Avinger Inc (AVGR) 2016 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Q2, 2016 Avinger, Inc. earnings conference call. At this time all participants are in a listen-only mode. (Operator Instructions) As a reminder, this conference is being recorded.

女士們先生們，美好的一天，歡迎來到 Avinger, Inc. 2016 年第二季度收益電話會議。此時所有參與者都處於只聽模式。 （操作員說明）提醒一下，正在錄製此會議。

I would like to introduce your host for today's conference, Ms. Caroline Corner. Ma'am, please begin.

我想介紹一下今天會議的主持人 Caroline Corner 女士。女士，請開始。

Thank you all for participating in today's call. Joining us today are Avinger's CEO, Jeff Soinski; Founder and Executive Chairman, Dr. John Simpson; and Chief Financial Officer, Matt Ferguson.

感謝大家參加今天的電話會議。今天加入我們的是 Avinger 的首席執行官 Jeff Soinski；創始人兼執行主席約翰·辛普森博士；和首席財務官馬特·弗格森 (Matt Ferguson)。

Earlier today, Avinger released financial results for the second quarter ended June 30, 2016. Before we begin, I would 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.

今天早些時候，Avinger 發布了截至 2016 年 6 月 30 日的第二季度財務業績。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，這是根據 1995 年《私人證券訴訟改革法》的安全港條款制定的。

Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements including, without limitation, our future financial expectations are based upon our current estimates and various assumptions. 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. Accordingly, you should not place undue reliance on these 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。所有前瞻性陳述，包括但不限於我們未來的財務預期，均基於我們當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。

For a list and 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.

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。除法律要求外，Avinger 不承擔因新信息、未來事件或其他原因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。

I'd now like to turn the call over to Jeff.

我現在想把電話轉給傑夫。

Thanks, Caroline. Good afternoon and thank you all for joining us. During the second quarter, we delivered the strongest growth of our installed base in a single quarter with 19 new lumivascular accounts added and recorded our highest quarterly revenue in the Company's history with $4.7 million in revenue.

謝謝，卡羅琳。下午好，謝謝大家加入我們。在第二季度，我們實現了單季度安裝量的最強勁增長，增加了 19 個新的 lumivascular 客戶，並創下了公司歷史上最高的季度收入，收入為 470 萬美元。

However, despite this progress, our second quarter revenue fell short of our expectations. As discussed on our conference call a couple of weeks ago when we reported preliminary revenue results, this lower than anticipated revenue was primarily related to lower than expected utilization of Pantheris during the quarter.

然而，儘管取得了這一進展，我們第二季度的收入仍未達到我們的預期。正如我們在幾週前報告初步收入結果時在電話會議上所討論的那樣，低於預期的收入主要與本季度 Pantheris 的利用率低於預期有關。

As those of you who follow us know, the second quarter was our first full quarter of Pantheris revenue, following FDA clearance and product launch on March 1, 2016. Although we came out of the gate stronger than anticipated in the first month of launch and have now shipped Pantheris to over 100 accounts with a majority of those accounts placing reorders in the second quarter, it's taken us longer than expected to consistently build utilization across our ordering accounts.

正如那些關注我們的人所知，第二季度是我們在 2016 年 3 月 1 日獲得 FDA 批准和產品發布後的第一個完整季度 Pantheris 收入。儘管我們在發布的第一個月就比預期更強大並且現在已經將 Pantheris 運送到 100 多個客戶，其中大多數客戶在第二季度重新訂購，我們花了比預期更長的時間來持續提高我們訂購客戶的利用率。

A number of factors influence utilization in a given account; to name a few, previous experience with our Ocelot image-guided catheter for CTO crossing, existing PAD volume in an account, the number of lumivascular physicians within an account, and tenure of sales representatives supporting the account. However, on our last call, we identified three main areas that we believe contributed to our slower than anticipated utilization ramp in the second quarter.

許多因素會影響給定帳戶的利用率；僅舉幾例，我們的 Ocelot 圖像引導導管用於 CTO 交叉的先前經驗、客戶中現有的 PAD 數量、客戶中的 lumivascular 醫生數量以及支持該客戶的銷售代表的任期。然而，在我們上次電話會議中，我們確定了三個主要領域，我們認為這些領域導致我們第二季度的利用率增長速度低於預期。

First, we had some early issues with device robustness, primarily related to the imaging fiber connection. As discussed on our last call, our R&D and operations teams were able to rapidly identify the issue and make a minor yet important improvement to the connection that has effectively addressed this issue.

首先，我們在設備穩健性方面遇到了一些早期問題，主要與成像光纖連接有關。正如我們在上次電話會議上所討論的那樣，我們的研發和運營團隊能夠快速識別問題，並對有效解決該問題的連接進行微小但重要的改進。

I am happy to report that these improved devices have now been used in hundreds of cases and are performing very well. While we will always be looking for opportunities to improve our devices, after seeing the continued positive results on the improved reliability of Pantheris we're confident in the strength of our product offering moving into the second half of the year.

我很高興地報告，這些改進的設備現在已經在數百個案例中使用並且表現非常好。雖然我們一直在尋找機會改進我們的設備，但在看到 Pantheris 可靠性不斷提高的持續積極成果後，我們對進入下半年的產品供應實力充滿信心。

Second, we've refined our selling messaging and training programs to help physicians understand how to best integrate Pantheris into their PAD treatment algorithms. Pantheris is a completely new approach with real-time information and precision of control never before available on an atherectomy device.

其次，我們改進了我們的銷售信息和培訓計劃，以幫助醫生了解如何最好地將 Pantheris 整合到他們的 PAD 治療算法中。 Pantheris 是一種全新的方法，具有實時信息和控制精度，這在以前的粥樣斑塊切除術設備上是前所未有的。

As physicians gain their initial experience with Pantheris, they are still learning how this new device can best fit into their PAD treatment paradigm. Although we initially guided physicians to begin by using Pantheris on relatively straightforward cases, we have now seen excellent clinical results from our more experienced users and especially our vision investigators in a broader variety of lesions and anatomies.

當醫生獲得 Pantheris 的初步經驗時，他們仍在學習這種新設備如何最適合他們的 PAD 治療模式。雖然我們最初指導醫生開始使用 Pantheris 處理相對簡單的病例，但我們現在已經看到我們更有經驗的用戶，尤其是我們的視力研究人員在更廣泛的病變和解剖學方面取得了出色的臨床結果。

We are sharing this positive case experience with our user base and have refined our selling methods to encourage physicians to use Pantheris in a wider variety of lesions and especially anywhere they would consider using a directional atherectomy device.

我們正在與我們的用戶群分享這一積極的案例經驗，並改進了我們的銷售方法，以鼓勵醫生在更廣泛的病變中使用 Pantheris，尤其是在他們考慮使用定向粥樣斑塊切除術設備的任何地方。

We've also enhanced our training programs for physicians and our sales reps to build clinical confidence in a more diverse and complex lesion set with the goal of helping physicians realize the unique benefits of using our lumivascular technology and Pantheris in more challenging lesions.

我們還加強了對醫生和銷售代表的培訓計劃，以建立對更多樣化和更複雜的病變集的臨床信心，目的是幫助醫生認識到在更具挑戰性的病變中使用我們的 lumivascular 技術和 Pantheris 的獨特優勢。

Third, we experienced a slower than anticipated ramp in sales force productivity, which is due in part to the relatively short tenure of many of our sales reps. We hired the majority of our catheter sales people in the last nine months, as we expanded our commercial organization in preparation for the launch of Pantheris. We are now focused on expanding not just the breadth but the depth of our commercial organization and have slowed the pace of new hiring to prioritize building the capability and productivity of our team on the field.

第三，我們的銷售人員生產力增長速度低於預期，部分原因是我們許多銷售代表的任期相對較短。我們在過去九個月聘請了大部分導管銷售人員，因為我們擴大了我們的商業組織，為 Pantheris 的推出做準備。我們現在的重點不僅是擴大我們商業組織的廣度，還包括擴大我們商業組織的深度，並且放慢了新招聘的步伐，以優先培養我們團隊在該領域的能力和生產力。

On this front, we have intensified the training regimen of our new people and are also providing our seasoned reps with additional education. Just last week, we had the entire sales force together for training focused on expanded clinical messaging and selling skills.

在這方面，我們加強了新員工的培訓方案，並為經驗豐富的銷售代表提供額外的教育。就在上週，我們讓整個銷售團隊一起接受了專注於擴展臨床信息傳遞和銷售技巧的培訓。

We've also seen a new level of energy and enthusiasm in the organization in response to the leadership of JD Simpson in his new role as Senior VP of Sales and Marketing. With his extensive background with our lumivascular platform and the PAD space more generally, JD has hit the ground running and we're confident he and his team will drive improved results in the second half of the year.

在 JD Simpson 擔任銷售和營銷高級副總裁的新職位的領導下，我們還看到了組織中新的活力和熱情。憑藉他在我們的 lumivascular 平台和更廣泛的 PAD 空間方面的廣泛背景，JD 已經開始運行，我們相信他和他的團隊將在今年下半年取得更好的成績。

We are still early in the launch of this revolutionary and highly differentiated technology. Our early clinical success with Pantheris on an expanding variety of lesion types and anatomies has confirmed our belief that our lumivascular platform and Pantheris image-guided atherectomy catheter will change the way physicians treat PAD.

