015 年第一季度相比增長 117%，與 2015 年第四季度相比增長 59%。與我們的燈箱成像顧問相關的收入為 120 萬美元和 100與去年第一季度相比增加了 %。與第四季度一致。一次性設備的收入為 330 萬美元，與 2015 年第一季度相比增長 20 - 125%，與第四季度相比增長 100 和 *C* 105%。 2016 年第一季度強勁的收入業績主要得益於 Pantheris 於 3 月初在美國上市。 2016 年第一季度的毛利率為 26%，低於 2015 年同期的 38%。下降的主要原因是與 Pantheris 的初始製造相關的成本和對其商業發布的預期，以及一些增加的庫存儲備和由於我們對 Pantheris 進行了修改，以解決從商業發布中獲得的早期經驗，因此產生了保修應計費用。 2016 年第一季度的運營費用為 1620 萬美元，而去年第一季度為 1020 萬美元。這一增長主要歸因於公司商業組織的擴張以及與 Pantheris 上市相關的營銷費用。我們預計這些營銷啟動費用在今年剩餘時間內不會繼續保持在同一水平，因此，我們預計第二季度的整體運營費用也將相對於第一季度略有下降。 2016 年第一季度的運營虧損為 1500 萬美元，而 2015 年第一季度為 940 萬美元。2016 年第一季度的淨虧損為 1620 萬美元，而 2015 年第一季度為 1040 萬美元。調整後的 EBITDA，其中作為一項非 GAAP 措施，2016 年第一季度虧損 1270 萬美元，而去年第一季度虧損 790 萬美元。轉向我們的資產負債表，截至 2016 年 3 月 31 日，現金和現金等價物總計 2690 萬美元，而截至 2015 年底為 4310 萬美元。季度末的總債務為 3000 萬美元。除了我們資產負債表上目前的現金外，我們還可以通過現有的債務安排立即獲得額外的 1000 萬美元，而超過 1000 萬美元的資金將基於截至 2018 年底的過去 12 個月收入達到 2500 萬美元而可用。今年。關於我們 2016 年的財務指引，我們繼續預計 2016 年的收入將在 2500 萬美元至 3000 萬美元之間，同比增長 1.34 億美元空間 *C* 134% 至 180%。我們還繼續預計 2016 年調整後的 EBITDA 將虧損 4000 萬至 4300 萬美元，比 2015 年虧損增加約 19% 至 28%。如果公司繼續擴大其與 Pantheris 推出相關的商業基礎設施，並投資進一步開發 lumivascular 平台產品。我們還繼續預計 2016 年每股淨虧損將在 4.35 美元至 4.55 美元之間，假設加權平均股數為 1280 萬股。在這一點上，我想把電話轉回傑夫。

Thanks, Matt. Well, our five primary focus for this year remains continuing to execute on the successful launch of Pantheris, expanding the base of lumivascular accounts, and driving utilization in existing accounts as Dr. Simpson discussed we are also making good progress although clinical and product development front. For our clinical study focused on the radiation reduction benefits of OCT guided atherectomy, we expect to finalize the protocol this quarter and initiate a moment enrollment in the third quarter. Our second study will be conducted in a large, blue owned hospital system and will compare clinical outcomes, quality metrics, and help economic measures associated with the lumivascular treatment of PAD against the matched historical cohort of endovascular treatments. Enrollment for this study has been approved by the relevant institutional review boards and is expected to also begin in the third quarter. As Dr. Simpson mentioned, our third study will be a randomized controlled trial comparing Pantheris safety and efficacy to other leading PAD treatments and is expected to track longer-term outcomes. We plan to refine the details of this study as we gain more commercial experience with Pantheris and will likely have the protocol defined and the site selected by year-end. With enrollment anticipated to commence early in 2017. Avinger is committed to real-world long-term comparative data, proving out the clinical efficacy and safety benefits of our lumivascular platform. We are excited about the body of data that will be created by these studies and look forward to sharing more details of the individual studies over the next couple of quarters. We have a philosophy of continuous product improvement at Avinger. We have already been making some minor product modifications to Pantheris, based on our early field experience. At the same time, we are making substantial progress on extending our lumivascular platform with Pantheris product line extensions that increase the range of anatomies and lesion types we can treat. Pantheris is configured today as best student suited to address PAD treatment in the larger vessels above or behind the knees such as the SFA and popliteal. We estimate that the market currently available to us represents approximately 50% of the overall PAD market. We have active R&D programs underway to develop a lower profile device for use in smaller vessels as well as enhanced cutting mechanisms that will allow us to address most lesions typically encountered in vessels from the hip to the ankle. Our goal is to file a 510(k) for the devices with the enhanced cutting capability in the third quarter of this year and to have FDA clearance by the end of this year. We anticipate that we will be in a position to file a 510(k) for the lower profile device earlier in 2017. And expect both of these new products to contribute to incremental revenue growth next year. In summary, we are pleased with our early momentum in 2016 and excited about our prospects going forward. With that, we would like to open the call to your questions.

謝謝，馬特。好吧，我們今年的五個主要重點仍然是繼續執行 Pantheris 的成功推出，擴大 lumivascular 賬戶的基礎，並推動現有賬戶的利用率，正如 Simpson 博士所討論的那樣，儘管臨床和產品開發前沿我們也取得了良好進展.對於我們專注於 OCT 引導的粥樣斑塊切除術的輻射減少益處的臨床研究，我們預計將在本季度完成協議並在第三季度啟動即時註冊。我們的第二項研究將在一個大型的藍軍自有醫院系統中進行，並將比較臨床結果、質量指標和幫助與 PAD 的 lumivascular 治療相關的經濟措施與匹配的血管內治療的歷史隊列。這項研究的招募已獲得相關機構審查委員會的批准，預計也將於第三季度開始。正如 Simpson 博士所提到的，我們的第三項研究將是一項隨機對照試驗，將 Pantheris 的安全性和有效性與其他領先的 PAD 治療進行比較，並有望追踪長期結果。隨著我們獲得更多 Pantheris 的商業經驗，我們計劃完善這項研究的細節，並且可能會在年底前定義協議和選擇站點。預計將於 2017 年初開始註冊。Avinger 致力於真實世界的長期比較數據，證明我們的 lumivascular 平台的臨床療效和安全性優勢。我們對這些研究將創建的數據主體感到興奮，並期待在接下來的幾個季度中分享個別研究的更多細節。在 Avinger，我們有持續改進產品的理念。根據我們早期的現場經驗，我們已經對 Pantheris 進行了一些小的產品修改。與此同時，我們在擴展我們的 lumivascular 平台方面取得了實質性進展，擴展了 Pantheris 產品線，增加了我們可以治療的解剖結構和病變類型的範圍。 Pantheris 今天被配置為最適合在膝蓋上方或後面的較大血管（如 SFA 和膕動脈）中進行 PAD 治療的最佳學生。我們估計我們目前可用的市場約佔整個 PAD 市場的 50%。我們正在進行積極的研發計劃，以開髮用於較小血管的低剖面設備以及增強的切割機制，這將使我們能夠解決從臀部到腳踝的血管中通常遇到的大多數病變。我們的目標是在今年第三季度為具有增強切割能力的設備提交 510(k)，並在今年年底前獲得 FDA 批准。我們預計我們將能夠在 2017 年早些時候為較小型設備提交 510(k) 申請。並預計這兩種新產品都將在明年為收入的增量增長做出貢獻。總而言之，我們對 2016 年的早期勢頭感到滿意，並對我們未來的前景感到興奮。有了這個，我們想打開您的問題的電話。

