Avinger Inc (AVGR) 2015 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Avinger, Inc.'s fourth-quarter 2015 earnings conference call.

女士們先生們，美好的一天，歡迎來到 Avinger, Inc. 的 2015 年第四季度收益電話會議。

(Operator Instructions).

（操作員說明）。

I would now like to introduce your first speaker for today, Leigh Salvo.

我現在想介紹您今天的第一位發言人 Leigh Salvo。

You have the floor.

請發言。

Thank you, Andrew, and thank you all for participating in today's call.

謝謝安德魯，感謝大家參加今天的電話會議。

Joining us today is Avinger's Founder and Executive Chairman, Dr. John Simpson; CEO, Jeff Soinski; and CFO, Matt Ferguson.

今天加入我們的是 Avinger 的創始人兼執行主席 John Simpson 博士；首席執行官傑夫·索因斯基；首席財務官馬特·弗格森 (Matt Ferguson)。

Earlier today, Avinger released financial results for the fourth quarter and full year ended December 31, 2015.

今天早些時候，Avinger 發布了截至 2015 年 12 月 31 日的第四季度和全年的財務業績。

Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

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，這些聲明是根據美國私人證券訴訟改革法案的安全港條款作出的1995.

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements.

本次電話會議中包含的任何不是歷史事實陳述的陳述都應被視為前瞻性陳述。

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.

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，以及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。

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

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。

Accordingly, you should not place undue reliance on these statements.

因此，您不應過分依賴這些陳述。

For a list and description of the risks and uncertainties associated with our business, please see our filings with the SEC.

有關與我們業務相關的風險和不確定性的列表和描述，請參閱我們向美國證券交易委員會提交的文件。

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.

除法律要求外，Avinger 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務，無論是因為新信息、未來事件還是其他原因。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 1, 2016.

本次電話會議包含時間敏感信息，僅截至 2016 年 3 月 1 日今天的現場直播準確無誤。

I'd now like to turn the call over to Dr. Simpson.

我現在想把電話轉給辛普森博士。

Thank you, Leigh.

謝謝你，利。

Following our FDA approval of our Pantheris product this morning, I would have to say that we're exhilarated.

在我們今天早上 FDA 批准我們的 Pantheris 產品之後，我不得不說我們很高興。

I even would want to say that exhilaration is maybe an understatement for the way we feel at Avinger, following the approval of the first-ever OCT guided directional atherectomy catheter.

我什至想說，在有史以來第一個 OCT 引導的定向粥樣斑塊切除術導管獲得批准後，我們對 Avinger 的感受可能是一種輕描淡寫的興奮。

And we welcome Pantheris now to the lumivascular family at Avinger.

我們現在歡迎 Pantheris 加入 Avinger 的 lumivascular 家族。

What a great journey.

多麼美好的旅程。

Along the way that we've met many wonderful patients, physicians, staffs, and helpers.

在此過程中，我們遇到了許多出色的患者、醫生、員工和助手。

Our early investigative efforts started needed in Katowice, Poland, with Stefan Kiesz; then Asuncion, Paraguay, with Adrian Ebner; then Cali, Colombia, with Dr. Pedro Martinez-Clark; and most recently Dr. Arne Schwindt in Muenster, Germany.

我們的早期調查工作需要在波蘭的卡托維茲與 Stefan Kiesz 一起開始；然後是巴拉圭的亞松森，與 Adrian Ebner；然後是哥倫比亞卡利，Pedro Martinez-Clark 博士；以及最近在德國明斯特的 Arne Schwindt 博士。

And I feel like it's important to acknowledge all of the individuals who participated in this.

我覺得對所有參與其中的人表示感謝很重要。

Because at each stop along the way, we made generally and very valuable and important observations that have led us to the concept of how we perform directional atherectomies and OCT guidance, and how we can make Pantheris better.

因為在沿途的每一站，我們都進行了普遍且非常有價值和重要的觀察，這些觀察使我們想到了我們如何進行定向粥樣斑塊切除術和 OCT 指導的概念，以及我們如何使 Pantheris 變得更好。

Today we want to start by thanking all those patients and physicians who participated in our early research work in the VISION study in the US.

今天，我們首先要感謝參與我們在美國 VISION 研究的早期研究工作的所有患者和醫生。

None of this could have happened without them, and the entire Avinger team remains committed to better patient care.

如果沒有他們，這一切都不可能發生，整個 Avinger 團隊仍然致力於更好的患者護理。

Together we're making lumivascular a reality.

我們一起使 lumivascular 成為現實。

And lumivascular is the term we use to characterize directed and intervention using OCT guidance.

lumivascular 是我們用來描述使用 OCT 指導的定向和乾預的術語。

So, each day, this becomes an even more amazing journey.

因此，每一天，這都將成為一個更加奇妙的旅程。

Over and over again, we're asked what makes Pantheris that different from all the other interventional catheters.

一遍又一遍，我們被問及是什麼讓 Pantheris 與所有其他介入導管不同。

We say there are many things, of course, but perhaps of the most important is the camera.

當然，我們說有很多東西，但也許最重要的是相機。

This, of course, leads to the next question, which is how do you make the camera that small?

當然，這會引出下一個問題，即如何將相機做得那麼小？

This then, of course, commits us to we have to admit that this is not a traditional camera, but rather a laser and fiber optic system that creates an image of the vessels.

當然，這讓我們不得不承認，這不是傳統的相機，而是可以創建容器圖像的激光和光纖系統。

So it acts like a camera, but it's even better than a camera because it not only sees from inside the vessel, but it actually sees through the vessel wall.

所以它的作用就像一個照相機，但它甚至比照相機更好，因為它不僅可以從容器內部觀察，而且實際上可以透過容器壁觀察。

And this is the information that allows the physician to determine the distribution of plaque in the vessel wall with the extraordinary accuracy and target the treatment only of the diseased portion of the vessel, leaving the healthy portion of the vessel alone.

正是這些信息使醫生能夠非常準確地確定斑塊在血管壁中的分佈，並僅針對血管的患病部分進行治療，而忽略血管的健康部分。

So this is the information not available from angiography or fluoroscopy, and that we've always needed to actually radically change the way vascular disease is treated.

所以這是血管造影或熒光透視無法獲得的信息，我們一直需要真正從根本上改變治療血管疾病的方式。

So now that Pantheris joins the lumivascular family as the first commercially available OCT-guided directional atherectomy catheter in the US, actually in the world, we're getting closer to reaching our goal of changing forever the way vascular disease is treated and help make the vascular interventionist ever more efficient and more effective.

因此，現在 Pantheris 加入了 lumivascular 家族，成為美國第一個商業化的 OCT 引導定向粥樣斑塊切除術導管，實際上是在世界上，我們離實現永遠改變血管疾病治療方式的目標越來越近，並有助於使血管介入醫生變得更加高效和有效。

The commercial version of Pantheris now includes multiple ease-of-use provisions of recommended by the VISION investigators, but it maintains the same imaging, cutting, and tissue management capabilities as used in the original Pantheris.

Pantheris 的商業版本現在包括 VISION 研究人員推薦的多個易於使用的條款，但它保持與原始 Pantheris 中使用的相同的成像、切割和組織管理功能。

The one new feature most related to ease of use is in the commercial version of Pantheris is that the occlusion balloon, used to help clear blood from the OCT imaging field, has been moved from the tip of a separate sheath to the shaft of the Pantheris.

與易用性最相關的一項新功能是在 Pantheris 的商業版本中，用於幫助清除 OCT 成像區域血液的閉塞球囊已從單獨護套的尖端移至 Pantheris 的軸.

This eliminates a separate sheath insertion, improves blood flow management while making -- and lets the -- while making the Pantheris more practical to use as a single operator.

這消除了單獨的護套插入，改善了血流管理，同時使——並讓——同時使 Pantheris 作為單個操作員更實用。

This has been a goal for us for a long time, to make this a single operator type intervention.

長期以來，這一直是我們的目標，使之成為單一操作員類型的干預。

So in Europe this has proven to be a very effective and welcome simplification.

所以在歐洲，這已被證明是一種非常有效和受歡迎的簡化。

Some doctors who have been our skeptics have said things like, okay, so this is not as complicated as I was told, and it does not take as long as I thought.

一些對我們持懷疑態度的醫生說過這樣的話，好吧，所以這並不像我被告知的那麼複雜，也不需要我想像的那麼久。

And then another doctor said, since this could require less [tests from] our hospital, we'll be very happy.

然後另一位醫生說，因為這可以減少我們醫院的[測試]，我們會很高興。

The above comments came from physicians who attended the recent live telecast of the LINC conference in Leipzig, Germany, following the telecast of two live Pantheris cases by Dr. Arne Schwindt.

上述評論來自參加最近在德國萊比錫舉行的 LINC 會議現場直播的醫生，此前 Arne Schwindt 博士直播了兩例 Pantheris 病例。

We had a record interest from physicians about bringing Lightboxes into their hospitals.