我們仍處於推出這項革命性和高度差異化技術的早期階段。我們在 Pantheris 的早期臨床成功中獲得了越來越多的病變類型和解剖結構，這證實了我們的信念，即我們的 lumivascular 平台和 Pantheris 圖像引導的粥樣斑塊切除術導管將改變醫生治療 PAD 的方式。

We ended the second quarter with a total of 126 lumivascular accounts and remain confident that we'll meet or exceed our goal of approximately 150 lumivascular accounts by the end of the year. This is a solid foundation to build on. Going forward, we will be working to maintain this positive momentum in new account acquisitions while increasing our emphasis on penetrating deeper and driving utilization in each account.

我們在第二季度結束時共有 126 個 lumivascular 賬戶，並且仍然相信我們將在今年年底達到或超過大約 150 個 lumivascular 賬戶的目標。這是一個堅實的基礎。展望未來，我們將努力在新客戶收購方面保持這種積極勢頭，同時更加重視更深入地滲透和提高每個客戶的利用率。

We are also working to expand our lumivascular platform with Pantheris product line extensions that will make even more of the approximately $500 million US atherectomy market available to us. These programs remain on track.

我們還致力於通過 Pantheris 產品線擴展來擴展我們的 lumivascular 平台，這將使我們能夠在約 5 億美元的美國粥樣斑塊切除術市場中佔有更多份額。這些計劃仍在進行中。

By the end of the year we expect to launch a version of Pantheris with an enhanced cutting capability and we expect to file for FDA clearance in the first half of 2017 on a lower profile device for expanded treatment of below-the-knee lesions.

到今年年底，我們預計將推出具有增強切割能力的 Pantheris 版本，並且我們預計將在 2017 年上半年申請 FDA 批准，用於擴大治療膝下病變的低剖面設備。

We have a lot of work to do and got off to a slower start than anticipated but we've already made important corrections and improvements. And I believe we have the right team in place to realize the potential of this disruptive technology.

我們有很多工作要做，起步比預期慢，但我們已經做出了重要的修正和改進。我相信我們擁有合適的團隊來實現這種顛覆性技術的潛力。

I'd now like to ask Dr. Simpson to share some of his recent case experiences and feedback from physicians who have used Pantheris, as well as outline our clinical programs. Following Dr. Simpson's remarks, Matt will review our Q2 financial results and review guidance for 2016. I will offer some closing remarks and then we'll 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，並概述我們的臨床計劃。在辛普森博士發表講話後，馬特將回顧我們第二季度的財務業績並回顧 2016 年的指導意見。我將發表一些結束語，然後我們將開始提問。約翰？

Thank you, Jeff. While we are reminded on a daily basis of the need to execute on all the near-term priorities, those that you have just discussed, I'd like to step back and say a word or two about the broader opportunities at Avinger.

謝謝你，傑夫。雖然我們每天都被提醒需要執行所有近期優先事項，但我想退後一步，談談 Avinger 更廣泛的機會。

I've spent a lot of time observing lumivascular procedures in cath labs all around the country. [It just seems] that so many of these cases are for patients coming back for a re-intervention after previous treatments with other technologies.

我花了很多時間在全國各地的導管室觀察 lumivascular 程序。 [看起來] 這些案例中有很多是針對在先前使用其他技術進行治療後返回進行重新干預的患者。

In the last few weeks I have seen patients with failed stents, balloons, directional atherectomy, rotational atherectomy and drug-coated balloon angioplasty. None of these treatments work as well as our competitors frequently allege. And in each case using Pantheris and frequently Ocelot as well -- many of these patients have been successfully treated with our technology. The key results have been excellent and I have more confidence than ever in the durability of these outcomes.

在過去的幾周里，我見過支架、球囊、定向斑塊切除術、旋轉斑塊切除術和藥物塗層球囊血管成形術失敗的患者。這些治療方法都沒有我們的競爭對手經常聲稱的那樣有效。在每種情況下，都使用 Pantheris 並經常使用 Ocelot——其中許多患者已通過我們的技術成功治療。關鍵結果非常好，我對這些結果的持久性比以往任何時候都更有信心。

A lot of physicians are taking notice of these results and the versatility of the Pantheris. For many seeing the devices work in actual procedures is all that's needed to turn them into lumivascular believers. But I'm also really looking forward to proving these results in a series of rigorous clinical trials and eventually making lumivascular the standard of care for the treatment of PAD.

許多醫生都注意到這些結果和 Pantheris 的多功能性。對於許多人來說，只要看到這些設備在實際手術中起作用，就足以讓他們成為光血管的信徒。但我也非常期待在一系列嚴格的臨床試驗中證明這些結果，並最終使 lumivascular 成為治療 PAD 的護理標準。

We recently announced a study in collaboration with Highmark Health and Allegheny Health Networks under the VITAL program that will examine the use of lumivascular in all varieties of PAD lesions.

我們最近宣布了一項與 Highmark Health 和 Allegheny Health Networks 在 VITAL 計劃下合作的研究，該研究將檢查 lumivascular 在各種 PAD 病變中的使用。

We believe this study will provide important clinical outcome and health economic information supporting the use of our lumivascular products for a first-line treatment for PAD and expect to begin enrollment in this study during the third quarter of 2016.

我們相信這項研究將提供重要的臨床結果和健康經濟信息，支持使用我們的 lumivascular 產品作為 PAD 的一線治療，並預計在 2016 年第三季度開始參加這項研究。

Another more targeted area we plan to go after is in-stent restenosis or ISR. This remains an especially challenging lesion subset to treat effectively, and we believe Pantheris will be particularly well suited to this task.

我們計劃追求的另一個更有針對性的領域是支架內再狹窄或 ISR。這仍然是一個特別具有挑戰性的有效治療的病變子集，我們相信 Pantheris 將特別適合這項任務。

Pantheris is the only directional atherectomy device that is not contra-indicated for ISRs. And we have seen the results when physicians have chosen to use Pantheris in this setting. Based on these strong results, and the clear visualization of stent struts under OCT, we'd very much like to be able to actively promote Pantheris for its use.

Pantheris 是唯一一種不禁忌 ISR 的定向粥樣斑塊切除術設備。當醫生選擇在這種情況下使用 Pantheris 時，我們已經看到了結果。基於這些強有力的結果，以及 OCT 下支架支柱的清晰可視化，我們非常希望能夠積極推廣 Pantheris 的使用。

We believe we could have the clinical data to file for the FDA clearance for an expanded Pantheris label to include in-stent restenosis by doing a relatively small trial of about 60 patients. We are currently working to design the details of this study but expect we will be able to begin enrolling and treating patients the first quarter of 2017.

我們相信，通過對大約 60 名患者進行相對較小的試驗，我們可以獲得臨床數據，以申請 FDA 批准擴大 Pantheris 標籤以包括支架內再狹窄。我們目前正在努力設計這項研究的細節，但預計我們將能夠在 2017 年第一季度開始招募和治療患者。

We're also working with our Scientific Advisory Board to design other studies to address the use of Pantheris in other types of lesions and in head to head studies comparing Pantheris against other products. We're focusing our efforts and resources in the areas that we expect to generate the highest clinical and commercial impact, and we look forward to sharing more details of these programs as the protocols are finalized and the studies are initiated.

我們還與我們的科學顧問委員會合作設計其他研究，以解決 Pantheris 在其他類型病變中的使用問題，以及將 Pantheris 與其他產品進行比較的頭對頭研究。我們正在將我們的努力和資源集中在我們期望產生最高臨床和商業影響的領域，我們期待在協議最終確定和研究啟動時分享這些項目的更多細節。

Before I turn the call over to Matt, I just want to add how gratifying it has been over the past several weeks to see physicians using Pantheris, to get great clinical outcomes in a wide variety of more challenging lesions, including the tibial vessels. As they come up the learning curve on Pantheris and gain more experience with the device, these early users are helping us understand the true potential of Pantheris.

在我把電話轉給馬特之前，我只想補充一下，在過去的幾周里，看到醫生使用 Pantheris，在包括脛骨血管在內的各種更具挑戰性的病變中取得了很好的臨床結果，這是多麼令人欣慰。隨著他們逐步了解 Pantheris 並獲得更多使用該設備的經驗，這些早期用戶正在幫助我們了解 Pantheris 的真正潛力。

These physicians are our most important partners in developing this technology and improving the standard of care for the millions of people suffering from PAD. And I'm proud to be associated with them.

這些醫生是我們在開發這項技術和提高數百萬 PAD 患者的護理標準方面最重要的合作夥伴。我很自豪能與他們聯繫在一起。

Based on the results they are achieving in the clinic, I'm more confident than ever in the future prospects of Pantheris and the ability of the lumivascular platform to radically change the way vascular disease is treated.

基於他們在臨床上取得的成果，我比以往任何時候都對 Pantheris 的未來前景以及 lumivascular 平台從根本上改變血管疾病治療方式的能力充滿信心。

With that I will now turn the call over to Matt.