(Operator Instructions) Jason Mills, Canaccord Genuity.

（操作員說明）Jason Mills，Canaccord Genuity。

Jeff, Matt, and John, congrats on a good start to the Pantheris era.

Jeff、Matt 和 John，祝賀 Pantheris 時代有了一個良好的開端。

Thank you, Jason. Appreciate it.

謝謝你，傑森。欣賞它。

Super. So I wanted to start there with Pantheris. You didn't break out specifically the Pantheris revenue -- catheter revenue in the quarter. But if we assume that the run rate for Also let also lot *C* ocelot *C* Ocelot improved modestly, would it be fair to assume that Pantheris catheter revenue was above $1 million or $1.31 million or $1.34 million? Am I in the ballpark there, just as a start?

極好的。所以我想從 Pantheris 開始。你沒有具體列出 Pantheris 的收入——本季度的導管收入。但是，如果我們假設 Also let also lot *C* ocelot *C* Ocelot 的運行率略有提高，那麼假設 Pantheris 導管收入超過 100 萬美元、131 萬美元或 134 萬美元是否公平？我在球場上嗎，只是作為一個開始？

Yes. I think you're in the right ballpark. We haven't broken out the individual products, but I think if you were to look at the historical trend for our disposable devices, which we have provided in past quarters, that we are very much in that same range for Ocelot sales and then the incremental disposable revenue that we generated in Q1 really was attributed to Pantheris. And then, of course, the Lightbox revenue has bounced around a bit from quarter to quarter, but we did provide that number. So I hope that helps.

是的。我認為你是在正確的球場。我們還沒有對個別產品進行細分，但我想如果你看一下我們在過去幾個季度提供的一次性設備的歷史趨勢，我們的 Ocelot 銷售額幾乎處於同一範圍內，然後是我們在第一季度產生的增量可支配收入確實歸因於 Pantheris。然後，當然，Lightbox 收入每個季度都有所反彈，但我們確實提供了這個數字。所以我希望能有所幫助。

You broke that out. So that was a known. So that leaves to my leads to my second question which is, the run rate in just a month, obviously, you only had it for a month, was better than what we had modeled. And you also gave detail, Jeff, that you penetrated 50% 60% of the accounts. Now, correct my assumption, if you might, but I am assuming that the Lightbox placement are in those facilities that plan to use it -- use Pantheris in addition to Ocelot. So eventually that gets to 100%, but given that you were in 60% this quarter for just a month, it would imply that, if we are calculating the ESP correctly, that your quarterly utilization rate in those 60% of accounts was north of 20 units per quarter. Was there any stocking or anything that would result in that utilization rate that I mentioned being wrong? And that certainly portends positively as we look at what we had modeled previously for the rest of the year. And, obviously, makes your guidance look imminently doable. Could you comment on those numbers and perhaps just give qualitative overview of the thoughts for the ramp through the rest of the year? Sorry for the long question, but (multiple speakers).

你把它弄壞了。所以這是眾所周知的。所以這讓我引出了我的第二個問題，即僅僅一個月的運行率，顯然，你只有一個月的運行率，比我們建模的要好。傑夫，你還提供了細節，你滲透了 50% 60% 的賬戶。現在，如果可以的話，糾正我的假設，但我假設燈箱放置在那些計劃使用它的設施中——除了 Ocelot 之外還使用 Pantheris。所以最終達到 100%，但考慮到您本季度僅一個月處於 60%，這意味著，如果我們正確計算 ESP，您在這 60% 的賬戶中的季度利用率高於每季度 20 個單元。是否有任何庫存或任何會導致我提到的利用率錯誤的東西？當我們查看我們之前為今年剩餘時間建模的內容時，這肯定預示著積極的跡象。而且，顯然，使您的指導看起來迫在眉睫。您能否對這些數字發表評論，也許只是對今年餘下時間的增長想法進行定性概述？很抱歉這個問題很長，但是（多位發言者）。

Appreciate the question, Jason. So really, we are just looking at one month as you know with the approval on March 1 of Pantheris revenue. And, really, what we are seeing in that month are the initial orders of Pantheris. And so it is, I think, too early to project utilization or reorder rates based on a single end month quarter. I think our second quarter revenue -- I think you are exactly right. We will now be focused on, of course, getting the initial orders in the remaining accounts, continuing to add new accounts, and, very importantly, driving utilization in our existing accounts. But I wouldn't project too much about utilization rates, based on the one month of revenue and based on the vast majority of those orders being initial orders and accounts. I will also say, though, that we are really pleased with how rapidly we were able to penetrate such a large percentage of our accounts. And I think that does speak to -- and we have talked about on past calls -- our efforts with (inaudible) committees, with physician training, with training of our sales force in advance of the actual approval of the commercial or enhanced version of Pantheris, where we were really answering Dr. Simpson's call to not squander the opportunity of the early clinical approval in the fourth quarter of last year of the clinical device. So I think it also -- we are, as we said in our press release and also in Matt's comments, we are reaffirming our guidance for the year. Again, we are at the end of the first quarter or just one month into this launch and we don't want to get too far ahead of ourselves here. But, of course, extremely pleased with how quickly we have come out of the gates and doing everything we possibly can to continue that positive momentum.