醫生們對將燈箱帶入他們的醫院產生了創紀錄的興趣。

Several physicians commented about preferring to purchase Pantheris rather than other planned atherectomy catheters that they were planning to bring into their lab.

幾位醫生評論說他們更願意購買 Pantheris 而不是他們計劃帶入他們實驗室的其他計劃中的粥樣斑塊切除術導管。

Most interventionists were impressed by Dr. Schwindt as he performed these two live Pantheris cases.

Schwindt 博士在執行這兩個活體 Pantheris 病例時給大多數干預主義者留下了深刻的印象。

And he performed them as a single operator, which in each case takes about 20 minutes in the ones that he used for the demonstration purposes.

他以單個操作員的身份執行了這些操作，在他用於演示目的的操作中，每次操作大約需要 20 分鐘。

Dr. Schwindt also explained how the Pantheris provided the potential to reduce radiation exposure.

Schwindt 博士還解釋了 Pantheris 如何提供減少輻射暴露的潛力。

So, safe; effective; not a lot of time; and, hopefully, less radiation are all favorable features individually.

所以，安全；有效的;時間不多；並且，希望更少的輻射都是單獨的有利特徵。

But together they are the foundation of our mission to radically change the PAD treatment forever.

但它們共同構成了我們徹底改變 PAD 治療的使命的基礎。

My prediction is we will look back on the live transmissions from LINC in a year or two as the turning point in the lumivascular attack on PAD.

我的預測是，我們將在一兩年內回顧 LINC 的實時傳輸，將其視為對 PAD 的 lumivascular 攻擊的轉折點。

We've only just begun our attack on PAD, and developments are already underway for the next two Pantheris devices, which include enhanced cutting capabilities and a lower crossing profile to treat distal lesions in smaller vessels.

我們才剛剛開始對 PAD 的攻擊，接下來的兩個 Pantheris 設備的開發已經在進行中，其中包括增強的切割能力和較低的交叉輪廓，以治療較小血管的遠端病變。

These will be exciting to update you on in the future.

這些將是激動人心的更新你在未來。

And with that, I will turn the call over to Jeff to discuss the recent Avinger business results and our plans for the coming year.

有了這個，我將把電話轉給傑夫，討論最近的 Avinger 業務成果和我們來年的計劃。

Jeff?

傑夫？

Thanks, John.

謝謝，約翰。

Good afternoon, and thank you all for joining us.

下午好，感謝大家加入我們。

Obviously an exciting day for Avinger, and it's great to be able to share it with all of you.

顯然對 Avinger 來說是激動人心的一天，很高興能夠與大家分享這一天。

Special congratulations and thanks to Dr. Simpson for his vision, and to him and the entire team here at Avinger who have been tireless in their pursuit of this goal.

特別祝賀並感謝 Simpson 博士的遠見卓識，並感謝他和 Avinger 的整個團隊為實現這一目標而不懈努力。

Needless to say, clearance and launch of Pantheris is a huge event for Avinger, and we're incredibly excited about the future.

不用說，Pantheris 的許可和發布對 Avinger 來說是一件大事，我們對未來感到無比興奮。

However, I'd like to begin with a look back at 2015.

然而，我想首先回顧一下 2015 年。

2015 was such an important year for Avinger.

2015 年對 Avinger 來說是非常重要的一年。

During the year, we became a publicly traded company, made substantial progress on our product development goals, and significantly expanded our operational and commercial infrastructure.

在這一年裡，我們成為一家上市公司，在產品開發目標方面取得了實質性進展，並顯著擴展了我們的運營和商業基礎設施。

We successfully completed our VISION clinical trial, which supported the 510(k) clearance of Pantheris.

我們成功完成了 VISION 臨床試驗，該試驗支持 Pantheris 的 510(k) 批准。

We increased the installed base of our lumivascular platform from 60 to 95 accounts.

我們將 lumivascular 平台的安裝基數從 60 個增加到 95 個。

And we continued to expand programs to drive utilization of our currently available image-guided catheters for CTO crossing.

我們繼續擴大計劃，以推動利用我們目前可用的圖像引導導管進行 CTO 交叉。

We also significantly expanded our sales and marketing infrastructure to support the US commercial launch of Pantheris this year.

我們還顯著擴展了我們的銷售和營銷基礎設施，以支持今年 Pantheris 在美國的商業發布。

Our clinical experience with the first-generation Pantheris in 2015 exceeded all of VISION's safety and efficacy endpoints, leading to 510(k) clearance of the clinical version of the device in October.

我們在 2015 年使用第一代 Pantheris 的臨床經驗超過了 VISION 的所有安全性和有效性終點，導致該設備的臨床版本在 10 月獲得 510(k) 批准。

All physician investigators were very pleased with the outcome, but most thought that ideally the catheter should be easier to use and the procedure should require less time.

所有醫生調查人員都對結果非常滿意，但大多數人認為理想情況下，導管應該更易於使用，並且手術所需的時間應該更少。

Based on this input, we immediately began working to incorporate their feedback into the second version of Pantheris, which was approved today.

基於這一意見，我們立即開始努力將他們的反饋納入今天獲得批准的第二版 Pantheris。

This enhanced version of Pantheris, which we are also launching commercially today, addresses both ease of use and procedure time improvements, as well as provides additional features such as lower crossing profile, 360-degree imaging, and improved manufacturability.

Pantheris 的增強版，我們今天也將推出商業版，它解決了易用性和手術時間改進的問題，並提供了其他功能，例如較低的交叉剖面、360 度成像和改進的可製造性。

Turning to the growth of our installed base, we added 35 lumivascular accounts during 2015 to reach a total of 95 lumivascular accounts at the end of the year.

談到我們安裝基礎的增長，我們在 2015 年增加了 35 個 lumivascular 賬戶，到年底達到 95 個 lumivascular 賬戶。

This represents a greater than 50% increase compared to where we ended 2014.

與 2014 年底相比，這意味著增長超過 50%。

In the third quarter, we continued to pilot and expand the Lightbox placement to purchase option, which along with sales of Lightboxes, led to 26 new lumivascular accounts added over the last two quarters.

在第三季度，我們繼續試點並擴大 Lightbox 放置到購買選項，這與 Lightbox 的銷售一起，導致在過去兩個季度增加了 26 個新的 lumivascular 客戶。

This was a notable acceleration compared to nine lumivascular accounts added in the first half of 2015.

與 2015 年上半年新增的 9 個 lumivascular 賬戶相比，這是一個顯著的加速。

In the fourth quarter, we added 13 new lumivascular accounts, including five Lightbox imaging consoles sold at new accounts, and a net increase of eight lumivascular accounts installed under one of our pilot programs.

在第四季度，我們增加了 13 個新的 lumivascular 帳戶，其中包括在新帳戶中銷售的 5 個 Lightbox 成像控制台，以及在我們的一個試點項目下安裝的 8 個 lumivascular 帳戶淨增。

Turning to sales and marketing, we recently added Joe Rafferty as Vice President of Sales.

談到銷售和市場營銷，我們最近任命 Joe Rafferty 為銷售副總裁。

Joe is a 30-year veteran in medical technologies sales and marketing, primarily with peripheral vascular and coronary products and procedures, and we are delighted to have his leadership in this key role as we launch Pantheris.

Joe 在醫療技術銷售和營銷領域擁有 30 年的經驗，主要從事外周血管和冠狀動脈產品和手術，我們很高興在我們推出 Pantheris 時有他的領導作用。

During the year, we expanded our salesforce headcount from 32 to 57, increasing our salesforce by 25 sales professionals, or approximately 80% compared to the end of 2014.

年內，我們的銷售人員人數從 32 人增加到 57 人，銷售人員增加了 25 名銷售專業人員，與 2014 年底相比增加了約 80%。

We have added, and will continue to add, infrastructure to support all of our new and legacy sales professionals.

我們已經添加並將繼續添加基礎架構，以支持我們所有新老銷售專業人員。

We made the decision to bring more new hires on board and advance the Pantheris launch to provide more time and opportunity for training on Pantheris.

我們決定招募更多新員工並推進 Pantheris 的發布，以便為 Pantheris 的培訓提供更多時間和機會。

We will continue to build our salesforce throughout the year, depending on the requirements identified during the Pantheris launch, with our current plan calling for a total of 70 sales professionals at year end.

根據 Pantheris 發布期間確定的要求，我們將在全年繼續建立我們的銷售隊伍，我們目前的計劃要求在年底總共招募 70 名銷售專業人員。

We have also been focused on preparing our lumivascular physicians for the launch of Pantheris.

我們還一直專注於讓我們的 lumivascular 醫生為 Pantheris 的推出做好準備。

To date, using cadaver labs and observation of actual cases in Europe, we've trained over 100 US physicians on the use of Pantheris.

迄今為止，利用屍體實驗室和對歐洲實際病例的觀察，我們已經培訓了 100 多名美國醫生使用 Pantheris。

With that, I will now turn the call over to Matt, who will review our Q4 financial results and provide guidance for 2016.