有了這個，我現在將把電話轉給馬特。

Thank you, John. Total revenue was in-line with our previously reported preliminary results of $4.7 million for the second quarter ended June 30, 2016. That was a 54% increase from the second quarter of 2015 and a 3% increase from the first quarter of 2016.

謝謝你，約翰。總收入與我們之前報告的截至 2016 年 6 月 30 日的第二季度 470 萬美元的初步結果一致。這比 2015 年第二季度增長了 54%，比 2016 年第一季度增長了 3%。

Revenues related to our Lightbox imaging consoles were $1.0 million, a 26% decrease compared to the second quarter of 2015, and a 16% decrease versus the first quarter of 2016. We believe the decline in Lightbox revenue in the second quarter relates to the increased flexibility in the Lightbox acquisition programs we are offering which resulted in our largest quarterly increase in the installed base of lumivascular accounts, but with a somewhat lower proportion of accounts acquiring Lightboxes through upfront purchases. We added 19 lumivascular accounts during the quarter, with four accounts purchasing Lightboxes.

與我們的 Lightbox 影像控制台相關的收入為 100 萬美元，與 2015 年第二季度相比下降 26%，與 2016 年第一季度相比下降 16%。我們認為第二季度 Lightbox 收入的下降與增加的我們提供的 Lightbox 收購計劃具有靈活性，這導致我們 lumivascular 客戶的安裝基數季度增幅最大，但通過前期購買獲得 Lightbox 的客戶比例略低。我們在本季度增加了 19 個 lumivascular 客戶，其中四個客戶購買了燈箱。

Revenues from disposable devices were $3.7 million, a 119% increase compared to the second quarter of 2015 and a 10% increase from the first quarter of 2016.

一次性設備的收入為 370 萬美元，與 2015 年第二季度相比增長 119%，與 2016 年第一季度相比增長 10%。

Gross margin for the second quarter of 2016 was 22%, down from 46% in the comparable quarter of 2015 and down from 26% in Q1, 2016. This decrease was primarily attributable to the cost associated with expanded manufacturing infrastructure related to the introduction of Pantheris against lower than anticipated volumes and lower manufacturing yields as we implemented our improvement in the imaging fiber connections.

2016 年第二季度的毛利率為 22%，低於 2015 年同期的 46% 和 2016 年第一季度的 26%。這一下降主要歸因於與引入Pantheris 反對低於預期的產量和較低的製造產量，因為我們在成像光纖連接方面實施了改進。

Operating expenses for the second quarter of 2016 were $13.3 million compared to $10.5 million in the second 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 年第二季度的運營費用為 1330 萬美元，而去年第二季度為 1050 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。

Loss from operations for the second quarter of 2016 was $12.3 million compared to $9.1 million for the second quarter of 2015. Net loss for the second quarter of 2016 was $13.5 million compared to $10.2 million in the second quarter of 2015. Adjusted EBITDA, which is a non-GAAP measure, was a loss of $10.3 million for the second quarter of 2016 compared to a $7.5 million loss for the second quarter of the previous year.

2016 年第二季度的運營虧損為 1230 萬美元，而 2015 年第二季度為 910 萬美元。2016 年第二季度的淨虧損為 1350 萬美元，而 2015 年第二季度為 1020 萬美元。調整後的 EBITDA，即根據非美國通用會計準則衡量，2016 年第二季度虧損 1030 萬美元，而去年第二季度虧損 750 萬美元。

Turning to our balance sheet, cash and cash equivalents totaled $22.4 million as of June 30, 2016, compared to $43.1 million as of December 31, 2015. Total debt at quarter end was $40.1 million. We expect that our available cash is sufficient to fund operations at least through the end of this year. Nevertheless, we recognize the importance of adding to our cash reserves and we are focused on raising additional capital in the near future.

轉向我們的資產負債表，截至 2016 年 6 月 30 日，現金和現金等價物總計 2240 萬美元，而截至 2015 年 12 月 31 日為 4310 萬美元。季度末總債務為 4010 萬美元。我們預計我們的可用現金足以為至少到今年年底的運營提供資金。儘管如此，我們認識到增加現金儲備的重要性，並且我們專注於在不久的將來籌集更多資金。

Turning now to our financial guidance for 2016, as we communicated on June 12, we expect 2016 revenue to be in the range of $19 million to $23 million representing year over year growth ranging from 78% to 115%.

現在轉向我們 2016 年的財務指導，正如我們在 6 月 12 日所傳達的那樣，我們預計 2016 年的收入將在 1900 萬美元至 2300 萬美元之間，同比增長 78% 至 115%。

We expect gross margin to increase steadily through the second half of the year and exit the year in the 40% to 45% range. This will translate to a gross margin for the full year in the range of 30% to 35%. We continue to expect adjusted EBITDA for 2016 to be a loss of $40 million to $43 million.

我們預計下半年毛利率將穩步增長，並在 40% 至 45% 的範圍內結束。這將轉化為全年 30% 至 35% 的毛利率。我們繼續預計 2016 年調整後的 EBITDA 將虧損 4000 萬至 4300 萬美元。

Assuming a share count for the year of 12.8 million shares, we continue to expect net loss per share for 2016 to be in the range of a loss of $4.35 to a loss of $4.55.

假設當年的股票數量為 1280 萬股，我們繼續預計 2016 年每股淨虧損將在 4.35 美元至 4.55 美元之間。

At this point I'd like to turn the call back to Jeff.

在這一點上，我想把電話轉回給傑夫。

Thanks, Matt. For the balance of the year, Avinger will be focused on increasing the utilization of Pantheris, making additional product improvements to Pantheris, training physicians in the benefits of our lumivascular technology, and improving the productivity of our sales force.

謝謝，馬特。在今年餘下的時間裡，Avinger 將專注於提高 Pantheris 的利用率，對 Pantheris 進行額外的產品改進，培訓醫生了解我們的 lumivascular 技術的好處，並提高我們銷售人員的生產力。

We are encouraged by the strong growth in new accounts, which speaks to the appeal of our lumivascular approach to the treatment of PAD. We are implementing a plan to further penetrate and increase utilization in each account. And while we continue to execute on our commercial and product development initiatives, we also remain committed to obtaining additional data proving out the clinical efficacy and outstanding safety profile of our lumivascular platform. And we look forward to updating you on our progress in all these areas.

我們對新客戶的強勁增長感到鼓舞，這說明了我們的 lumivascular 方法對 PAD 治療的吸引力。我們正在實施一項計劃，以進一步滲透並提高每個賬戶的利用率。在我們繼續執行我們的商業和產品開發計劃的同時，我們也將繼續致力於獲取更多數據，以證明我們的 lumivascular 平台的臨床療效和出色的安全性。我們期待著向您通報我們在所有這些領域取得的進展。

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) Josh Jennings of Cowen and Company.

（操作員說明）Cowen and Company 的 Josh Jennings。

I was hoping to just start -- I mean, you guys listed three causal factors for the initial ramp in this first full quarter of Pantheris launch. I just wanted to make sure we were clear on those three issues.

我希望剛剛開始——我的意思是，你們列出了 Pantheris 發布的第一個完整季度的初始斜坡的三個因果因素。我只是想確保我們清楚這三個問題。

So, the quality issue with Pantheris, we should consider them fully resolved. And then two, just in terms of integrating Pantheris into physician practices and pursuing more complex lesions, the sales force is fully marketing that pursuit. And then lastly just on sales force productivity improvements, I just wanted to make sure that we weren't seeing any significant attrition over the last couple of months or anything out of the -- normal in terms of what you've been seeing historically.

所以，Pantheris的質量問題，我們應該算是徹底解決了。其次，就將 Pantheris 整合到醫生實踐和追求更複雜的病變方面而言，銷售人員正在充分營銷這種追求。最後，關於銷售人員生產力的提高，我只是想確保在過去幾個月裡我們沒有看到任何重大的人員流失，或者任何與歷史上看到的不正常的情況。

So why don't I go ahead and address those, Josh, and ask Dr. Simpson and Matt to chime in if they have additional thoughts. But yes; as we said on the call, we were able to quickly identify the source of the imaging fiber weakness and have significantly strengthened that connection.

那麼，為什麼我不繼續解決這些問題，Josh，如果 Simpson 博士和 Matt 有其他想法，請他們插話。但是，是的;正如我們在電話中所說，我們能夠快速確定成像光纖弱點的來源，並顯著加強了這種聯繫。

We've been -- started shipping that product very early in the quarter and now have seen literally hundreds of cases with very, very positive results and increased device robustness even in more challenging anatomies and lesions, and a significant reduction in any complaint rates related to imaging fiber connections.

我們已經 - 在本季度很早就開始運送該產品，現在已經看到數百個案例，即使在更具挑戰性的解剖結構和病變中，也有非常非常積極的結果和更高的設備穩健性，並且任何相關的投訴率都顯著降低成像光纖連接。

We do consider that issue effectively addressed. We'll, of course, always continue to look for areas to improve the device. We are very focused on expanding our platform with our line extensions for more enhanced cutting and the lower profile device for expanded below-the-knee usage. But all of that is tracking very well.