感謝這個問題，傑森。所以真的，我們只關注 3 月 1 日 Pantheris 收入批准的一個月。而且，實際上，我們在那個月看到的是 Pantheris 的初始訂單。因此，我認為，基於單個月底季度來預測利用率或再訂購率還為時過早。我認為我們第二季度的收入——我認為你是完全正確的。當然，我們現在將專注於在剩餘賬戶中獲得初始訂單，繼續添加新賬戶，並且非常重要的是，推動我們現有賬戶的利用率。但我不會根據一個月的收入和這些訂單中的絕大多數是初始訂單和賬戶，對利用率做出太多預測。不過，我還要說的是，我們真的很高興能夠如此迅速地滲透到我們如此大比例的賬戶中。我認為這確實說明了——我們在過去的電話會議上也談到了——我們在（聽不清）委員會、醫師培訓、銷售人員的實際批准之前對我們的銷售人員進行的努力。 Pantheris，我們真正響應了 Simpson 博士的呼籲，不要浪費去年第四季度臨床設備早期臨床批准的機會。所以我認為它也是——正如我們在新聞稿和馬特的評論中所說的那樣，我們正在重申我們今年的指導方針。同樣，我們正處於第一季度末或本次發布僅一個月，我們不想在這裡走得太遠。但是，當然，我們對我們走出大門的速度如此之快並儘我們所能繼續保持這種積極勢頭感到非常高興。

That is helpful color, Jeff. I appreciate that. Just -- I have several questions, but I will limit it to one more and then get back into queue. With respect to penetration of accounts, you are 60% of them exiting the quarter, how does it look for you to penetrate the remainder of the 107, at least, let alone any additional accounts that you add here in the June quarter?

這是有用的顏色，傑夫。我很感激。只是-- 我有幾個問題，但我會再限制一個，然後再回到隊列中。關於賬戶的滲透率，你有 60% 的人退出了這個季度，你如何看待你滲透 107 的其餘部分，至少，更不用說你在 6 月季度在這裡添加的任何額外賬戶了？

Yes. I think you have certainly given the efforts that have started even prior to the approval of Pantheris and our continued efforts and progress and, mostly, the appeal of this lumivascular approach and excitement around Pantheris and as well as the, of course, strong atherectomy reimbursement. We feel our prospects are very good to continue that penetration.

是的。我想你肯定已經給出了在 Pantheris 獲批之前就已經開始的努力以及我們持續的努力和進步，主要是這種 lumivascular 方法的吸引力和 Pantheris 周圍的興奮，當然還有強大的斑塊切除術報銷.我們認為繼續滲透的前景非常好。

Joss Josh Jennings, Cowen and Company.

喬斯·喬什·詹寧斯，考恩公司。

I would like to second Jason's congratulations on the momentum and the early success with the Pantheris launch. If I could start off with just a question, maybe for Dr. Simpson and Jeff, Dr. Simpson you talked about the safety and efficacy of the Pantheris device. And I was just hoping for some incremental color just on how the vision trial date data is being digested now that you are officially marketing it with a commercial launch here with the Pantheris.

我想附和 Jason 對 Pantheris 發射的勢頭和早期成功的祝賀。如果我可以從一個問題開始，也許對於辛普森博士和傑夫，辛普森博士，你談到了 Pantheris 裝置的安全性和有效性。我只是希望在視覺試驗日期數據如何被消化的情況下獲得一些增量顏色，因為您正在通過在這裡與 Pantheris 一起進行商業發布來正式營銷它。

Yes. So continued excitement that is really amazing because, you know, we had no vascular perforations in the vision trial and we have had no perforations during the commercial launch. Either, I don't actually have the numbers or how many cases we have done, but it is a large, noticeable number. And the perforation risk was not really dramatic. They are very totally consistent with vision. We would know about it by now. And it is actually absolutely consistent with everything we have seen in Vision. There have been no surprises in terms of the function of the devices. We are seeing the devices used by new doctors and perhaps they are not quite as gentle with the device, maybe, as I would want them to be, but I just believe that it is -- everything is totally consistent. So for sure, there have been no surprises along those lines. And maybe it is a favorable surprised just to know that we have been able to reconfirm everything that we saw in Vision.

是的。如此持續的興奮真是太棒了，因為，你知道，我們在視力試驗中沒有血管穿孔，在商業發布期間我們也沒有穿孔。要么，我實際上沒有數字或我們已經完成了多少案例，但這是一個很大的、引人注目的數字。而且穿孔風險並不是很嚴重。它們與願景非常完全一致。我們現在就會知道了。而且它實際上與我們在Vision中看到的一切完全一致。就設備的功能而言，沒有任何驚喜。我們正在看到新醫生使用的設備，也許他們對設備的使用並不像我希望的那樣溫和，但我只是相信它是——一切都完全一致。所以可以肯定的是，在這些方面沒有任何意外。知道我們能夠重新確認我們在 Vision 中看到的一切，這也許是一個驚喜。

Great. And just in terms of how they are perceiving them the Vision data well and how competitive it is with other data that are out there, our understanding (inaudible) trial was one of the more rigorous data sets for 510(k) approval (inaudible) data with the other devices on the market having -- the clinicians having longer experience with those. But (inaudible) this data set resonating with clinicians, is the follow-up there?

偉大的。就他們如何很好地感知 Vision 數據以及它與現有其他數據的競爭力而言，我們的理解（聽不清）試驗是 510(k) 批准（聽不清）的更嚴格的數據集之一市場上其他設備的數據——臨床醫生對這些設備有更長的經驗。但是（聽不清）這個數據集引起了臨床醫生的共鳴，是否有後續行動？

I think for sure, yes, it does resonate with everybody. Everybody wants a larger data set when the process (inaudible) what we were alluding to in the call was all of the different calls trials that we would do to expand that data set. But to say that you can treat patients with the profoundly low risk of dissection -- vascular perforation or any kind of complication is just really (inaudible). I don't think anybody now sort of questions the Vision data. I think at one point they might have said, well, maybe this is just a little bit too good to be true. But I think it is not -- and obviously, also this will translate into better long-term outcomes. We (inaudible) be able to confirm that we can have (inaudible) seizure with less radiation. So I think that the vision Everything that we have seen so far really is well aligned with all the Vision data, which I think the world is beginning to accept the Vision data as relevant. Small trial, but relevant data. I think it would be hard to deny that now.

我肯定地認為，是的，它確實引起了每個人的共鳴。當我們在通話中提到的過程（聽不清）是我們為擴展該數據集而進行的所有不同的通話試驗時，每個人都想要一個更大的數據集。但是說你可以治療夾層風險極低的患者——血管穿孔或任何類型的並發症是真的（聽不清）。我認為現在沒有人質疑 Vision 數據。我想在某一時刻他們可能會說，好吧，也許這有點太好了而不是真的。但我認為它不是——而且顯然，這也將轉化為更好的長期結果。我們（聽不清）能夠確認我們可以用更少的輻射進行（聽不清）癲癇發作。因此，我認為到目前為止我們所看到的願景 Everything 確實與所有 Vision 數據保持一致，我認為世界正在開始接受 Vision 數據的相關性。小試驗，但相關數據。我認為現在很難否認這一點。

Excellent. And then, Jeff, you talked about the pathway for the below the knee device. Any further color you can give us on just what is going to be required to get that -- the regulatory approval and some of the timelines out in the next year?