有了這個，我現在將把電話轉給馬特，他將審查我們第四季度的財務業績並為 2016 年提供指導。

We'll then review our key objectives for 2016 and open the call for your questions.

然後，我們將回顧 2016 年的主要目標，並開始徵集您的問題。

Matt?

馬特？

Thank you, Jeff.

謝謝你，傑夫。

Total revenue was $2.9 million for the fourth quarter ended December 31, 2015, a 7% decrease from the fourth quarter of 2014 and a 5% increase from the third quarter of 2015.

截至 2015 年 12 月 31 日的第四季度總收入為 290 萬美元，比 2014 年第四季度下降 7%，比 2015 年第三季度增長 5%。

Lightbox imaging console sales were $1.2 million, a 19% decrease compared to the fourth quarter of 2014 and a 37% increase from the third quarter of 2015.

Lightbox 影像控制台銷售額為 120 萬美元，與 2014 年第四季度相比下降 19%，與 2015 年第三季度相比增長 37%。

Revenue from disposable devices were $1.7 million, a 4% increase compared to the fourth quarter of 2014 and an 11% decrease from the third quarter of 2015.

一次性設備的收入為 170 萬美元，與 2014 年第四季度相比增長 4%，與 2015 年第三季度相比下降 11%。

Revenue results in the fourth quarter of 2015 reflect an increased focus on expanding and training our commercial organization and growing the number of lumivascular accounts in anticipation of the US launch of Pantheris.

2015 年第四季度的收入結果反映出更加註重擴大和培訓我們的商業組織，並增加 lumivascular 客戶的數量，以期在美國推出 Pantheris。

Gross margin for the fourth quarter of 2015 was 37%, down from 49% in the comparable quarter of 2014.

2015 年第四季度的毛利率為 37%，低於 2014 年同期的 49%。

This decrease was primarily attributable to the growth of our manufacturing infrastructure, again in anticipation of Pantheris' commercial launch in the current quarter.

這一減少主要歸因於我們製造基礎設施的增長，同樣是因為預期 Pantheris 將在本季度進行商業發布。

Operating expenses for the fourth quarter of 2015 were $13.4 million compared to $8.5 million in the fourth quarter of 2014.

2015 年第四季度的運營費用為 1340 萬美元，而 2014 年第四季度為 850 萬美元。

This growth was primarily attributable to Pantheris development expenses, expansion of our commercial organization, and increased expenses associated with operating a publicly traded company.

這一增長主要歸因於 Pantheris 開發費用、我們商業組織的擴張以及與運營一家上市公司相關的費用增加。

Loss from operations for the fourth quarter of 2015 was $12.3 million compared to $7 million for the fourth quarter of 2014.

2015 年第四季度運營虧損為 1230 萬美元，而 2014 年第四季度為 700 萬美元。

Net loss for the fourth quarter of 2015 was $13.5 million compared to $8.2 million in the fourth quarter of 2014.

2015 年第四季度淨虧損為 1350 萬美元，而 2014 年第四季度為 820 萬美元。

Adjusted EBITDA, which is a non-GAAP measure, was a loss of $9.8 million for the fourth quarter of 2015 compared to a $6.5 million loss for the fourth quarter of 2014.

調整後的 EBITDA 是一項非 GAAP 指標，2015 年第四季度虧損 980 萬美元，而 2014 年第四季度虧損 650 萬美元。

Turning to our balance sheet, cash and cash equivalents totaled $43.1 million as of December 31, 2015, compared to $12.3 million as of December 31, 2014.

轉向我們的資產負債表，截至 2015 年 12 月 31 日，現金和現金等價物總計 4310 萬美元，而截至 2014 年 12 月 31 日為 1230 萬美元。

In addition to our current cash balance, the debt transaction we completed in September also allows us to draw down an additional $10 million any time through the end of the second quarter of 2016.

除了我們當前的現金餘額外，我們在 9 月份完成的債務交易還使我們能夠在 2016 年第二季度末的任何時間額外提取 1000 萬美元。

And it also provides for an additional tranche of $10 million, based on achieving a minimum of $25 million in trailing 12-month revenue by the end of 2016.

它還提供了 1000 萬美元的額外付款，前提是到 2016 年底前 12 個月的收入至少達到 2500 萬美元。

This access to additional capital, which is at our option, significantly increases our flexibility as to when we return to the equity markets to raise additional capital.

我們可以選擇獲得額外資本，這大大增加了我們何時返回股票市場籌集額外資本的靈活性。

Turning now to our financial guidance for 2016.

現在轉向我們 2016 年的財務指導。

2016 revenue is expected to be in the range of $25 million to $30 million, representing year-over-year growth ranging from 134% to 180%.

2016 年收入預計在 2500 萬美元至 3000 萬美元之間，同比增長 134% 至 180%。

Our revenue forecast assumes expansion of our installed base of lumivascular accounts to approximately 150 by year-end.

我們的收入預測假設到年底我們的 lumivascular 賬戶安裝基數擴大到大約 150 個。

It also assumes an immediate initiation of Pantheris sales.

它還假定立即啟動 Pantheris 銷售。

But since we are just 30 days from the end of the quarter, we expect Pantheris to contribute modest revenue this quarter and then ramp steadily from there as we move through the year.

但由於距離本季度末僅 30 天，我們預計 Pantheris 本季度將貢獻適度的收入，然後在我們度過這一年時從那裡穩步增長。

Gross margin will also reflect a significant continued ramp-up of our manufacturing infrastructure.

毛利率也將反映出我們製造基礎設施的顯著持續增長。

For the year, we expect gross margin to be in the range of 40% to 43%.

今年，我們預計毛利率將在 40% 至 43% 之間。

However, due to continued ramp-up costs in Q1, we expect a significantly lower gross margin in the first quarter, at approximately 20%.

然而，由於第一季度成本持續上升，我們預計第一季度的毛利率將大幅下降，約為 20%。

Adjusted EBITDA for 2016 is projected to be a loss of $40 million to $43 million as we further invest in the development of our lumivascular platform products and continue to expand our commercial infrastructure.

由於我們進一步投資開發我們的 lumivascular 平台產品並繼續擴展我們的商業基礎設施，2016 年調整後的 EBITDA 預計將虧損 4000 萬至 4300 萬美元。

Net loss per share for 2016 is projected to be $4.35 to $4.55, and this assumes a weighted average share count of 12.8 million.

2016 年每股淨虧損預計為 4.35 美元至 4.55 美元，假設加權平均股數為 1280 萬股。

And at this point, we will now turn the call back to Jeff for closing remarks.

在這一點上，我們現在將把電話轉回 Jeff 的結束語。

Well, I hope you can take away from our call how excited we all are about the year ahead for Avinger.

好吧，我希望你能從我們的電話中帶走我們所有人對 Avinger 來年的興奮之情。

Our number-one priority for 2016 is a successful US launch of Pantheris, taking advantage of our growing salesforce and our expanding installed base of lumivascular accounts.

我們 2016 年的首要任務是在美國成功推出 Pantheris，利用我們不斷增長的銷售隊伍和不斷擴大的 lumivascular 客戶群。

As Dr. Simpson mentioned, we will continue our design and testing of Pantheris catheters with enhanced cutting capabilities and lower profiles to treat below-the-knee vessels and to further expand our market opportunity.

正如 Simpson 博士所提到的，我們將繼續設計和測試 Pantheris 導管，該導管具有增強的切割能力和更小的外形以治療膝下血管並進一步擴大我們的市場機會。

In addition, we will evaluate our options for the comparative clinical trials as we continue to build the clinical body of evidence in support of our lumivascular approach for the treatment of PAD.

此外，隨著我們繼續建立臨床證據以支持我們治療 PAD 的 lumivascular 方法，我們將評估我們的比較臨床試驗的選擇。

And at this point, we'd like to open the call for your questions.

在這一點上，我們想打開您的問題的電話。

(Operator Instructions).

（操作員說明）。

Jason Mills, Canaccord Genuity.

Jason Mills，Canaccord Genuity。

Congrats on the commercial Pantheris approval.

祝賀 Pantheris 獲得商業批准。

So, I'd like to start with a 20,000-foot question.

所以，我想從一個 20,000 英尺的問題開始。

It's been a bit over a year since you executed your initial public offering.

自您執行首次公開募股以來已經一年多了。

And I was wondering if you could give your current perspective on the competitive landscape in peripheral intervention as you get set to launch Pantheris immediately in the market, relative to what you saw a year ago when you went public, and just what you see as the opportunity initially for Pantheris in the US specifically.

我想知道當你準備立即在市場上推出 Pantheris 時，你是否可以就外圍干預的競爭格局給出你目前的看法，相對於你一年前上市時所看到的，以及你所看到的Pantheris 最初在美國的機會。

Yes, Jason, let me start off and give my -- from a clinical perspective, and then Jeff and Matt can certainly add in more of the business perspective.