我們確實認為該問題已得到有效解決。當然，我們將始終繼續尋找改進設備的地方。我們非常專注於通過我們的產品線擴展來擴展我們的平台，以實現更強大的切割效果和更薄的設備，以擴大膝蓋以下的使用範圍。但所有這些都跟踪得很好。

As it relates to the sales force, one of the reasons that we brought everyone together last week was to enhance and fully communicate our training related to supporting physicians in a wider variety of lesions.

關於銷售人員，上週我們將所有人聚集在一起的原因之一是加強和充分交流我們與支持醫生處理更廣泛病變相關的培訓。

Now that we've been out there, especially with our more experienced users, getting a lot of very positive case experience down in the tibial vessels in more challenging lesions, and Dr. Simpson can add to that. We've been developing case studies and teaching tools that we can use to train the sales force. And by extension, physicians are utilizing the devices. Also as they get more experienced with the device they naturally build more confidence and are willing and able to take the device into a broader lesion set.

現在我們已經在那裡，特別是我們更有經驗的用戶，在脛骨血管中獲得了很多非常積極的病例經驗，在更具挑戰性的病變中，Simpson 博士可以補充這一點。我們一直在開發可用於培訓銷售人員的案例研究和教學工具。並且通過擴展，醫生正在使用這些設備。此外，隨著他們對設備的體驗越來越豐富，他們自然會建立更多的信心，並且願意並且能夠將該設備用於更廣泛的病變組。

And then finally as it relates to attrition, we really haven't seen any kind of meaningful attrition in the sales force. We've made a couple of corrections. We continue to look to strengthen that group. But we have, and I will tell you, I can speak with a lot of confidence around this just coming off of a couple of days in Chicago with the Group.

最後，由於它與人員流失有關，我們確實沒有在銷售人員中看到任何有意義的人員流失。我們做了一些更正。我們繼續尋求加強該小組。但是我們有，而且我會告訴你，我可以非常自信地談論這個剛剛在芝加哥與小組一起結束的幾天。

We have a very strong group of sales professionals. They're committed, they are enthusiastic. JD has, I think, made a big impact in terms of increasing the enthusiasm and pulling everyone together and driving a spirit of accountability, especially towards utilization. And so, I'm really very much looking forward to what they can do and what we can help them do in the second half of the year.

我們擁有一支非常強大的銷售專業團隊。他們投入，他們熱情。我認為，京東在提高熱情、將所有人團結在一起以及推動問責精神方面產生了重大影響，尤其是在利用率方面。因此，我真的非常期待下半年他們能做什麼以及我們能幫助他們做什麼。

John, do you have anything you want to add around the cases?

約翰，關於案件，你有什麼要補充的嗎？

Yes. I would say, Josh, that some of the cases -- well, almost all the cases have been really, really exciting. We had treated these below-the-knee lesions that perhaps I thought we might not be treating yet, and the results have been really outstanding. We've also had, as it relates to driving physician adoption, I think the better we understand treatment the more likely physicians are to adopt this technology.

是的。喬希，我會說，有些案例——好吧，幾乎所有案例都非常非常令人興奮。我們已經治療了這些膝蓋以下的病變，也許我認為我們可能還沒有治療，結果非常出色。我們也有，因為它與推動醫生採用有關，我認為我們對治療的了解越多，醫生就越有可能採用這項技術。

We had a procedure last week where the physician treated a directional atherectomy restenosis lesion with the Pantheris and saw during that treatment phase that all the media was missing secondary to the previous treatment. So there is no doubt this sort of confirms Prakash Krishnan's theory that in humans if you take the media out of an artery it's likely to create a very large scar. This would be (inaudible) external elastic lamina removed; although the atrium looks really good, the OCT image that we derived the other day showed that this vessel had been too aggressively treated.

我們上週進行了一次手術，醫生用 Pantheris 治療了一個定向粥樣斑塊切除術再狹窄病變，並在治療階段看到所有媒體都在先前的治療中繼發性缺失。所以毫無疑問，這證實了 Prakash Krishnan 的理論，即在人類中，如果你從動脈中取出介質，它很可能會產生一個非常大的疤痕。這將是（聽不清）外部彈性層被移除；雖然心房看起來確實不錯，但是我們前幾天導出的OCT圖像顯示，這根血管被過度處理了。

You could argue, well, had you put a drug on that, that might have suppressed all of that. I think that was really, really unrealistic to believe that kind of suppression can come from a drug. But the point really being is that physicians will adopt the technology that gives the best possible safety and efficacy profile eventually. Right now we still see physicians sometimes pressed to hurry to do cases with technologies that are probably not the safest and/or the most efficacious, but maybe they are the fastest. So we have to work our way through that, we have to educate the physicians.

你可能會爭辯說，好吧，如果你在上面放了一種藥物，那可能會抑制所有這些。我認為相信這種抑制可以來自藥物是真的，真的是不現實的。但真正重要的是，醫生最終將採用能夠提供最佳安全性和有效性的技術。現在，我們仍然看到醫生有時被迫急於使用可能不是最安全和/或最有效但可能是最快的技術來處理病例。所以我們必須努力解決這個問題，我們必須教育醫生。

Our sales force is really doing, I think, a much reinvigorated job just based on the experience that we had in Chicago. So I feel really good about that. I feel really good about market adoption with the physician base. And we do -- we just expand that base, right. So that's where we are targeting now.

我認為，根據我們在芝加哥的經驗，我們的銷售團隊確實在做一項煥然一新的工作。所以我對此感覺很好。我對醫生群體的市場採用感到非常滿意。我們這樣做 - 我們只是擴大了這個基礎，對吧。這就是我們現在的目標。

And I just wanted -- one of the ways to expand, I guess, or penetrate the market is to through the next iteration of Pantheris devices, enhanced cutting capability device, as well below-the-knee device. Can you help us just think about what's required? I know you're planning on filing 510ks for both of those, but is there any certain number of patients or is it just all primarily just a safety study or do you just have -- already have your predicate in the Pantheris that this path can be streamlined?

我只是想——我想，擴展或滲透市場的一種方法是通過下一代 Pantheris 設備、增強的切割能力設備以及膝蓋以下設備。你能幫我們想想需要什麼嗎？我知道你計劃為這兩個項目申請 510ks，但是是否有一定數量的患者，或者它主要只是一項安全研究，或者你是否已經 - 已經在 Pantheris 中有了你的斷言，這條道路可以精簡？

Yes. So, we did believe that path can be steamlined. We do not yet have a commitment from the FDA that that is actually factual. But for the enhanced cutting device it's a pretty subtle change to the cutter edge, but it's very, very effective. And we believe and we'll try to, we hope for that being a letter to file, because it doesn't really change significantly the former function of the device, and therefore, we don't believe that it would require even a special 510k.

是的。所以，我們確實相信路徑可以簡化。我們還沒有得到 FDA 的承諾，這實際上是事實。但是對於增強型切割裝置來說，它是對刀刃的一個非常微妙的變化，但它非常非常有效。我們相信並且我們會努力，我們希望這是一封提交的信，因為它並沒有真正顯著改變設備以前的功能，因此，我們認為它甚至不需要特殊的510k。

That is to be determined, but we actually are pretty optimistic about that. And then the below the knee device is fascinating in that the 7 French device that we're using above-the-knee has now proved to be profoundly reliable and effective below the knee, even without the apposition balloon being inflated because it's so large that it takes up a lot of the space in the artery.

這是有待確定的，但我們實際上對此非常樂觀。然後膝蓋以下的設備很吸引人，因為我們在膝蓋以上使用的 7 French 設備現在已被證明在膝蓋以下非常可靠和有效，即使沒有對位氣球充氣，因為它太大了它佔據了動脈中的很多空間。

We have actually an effective below-the-knee device currently, but for it to be more effective we'd like to reduce it one French size, so take it down to 6 French. And we've been seeing those devices coming out of the R&D group recently; they do look very favorable. And one of interesting things is that -- and it confirms our overall thinking, and that is because we are just reducing the size of the device over the optical imaging fiber, it takes up very little space. Then we have the chance to make these devices smaller than most people might have appreciated.

我們目前實際上有一個有效的膝蓋以下設備，但為了更有效，我們想將它縮小一個法國尺碼，所以將它縮小到 6 個法國尺碼。我們最近看到這些設備從研發小組出來；他們看起來確實很受歡迎。一件有趣的事情是——它證實了我們的整體想法，那是因為我們只是在光學成像光纖上減小了設備的尺寸，它佔用的空間非常小。然後我們就有機會把這些設備做得比大多數人想像的要小。

So ultimately, we've been able to go to very, very small vessels, but all the below-the-knee vessels, particularly the tibials, anterior tibial, posterior tibial, perennial; all of those vessels are going to be effectively treated. And the enhanced cutting version of the device will cut dense fibrous plaque. We think it will cut calcium; we're not really seeking a calcification indication with the current technology. But it's very, very effective and we've seen that in all our experimental models. So I feel very confident that that's the case.