出色的。然後，傑夫，你談到了膝下裝置的路徑。你能給我們進一步的顏色來說明實現這一目標所需的條件——監管批准和明年的一些時間表嗎？

Yes. So Jason, -- I'm sorry, Josh. We look at both devices and the enhanced cutting capability as well as the lower profile as 510(k) filings. And we do not anticipate that there will be any clinical studies required. And so we are well along in development of both products. Very pleased with R&D effort and focus. And are on track. I think this is the first time we are provide specific timelines as to when we will be filing and, of course, we anticipate no surprises in the approval timelines with FDA.

是的。所以傑森，- 對不起，喬希。我們將這兩種設備和增強的切割能力以及較低的配置視為 510(k) 文件。我們預計不需要任何臨床研究。因此，我們在開發這兩種產品方面進展順利。對研發工作和專注度非常滿意。並且走上正軌。我認為這是我們第一次提供關於何時提交申請的具體時間表，當然，我們預計 FDA 的批准時間表不會有任何意外。

Excellent. Just one last follow-up. Vessel prep and followed by drug coated baleen balloon has garnered some momentum here over the last 6 to 12 months and understand that longer-term the prospects of Pantheris being a single device solution for a wide variety of lesion sets is -- again, we understand that. But just in the interim, would you guys ever consider a distribution partner with a company that has a drug coated balloon either in international markets as you have CE Mark approval or even domestically? Thanks a lot.

出色的。最後一次跟進。在過去的 6 到 12 個月裡，血管準備和隨後的藥物塗層鯨須氣球在這裡獲得了一些勢頭，並且了解到 Pantheris 的長期前景是針對各種病變組的單一設備解決方案 - 再一次，我們理解那。但在此期間，你們是否會考慮與一家擁有藥物塗層氣球的公司建立分銷合作夥伴，無論是在獲得 CE 標誌批准的國際市場上，還是在國內？多謝。

Yes. So I think we do see the drug coated balloons being used. They are used for drug delivery. They are not being used for angioplasty effect, which is (inaudible) used post Pantheris. And I think we would be open to all kinds of considerations. I think, overall, I personally believe that the majority of the patients could be effectively treated, certainly they do not need additional angioplasty whether they need drug or not is -- that would be a part of the study to define that. I think probably more people are getting drug than needed so I would really sort of -- my leaning would be toward trying to study that and find out what the real answer is. But, overall, if I can create a pretty much normal artery, then angiographically and by OCT, the OCT images are really dramatic in terms of how big the lumen is you have created -- how big the lumen is and what the (inaudible) like. It is really -- that part is so special and so unique that it is going to drive adoption, I think, in a big-time way. I personally think it will drive us away from drug. For sure, it is already driven us away from stent. It's going to drive us away from just balloon angioplasty. I personally believe. And also eventually away from the drug.

是的。所以我認為我們確實看到了使用藥物塗層的氣球。它們用於藥物輸送。它們不用於血管成形術效果，這是（聽不清）在 Pantheris 之後使用的。我認為我們會對各種考慮持開放態度。我認為，總的來說，我個人認為大多數患者可以得到有效治療，當然他們不需要額外的血管成形術，無論他們是否需要藥物——這將是定義這一點的研究的一部分。我認為吸毒的人可能比需要的多，所以我真的有點——我傾向於嘗試研究它並找出真正的答案是什麼。但是，總的來說，如果我可以創建一個非常正常的動脈，然後通過血管造影和 OCT，OCT 圖像在您創建的管腔有多大方面確實非常引人注目 - 管腔有多大以及（聽不清）喜歡。它真的——那部分是如此特別和獨特，以至於我認為它將以一種重要的方式推動採用。我個人認為它會讓我們遠離毒品。可以肯定的是，它已經讓我們遠離了支架。它將使我們遠離球囊血管成形術。我個人相信。也最終遠離毒品。

I would like to build on what Dr. Simpson said around stent usage. One of the things that was so exciting coming out of the Vision data was the very low usage of stents at around 4% across the study. We continue to see in our early clinical experience a very, very minimal stent usage in placement. A big part of what we are all about with this technology and this lumivascular platform is to provide information for the physician so they can decide what is best for their patient. Now, in some cases, they do decide to use DCV, they are certainly a factor in the market. But we want to empower them with information. We want to empower them eventually with data to help make those decisions better. Having said that, as you know, there is a large degree of interest in the combination of the significant debulking provided by directional atherectomy prior to use of a drug coated balloon. I think we will very much benefit from that -- the building body of evidence from other companies as well as the clinical acceptance of the need for this plaque debulking prior to deployment of a drug coated balloon. So again, I think that works to our benefit.

我想以 Simpson 博士關於支架使用的觀點為基礎。從 Vision 數據中得出的令人興奮的事情之一是整個研究中支架的使用率非常低，約為 4%。在我們的早期臨床經驗中，我們繼續看到在放置中使用非常非常少的支架。我們對這項技術和這個 lumivascular 平台所做的很大一部分是為醫生提供信息，以便他們可以決定什麼對他們的病人最好。現在，在某些情況下，他們確實決定使用 DCV，他們肯定是市場的一個因素。但我們想用信息賦予他們權力。我們希望最終通過數據賦予他們權力，以幫助他們更好地做出這些決定。話雖如此，正如您所知，在使用藥物塗層球囊之前，人們對通過定向旋磨術提供的顯著減瘤組合產生了很大的興趣。我認為我們將從中獲益良多——來自其他公司的大量證據以及臨床接受在部署藥物塗層球囊之前對這種斑塊減滅的需求。因此，我再次認為這對我們有利。

Chris Cooley, Stephens.

克里斯庫利，斯蒂芬斯。

Good afternoon, everyone. Let me just continue the (inaudible) of the favorable sentiments. It is a great first start for Pantheris. (inaudible) very proud of the results. If I may, just maybe remind us a little bit about the sales force. Your clearly expanding the number of reps there. Could you give us some color about the types of adds that you are bringing on and then, additionally, along those same lines, how are they allocating their time? Just trying to get it maybe a required proctoring, so I know you want some great outcomes early on with this technology and with enhancements you have made to the Pantheris device. Just (inaudible) during the learning curve. And then I have got one quick follow-up. Thank you.