是的，Jason，讓我從臨床角度開始，然後 Jeff 和 Matt 肯定可以加入更多的商業角度。

I think that the right now we are seeing reports coming in from all the different devices that are being used to treat peripheral artery disease.

我認為現在我們正在看到來自所有用於治療外周動脈疾病的不同設備的報告。

I think we see that drug-eluting balloons have -- there's a little bit of a reality check with drug-eluting balloons.

我想我們看到藥物洗脫球囊有——藥物洗脫球囊有一點現實檢驗。

They definitely make some improvement, but drug-eluting balloons need help across the board.

他們確實做出了一些改進，但藥物洗脫氣球需要全面的幫助。

And there are several trials that are ongoing to look at atherectomy, followed by drug-eluting balloons.

並且有幾項試驗正在進行中，以研究斑塊切除術，然後是藥物洗脫球囊。

And of course my position is that atherectomy by itself, done correctly with Pantheris, will be -- will not require the drug-eluting balloon to be used nearly as often, perhaps maybe as it might be with the SilverHawk.

當然，我的立場是，用 Pantheris 正確完成的粥樣斑塊切除術本身將——不需要像 SilverHawk 那樣經常使用藥物洗脫球囊。

There's also some risk of using the drug-eluting balloon after aggressive atherectomy.

在積極的粥樣斑塊切除術後使用藥物洗脫球囊也存在一些風險。

If you cut too deeply in the artery wall, then you can get aneurysms.

如果你在動脈壁上切得太深，那麼你就會得到動脈瘤。

Because the drug that's on the balloon is there to prevent scarring and healing from occurring, and that's really required if you've cut too deeply in the artery wall.

因為氣球上的藥物可以防止疤痕和癒合的發生，如果你在動脈壁上切得太深，那真的是必需的。

So I think, overall, the landscape is more favorable for us now than it might have been a year ago.

所以我認為，總的來說，現在的形勢比一年前對我們更有利。

Because I think at that time the drug-eluting balloon was thought to be a panacea.

因為我覺得那個時候藥物洗脫球被認為是靈丹妙藥。

And that is well-established now that that is absolutely just not the case.

現在已經確定事實並非如此。

It's certainly not a panacea, but it could have relevance.

它當然不是靈丹妙藥，但它可能具有相關性。

And I wouldn't exclude it from saying that it cannot be used after our device, but I think it's not going to be required nearly as often.

我不會排除它不能在我們的設備之後使用，但我認為它不會經常被需要。

And I think also the interest in trying to find some way to avoid stents is increasing because as the stent dwell time, let's say, in the patient increases, fractures increase.

而且我認為，人們對嘗試找到避免使用支架的方法的興趣也在增加，因為隨著支架停留時間的增加，比方說，患者體內的骨折增加。

As fractures increase, then restenosis increase and stent failure increase.

隨著骨折增加，再狹窄增加並且支架失效增加。

So I think that it's really favorable for us.

所以我認為這對我們真的很有利。

And I don't think that it's a -- I don't think it's just my imagination.

我不認為這是——我不認為這只是我的想像。

I think if you look at the doctors who never really want to put a stent in, if they could avoid it, they would.

我想如果你看看那些從來不想置入支架的醫生，如果他們能避免的話，他們會的。

And the hospitals love that because they are -- they definitely are -- they have to pay for the stents.

醫院喜歡這樣，因為他們——他們肯定是——他們必須為支架付費。

The other issue, though, I think that is not as well appreciated as maybe some people think is that the radiation exposure reduction associated with the potential -- we haven't really documented that currently, but with certainty it will occur in my mind, eventually -- that we can just do this without nearly as much radiation.

不過，我認為另一個問題並沒有像某些人認為的那樣受到重視，那就是與潛在相關的輻射暴露減少——我們目前還沒有真正記錄下來，但可以肯定的是，它會在我的腦海中發生，最終——我們可以在幾乎沒有輻射的情況下做到這一點。

And that has to be just a huge driver for the interventional group, as far as I can see.

據我所知，這一定是乾預小組的巨大推動力。

And, certainly, that's the way I look at it.

當然，這就是我看待它的方式。

So I think the bloom is off the rose a little bit for drug-eluting balloons.

因此，我認為藥物洗脫氣球的開花已經有點過了。

They do have value, but they are not a panacea.

它們確實有價值，但它們不是萬靈藥。

Nobody wants to put in a lot of stents, and they like to do stuff with less radiation.

沒有人願意放很多支架，他們喜歡做輻射少的事情。

I think we give that -- that is the option that we actually provide that is really, really, really, totally unique.

我認為我們提供了——那是我們實際提供的選項，它真的、真的、真的、完全是獨一無二的。

Yes, I think that was a very comprehensive answer from Dr. Simpson.

是的，我認為辛普森博士的回答非常全面。

But maybe just to add a couple of things to that clinical perspective is, first of all, as you look at the market, I think we continue to see a high degree of interest and strong growth with directional atherectomy, and the significant debulking that directional atherectomy can provide versus more of a vessel prep approach that would be followed by some kind of adjunctive treatment.

但也許只是為臨床觀點添加幾件事，首先，當你看市場時，我認為我們繼續看到定向斑塊切除術的高度興趣和強勁增長，以及定向斑塊切除術的顯著減瘤粥樣斑塊切除術可以提供更多的血管準備方法，然後進行某種輔助治療。

What's also very exciting about the landscape that we enter is that we are a familiar device in the terms of -- to the degree that we are a directional atherectomy device, but we provide the additional empowerment of real-time visualization, which has the direct clinical results that Dr. Simpson speaks of.

我們進入的領域也非常令人興奮的是，就我們是定向斑塊切除術設備而言，我們是一個熟悉的設備，但我們提供了實時可視化的額外授權，它具有直接辛普森醫生所說的臨床結果。

But it also empowers the physician to make better decisions as to what they want to do next.

但它也使醫生能夠就他們下一步想做什麼做出更好的決定。

And so, just as we have this powerful clinical proposition, we think we are extremely well positioned and very much on trend with the focus on safety and quality-based metrics in healthcare institutions.

因此，正如我們擁有這個強大的臨床主張一樣，我們認為我們處於非常有利的位置並且非常關注醫療機構中基於安全和質量的指標的趨勢。

And we've talked in previous calls about our economic value proposition with less need for retreatment because of less restenosis, with less need for adjunctive therapy because of the empowerment of visualization enabling you to -- the physician to not damage the vessel, but also to see how they left the vessel.

我們在之前的電話會議中談到了我們的經濟價值主張，即由於再狹窄較少而無需再治療，由於可視化的授權使您能夠減少對輔助治療的需求 - 醫生不會損壞血管，而且看看他們是如何離開船隻的。

And then less exposure to radiation, which I think in the past year has become even more of an issue in the institutional setting, as well as the strong desire to reduce exposure to contrast media for patients.

然後減少輻射暴露，我認為這在過去一年中已成為機構環境中的一個更大問題，以及減少患者接觸造影劑的強烈願望。

So, it all comes together, I think, both on a clinical proposition basis and an economic value proposition basis.

因此，我認為，這一切都基於臨床命題和經濟價值命題。

And we're committed to developing data to support both.

我們致力於開發數據來支持這兩者。

That's helpful, guys.

這很有幫助，伙計們。

I appreciate it.

我很感激。

And just two follow-ups and then I'll get back in queue.

只需兩次跟進，然後我就會回到隊列中。

The first, your guidance for how the installed base will grow over the year; it seems pretty obvious that you have taken the last couple of quarters' run rate at 13 and annualized that to get to right around 50, or a little above 50.

首先，您對安裝基礎在一年中如何增長的指導；很明顯，您已將過去幾個季度的運行率為 13，並將其年化為 50 左右，或略高於 50。

Should we be thinking about the new customers in that linear fashion -- is the first question -- or will it be more front- or back-end loaded for whatever reason?

我們應該以線性方式考慮新客戶——這是第一個問題——還是出於某種原因它會更多地加載前端或後端？

And then secondly, you mentioned also some of the development work you're doing, both below-the-knee Pantheris lower profile, and also you've talked in the past about a calcium cutting device, as well as longer-term in coronary.

然後其次，你還提到了你正在做的一些開發工作，包括膝蓋以下的 Pantheris 低調，你過去也談到過鈣切割裝置，以及長期用于冠狀動脈的.

Can you give us any more granular detail on the commencements of trials or registries, or things that would move you towards an approval in any of those areas over the next couple of years as well?

您能否向我們提供有關試驗或註冊的開始的更詳細的細節，或者在未來幾年內也會使您在這些領域中的任何一個獲得批准的事情？

Thanks a lot.

多謝。

Congrats on the approval.

恭喜獲批。

Thanks, Jason.

謝謝，傑森。

Why don't I start with the build of the installed base, and then let Dr. Simpson speak to the pipeline products.

為什麼我不從安裝基礎的構建開始，然後讓辛普森博士談論管道產品。

As we developed our forecasts and our program for 2016, I think we took a very thoughtful and grounds-up approach.