所以最終，我們已經能夠到達非常非常小的血管，但所有膝蓋以下的血管，特別是脛骨、前脛骨、後脛骨、常年性血管；所有這些船隻都將得到有效處理。並且該設備的增強切割版本將切割緻密的纖維斑塊。我們認為它會減少鈣；我們並不是真的在用目前的技術尋找鈣化跡象。但它非常非常有效，我們已經在所有實驗模型中看到了這一點。所以我非常有信心是這樣的。

I think all of these different -- the improvements, the strengthening of the optical fiber, the enhanced cutting efficiency and smaller size, all of this plays into an expanded role for Pantheris and associated devices in the treatment of PAD, particularly below-the-knee and that's why the safety profile is so important. So, I think that to me even increases my confidence even more about the opportunity for us going forward.

我認為所有這些不同——光纖的改進、加強、切割效率的提高和尺寸的縮小，所有這些都為 Pantheris 和相關設備在 PAD 治療中發揮了更大的作用，尤其是在-膝蓋，這就是安全性如此重要的原因。所以，我認為這對我來說甚至增加了我對我們前進的機會的信心。

One last question, Jeff or Matt. I know it's been a short time since the preliminary announcement, but you've had some positive things happen over the past couple of weeks. And just wanted to get an update in terms of your confidence in terms of the new guidance range that you reiterated today.

最後一個問題，傑夫或馬特。我知道距離初步公告發布已經很短的時間，但在過去的幾周里你已經發生了一些積極的事情。只是想了解您對今天重申的新指導範圍的信心。

You know, Josh, it has been only a couple of weeks, but I'll tell you, we are really pleased with the amount of progress that we've made, not only in terms of kind of packaging and delivering these case studies, we continue to see more and more positive cases in a wider variety of lesions.

你知道，Josh，才過去幾週，但我會告訴你，我們對我們所取得的進展感到非常滿意，不僅是在包裝類型和交付這些案例研究方面，我們繼續在更廣泛的病變中看到越來越多的陽性病例。

We are -- and again, as I said, the performance of this improved device has just been excellent. So as we continue to go out we've also enhanced our training programs. We're putting our training in great proximity to cases with new physicians and providing additional training for our existing physicians. So we're moving on this in real time; we're really pleased with the results, and frankly, we just have more visibility five months into launch now.

我們 - 正如我所說的那樣，這款改進設備的性能非常出色。因此，隨著我們繼續走出去，我們也加強了我們的培訓計劃。我們的培訓非常接近新醫生的病例，並為我們現有的醫生提供額外的培訓。因此，我們正在實時推進這項工作；我們對結果非常滿意，坦率地說，我們在推出五個月後才獲得了更多的知名度。

So we have a lot of confidence in the second half of the year. But as an organization, we are focused on execution. And we know we have to execute and build not only the confidence of our organization internally, which I would say is on a very, very positive and solid trajectory, but also of our investor base, but a lot of confidence here in Avinger.

所以我們對下半年很有信心。但作為一個組織，我們專注於執行。我們知道我們不僅要在內部執行和建立我們組織的信心，我想說這是在非常、非常積極和穩固的軌道上，而且我們的投資者基礎，還有對 Avinger 的很多信心。

Jason Mills of Canaccord Genuity.

Canaccord Genuity 的傑森·米爾斯 (Jason Mills)。

So let's start with, I guess, somewhat of a multi-part question. With the exception of the Allegheny study, which fortunately isn't costing you guys that much, the studies that JD has talked about are the ones that I think a lot of physicians would like to see; obviously you're hearing that as well.

因此，我想，讓我們從一個多部分問題開始吧。除了 Allegheny 研究，幸運的是，它並沒有讓你們花費太多，JD 談到的研究是我認為很多醫生都希望看到的；顯然你也聽到了。

But they do cost a fair bit of money in a time where you're trying to be very prudent with cash that you have on hand, unless they're going to tell you can raise sufficient funds to just go full-bore ahead. So, could you give us a sense for how you're balancing the current capital position and your desire to raise the clinical evidence to the point for the lumivascular technology? I think that will be very helpful commercially.

但在你試圖非常謹慎地使用手頭現金的時候，他們確實花費了相當多的錢，除非他們會告訴你可以籌集到足夠的資金來全力以赴。那麼，您能否告訴我們您如何平衡當前的資本狀況和將臨床證據提高到 lumivascular 技術的願望？我認為這在商業上會很有幫助。

Yes. So as you said, the study under the VITAL program is being funded by Highmark. And so, that doesn't provide a cash drain. In fact, the utilization of catheters under that study adds to our revenue stream.

是的。正如您所說，VITAL 計劃下的研究由 Highmark 資助。因此，這不會造成現金流失。事實上，根據該研究使用導管增加了我們的收入來源。

Dr. Simpson talked about the interest in an ISR indication, and that came directly from -- we pulled our Scientific Advisory Board together in the second quarter; we call them our science lab, which is made up of thought leaders and treating physicians in the endovascular space and PAD. And there was a lot of excitement and enthusiasm about their own personal experience and other cases that they had seen where physicians had used Pantheris in in-stent restenosis. And based on that excitement, we really do believe that that has real commercial and clinical bang for the buck.

Simpson 博士談到了對 ISR 適應症的興趣，這直接來自——我們在第二季度召集了我們的科學顧問委員會；我們稱他們為我們的科學實驗室，該實驗室由血管內空間和 PAD 方面的思想領袖和治療醫師組成。他們對自己的個人經歷和他們看到的醫生使用 Pantheris 治療支架內再狹窄的其他病例感到非常興奮和熱情。基於這種興奮，我們確實相信這具有真正的商業和臨床效果。

The way -- where we are and kind of a timing standpoint on that process is we're in our study design and protocol development. We will be filing for IDE approval, our plan is in the fourth quarter, but we won't actually start enrolling patients in that study until the beginning of 2017.

方式——我們在這個過程中的位置和時間點是我們在我們的研究設計和協議開發中。我們將申請 IDE 批准，我們的計劃是在第四季度，但我們要到 2017 年初才能真正開始招募患者參與該研究。

So the real expense behind that will be in early 2017, we'll begin -- I guess we'll begin feeling that expense. We don't think, and I don't want to specific numbers out right now, but according to our internal plans and input from our advisors that that will require a large number of patients. And we don't think that will be a large cash drain relative to the value of the study.

所以這背後的真正費用將在 2017 年初出現，我們將開始——我想我們將開始感受到這筆費用。我們不認為，我現在也不想透露具體數字，但根據我們的內部計劃和顧問的意見，這將需要大量患者。而且我們認為，相對於研究的價值而言，這不會造成大量現金流失。

That's helpful. I was wondering if you could maybe elaborate on sort of the larger and more head to head studies that you guys have talked about in the past. I know Dr. Simpson's talked about the desire to finally show maybe a head to head with other atherectomy devices or even with drug-eluting balloons whether it be Pantheris plus DEB versus DEB alone to see if the latter -- the former actually does just as well.

這很有幫助。我想知道你們是否可以詳細說明你們過去討論過的規模更大、更深入的研究。我知道 Simpson 博士談到了希望最終展示與其他粥樣斑塊切除術設備或什至與藥物洗脫球囊的正面交鋒，無論是 Pantheris 加 DEB 還是單獨使用 DEB，看看後者是否——前者實際上與藥物洗脫球囊是否一樣出色地。

Could you talk about those kinds of studies? It sounds like perhaps those are a little further out, once you're in more solid footing from a capital perspective. Is that right? And maybe talk about your ?- the sort of timeline for those over the next couple of years, maybe.

你能談談這些研究嗎？從資本的角度來看，一旦你站穩腳跟，聽起來這些可能會更遠一些。是對的嗎？也許談談你的？ - 未來幾年的時間表，也許吧。

So, we're definitely convinced that this is an important study. You reflected the way you worded your question with a little bit of bias, because you said what about Pantheris versus DEB versus DEB alone, implying that you believe that DEB alone could be an effective form of therapy. I am just jerking your chain a little bit.

所以，我們絕對相信這是一項重要的研究。你反映了你用一點偏見措辭你的問題的方式，因為你說了 Pantheris 與 DEB 與單獨的 DEB 的區別，這意味著你相信單獨的 DEB 可能是一種有效的治療形式。我只是稍微拉動你的鏈條。

So DEB by itself has not proven to be an effective form of therapy in Europe or even in any of the early studies here in the US. So, it's going to be DEB following something to prep the artery. Do you see the humor in my answer, or you don't see it?

所以 DEB 本身在歐洲甚至在美國的任何早期研究中都沒有被證明是一種有效的治療形式。所以，這將是 DEB 跟隨一些東西來準備動脈。您是看到我的回答中的幽默，還是沒有看到？

Yes, I do, I do. I actually think the study you would prefer is DEB plus Pantheris versus Pantheris alone, I misspoke -- my fault.

是的，我願意，我願意。實際上，我認為您更喜歡的研究是 DEB 加 Pantheris 與單獨的 Pantheris，我說錯了——我的錯。

Yes, that's correct. I just wanted to make sure that you knew what correct study was. So, yes, I think that is the study that I would like to do early on. And what I would like to do is have a study -- and this is still to be determined, this is what we are discussing. But, I would like to use Pantheris in a series of patients and treat their arteries so the stenosis gets down to maybe 30%. And then randomize the patients at that point to drug-eluting balloon or to more Pantheris to take it down to zero, and to see which -- I think that will be the fascinating group. Because I think everybody tends to accept now that DEB needs something done before.