大家下午好。讓我繼續（聽不清）有利的情緒。對於 Pantheris 來說，這是一個很好的開端。 （聽不清）對結果感到非常自豪。如果可以的話，也許可以提醒我們一些關於銷售人員的事情。你明顯增加了代表的數量。您能否給我們一些關於您帶來的添加類型的顏色，然後，另外，沿著同樣的思路，他們如何分配時間？只是試圖獲得它可能需要監考，所以我知道你希望通過這項技術和你對 Pantheris 設備所做的改進儘早取得一些好的結果。就在學習曲線期間（聽不清）。然後我得到了一個快速跟進。謝謝。

So as we continue to build our sales force, as you know, we added five sales professionals this quarter and we will continue to build up to that number of 70 and I feel like we are very much on track to do that. We are adding what we call area sales managers or territory sales managers who are focused on supporting physicians at the individual account level. And their activities and their time is spent really across two areas.

因此，正如您所知，隨著我們繼續建立我們的銷售隊伍，本季度我們增加了五名銷售專業人員，我們將繼續增加到 70 名，我覺得我們正在朝著這個目標邁進。我們正在添加我們所謂的區域銷售經理或區域銷售經理，他們專注於在個人賬戶級別支持醫生。他們的活動和他們的時間實際上是在兩個領域度過的。

One is driving utilization, supporting physicians in cases, and we have invested quite a bit in training to make sure that they could provide very competent and confident support of physicians and certainly help drive those early positive clinical outcomes. But they also are tasked -- and Joe Rafferty, our new Vice President of Sales, I think, has really added another level of discipline, accountability, and I think healthy process to our Company so that they are focused and tasked with adding and prospecting for new lumivascular accounts.

一個是推動利用率，在病例中支持醫生，我們在培訓方面投入了大量資金，以確保他們能夠為醫生提供非常稱職和自信的支持，並且肯定有助於推動那些早期積極的臨床結果。但他們也有任務——我認為，我們新任銷售副總裁喬·拉弗蒂 (Joe Rafferty) 確實為我們公司增加了另一層紀律、問責制，而且我認為這是健康的流程，因此他們專注於增加和尋找新的任務對於新的 lumivascular 帳戶。

A lot of the emphasis is on targeting the right accounts who have or have the ability to build the PAD volume, but who also understand and buy into the clinical benefits of our approach. And so, it is hard to quantify how that is split. I would say more on driving utilization in early Pantheris case experience, but then, in addition, prospecting for new business and accounts or kind of proselytizing.

很多重點是針對擁有或有能力建立 PAD 量的正確客戶，但他們也了解併購買我們方法的臨床益處。因此，很難量化它是如何分裂的。我會說更多關於推動早期 Pantheris 案例經驗的利用率，但除此之外，還包括尋找新業務和客戶或進行某種形式的傳教。

And then, sales management certainly helps at the executive level along with our lumivascular sales managers, who are focused more on the capital piece.

然後，銷售管理肯定會在執行層面與我們的 lumivascular 銷售經理一起提供幫助，他們更專注於資本部分。

And the only thing I will add here, Chris, is you see we have continued that accelerated pace of adoption of the lumivascular platform. We are, of course, selling Lightboxes, but we also are executing against our placement to purchase initiative and driving evaluations. We have introduced now with the launch of Pantheris also a rental model. And that's -- we are starting to get our first experience with that model during this quarter as well.

克里斯，我唯一要補充的是，你看到我們繼續加快採用 lumivascular 平台的步伐。當然，我們是在銷售燈箱，但我們也正在根據我們的位置執行購買計劃和推動評估。隨著 Pantheris 的推出，我們現在也推出了一種租賃模式。那就是 - 我們也在本季度開始獲得對該模型的首次體驗。

So providing the opportunity to listen to customers, to provide a solution that works for them, and, most importantly, get this empowering and completely differentiated technology in the physicians' hands more quickly.

因此，提供機會傾聽客戶的意見，提供適合他們的解決方案，最重要的是，讓醫生更快地掌握這種強大且完全差異化的技術。

Super. And then, just a quick follow-up. Very impressed with the three trials that you're getting ready to commence. I think that is tremendous that you're going to have that kind of data and I think it is going to be very unique within the space.

極好的。然後，只是快速跟進。您準備開始的三項試驗給我留下了深刻的印象。我認為你將擁有那種數據是巨大的，而且我認為它在該領域將是非常獨特的。

Just curious, though, if I could pressure you a little bit more there. I realize you have given us a ton already, but help us think maybe about the size of some of these trials and maybe when, under maybe a best case type scenario, you could complete enrollment and possibly start to see some of that data. In particular I was interested in the core lab adjudicated opportunity there, starting in early 2017. I think that will be very, very telling data.

不過，只是好奇，我是否可以在那裡給你多一點壓力。我知道您已經給了我們很多，但請幫助我們考慮其中一些試驗的規模，以及在可能是最佳案例類型的情況下，您何時可以完成註冊並可能開始查看其中一些數據。我尤其對那裡的核心實驗室裁決機會感興趣，從 2017 年初開始。我認為這將是非常非常有說服力的數據。

So any additional color you could provide there would be great.

因此，您可以提供的任何其他顏色都很棒。

Yes. Maybe I will take a couple of the studies and the timing, and then, obviously, Dr. Simpson can add, I think, some great perspective.

是的。也許我會進行一些研究和時間安排，然後，很明顯，辛普森博士可以添加一些很棒的觀點。

But as it relates to the first study, the radiation reduction study, which will have a number of other acute and secondary endpoints that are tracked, that is an acute study. So, we will initiate enrollment in the third quarter, is what we anticipate. And we anticipate completing enrollment by the end of the fourth quarter.

但由於它與第一項研究有關，即輻射減少研究，該研究將跟踪許多其他急性和次要終點，這是一項急性研究。因此，我們將在第三季度開始招生，這是我們的預期。我們預計在第四季度末完成註冊。

So you should see data coming out from that study relatively soon. The enrollment period for the health economic study that we are conducting in a Blue owned system, again, that will begin enrollment in the third quarter and that is anticipated to be a one-year enrollment period. With, then, a two-year follow-up period.

所以你應該很快就會看到這項研究的數據。我們在 Blue 擁有的系統中進行的健康經濟研究的註冊期再次將在第三季度開始註冊，預計註冊期為一年。然後，有兩年的跟進期。

But, of course, there will be opportunities for data to be pulled, analyzed, and presented along the way. But, just to give you a sense of timing and timetables for those two studies, we have not finalized the protocols and final design for the randomized trial, which will compare to other atherectomy treatments that you mentioned, Chris.