在我們制定 2016 年的預測和計劃時，我認為我們採取了非常深思熟慮和基於基礎的方法。

When we look at building our installed base, we do believe that we will continue that, as you pointed out, that accelerated pace of adoption based on, now, Pantheris being available.

當我們著眼於建立我們的安裝基礎時，我們確實相信我們將繼續，正如您所指出的那樣，基於現在可用的 Pantheris 加快採用速度。

As well as the larger sales force, but also the fact that we have introduced or added some more flexibility into the Lightbox acquisition model.

除了更大的銷售隊伍，還有我們在 Lightbox 收購模型中引入或增加了更多靈活性這一事實。

Both our placement to purchase option, which we have talked about on past calls, as well as now the introduction of a rental model with the approval of Pantheris.

我們在過去的電話中談到了我們的購買選擇權，以及現在在 Pantheris 的批准下引入的租賃模式。

So that will enable us to continue to accelerate, I think, the expansion of the installed base of throughout the year.

我認為，這將使我們能夠繼續加速全年安裝基礎的擴展。

We don't see that as a hockey stick kind of build.

我們不認為這是曲棍球棒的構造。

We are focused, and our salesforce I think is doing an excellent job, on prioritizing targeting the right hospitals and outpatient labs where physicians who are committed to the benefits of the lumivascular approach, physicians who want to build their practice working with us, and who we think can really even add to our knowledge and share data and experience as we refine our products and programs.

我們很專注，而且我認為我們的銷售人員做得很好，優先針對正確的醫院和門診實驗室，在那裡，致力於 lumivascular 方法的醫生，想要與我們合作建立他們的實踐的醫生，以及誰我們認為，在我們改進我們的產品和程序時，它甚至可以真正增加我們的知識並共享數據和經驗。

So our long-term goal is to be the leader in this space and ultimately to change the standard of care for PAD.

因此，我們的長期目標是成為該領域的領導者，並最終改變 PAD 的護理標準。

And we think an important part of that is targeting the right physicians and prioritizing getting on board with folks who really want to be part of this lumivascular revolution.

我們認為，其中一個重要部分是針對合適的醫生，並優先考慮真正想參與這場 lumivascular 革命的人們。

So, I guess the simple answer is we don't see this as a hockey stick.

所以，我想簡單的答案是我們不認為這是曲棍球棒。

We see it as an accelerating pace of expansion, but throughout the year.

我們認為這是一個加速的擴張步伐，但貫穿全年。

So John, I don't know if you want to (multiple speakers).

約翰，我不知道你是否願意（多位發言者）。

Yes.

是的。

I would maybe just briefly address the issues associated with the calcium cutter.

我可能只是簡單地談談與鈣切割機相關的問題。

I think I have helped develop calcium cutters for many years, so I feel pretty comfortable with that.

我想我已經幫助開發鈣切割器多年，所以我對此感到很自在。

And I -- but I don't think that our device that we're talking about -- more efficient cutting -- definitely would be calcium would be a part of more efficient cutting.

而且我 - 但我不認為我們正在談論的設備 - 更有效的切割 - 肯定是鈣會成為更有效切割的一部分。

But it would not be restricted to just calcium.

但它不會僅限於鈣。

I think we have -- there are other things that we would like to explore which we're actually exploring, and probably some of that will be O-US.

我認為我們有——還有其他我們想要探索的東西，我們實際上正在探索，其中一些可能是 O-US。

We will explore issues associated with in-stent restenosis, we can -- with just restenosis, just period.

我們將探索與支架內再狹窄相關的問題，我們可以——只有再狹窄，只有時期。

Calcium, smaller vessels, below the knee -- all those things, I think, are up for grabs.

鈣、較小的血管、膝蓋以下——我認為所有這些東西都可以爭取。

I feel confident that we have the best device you could ever imagine to execute on the promise of being able to treat heavily calcified arteries, and also small vessels where you have to be very careful with the vessel while you're treating it.

我有信心我們擁有您能想像到的最好的設備，可以兌現能夠治療嚴重鈣化動脈的承諾，以及治療血管時必須非常小心的小血管。

All the below-the-knee vessels fall into that category.

所有膝蓋以下的血管都屬於這一類。

And then once those devices are more formally evaluated, and we have more confidence in them, then particularly the small device will be very similar to what we would expect to be used in the coronary arteries.

然後，一旦這些設備得到更正式的評估，並且我們對它們更有信心，那麼特別是小型設備將與我們期望用于冠狀動脈的設備非常相似。

And you asked for timelines.

你問了時間表。

And it would be great if I could really give you timelines and I would love to do it, but I don't think I could do that really rationally at this point.

如果我真的能給你時間表就太好了，我很樂意這樣做，但我認為目前我無法真正理性地做到這一點。

But tell you that for sure we are fully capable of doing this and we're actually working on it as we speak.

但可以肯定的是，告訴你我們完全有能力做到這一點，而且我們正在努力解決這個問題。

Great, guys.

太好了，伙計們。

Thanks.

謝謝。

Josh Jennings, Cowen and Company.

喬希·詹寧斯、考恩公司。

Just want to reiterate Jason's congratulations on the commercial Pantheris approval.

只想重申傑森對 Pantheris 商業批准的祝賀。

I wanted to first ask just about the launch.

我想先問一下發射。

You've had some time to train 100 doctors and get some more accounts to adopt the Lightbox.

您已經花了一些時間來培訓 100 名醫生並獲得更多帳戶來採用 Lightbox。

Just wanted to -- I was curious, within those 100 doctors, any kind of directional relay on how many accounts have been trained, any guidance on how many docs you expect to train by the end of 2016, and just any more color on the training process?

只是想 - 我很好奇，在這 100 名醫生中，關於有多少客戶接受過培訓的任何類型的定向中繼，關於您希望在 2016 年底培訓多少醫生的任何指導，以及任何更多顏色訓練過程？

And is there anything within the label from a training perspective that needs to be completed for physicians before they start moving forward with full-scale adoption?

從培訓的角度來看，標籤中是否有任何內容需要醫生在開始全面採用之前完成？

So, let me start off by talking about the physician training.

那麼，讓我先談談醫師培訓。

As you may recall, our generation-one device, our first device, had a balloon on a separate sheath that we used to occlude the blood flow so we could really get good OCT images.

您可能還記得，我們的第一代設備，我們的第一台設備，在一個單獨的護套上有一個氣球，我們用它來阻斷血流，這樣我們才能真正獲得良好的 OCT 圖像。

And it was one of the frustrating parts of the procedure, and we've eliminated that completely.

這是程序中令人沮喪的部分之一，我們已經完全消除了它。

So that balloon now has been moved away from the sheath, the tip of that sheath.

所以那個氣球現在已經離開了鞘，那個鞘的尖端。

Now it actually sits on the Pantheris catheter itself and is a much more efficient and much more effective tool for managing blood and providing [flush].

現在它實際上位於 Pantheris 導管本身，是一種更有效的管理血液和提供 [沖洗] 的工具。

So our images are better; the cases are easier.

所以我們的形象更好；案件更容易。

And now, then, the training of the physician is a lot easier.

而現在，醫生的培訓要容易得多。

So, as it relates to the question, I think that we've seen this already in training -- the docs in the cath labs, also watching the cases in Europe -- that they really are surprised, genuinely surprised, that this is simpler than they could have imagined it to be, based on their early experience.

所以，就這個問題而言，我認為我們已經在培訓中看到了這一點——導管室的文檔，也在觀察歐洲的病例——他們真的很驚訝，真的很驚訝，這更簡單根據他們早年的經驗，這比他們想像的要多。

And the separate sheath with the separate balloon for occlusion, that just added some complexity to the procedure that everybody wanted to get rid of.

單獨的護套和單獨的球囊用於閉塞，只是增加了每個人都想擺脫的程序的複雜性。

And I'm thrilled with the way that has been dealt with.

我對這種處理方式感到非常興奮。

So, I think that that translates into easier to train physicians.

所以，我認為這意味著更容易培訓醫生。

And I'm excited.

我很興奮。

I can't tell you.

我不能告訴你。

Exhilaration is really such a -- not an adequate term to say how excited we are to get the cases started.

興奮真的是這樣——不足以表達我們對開始案件的興奮程度。

Our goal is to start the cases tomorrow.

我們的目標是明天開始審理案件。

So we'll hopefully -- and these will be docs that have been looking at finding cases for us.

所以我們希望 - 這些將是一直在為我們尋找案例的文檔。

It's interesting, too, because many of the doctors have cases that they have wanted to actually wait for Pantheris, only because it's safer.

這也很有趣，因為許多醫生都有他們想要真正等待 Pantheris 的案例，只是因為它更安全。

And it's safer and it's more effective than anything else that they could provide, right now.

而且它比他們現在可以提供的任何其他東西都更安全、更有效。

And I think the training, I think, is going to be really good.

而且我認為培訓會非常好。

It's going to be exciting, and I think the world is ready for it.