對，那是正確的。我只是想確保你知道什麼是正確的學習。所以，是的，我認為這是我想儘早進行的研究。我想做的是進行一項研究——這仍有待確定，這就是我們正在討論的內容。但是，我想在一系列患者中使用 Pantheris 並治療他們的動脈，使狹窄降低到 30% 左右。然後將此時的患者隨機分配到藥物洗脫球囊或更多的 Pantheris 以將其降至零，然後看看哪個——我認為這將是一個迷人的群體。因為我認為現在每個人都傾向於接受 DEB 之前需要做的事情。

You could pre-dilate but I think everybody is moving toward atherectomy followed by DEB. I just think atherectomy alone done correctly, you really don't need the DEB. But it has to be proven. And that would be the study that would be the most appealing from my own perspective.

你可以預擴張，但我認為每個人都在轉向斑塊切除術，然後是 DEB。我只是認為單獨進行粥樣斑塊切除術是正確的，你真的不需要 DEB。但它必須被證明。從我自己的角度來看，這將是最吸引人的研究。

I think there is a lot of discussion about that internally. We presented that to the science lab and some of them, they're well, yes, but maybe just Pantheris versus the SilverHawk maybe. But I think people are moving more toward DEB and atherectomy. And there is no better way to do it than with Pantheris because we can avoid cutting too deeply into the arterial wall, we can avoid the aneurismal risk; which there is a risk of aneurism following excessive de-bulking and then drug.

我認為內部對此有很多討論。我們向科學實驗室和其中一些人展示了它，他們很好，是的，但也許只是 Pantheris 與 SilverHawk 的對比。但我認為人們更傾向於 DEB 和粥樣斑塊切除術。沒有比 Pantheris 更好的方法了，因為我們可以避免切入動脈壁太深，我們可以避免動脈瘤的風險；在過度減瘤和藥物治療後存在動脈瘤風險。

So, I think we're better positioned than anyone else really to address the studies. We're committed to doing them, but we're not offering up any timelines currently. I don't think that would be appropriate; it's a little bit early for that.

所以，我認為我們比其他任何人都更有能力真正解決這些研究。我們致力於實現這些目標，但目前我們不提供任何時間表。我認為那不合適；現在還為時過早。

That's fair. And it's always been intuitive to me exactly what you said, but of course those trials cost a fair bit of money and there are other things that you are working on, other things that require those funds now. So, we'll look forward to the time when we see an IDE established and the trial enrolling. Do you think it is -- I mean, not to put a timeline on it specifically, but is it in the next 18 to 24 months or do you think it's further out than that?

這還算公平。你所說的對我來說一直很直觀，但當然這些試驗花費了相當多的錢，還有你正在做的其他事情，現在需要這些資金的其他事情。因此，我們將期待看到 IDE 建立和試用註冊的時間。你認為它是——我的意思是，不要具體設定時間表，而是在接下來的 18 到 24 個月內，還是你認為它比那更遠？

No, I think for sure, it's earlier than that; it's for sure sooner than the next 18 months, for sure.

不，我肯定地認為，它比那早；肯定會比接下來的 18 個月更快，這是肯定的。

All right.

好的。

Although we haven't published or committed to specific timelines, our internal thinking and planning now is that that would be a 2017 initiative, at least on a pilot basis.

雖然我們尚未公佈或承諾具體的時間表，但我們現在的內部想法和計劃是，這將是 2017 年的一項舉措，至少在試點基礎上。

That's helpful. Yes, right. That makes sense and that gives us a little bit of a sense for what you're working towards next year. Matt, in terms of cash burn, it looks like you maintained your adjusted EBITDA guidance. But, you said you were comfortable getting through the balance of the year with current cash on hand, but what will you be left with at the end of the year? Can you just give us some of the mechanics of cash burn assuming you hit let's say the midpoint of your revenue range and your gross margin range?

這很有幫助。對，對。這是有道理的，這讓我們對你明年的工作有了一些了解。馬特，就現金消耗而言，您似乎保持了調整後的 EBITDA 指導。但是，您說您可以輕鬆地用手頭的現金度過今年的餘額，但到年底您會剩下什麼？假設您達到了收入範圍和毛利率範圍的中點，您能否給我們一些現金消耗的機制？

Yes, sure. So, we would -- I mean the current cash would get us to the end of the year. We expect the cash burn to be kind of in the $10 million to $11 million range per quarter. So, it wouldn't leave much at the end of the year. So that leads directly to the additional comment that we made about recognizing the importance of putting more cash in the balance sheet. And that's something that we are committed to doing in the near future.

是的，當然。所以，我們會 - 我的意思是目前的現金將使我們到今年年底。我們預計每季度的現金消耗將在 1000 萬至 1100 萬美元之間。因此，它不會在年底留下太多。因此，這直接導致了我們就認識到在資產負債表中投入更多現金的重要性所做的額外評論。這是我們承諾在不久的將來要做的事情。

Got it, got it. And then lastly for me and I'll let some others jump in. Jeff, I wonder if you could comment on Pantheris launched in early March and you had sort of between then and now, sort of early August, you had the issue with the fiber, the OCT fiber.

明白了，明白了。最後對我來說，我會讓其他人參與進來。傑夫，我想知道你是否可以對 Pantheris 於 3 月初發布發表評論，從那時到現在，大約在 8 月初，你遇到了問題光纖，OCT 光纖。

I am wondering if there are any trends lately -- sort of similar to Josh's question -- trends lately in terms of whether it would units per rep or units per high volume account or per experienced account, if you sort of denote those accounts as Ocelot users that you could share with us to help investors feel a bit more comfortable that things -- or you have a hiccup, things are moving in the right direction. Is there anything that you would point out?

我想知道最近是否有任何趨勢——有點類似於 Josh 的問題——最近的趨勢是每個代表的單位數還是每個大批量客戶或每個有經驗的客戶的單位數，如果你將這些帳戶表示為 Ocelot您可以與我們分享的用戶，以幫助投資者對事情感到更舒服一點——或者您有一個小問題，事情正在朝著正確的方向發展。您有什麼要指出的嗎？

I'm not sure if there is specific number --

我不確定是否有具體數字——

On kind of a month-to-month basis.

按月計算。

-- specific numbers that we would put out on this call. However, we are seeing this increased utilization in accounts where they get to a point where they build the confidence to start using the device in a more diverse lesion set. So, by and large, our more experienced users, those who've been involved with Pantheris and with OCT imaging longer and have more experienced reps.

- 我們將在此次電話會議上公佈的具體數字。然而，我們看到客戶的利用率有所提高，他們達到了建立信心開始在更多樣化的病變集中使用該設備的地步。因此，總的來說，我們更有經驗的用戶，那些參與 Pantheris 和 OCT 成像的時間更長，並且有更多經驗的代表。

And so, where we see reps being on -- well, physicians being on-board with us longer in lumivascular and reps being on-board with us longer, we are seeing sequential increase in utilization. But it's really kind of a trend which will show up obviously in our -- we anticipate will show up in our revenue numbers. But it is a building situation.

因此，在我們看到銷售代表上線的地方——好吧，醫生在 lumivascular 上與我們合作的時間更長，而銷售代表在我們身上的時間更長，我們看到利用率連續增加。但這確實是一種趨勢，它會明顯地出現在我們的——我們預計會出現在我們的收入數字中。但這是一種建築情況。

We're hopeful that more and more of these accounts, because so many did get on-board with Pantheris very early in the process, will start to drive that increased utilization. We also are focusing on bringing new users in in existing accounts. And where we've been successful in doing that, you can imagine the direct impact that has on increased utilization and efficiency of that Lightbox.

我們希望越來越多的這些賬戶，因為很多人在這個過程的早期就加入了 Pantheris，將開始推動利用率的提高。我們還專注於在現有帳戶中引入新用戶。在我們成功做到這一點的地方，您可以想像這對提高燈箱的利用率和效率產生的直接影響。

Got it, okay. So sorry, just last follow-up, to just follow up on that. So, the idea there is just that chip shot SFA, short focal lesions; Pantheris may be the best technology but there may be a few technologies that can get that job done. So they may fall back on what they're using or they have to be incentivized by a competitor to use their device there.

知道了，好的。很抱歉，只是最後一次跟進，只是跟進。所以，這個想法就是 chip shot SFA，短焦病變； Pantheris 可能是最好的技術，但可能有一些技術可以完成這項工作。因此，他們可能會退回到他們正在使用的東西，或者他們必須受到競爭對手的激勵才能在那裡使用他們的設備。

But when it comes to a more difficult lesion where I guess the stakes are higher for lack a of a better way to put it, they're are less comfortable using another technology and therefore give you a shot. So you would effectively be working your way backwards, but working your towards -- from difficult lesions to the chip shot to over time as you show your chops on the difficult side. Is that the right way to look at it?