但是，當然，在此過程中會有機會提取、分析和呈現數據。但是，只是為了讓您了解這兩項研究的時間安排和時間表，我們還沒有最終確定隨機試驗的方案和最終設計，這將與您提到的其他粥樣斑塊切除術治療進行比較，Chris。

But, I would anticipate generally a one-year enrollment period for a study like that with a minimum one to two year, but probably two-year follow-up. With, then, the ability to pull data at different points along the way. I don't know if you want to add any perspective to that, Dr. Simpson.

但是，我預計像這樣的研究通常需要一年的註冊期，至少需要一到兩年，但可能需要兩年的跟進。然後，能夠在沿途的不同點提取數據。我不知道你是否想對此添加任何觀點，辛普森博士。

Yes. I might say it a little bit differently. I don't think the enrollment would take that long and I don't think that we would require much be beyond a one-year follow-up. I think that would be, if that is required, it would be inconsistent with the existing trials that have been ongoing out there in the trial size -- the trial size is it rates pretty dramatically from the small trials in the 100 patients per arm to 300 patients per arm for the maximum.

是的。我可能會說得有點不同。我不認為註冊會花那麼長時間，而且我認為我們不需要超過一年的跟進。我認為那將是，如果需要的話，它將與試驗規模中正在進行的現有試驗不一致——試驗規模是從每組 100 名患者的小型試驗到每組最多 300 名患者。

So I don't see the -- it depends on the trial size, of course, and how long the enrollment takes. And then, also, the lesion characteristics that are going to be used for the inclusion-exclusion criteria, I don't feel like that is going to be a daunting trial and I think the enthusiasm for enrollment will be high. And it doesn't even have to be an enrollment 1 to 1. Maybe there is some bias toward more Pantheris in the enrollment -- in the atherectomy for Pantheris.

所以我看不到——當然，這取決於試驗規模，以及註冊需要多長時間。然後，還將用於納入排除標準的病變特徵，我不認為這將是一項艱鉅的試驗，我認為入組的熱情會很高。而且它甚至不必是 1 對 1 的註冊。也許在註冊中存在更多 Pantheris 的偏見——在 Pantheris 的動脈粥樣硬化切除術中。

So I don't -- I feel like that you said the right thing, because it is very conservative. That is what you're supposed to say. But I think that is a little bit too conservative.

所以我不——我覺得你說的是對的，因為它非常保守。那是你應該說的。但我認為這有點過於保守了。

Understood. And if I could just maybe squeeze one last one here then I will get back into queue. When you look at the placements -- or, I should say, the growth in the installed base of the Lightboxes units out there. It should grow the lumivascular platform.

明白了。如果我能在這裡擠出最後一個，那麼我會回到隊列中。當您查看展示位置時——或者，我應該說，燈箱單元安裝基數的增長。它應該生長 lumivascular 平台。

It seems if I'm just going to look at the last two quarters as the run rate, the bias here is towards the rental or the initial placement [of the] purchase type model. Are there any opportunities that you can have on that front to step on the proverbial gas and further accelerate that installed base here in the short run? Is that effectively becoming the default entry for the new systems?

似乎如果我只是將最後兩個季度視為運行率，這裡的偏差是針對購買類型模型的租金或初始安置。在這方面，您是否有任何機會可以在短期內踩到眾所周知的氣體並進一步加速這裡的安裝基礎？這是否有效地成為新系統的默認條目？

Well, we did share the number of accounts that were sold during the quarter as well. And we continue to sell a significant number of Lightboxes. And the idea with the conversion program or the placement to purchase program is to eventually convert those to either a sale or a rental or some other kind of option, including one of our leasing options.

好吧，我們也確實分享了本季度售出的賬戶數量。我們繼續銷售大量的燈箱。轉換計劃或購買計劃的想法是最終將它們轉換為銷售或租賃或其他類型的選擇，包括我們的租賃選擇之一。

So the whole reason for introducing this more flexible model is to accelerate the adoption. I think the broader -- very broad appeal and as more experience is gained in the market with Pantheris, we will continue to see an acceleration of placements, but we have guided to 150 by the end of the year. We are well on track to achieve that. But I think inherent in that guidance would be an acceleration through the remaining three quarters.

因此，引入這種更靈活的模型的全部原因是為了加速採用。我認為更廣泛的——非常廣泛的吸引力，隨著 Pantheris 在市場上獲得更多的經驗，我們將繼續看到安置的加速，但我們已經指導到今年年底達到 150 個。我們正在順利實現這一目標。但我認為，在剩下的三個季度中，該指導的內在將是一個加速。

Thanks again, and congratulations on a great quarter.

再次感謝，並祝賀一個偉大的季度。

Jason Mills, Canaccord Genuity.

Jason Mills，Canaccord Genuity。

Surprised to get in again, guys, but thank you.

很驚訝再次進入，伙計們，但是謝謝你們。

Let me follow up on that last question from Chris, Jeff, asked in a different way. Do you expect the mix to change much, relative to what you have seen the last couple of quarters between the various placement models that you have -- sale, purchase to placement, rental, et cetera?

讓我跟進 Chris Jeff 以不同方式提出的最後一個問題。相對於過去幾個季度您所擁有的各種安置模型（銷售、購買到安置、租賃等）之間的情況，您預計這種組合會發生很大變化嗎？

Yes. It is hard to predict with great specificity, but we expect to see a similar kind of ratio as we move forward, especially as more of these placements and evaluations are completed and become eligible for transactional -- for purchases. So I would expect the similar kind of ratio, but, obviously, our goal is to get people started on Pantheris as quickly as possible, because we want more patients get access to this technology.

是的。很難非常具體地預測，但我們希望在我們前進的過程中看到類似的比率，特別是隨著更多的這些安置和評估完成並有資格進行交易 - 購買。所以我希望有類似的比率，但很明顯，我們的目標是讓人們盡快開始使用 Pantheris，因為我們希望更多的患者能夠獲得這項技術。

Sure. That makes sense. And then, Dr. Simpson, thank you for the -- and, Jeff, thank you for the detail -- details on the studies. In addition to the study, the three studies you mentioned, Dr. Simpson, I am curious just based on your conversations with physicians, whether or not you expect physicians to run their own studies, sponsored studies that we might see at some point over the next couple of years. My guess is you are into some high-volume clinics, labs, and you might have a few folks that have enough volume to want to publish on it at some point. Just wondering if you have any visibility into that.