這將是令人興奮的，我認為世界已經為此做好了準備。

It's a little bit of a shockwave I think for some of the people, but I'm really -- I couldn't be more excited, and confident that the training is going to go well.

我認為這對某些人來說有點衝擊波，但我真的 - 我非常興奮，並且相信培訓會順利進行。

And speaking, Josh, to some of the numbers questions you asked: when you look at the number of physicians we've trained compared to our current installed base, or our installed base at the end of the year, we've trained physicians representing more than 90% of our current lumivascular accounts.

Josh，關於您提出的一些數字問題：當您查看我們培訓的醫生人數與我們目前的安裝基數或我們在年底的安裝基數相比時，我們培訓的醫生代表我們目前 90% 以上的 lumivascular 賬戶。

And so, we took full advantage -- and Dr. Simpson challenged the organization to take advantage of that early clinical approval of Pantheris so that we can move this process forward.

因此，我們充分利用了 - 辛普森博士向該組織提出挑戰，要求該組織利用 Pantheris 的早期臨床批准，以便我們能夠推進這一進程。

It was at the training session that we executed -- it was a couple-of-hour didactic training session, followed by a hands-on cadaver lab.

正是在我們執行的培訓課程中——這是一個幾個小時的教學培訓課程，然後是一個動手的屍體實驗室。

We did these in regional centers around the country so that we could make it easy for travel for the physicians.

我們在全國各地的區域中心進行了這些工作，以便我們可以方便醫生的旅行。

But there was a large degree of commitment for these individuals to join us for this training session.

但是，這些人對參加我們的培訓課程有很大的承諾。

And the feedback was extraordinarily positive coming out of every session.

每次會議的反饋都非常積極。

So we think we've done a good job of preparing at least the lead physician user in these accounts, prior to the launch of Pantheris.

因此，我們認為，在 Pantheris 推出之前，我們已經做好了至少讓這些賬戶中的主要醫生用戶做好準備的工作。

As we grow our installed base throughout the year, of course there will be the opportunity to train physicians within each of those accounts.

隨著我們全年安裝基礎的擴大，當然會有機會在每個賬戶中培訓醫生。

We've put out a target of approximately 150 accounts by year-end.

我們制定了到年底大約有 150 個帳戶的目標。

But we also will to look to continue to expand the usage within hospitals by training additional physicians.

但我們也希望通過培訓更多的醫生來繼續擴大醫院內的使用。

So we're not guiding to a specific number of trained physicians by the end of the year.

因此，我們不會在年底前指導具體數量的訓練有素的醫生。

But it is something that we are focused on, in addition to providing opportunities for advanced training and continued training of our current lumivascular physicians.

但這是我們關注的事情，除了為我們目前的 lumivascular 醫生提供高級培訓和繼續培訓的機會。

One other thing that we did in the fourth quarter that I think was extremely useful and will help us through this lunch period of Pantheris is we took several of our physician investigators -- 12 of our physicians -- over to Europe, where they could observe live cases with the commercial version of Pantheris.

我們在第四季度做的另一件事我認為非常有用並且會幫助我們度過 Pantheris 的這個午餐時間，那就是我們把我們的幾名醫生調查員——我們的 12 名醫生——帶到了歐洲，他們可以在那裡觀察帶有商業版 Pantheris 的現場案例。

And they were well prepared, and have been very involved in these training sessions to serve as physician proctors for new lumivascular physicians, or those physicians who aren't as familiar with atherectomy or image-guided atherectomy, which is brand-new.

他們做好了充分的準備，並積極參與這些培訓課程，作為新的 lumivascular 醫生或那些不熟悉斑塊切除術或圖像引導斑塊切除術的醫生的監督員，這是全新的。

So we will continue to make that investment.

因此，我們將繼續進行這項投資。

We've invested, at the same time, in training, and continued training and improved training of our salesforce.

同時，我們在培訓方面進行了投資，並繼續培訓和改進了我們銷售人員的培訓。

And we've talked about that on past calls.

我們在過去的電話中討論過這個問題。

But everything we've been doing, really over the last quarter, has not only been about continuing to build the installed base, driving experience with Ocelot, but preparing for this day, today, the launch of Pantheris.

但我們一直在做的一切，真的在上個季度，不僅是繼續建立安裝基礎，使用 Ocelot 駕駛體驗，而且為今天，今天，Pantheris 的發布做準備。

Great.

偉大的。

Thanks for that.

感謝那。

And I just wanted to follow up on one of your comments in the prepared remarks just about -- or maybe it was an answer to Jason's question -- about the clinical development.

我只是想跟進你在準備好的評論中的一條評論——或者這可能是對傑森問題的回答——關於臨床開發。

The clinical evidence development strategy initiatives -- have there any been any further thoughts in terms of moving forward with any further clinical trials, or on the clinical effectiveness or cost-effectiveness side?

臨床證據開發戰略舉措——在推進任何進一步的臨床試驗方面，或者在臨床有效性或成本效益方面，是否有任何進一步的想法？

So we do have clinical trials that are underway that we're structuring.

因此，我們確實正在進行我們正在構建的臨床試驗。

I can't say that we started that trials yet, but we have a trial.

我不能說我們已經開始試驗了，但我們已經進行了試驗。

The first one will be a radiation reduction trial.

第一個將是輻射減少試驗。

So we'll be looking at the reduction in time required and -- I'm sorry, radiation exposure required -- to do Pantheris procedures versus SilverHawk.

因此，我們將研究與 SilverHawk 相比，與 SilverHawk 相比，我們將研究所需時間的減少——對不起，需要輻射暴露。

And that will be the first trial that I think you'll see.

那將是我認為你會看到的第一個試驗。

We certainly have trials that we are -- we've talked about it a lot with everyone, I think, having a randomized comparison between our device versus the other atherectomy catheters and/or doing a Pantheris procedure, and then at the end of that procedure randomizing the patient then to a drug-eluting balloon or more Pantheris, more atherectomy would be another thought.

我們當然有我們正在進行的試驗——我想我們已經和每個人談了很多，在我們的設備和其他粥樣斑塊切除術導管之間進行隨機比較和/或進行 Pantheris 手術，然後在最後程序將患者隨機分配到藥物洗脫球囊或更多的 Pantheris，更多的粥樣斑塊切除術將是另一個想法。

But these are all -- they are discussed aggressively on a daily basis.

但這些都是——他們每天都在積極討論。

But I think it would be inappropriate right now to actually put any timelines on that, except to say maybe that the radiation reduction study is imminent.

但我認為現在就此設置任何時間表是不合適的，除了說也許輻射減少研究迫在眉睫。

Yes.

是的。

And I think the one additional study that you are referring to, Josh, is we have talked about, and we are well along in our plans to initiate a clinical trial focused on these quality-based metrics and the economic benefits of Pantheris in partnership with a large capitated system.

Josh，我認為你提到的另一項研究是我們已經討論過的，我們正在計劃啟動一項臨床試驗，重點關注這些基於質量的指標和 Pantheris 的經濟效益，與一個大的資本化系統。

So as we get further along and closer to enrollment in that study, we'll share more news and certainly announce when we begin enrollment.

因此，隨著我們在該研究中取得進一步進展並接近招募，我們將分享更多新聞，並且肯定會宣布我們何時開始招募。

Thanks.

謝謝。

And just the last question, just on guidance; I know you don't want to give specifics on your assumptions between capital and disposable revenue, but any incremental directional help would be appreciated.

最後一個問題，只是關於指導；我知道您不想詳細說明您在資本和可支配收入之間的假設，但我們將不勝感激任何增量定向幫助。

And maybe just if you could let -- is one of your assumptions that the capital revenues or capital sales are going to grow year-over-year in 2016?

也許只是如果你可以 - 你的假設之一是資本收入或資本銷售將在 2016 年同比增長嗎？

Thanks a lot.

多謝。

And congrats again.

再次恭喜。

Yes, Josh, maybe I could take that.

是的，喬什，也許我可以接受。

In terms of our capital sales versus disposable, we really are, I think, moving more and more, now that Pantheris is approved, to being a company that is driven by disposable sales and less so by capital sales, which is maybe more where we've been over the last couple of years.

就我們的資本銷售與一次性銷售而言，我認為，既然 Pantheris 獲得批准，我們確實越來越多地成為一家由一次性銷售驅動的公司，而不是由資本銷售驅動的公司，這可能是我們更多的地方在過去的幾年裡。

And I would say inherent in our guidance, when you look at going from 95 accounts at the end of 2015 up to a total of 150 by the end of 2016, we would assume probably somewhere in the one-quarter to one-third of those would be sold Lightboxes or capital sales.

我想說我們的指導中固有的，當你看到從 2015 年底的 95 個賬戶到 2016 年底的總數 150 個時，我們可能會假設其中的四分之一到三分之一將出售燈箱或資本銷售。

And the others would take advantage of one of our placement to purchase programs or rental program, or something along that line.