但是，當涉及到更困難的病變時，我認為由於缺乏更好的表達方式而風險更高，他們不太願意使用另一種技術，因此會給你一個機會。所以你會有效地向後工作，但會朝著你的方向努力——從困難的病變到切球，再到隨著時間的推移，你會在困難的一面展示你的印章。這是看待它的正確方式嗎？

It's a great comment. And a lot of accounts we're in, because the majority of our installed bases and hospitals aren't seeing a lot of kind of chip shot lesions. And so as we -- and the benefits of real time visualization and the extremely positive safety profile of Pantheris are realized to a large degree in these more challenging lesions.

這是一個很好的評論。我們有很多賬戶，因為我們的大多數安裝基地和醫院都沒有看到很多類型的芯片損傷。因此，我們——在這些更具挑戰性的病變中，實時可視化的好處和 Pantheris 極其積極的安全性在很大程度上得到了實現。

You remember the data we generated [envisioned] in our CTO subset, which was outstanding. And so, as physicians have more cases that are viable for them to use Pantheris, as they have the success, their staff and they themselves also become more facile with the device, the setup becomes easier. They just become more used to using it and that naturally extends the usage as well, which is kind of reiterating your point, Jason.

您還記得我們在 CTO 子集中生成 [設想] 的數據，這些數據非常出色。因此，隨著醫生有更多的案例可以讓他們使用 Pantheris，隨著他們取得成功，他們的員工和他們自己也變得更容易使用該設備，設置變得更容易。他們只是變得更習慣使用它，自然而然地也擴展了使用範圍，這在某種程度上重申了你的觀點，Jason。

Chris Cooley of Stephens.

斯蒂芬斯的克里斯庫利。

Maybe just a quick one from me following on kind of the study theme. I think you're on track or you were on track to complete your radiation reduction study during the fourth quarter. So, when you think about an enhanced safety profile, maybe more so from both the operator and the staff's perspective, could you maybe just give us an update if that's still tracking, and when you think you will have those study results? Then I have a couple follow-ups.

也許只是我的一個快速的學習主題。我認為您正在按計劃或按計劃在第四季度完成減少輻射的研究。因此，當您考慮增強安全性時，從操作員和員工的角度來看可能更是如此，如果仍在跟踪，您是否可以給我們一個更新，以及您認為什麼時候會得到這些研究結果？然後我有幾個後續行動。

Yes. So, as we met with our science lab, Chris, the ISR and the pilot study that Dr. Simpson spoke about with DEB and others kind of took more of a priority than a large scale radiation study. And so, what we'll be doing and presenting as the data becomes available is working within the existing data sets and case histories within our current users and especially in certain sites and developing that data for presentation. Because we're seeing such a strong radiation reduction just through tracking radiation utilization in our existing sites outside of a defined and expensive study.

是的。因此，當我們與我們的科學實驗室 Chris 會面時，Simpson 博士與 DEB 和其他人談到的 ISR 和試點研究比大規模輻射研究更受重視。因此，當數據可用時，我們將要做的和展示的是在我們當前用戶的現有數據集和案例歷史中工作，尤其是在某些站點中，並開發該數據以進行展示。因為我們僅通過在明確且昂貴的研究之外跟踪我們現有站點的輻射利用，就看到瞭如此強烈的輻射減少。

So, there has been a bit of a prioritization or shift in prioritization as to where we are going to be spending our clinical dollars. And kind of really in response to Josh's question earlier, as we have -- are focusing and making sure that we're using these resources most efficiently and most directly related to commercial impact.

因此，關於我們將把臨床資金花在哪裡，已經有了一些優先次序或優先次序的轉變。就像我們之前對喬希的問題的回應一樣，我們正在關注並確保我們最有效地使用這些資源，並且與商業影響最直接相關。

Makes perfect sense, get more bang for your buck that way. I follow you, just wanted to make sure we're on the same page.

非常有道理，這樣可以讓您物有所值。我跟著你，只是想確保我們在同一頁面上。

I appreciate the question.

我很欣賞這個問題。

If I could let me push a little bit when you talk about some of the new initiatives that JD has brought on board now to the sales force and the sales force being obviously reenergized and committed.

當你談論京東現在為銷售團隊帶來的一些新舉措時，如果我可以讓我稍微推動一下，並且銷售團隊顯然正在重新煥發活力和投入。

Because if we just think back since the time of the Company's IPO, JD was there in the early days, John was there for about three months, you yourself, Jeff, ran sales on an interim basis for about five months and then Joe was there for six months.

因為如果我們回想一下自公司首次公開募股以來，京東早期在那裡，約翰在那里大約三個月，你自己，傑夫，臨時銷售大約五個月，然後喬在那裡六個月。

What's maybe different now that the sales force is more excited about and gives them -- or gives you enhanced confidence that on a go forward basis the go-to-market message is right now, and you can see the sequential and year-over-year improvement in sales growth that clearly the technology has the potential for -- significantly has potential to exceed?

現在可能有什麼不同，因為銷售人員對他們更加興奮並給予他們——或者讓你更有信心，在前進的基礎上，進入市場的信息現在是正確的，你可以看到連續的和年復一年的——銷售增長的年度改善，顯然該技術具有潛力 - 顯著有潛力超過？

I would say the biggest difference here is that JD really has been here since the founding of the Company and he lives and breathes and understands lumivascular at such a deep level.

我想說這裡最大的不同是 JD 自公司成立以來就一直在這裡，他在如此深的層次上生活、呼吸和理解 lumivascular。

And so, that knowledge and the experience of the subtleties of lumivascular, the benefits of lumivascular, what it really takes to drive utilization in these accounts through his experience with Ocelot and really being with this technology from the beginning gives him a tremendous amount of credibility and confidence and also I think insight to drive improvements in our programs.

因此，關於 lumivascular 的微妙之處的知識和經驗，lumivascular 的好處，通過他在 Ocelot 的經驗以及從一開始就真正使用這項技術真正需要什麼來推動這些賬戶的使用，這給了他巨大的可信度和信心以及我認為推動我們計劃改進的洞察力。

JD is also a very strong leader. And the sales force has rallied around him in an incredibly positive way. This is I think a sea change in terms of the attitude and the commitment and the enthusiasm of the sales force since JD came on-board.

京東也是一個非常強大的領導者。銷售人員以一種令人難以置信的積極方式團結在他周圍。我認為，自從京東加入以來，就銷售人員的態度、承諾和熱情而言，這是一個巨大的變化。

So, there's some kind of more qualitative things but then there is just the fact that he has the experience with lumivascular, which frankly we think that's one of the reasons the ramp has taken a little slower than we had anticipated. This is a totally new, unique and disruptive technology. And so, having a leader in place that can understand that and can express that and rally the troops around it I think is very important and I think that's the difference.

所以，有一些更定性的東西，但事實是他有 lumivascular 的經驗，坦率地說，我們認為這是斜坡比我們預期的慢一點的原因之一。這是一項全新的、獨特的、顛覆性的技術。因此，我認為擁有一位能夠理解這一點並能夠表達這一點並將其團結起來的領導者非常重要，我認為這就是不同之處。

Understood. And then just maybe two quickie modeling ones from me and then I'll get back in queue. Kind of along those lines clearly you've faced some aggressive, I guess I'll use that verbiage, counter-detailing from competitors as maybe a little bit stronger than one would anticipate at this juncture in a launch. I think that speaks to the long-term potential of Pantheris and the lumivascular platform more broadly.

明白了。然後可能只是我的兩個快速建模，然後我會回到隊列中。沿著這些路線顯然你遇到了一些激進的，我想我會使用競爭對手的措辭，反細節可能比人們在發布的這個時刻預期的要強一些。我認為這更廣泛地說明了 Pantheris 和 lumivascular 平台的長期潛力。

But can you kind of help us better understand what you're assuming to a certain extent or when you think about your revised top-line guidance range whether it be continuation of these type of counter-detailing events, more moderate utilization growth in the installed based? Just kind of help maybe give us metrics around what drives the revised revenue range.

但是你能不能幫助我們更好地理解你在某種程度上的假設，或者當你考慮修改後的頂線指導範圍時，無論是繼續這些類型的反細節事件，安裝的利用率增長更溫和基於？只是某種幫助可能會為我們提供有關推動修訂後收入範圍的指標。

And then, just lastly, just to push back a little bit on Matt, I think your verbiage was cash, at least enough cash to get through the calendar year-end. But if we do a burn of $10 million to $11 million a quarter and you have approximately [$22 million] at quarter's end -- just curious if you have some additional levers there that you can pull to extend the cash balances. Or alternatively if we should interpret the guide as maybe being more conservative either in the revenue growth ramp or in terms of the margin expansion? Thanks.

然後，最後，為了反駁馬特，我認為你的措辭是現金，至少有足夠的現金來度過日曆年末。但是，如果我們每個季度燒掉 1000 萬到 1100 萬美元，而在季度末你有大約 [2200 萬美元]——只是想知道你是否有一些額外的槓桿可以用來擴大現金餘額。或者我們是否應該將指南解釋為在收入增長斜坡或利潤率擴張方面可能更加保守？謝謝。

Sure, Chris. Let me try to take those one at a time. So, in terms of the revenue guidance, we've looked at it from a bunch of different angles. And we've certainly spent a lot of time analyzing it. And we've been doing that since even before the launch, but we do have some actual sales track record under our belts now to further inform the forecast that we make at this point.