當然。這就說得通了。然後，辛普森博士，謝謝你——傑夫，謝謝你提供的細節——研究的細節。除了這項研究，辛普森博士，你提到的三項研究，根據你與醫生的談話，我很好奇你是否希望醫生進行他們自己的研究，贊助研究，我們可能會在未來的某個時候看到接下來的幾年。我的猜測是你進入了一些大批量的診所、實驗室，並且你可能有一些人有足夠的數量想要在某個時候發布它。只是想知道您是否對此有任何了解。

Yes. For sure, that is always the case, I would say, Jason. And I think the docs in general [says he has] enthusiasm for the lumivascular approach is going to drive them to do their own studies and you may have talked to JJ Desai, recently, Dr. Broadman and [Arnie Swett] who are in the process of doing some of that reporting on their own experiences.

是的。當然，情況總是如此，我會說，傑森。而且我認為一般的文檔 [說他有] 對 lumivascular 方法的熱情將驅使他們進行自己的研究，你可能最近與 JJ Desai、Broadman 博士和 [Arnie Swett] 進行了交談，他們在根據自己的經驗進行一些報告的過程。

So we will definitely see that going forward. I think that it is going to be driven by some of the really -- obviously, the truly unique features of this and there will be some anecdotal reports on some unique anatomies that we would not have imagined treating with vein grafts that are a little bit surprising, I suppose. But there are so many opportunities here that it would be always, absolutely the case that there would be single center reports. That would do nothing, though, to dissuade us, if you will, from doing our own Barger trials and I think it will be the merger of all of these decision center sites and then our more expanded trial that will grow this database fairly quickly.

所以我們肯定會看到這一點。我認為這將由一些真正 - 顯然，真正獨特的特徵驅動，並且會有一些關於一些獨特解剖結構的軼事報導，我們不會想像用稍微有點靜脈移植物治療令人驚訝，我想。但是這裡有太多的機會，以至於總是、絕對會有單一中心的報告。不過，如果你願意的話，這不會阻止我們進行我們自己的 Barger 試驗，我認為這將是所有這些決策中心站點的合併，然後我們更廣泛的試驗將相當快地增長這個數據庫。

I expect this database to develop much more quickly than maybe some of the databases that might have surrounded [Ocelot] or DVI (technical difficulty) previous devices. So I could not be more excited about it. I think the single center contribution will be notable.

我希望這個數據庫的開發速度可能比圍繞 [Ocelot] 或 DVI（技術難度）以前的設備的某些數據庫快得多。所以我對此感到非常興奮。我認為單中心的貢獻將是顯著的。

That is helpful. And then, last question from me, and let others jump in again, if they have any other questions, but in talking to some physicians at Charing Cross and a few other meetings this spring, what was striking to me -- to us -- was the utilization of Pantheris in early in very challenging lesions sets. So I saw a few pictures where Pantheris was used and quite long lesions, very heavily calcified lesions.

這很有幫助。然後，我的最後一個問題，如果其他人有任何其他問題，請讓他們再次參與，但是在今年春天與查令十字街的一些醫生和其他幾次會議交談時，讓我——對我們——印象深刻的是——是在非常具有挑戰性的病變組早期使用 Pantheris。所以我看到了幾張使用了 Pantheris 的照片和相當長的病變，非常嚴重的鈣化病變。

Frankly, probably not considered your chip shots at all. And some CTOs as well. Obviously, utilization of Ocelot was employed there.

坦率地說，可能根本沒有考慮過你的籌碼。還有一些 CTO。顯然，那裡使用了 Ocelot。

So could you talk about what some of those cases and whether you have been surprised by the utilization early days here with Pantheris in those challenging lesion sets and what that maybe portends for its use it going forward?

那麼，您能否談談其中的一些案例，以及您是否對 Pantheris 在這些具有挑戰性的病變組中的早期利用感到驚訝，以及這可能預示著它在未來的使用是什麼？

Well, I do believe that what almost always happens is that the doctor on their first case will do just exactly what you say. And on the second case, for sure, it will be nothing like what you say and so there is very little -- whatever coaching and advice that we give, they radically depart from that from really, really early going. Of the part that I do find really quite remarkable is how nicely the device is working in some really complex anatomy. Maybe the really heavily calcified arteries are still a bit of a stretch for us, but we definitely will be -- and that is a part of our mission -- to make a more aggressive cutter, if you will, a more efficient cutter for dealing with that.

嗯，我確實相信幾乎總是會發生的情況是，他們的第一個病例的醫生會完全按照你說的去做。對於第二種情況，可以肯定的是，它不會像你說的那樣，所以很少 - 無論我們提供什麼指導和建議，他們都從根本上偏離了真正非常早期的目標。我確實發現非常了不起的部分是該設備在一些非常複雜的解剖結構中的工作效果。也許真正嚴重鈣化的動脈對我們來說仍然有點困難，但我們肯定會——這是我們使命的一部分——製造一個更積極的切割器，如果你願意的話，一個更有效的切割器來處理接著就，隨即。

So I feel like that everything that I see is very reassuring. I feel like also that the exciting part is that it is -- any of the improvements are always within the achievable domain of our engineering base. So they are really, really good at dealing with all of these issues. And I feel like that the early going, the long lesions, which kind of surprised us, and I know a couple of lesions that you must have been looking at.

所以我覺得我所看到的一切都很安心。我還覺得令人興奮的部分是——任何改進總是在我們工程基礎的可實現範圍內。所以他們真的非常擅長處理所有這些問題。我覺得早期的病灶很長，這讓我們感到驚訝，而且我知道你一定一直在看一些病灶。

But, obviously, when you think about a long lesion, frequently, the long lesion has two really tight spots, the top at the bottom. So if you treat the two, really, the proximal distal caps, if you treat them with Pantheris, in a very predictable way, the rest of the lesion becomes a little bit less important. But it tells you how much we are evolving our database and how much we are learning to better understand the distribution of the plaque, what it does inside the artery. And how best to treat it.

但是，很明顯，當你想到長損傷時，長損傷通常有兩個非常緊密的點，頂部位於底部。所以如果你治療這兩個，真的，近端遠端帽，如果你用 Pantheris 治療它們，以一種非常可預測的方式，其餘的病變變得不那麼重要了。但它會告訴您我們正在如何改進我們的數據庫以及我們正在學習多少以更好地了解斑塊的分佈以及它在動脈內的作用。以及如何最好地對待它。

And these are all things that we never had, Jason, as you already know -- we have never had that available to us before. So it is already influencing the outcomes and it is also influencing the physician adoption. They are willing to try it in places that I would probably think you have got to be crazy. And it is actually working out pretty well in many of those cases.

這些都是我們從未擁有過的東西，Jason，正如你已經知道的那樣——我們以前從未擁有過這些東西。所以它已經影響了結果，也影響了醫生的採用。他們願意在我認為你一定會發瘋的地方嘗試。在許多情況下，它實際上效果很好。

Steve Leachman, Oppenheimer.