其他人會利用我們的一個安置來購買程序或租賃程序，或者類似的東西。

So, as a result, I would expect that -- without giving a specific number for capital sales -- I wouldn't expect an increase there, necessarily; that most of the increase would be driven -- increase in our overall sales would be driven by disposable sales, primarily Pantheris.

因此，因此，我預計——在沒有給出資本銷售的具體數字的情況下——我預計不會有增長，這是必然的；大部分增長將受到推動——我們整體銷售額的增長將由一次性銷售推動，主要是 Pantheris。

Very helpful.

很有幫助。

Thanks.

謝謝。

Chris Cooley, Stephens, Inc.

Chris Cooley, Stephens, Inc.

Let me just echo everyone else's prior favorable sentiments: congrats on the Pantheris approval.

讓我重複一下其他人之前的讚同情緒：祝賀 Pantheris 獲得批准。

Let me just maybe go back.

讓我回去吧。

I wanted to clarify a prior question and maybe look into 2016 a little bit more in-depth.

我想澄清一個先前的問題，並可能更深入地研究 2016 年。

Has your position changed regarding the potential timing for a -- let's call it a gen 3 Pantheris from around calendar year-end of this year?

關於可能的時間，您的立場是否發生了變化 - 讓我們稱其為今年日曆年底左右的第 3 代 Pantheris？

Or is that maybe just semantics in your prior responses there, that you're premature, I think is how you phrased it, to outline a timeline for that next-gen, lower-profile, and potentially more efficient calcium cutting device?

或者這可能只是您之前的回應中的語義，我想您是如何措辭的，為下一代、低調且可能更高效的鈣切割設備勾勒出時間表？

I just want to make sure I'm clear on the expecting timing for that, let's call it, gen 3.

我只是想確保我清楚預期的時間，我們稱之為第 3 代。

Yes, okay, let me -- this is John again -- let me just to respond to that.

是的，好吧，讓我——我又是約翰——讓我來回應一下。

So, we have active programs that are ongoing, and we're excited about that.

因此，我們有正在進行的活動計劃，我們對此感到興奮。

I think we would expect that the innovation in that space is going to be tested O-US, which is what we've almost always done, and at some of the sites that we outlined earlier, mostly in Muenster, is my guess.

我認為我們希望該領域的創新將在 O-US 進行測試，這幾乎是我們一直在做的，我猜是在我們之前概述的一些地點，主要是在明斯特。

And I think that we'd like to be able to give you timelines, but I think it's a little bit premature until we have a little bit more visibility on -- we know that these devices are -- the designs have been pretty much completed and that they are manufacturable and that they are testable, as soon as we get all the forms filled out, if you will.

而且我認為我們希望能夠為您提供時間表，但我認為現在還為時過早，直到我們對這些設備有更多的了解 - 我們知道這些設備 - 設計已經基本完成並且它們是可製造的並且它們是可測試的，只要我們填寫完所有表格，如果你願意的話。

So it's more of that than it is any significant iterative risk, I would think, in the designs.

因此，我認為，在設計中，它比任何重大的迭代風險都重要。

But (multiple speakers) I do believe that you'll see some good information.

但是（多位發言者）我相信你們會看到一些好的信息。

But I think it's a little bit early to offer up -- well, for me personally, I don't feel very comfortable giving any timelines because I don't think we have very good visibility on that, but we do have some assumptions.

但我認為現在提供還為時過早——嗯，就我個人而言，我不太願意給出任何時間表，因為我認為我們對此沒有很好的了解，但我們確實有一些假設。

And Matt has a sheet in front of him now that he must be reflecting on that, (laughter) as he is looking at something with numbers.

現在 Matt 面前有一張紙，他一定在反思它，（笑聲）他正在看一些有數字的東西。

Well, I'm certainly not going to share everything on this sheet in front of me.

好吧，我當然不會在我面前分享這張表上的所有內容。

But I guess I would just say, Chris, that we -- in the guidance that we gave as far as revenue, we are not assuming any specific contributions from new devices beyond this version of Pantheris that was just approved today.

但我想我只想說，克里斯，我們 - 在我們給出的收入指導中，我們沒有假設除了今天剛剛批准的這個版本的 Pantheris 之外的新設備的任何具體貢獻。

So, no additional expansion of our addressable market, based on having a device for cutting calcium or below-the-knee treatment during 2016.

因此，基於在 2016 年期間擁有用於減少鈣化或膝下治療的設備，我們的潛在市場不會進一步擴大。

That's our assumption.

這是我們的假設。

Can I draw an analogy here?

我可以在這裡打個比方嗎？

This is probably totally inappropriate in a call like this.

這在這樣的通話中可能是完全不合適的。

But the question that has just been posed seems to me like -- a little bit like asking the guy that -- the team that just won the NFC championship, what are their thoughts are on the Super Bowl.

但剛剛提出的問題在我看來就像是——有點像問那個人——剛剛贏得 NFC 冠軍的球隊，他們對超級碗有什麼看法。

And they want to just celebrate winning the NFC championship for a night.

他們只想慶祝贏得 NFC 冠軍一晚。

(laughter) And so I think maybe I'm a little bit in the mode of I am so thrilled and/or exhilarated -- I don't even know what the right term is -- about getting this milestone, because you know we've been pursuing this for more than years and years and years.

（笑聲） 所以我想也許我有點太激動和/或興奮了——我什至不知道正確的術語是什麼——關於獲得這個里程碑，因為你知道我們多年來，我一直在追求這個目標。

That doesn't mean that I'm not cognizant of the challenges in front of us with calcium cutting and in-stent restenosis, just restenosis period.

這並不意味著我沒有意識到我們面前的鈣切割和支架內再狹窄的挑戰，只是再狹窄期。

Eager to take those challenges on, but tonight we're celebrating the NFC championship, I guess.

渴望接受這些挑戰，但今晚我們要慶祝 NFC 冠軍，我猜。

Well, we're also (multiple speakers).

好吧，我們也是（多個發言者）。

And we're still thinking about the Super Bowl, yes (multiple speakers).

我們還在考慮超級碗，是的（多位發言人）。

Got to win the Super Bowl, guys.

必須贏得超級碗，伙計們。

Just my follow-up, then, as it pertains to the 2016 guidance: Matt, could you maybe give us a little bit of a better feel for the disposables between what we're seeing from Pantheris versus what we would see on the CTO side?

那麼，這只是我的後續行動，因為它與 2016 年指南有關：馬特，你能否讓我們更好地了解我們從 Pantheris 看到的與我們在 CTO 方面看到的一次性用品？

And then maybe similarly now, you have a new head of sales fully in place, you've added reps.

然後可能與現在類似，你有一個新的銷售主管完全到位，你已經增加了銷售代表。

Talk to us about maybe some of the metrics that you are holding them to as they go through the year in terms of productivity within existing accounts, as well as account expansion.

與我們談談在現有客戶的生產力以及客戶擴展方面，您在過去一年中可能持有的一些指標。

Just maybe walk us through some of that with broad strokes.

也許只是粗略地引導我們完成其中的一些。

Thanks so much.

非常感謝。

Well, in terms of catheter sales and how we think about it, we really do think about it as a total lumivascular opportunity within each account.

好吧，就導管銷售和我們如何看待它而言，我們確實將其視為每個帳戶中的一個完整的 lumivascular 機會。

And especially given that every account that has acquired a Lightbox through any of our various programs has already expressed -- they've already shown interest in Ocelot by using it and gaining success with it so far.

特別是考慮到每個通過我們的各種計劃獲得 Lightbox 的帳戶都已經表達了 - 他們已經通過使用 Ocelot 表現出興趣，並且到目前為止取得了成功。

We would expect that that would continue to be an important part of our overall portfolio.

我們希望這將繼續成為我們整體投資組合的重要組成部分。

And we think a lot and talk a lot about the ways that we can provide motivation and incentives for when there is a CTO, for both an Ocelot and a Pantheris to be used in the procedure.

我們想了很多，也談了很多關於當有 CTO 時我們可以提供動力和激勵的方式，在程序中同時使用 Ocelot 和 Pantheris。

All of that said, the opportunity is clearly much larger in the atherectomy space.

綜上所述，旋切術領域的機會顯然要大得多。

And we see it as -- there's probably 4 to 5 times larger just in terms of the overall market opportunity.

我們認為——就整體市場機會而言，可能要大 4 到 5 倍。

Now, you might have to discount that a little bit because we can't address the entire market at this point.

現在，你可能不得不打折一點，因為我們目前無法解決整個市場。

We think about being able to address about half the market for atherectomy cases to start out with.

我們考慮能夠解決大約一半的粥樣斑塊切除術病例市場。

But as a result, we do think of the Pantheris opportunity and the Pantheris sales in 2016 as being a multiple of what we've been able to do with Ocelot so far, and what we'd expect it to be, going forward.

但結果是，我們確實認為 Pantheris 的機會和 2016 年的 Pantheris 銷售是我們迄今為止能夠與 Ocelot 一起做的事情的倍數，以及我們對未來的預期。

(multiple speakers)

（多個揚聲器）

It's also fair to share that -- so, we'll leave tonight to start the cases tomorrow.