當然，克里斯。讓我試著一次拿走那些。因此，就收入指導而言，我們從許多不同的角度進行了研究。我們當然花了很多時間來分析它。我們甚至在發布之前就一直在這樣做，但我們現在確實有一些實際的銷售記錄，可以進一步為我們目前所做的預測提供信息。

So, we looked at it on an account-by-account basis, looking at the trends that existed at each account, and we then added the specific situation at that account knowing the individual physicians there and the sales professional that's handling the account or groups of sales people that are working in that account. So, we really looked at it at a very granular level.

因此，我們逐個賬戶地查看它，查看每個賬戶存在的趨勢，然後我們添加該賬戶的具體情況，了解那裡的個別醫生以及處理該賬戶或小組的銷售專業人員在該客戶中工作的銷售人員。所以，我們真的在非常細粒度的層面上看待它。

In terms of the assumptions that we're making, we are continuing to expect most of the growth that we're going to see in the back half of this year and largely through next year, driven by growth in Pantheris revenue. And we would expect to continue to see an expansion of our account base. We're comfortable given what we've been able to do in the first half of the year that we'll get to the 150 number or perhaps a bit better than that in terms of the number lumivascular accounts. And we've modeled in modest utilization increases for our lumivascular catheters and particularly for Pantheris.

就我們所做的假設而言，我們繼續預計今年下半年以及明年大部分時間將看到的大部分增長，都是由 Pantheris 收入的增長推動的。我們希望繼續看到我們的客戶群擴大。考慮到我們在今年上半年所做的事情，我們感到很舒服，我們將達到 150 個數字，或者在 lumivascular 賬戶的數量方面可能比這更好一點。我們已經模擬了我們的 lumivascular 導管，特別是 Pantheris 的利用率適度增加。

So, I think given the initiatives that we've put in place and that Jeff just talked through, we feel very comfortable and confident with the revenue guidance. And we're just looking forward to showing that over the next couple of quarters here.

因此，我認為鑑於我們已經採取的舉措以及 Jeff 剛剛談到的舉措，我們對收入指導感到非常滿意和自信。我們只是期待在接下來的幾個季度裡展示這一點。

I think your other main question really had to do with cash burn. And, I guess, I would say that we've modeled out the expenses and the gross margin along with the revenue ramp that we're expecting in the second half of the year, and that's what gets us to the cash utilization that we talked about of $10 million to $11 million per quarter.

我認為你的另一個主要問題確實與現金消耗有關。而且，我想，我會說我們已經模擬了費用和毛利率以及我們預計下半年的收入增長，這就是我們談到的現金利用率的原因每個季度大約 1000 萬到 1100 萬美元。

I do think there's some opportunity for improving on that, whether it's from improved top-line or other areas where we may be able to manage our expenses a little bit more tightly, but we've got a lot of important work to do. So, we're not necessarily looking to defer cost any further than we already have in the plan that we've discussed with our Board and that is the foundation for the guidance that we've given. There perhaps may be some other alternatives in terms of looking to bring cash into the Company, but the primary approach is to go out and raise some money during the second half of the year here.

我確實認為有一些改進的機會，無論是來自改進的頂線還是我們可以更嚴格地管理我們的開支的其他領域，但我們還有很多重要的工作要做。因此，與董事會討論的計劃相比，我們不一定要進一步推遲成本，這是我們給出的指導的基礎。就尋求將現金帶入公司而言，或許還有其他一些選擇，但主要方法是在今年下半年走出去籌集一些資金。

So, hopefully that addresses what you're talking about. Let me know if there is a particular follow-up.

所以，希望這能解決你所說的問題。讓我知道是否有特定的後續行動。

Steve Lichtman of Oppenheimer.

奧本海默的史蒂夫·利希特曼。

I think you mentioned last time in the quarter there were 15 Lightboxes placed through alternative pathways. Can you update us on which programs you guys are focused on using today, as options for customers for a Lightbox acquisition?

我想你上次在本季度提到過有 15 個燈箱是通過替代途徑放置的。你能告訴我們你們今天專注於使用哪些程序，作為客戶購買 Lightbox 的選項嗎？

So, our overall philosophy is to improve our targeting of accounts to drive utilization, Steve, and to not let the -- introduce, as you know, we started this actually when I was running sales back in the middle of last year, to put a little more flexibility into our capital acquisition model. So, by and large, most of the boxes added and accounts added in the second quarter were related to our placement-to-purchase program, which is really an evaluation with terms of an acquisition of the Lightbox pre-negotiated upfront.

所以，我們的總體理念是改善我們的客戶目標以提高利用率，史蒂夫，而不是讓 - 介紹，正如你所知，我們實際上是在去年年中我負責銷售時開始的，把我們的資本收購模式更加靈活。因此，總的來說，第二季度添加的大多數盒子和添加的帳戶都與我們的購買計劃有關，這實際上是對預先協商的 Lightbox 收購條款的評估。

We also introduced at the beginning of this year a rental model and we saw some activity in the rental as well, and of course have our existing options of purchase, outright purchase or purchase through a lease program. So, we're really trying to put our sales representatives in a position where they could listen to their customers, understand their needs and not let the capital process delay utilization of the device.

我們還在今年年初推出了租賃模式，我們也看到了一些租賃活動，當然還有我們現有的購買、直接購買或通過租賃計劃購買的選擇。所以，我們真的在努力讓我們的銷售代表能夠傾聽客戶的聲音，了解他們的需求，而不是讓資本流程延遲設備的使用。

Because we're so confident in the results that a physician will receive after they've been trained and begin using not only Pantheris, but also Ocelot for CTO crossing that that will lead to acquisition in that account.

因為我們對醫生在接受培訓並開始使用 Pantheris 和 Ocelot 進行 CTO 交叉後會收到的結果非常有信心，這將導致該帳戶的收購。

So, it's really a mixed bag. There is structure around the different options, but the idea is to enable our sales reps to be able to listen to their customers and work with us to design a program for the specific needs of that customer to get this technology into the physicians' hands as soon as possible.

所以，這真的是一個混合包。圍繞不同的選項有結構，但我們的想法是使我們的銷售代表能夠傾聽他們的客戶並與我們合作設計一個程序來滿足該客戶的特定需求，以便將這項技術交到醫生手中盡快。

And those place-to-purchase, those have minimum catheter commitments in there of course, I would assume. And I would also assume those commitments kind of build over time; they're not as stringent early on, after a customer gets a box versus later on. Is that fair?

我認為，那些購買地點，當然有最少的導管承諾。而且我還假設這些承諾會隨著時間的推移而建立；他們在早期並沒有那麼嚴格，在客戶拿到盒子之後與後來相比。這公平嗎？

Well, there is a wide verity, Steve. The main goal of the placement-to-purchase program is to get into the account and make sure that the account is having a good experience with it and leverage that to convert it into a purchase or a rental agreement or some kind of permanent arrangement. And the kind of arrangement you're talking about is something that we could do but is not -- we haven't gone down that path in very many cases so far.

好吧，史蒂夫，這是一個廣泛的事實。放置到購買計劃的主要目標是進入帳戶並確保該帳戶具有良好的體驗，並利用它來將其轉化為購買或租賃協議或某種永久性安排。你所說的那種安排是我們可以做但不是的事情——到目前為止，在很多情況下我們還沒有走那條路。

So, but there is a mix and it depends on the given situation and in a sense of value of the account, what we're willing to do. But the number one goal with the program is just to get them up and running and get them experiencing the positive benefits of using lumivascular, both Pantheris and Ocelot.

所以，但是有一個混合，它取決於給定的情況和帳戶的價值感，我們願意做什麼。但該計劃的首要目標只是讓他們啟動並運行並讓他們體驗使用 Pantheris 和 Ocelot 的 lumivascular 的積極好處。

Okay, got it. And then, just lastly from me, any data publications, I guess perhaps they'd be single center or presentations over the next 6 to 12 months that would highlight some of the early positive experience that you've seen post launch?

好，知道了。然後，最後來自我的是，任何數據出版物，我想在接下來的 6 到 12 個月內，它們可能是單一中心或演示文稿，它們會突出您在發布後看到的一些早期積極體驗？

Yes. Well as you know we have VIVA coming up, (inaudible) is also coming up and we expect to be on the podium at both conferences.

是的。正如您所知，我們即將推出 VIVA，（聽不清）也即將推出，我們希望在這兩個會議上都能登上領獎台。

Thank you. At this time, there are no other questions in queue. I'd like to turn it to Mr. Jeff Soinski for any closing remarks.

謝謝。此時，隊列中沒有其他問題。我想請 Jeff Soinski 先生髮表任何結束語。

Well, I would just to like to close by thanking you all for joining our call this afternoon. We appreciate your interest in our Company and we're excited to update you on our progress when we report our third quarter results. Thank you very much and have a pleasant evening.

好吧，我只想感謝大家今天下午加入我們的電話會議。我們感謝您對我們公司的興趣，我們很高興在報告第三季度業績時向您通報我們的進展情況。非常感謝，祝您度過一個愉快的夜晚。

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program. You may now disconnect.

女士們，先生們，感謝你們參加今天的會議。程序到此結束。您現在可以斷開連接。