史蒂夫·利奇曼，奧本海默。

I was wondering, in this first quick conversion of the 60% of lumivascular accounts, what you are seeing from a training perspective. How is that going relative to expectations? Are you seeing a quicker ramp than expected? Any commentary around the initial training.

我想知道，在 60% 的 lumivascular 帳戶的第一次快速轉換中，您從培訓的角度看到了什麼。與預期相比情況如何？您是否看到比預期更快的增長？關於初始培訓的任何評論。

As you know, we started training docs in the latter part -- or in the first quarter and at the end of the first quarter, I think we gave numbers on our call on March 1 as to where we were, but we were at about 131 -- a little over 130 docs trained. As of today, we are well over 170 and we have another training tomorrow, which will put as well over 180 docs. So we continue to train.

如您所知，我們在後半部分或在第一季度和第一季度末開始培訓文檔，我想我們在 3 月 1 日的電話會議上給出了我們所處位置的數字，但我們大約在131——超過 130 名受過培訓的醫生。截至今天，我們已經超過 170 名，明天我們將進行另一次培訓，這將提供超過 180 名文檔。所以我們繼續訓練。

We have trained eight -- we had eight training sessions and seven different locations in the first quarter and another four so far in the second quarter this year. So I think it does two things.

我們已經培訓了八人——今年第一季度我們在七個不同的地點進行了八次培訓，今年第二季度到目前為止還有四次。所以我認為它做了兩件事。

First of all, it speaks to the appeal and effectiveness of the training, but especially our lumivascular platform. But also, again, supports the ramp here of Pantheris as we move forward.

首先，它說明了培訓的吸引力和有效性，尤其是我們的 lumivascular 平台。但同樣，在我們前進的過程中，支持 Pantheris 的斜坡。

Great. Thanks, Jeff. And then, just secondly on the radiation study, certainly the lower radiation benefit makes sense. Something we talked about before. Just wondering what you think -- what you will be able to do with this data. Certainly the physicians I assume already know the benefits, could be helpful for them as they approach hospitals or is it potentially an economics/payer perspective? Just curious on the potential benefits of that trial.

偉大的。謝謝，傑夫。然後，僅次於輻射研究，較低的輻射益處當然是有道理的。我們之前談過的事情。只是想知道您的想法——您將能夠使用這些數據做什麼。當然，我假設的醫生已經知道這些好處，在他們去醫院時可能對他們有所幫助，或者這是否可能是經濟學/付款人的角度？只是好奇該試驗的潛在好處。

Yes. I think that everyone knows and we are seeing and we are seeing this, not only in single site studies that we have shared that data before, but also in our clinical practice. And I think there continues to be very high level of importance being placed on reducing radiation, both from the physician standpoint, but as well as the institutional standpoint. Because, as you mentioned, not only are there negative health benefits -- effects, there is also certainly a real cost as to physicians have to sit out for up to two weeks at a time because their radiation levels get too high.

是的。我認為每個人都知道並且我們正在看到並且我們正在看到這一點，不僅在我們之前共享數據的單點研究中，而且在我們的臨床實踐中。而且我認為無論是從醫生的角度還是從機構的角度來看，減少輻射仍然非常重要。因為，正如你所提到的，不僅對健康有負面影響，而且肯定會有實際成本，因為醫生不得不一次坐下長達兩週，因為他們的輻射水平太高了。

So we think by quantifying that reduction, we certainly move the ball forward. We are also going to be tracking secondary endpoints, consistent with other endovascular trials like luminal gain and adjunctive therapy use and building more of that data set. Again, as Dr. Simpson has mentioned, we continue to be thrilled with the extremely safe profile of this device and the lack of preparations and clinically significant dissections.

因此，我們認為通過量化這種減少，我們肯定會向前推進。我們還將跟踪次要終點，與其他血管內試驗（如管腔增益和輔助治療使用）一致，並建立更多該數據集。同樣，正如 Simpson 博士所提到的，我們繼續對這種設備的極其安全的配置文件以及缺乏準備和具有臨床意義的解剖感到興奮。

And so as we move forward, we are excited to continue to build that data as well. In a controlled setting. And then, finally, there will be other endpoints such as exposure to contrast media for patients, which has a very real cost and health risk to patients. So there is going to be a lot of data coming out of this study beyond just radiation reduction. And we will share more details around that once we initiate enrollment. But I think a rich data set that goes beyond just radiation reduction.

因此，在我們前進的過程中，我們也很高興能繼續構建這些數據。在受控的環境中。然後，最後，還有其他終點，例如患者接觸造影劑，這對患者有非常實際的成本和健康風險。因此，除了減少輻射之外，這項研究還將產生大量數據。一旦我們開始註冊，我們將分享更多細節。但我認為豐富的數據集不僅僅是減少輻射。

Great.

偉大的。

Yes. I think, as somebody who has had to go to the sidelines once because my badge was over radiated, I would have to say that it is not very reassuring, either, that you have to go to the sidelines and because the radiation effects do not go away just because you're on the sidelines. So I believe that when I have to be payers who will not have to be providers hospitals (inaudible), the docs will gravitate toward this because they don't want it.

是的。我想，作為一個曾經因為我的徽章被過度輻射而不得不去場邊的人，我不得不說這也不是很令人放心，你必須去場邊，因為輻射效應不會走開只是因為你在場邊。所以我相信，當我必須成為支付者而不必成為提供者醫院（聽不清）時，醫生會傾向於這樣做，因為他們不想要它。

They understand the issues. They don't want the radiation, is what I am saying.

他們了解問題。他們不想要輻射，這就是我所說的。

Certainly makes sense. Thanks, Dr. Simpson. Thanks, Jeff.

當然有道理。謝謝，辛普森博士。謝謝，傑夫。

Ladies and gentlemen, that concludes our question-and-answer session. I would now like to turn the call back over to Jeff Soinski, for any closing remarks.

女士們，先生們，我們的問答環節到此結束。我現在想將電話轉回給 Jeff Soinski，請他發表任何結束語。

I would like to thank you again for joining our call. We sincerely appreciate your interest in our Company and what we are trying to do here and look forward to updating you on our continued progress. Thank you.

我想再次感謝您加入我們的電話會議。我們衷心感謝您對我們公司的興趣以及我們在這裡所做的努力，並期待向您通報我們的持續進展。謝謝。

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude today's program. You may now disconnect. Everyone, have a great day.

女士們，先生們，感謝你們參加今天的會議。今天的節目到此結束。您現在可以斷開連接。大家，祝你有美好的一天。