分享這一點也很公平——所以，我們今晚離開，明天開始審理案件。

And the number of patients that have been signed up by the doctors is that same multiple that Matt is just talking about.

醫生登記的患者數量與馬特剛才所說的相同。

So, if they could find a couple of Ocelot cases, that was great for their first experience.

所以，如果他們能找到幾個 Ocelot 箱子，那對他們的第一次體驗來說就很棒了。

And we're talking about eight or nine Pantheris first cases in a lot of hospitals, because the prevalence of the disease that is treatable with the Pantheris is just much more common than the CTO prevalence and the treatment of the CTO.

我們在很多醫院談論八九個 Pantheris 首例病例，因為可以用 Pantheris 治療的疾病的患病率比 CTO 患病率和 CTO 的治療要普遍得多。

So I do expect that based on all the information we have, and the doctors that -- so, we have three doctors that are clamoring to do the first cases tomorrow.

所以我確實希望根據我們掌握的所有信息和醫生——所以，我們有三位醫生吵著要明天做第一批病例。

And I think we could probably do, if we did all the cases, we could do 15 cases tomorrow, if we did it.

而且我認為我們可能會做，如果我們做了所有的案例，如果我們做了的話，明天我們可以做 15 個案例。

There's no chance of that we're going to be able to do that.

我們不可能做到這一點。

But this never occurred with the Ocelot or with the balloon angioplasty of ACS, or the DVI device back in the early at atherectomy days, either.

但這從未發生在 Ocelot 或 ACS 的球囊血管成形術，或早期的粥樣斑塊切除術早期的 DVI 設備上。

So, this is really, really, profoundly unique, which leads to legitimate exhilaration.

所以，這真的、真的、非常獨特，這會導致合理的興奮。

I'm just going to keep using that term until you guys get -- the phrase is sort of nauseating for you.

我將繼續使用這個詞，直到你們明白——這個詞讓你們有點噁心。

Chris, I know you're aware of the powerful data -- of course, small numbers -- but the very strong results, positive results, we got in CTOs, or lesions that started as a CTOs, in our VISION trial.

克里斯，我知道你知道強大的數據——當然，數字很小——但在我們的 VISION 試驗中，我們在 CTO 中得到了非常強大的結果，或者從 CTO 開始的病變。

Not only in terms of delivering a TLR rate by lesion equivalent to the lesion set overall at only 6.5%, but also only having one stent placed in 33 CTOs.

不僅在按病灶提供 TLR 率方面相當於整個病灶集僅為 6.5%，而且在 33 個 CTO 中只放置了一個支架。

And so, we think it makes excellent sense to have a total lumivascular approach.

因此，我們認為採用全 lumivascular 方法非常有意義。

And as Matt talked about, we're exploring promotional opportunities, such as procedural pricing, et cetera, to stimulate that.

正如馬特所說，我們正在探索促銷機會，例如程序定價等，以刺激這一點。

But it just makes sense to cross the CTO, stay inside the true lumen, and set it up perfectly for treatment with Pantheris.

但穿過 CTO，留在真正的管腔內，並完美地設置它以使用 Pantheris 進行治療是有意義的。

And I think that with us -- an expanding installed base, with lumivascular being used in more procedures because of atherectomy, that we will get an uptick on Ocelot, because about 20% of lesions start out as a CTO.

而且我認為，隨著我們——一個不斷擴大的安裝基礎，由於動脈粥樣硬化切除術， lumivascular 被用於更多的程序，我們將在 Ocelot 上得到提振，因為大約 20% 的病變開始於 CTO。

The primary driver of growth from the disposable side of the business and the business overall is Pantheris, but I believe Ocelot will benefit as well.

一次性業務和整體業務增長的主要驅動力是 Pantheris，但我相信 Ocelot 也會受益。

That is a terrific device.

那是一個了不起的設備。

Okay.

好的。

Thank you very much.

非常感謝。

(Operator Instructions).

（操作員說明）。

Steven Lichtman, Oppenheimer.

史蒂文·利希特曼，奧本海默。

This is Denis Kelleher filling in for Steve.

我是丹尼斯·凱萊赫 (Denis Kelleher)，代替史蒂夫。

First, congrats on the Pantheris approval.

首先，祝賀 Pantheris 獲得批准。

Just two questions.

只是兩個問題。

Just to confirm and understand there were some trials underway, will there be any dated presentations or posters at the cardiovascular conferences this year?

只是為了確認和了解正在進行的一些試驗，今年的心血管會議上是否會有任何註明日期的報告或海報？

So, as we look at -- first of all, we will have a strong presence at the different conferences this year.

因此，正如我們所看到的——首先，我們將在今年的不同會議上有很強的影響力。

We're going to be at OEIS.

我們將在 OEIS。

We'll be at NCVH, SVS, CVC, SCAI, VIVA, and TCT.

我們將參加 NCVH、SVS、CVC、SCAI、VIVA 和 TCT。

Although I'm not sure if we'll have a booth at TCT, we will have a presence there, and as well as regional shows.

雖然我不確定我們是否會在 TCT 有一個展位，但我們會在那裡展示，以及區域性展覽。

And so, we will continue to develop data.

因此，我們將繼續開發數據。

Even at LINC -- I'm not sure if you saw any of that, Steve -- some of our physician investigators and partners in Europe who have been using Pantheris did present their own single site data.

即使在 LINC——史蒂夫，我不確定你是否看到過這些——我們在歐洲使用 Pantheris 的一些醫生調查員和合作夥伴確實提供了他們自己的單一站點數據。

We think there will be more opportunity for either our US-based or European-based former VISION investigators or early lumivascular adopters to develop and present some of their own data.

我們認為我們在美國或歐洲的前 VISION 研究人員或早期 lumivascular 採用者將有更多機會開發和展示他們自己的一些數據。

And then, as we move into the second half of the year, hopefully we'll have some additional data to present from some of our ongoing studies.

然後，隨著我們進入今年下半年，希望我們能從一些正在進行的研究中獲得一些額外的數據。

But we'll be a bit more precise, timelines out, as we move forward throughout the year.

但隨著我們全年向前推進，我們會更精確一些，確定時間表。

Okay, great.

好的，太好了。

That's helpful.

這很有幫助。

And secondly for Matt, just what kind of acceleration in Ocelot are you assuming in your 2016 guidance?

其次，對於 Matt，您在 2016 年的指導中假設 Ocelot 的加速是怎樣的？

Or is that -- would that largely be [upset]?

或者是——這主要是 [沮喪] 嗎？

We've assumed only modest changes in Ocelot from year-to-year, just given the trend that we've been on over the course of 2015.

考慮到我們在 2015 年的趨勢，我們假設 Ocelot 每年只有適度的變化。

But I do think there is a lot of opportunity.

但我確實認為有很多機會。

That probably does represent some upside potential to the numbers that we gave.

這可能確實代表了我們給出的數字的一些上行潛力。

But I think there's just a lot of focus on Pantheris right now.

但我認為現在很多人都在關注 Pantheris。

There are a lot of good results and potential with Ocelot, as well.

Ocelot 也有很多好的結果和潛力。

And I think we'll just have to see as we have both products in the market and how the mix plays out.

而且我認為我們只需要看看我們在市場上擁有這兩種產品以及組合將如何發揮作用。

Thanks.

謝謝。

(multiple speakers) expect to see some -- a lot of single center presentations.

（多位發言人）希望看到一些——很多單中心演示。

Because everybody wants to talk about their Pantheris experience (technical difficulty) in the early going, and it will be -- I think that's going to be a lot more interesting to the academic and scientific community than the Ocelot.

因為每個人都想在早期談論他們的 Pantheris 經歷（技術難度），而且它會 - 我認為這對學術界和科學界來說比 Ocelot 更有趣。

Understood.

明白了。

Thanks.

謝謝。

Thank you.

謝謝。

That's all the questions that we have in the queue at this time, so I'd like to turn the call back over to management for closing remarks.

這就是我們此時隊列中的所有問題，所以我想將電話轉回給管理層以作結束髮言。

Well, thank you very much for joining our call this afternoon.

非常感謝您今天下午加入我們的電話會議。

It's not only an exciting time; it's an exciting day for Avinger as we commence commercial launch of Pantheris.

這不僅是一個激動人心的時刻；當我們開始 Pantheris 的商業發佈時，這對 Avinger 來說是激動人心的一天。

We appreciate your interest in our Company and your continued interest in our progress.

我們感謝您對我們公司的興趣以及您對我們進步的持續關注。

Thank you very much.

非常感謝。

Thank you.

謝謝。

Ladies and gentlemen, thank you again for your participation in today's conference.

女士們，先生們，再次感謝你們參加今天的會議。

This now concludes the program and you may all disconnect your telephone lines at this time.

程序到此結束，此時你們都可以斷開電話線。

Everyone have a great day.

每個人都有美好的一天。