Elutia Inc (ELUT) 2025 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen. Welcome to Elutia's second-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們、先生們，午安。歡迎參加 Elutia 2025 年第二季財務業績電話會議。（操作員指示）請注意，今天的會議正在錄音。

I would now like to hand the conference over to Matt Steinberg with FINN Partners. Thank you. You may begin.

現在我想將會議交給 FINN Partners 的 Matt Steinberg。謝謝。你可以開始了。

Thank you, operator, and thank you, all, for participating in today's call. Earlier today, Elutia released financial results for the quarter ended June 30, 2025. A copy of the press release is available on the company's website.

謝謝接線員，也謝謝大家參加今天的電話會議。今天早些時候，Elutia 發布了截至 2025 年 6 月 30 日的季度財務業績。新聞稿副本可在該公司網站上查閱。

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 the federal securities laws, which are pursuant to the Safe Harbor provision 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中發表聲明，其中包括聯邦證券法所定義的前瞻性聲明，這些聲明符合 1995 年《私人證券訴訟改革法案》的安全港條款。

Any statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation, those relating to our operating trends and future financial performance 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.

本電話會議中包含的任何與歷史事實無關或與對未來事件、結果或表現的預期或預測無關的陳述均為前瞻性陳述。所有前瞻性陳述，包括但不限於與我們的營運趨勢和未來財務表現有關的陳述，均基於我們目前的估計和各種假設。這些聲明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聲明預期或暗示的結果或事件有重大差異。

Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings within the SEC, including Elutia's annual report on Form 10-K for the year ended December 31, 2024, accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC.

因此，您不應過度依賴這些聲明。有關我們業務相關的風險和不確定性的清單及描述，請參閱我們向美國證券交易委員會 (SEC) 提交的公開文件中的「風險因素」部分，包括 Elutia 截至 2024 年 12 月 31 日的 10-K 表格年度報告，該報告可在美國證券交易委員會網站 www.sec.gov 上查閱。此類因素可能會在 Elutia 向美國證券交易委員會提交的其他文件中不時更新。

The conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 14, 2025. Elutia disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, either because of new information, future events, or otherwise.

電話會議包含時間敏感信息，並且僅截至今天（2025 年 8 月 14 日）的現場直播時準確。Elutia 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，除非法律要求，無論是由於新資訊、未來事件或其他原因。

Also during this presentation, we referred to gross margin, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to the most directly comparable GAAP financial measure is available in the company's financial results release for the second quarter ended June 30, 2025, which is accessible on the SEC's website and posted on the Investor page of the Elutia website at www.elutia.com.

此外，在本次演示中，我們提到了毛利率（不包括無形資產攤銷），這是一種非公認會計準則財務指標。此非 GAAP 財務指標與最直接可比較的 GAAP 財務指標的對帳可在公司截至 2025 年 6 月 30 日的第二季度財務業績報告中查閱，該報告可在美國證券交易委員會 (SEC) 網站上查閱，也可在 Elutia 網站 www.elutia.com 的投資者頁面上發布。

And with that, I will turn the call over to Elutia's CEO, Randy Mills.

說完這些，我將把電話轉給 Elutia 的執行長 Randy Mills。

Thank you, Matt, and welcome one and all to our second-quarter 2025 earnings call. Let me start with a rundown of today's topics.

謝謝你，馬特，歡迎大家參加我們 2025 年第二季財報電話會議。首先讓我來概述一下今天的主題。

And first and foremost, I want to provide some color on the success we continue to have with our EluPro launch and the commercial success we continue to have there. Then I'm going to switch gears in, I'm going to talk a little bit about the tremendous work our development teams are doing in the reconstruction pipeline that we have underway. I'm then going to turn it over to Matt, who's going to provide an update, which we have some pretty significant updates on the litigation front. And then lastly, Matt will also do, as he always does, a rundown of our financial progress.

首先，我想介紹一下我們在 EluPro 的推出以及商業上的成功。然後我要轉換話題，稍微談談我們的開發團隊在我們正在進行的重建過程中所做的大量工作。然後我將把時間交給馬特，他將提供最新消息，我們在訴訟方面有一些非常重要的更新。最後，馬特還將像往常一樣，概述我們的財務進展。

Lastly, as I indicated in the press release, on the business development front, we have a number of strategic opportunities that we're sort of in the middle of that we're driving towards conclusion, and we anticipate having more to say on those in the near future here.

最後，正如我在新聞稿中所指出的，在業務發展方面，我們有許多策略機遇，我們正處於其中並正在努力達成目標，我們預計在不久的將來會就這些機會發表更多看法。

But let's just jump right in with a review of EluPro's first year and what a year it was. On the commercial side, 49% sequential growth this quarter over last quarter built on the back of seven national GPO contracts that the team has secured. As we've said all along, the key to revenue growth has to do with the number of hospital systems we can get into, and we're currently at 161 hospital systems actively ordering. And then lastly, a lot of this growth has been facilitated by the tremendous partnership that we've developed with our friends at Boston Scientific. But it's great commercial success that has been built really on a great scientific foundation that we have at Elutia.

但是，讓我們直接回顧一下 EluPro 的第一年以及這一年是怎樣的一年。在商業方面，由於團隊已獲得七份全國 GPO 合同，本季環比增長 49%。正如我們一直所說的那樣，收入成長的關鍵在於我們能夠進入的醫院系統的數量，目前我們有 161 個醫院系統正在積極訂購。最後，我們與波士頓科學公司的朋友建立的牢固的合作關係在很大程度上促進了這一增長。但它的巨大商業成功確實建立在 Elutia 偉大的科學基礎之上。

Our drug-eluting technology, particularly our biologics drug-eluting technology, we think is the best in the world in this first year. I think we've done a good job of validating that. Five peer reviewed publications in the first year alone, validating not just the product, but the base technology.

我們認為我們的藥物洗脫技術，特別是我們的生物製劑藥物洗脫技術，在第一年就是世界上最好的。我認為我們已經很好地驗證了這一點。光是第一年就有五份同行評審出版物，不僅驗證了產品，還驗證了基礎技術。

We won the Edison Award. I got to actually go and receive at what I would call the nerd Oscars for innovation in medical technology. Two medical device network excellence awards, one for product innovation, which is a surprise, another for product launch, really combining what the two teams working together are able to accomplish.

我們贏得了愛迪生獎。我實際上去參加了被我稱為「書呆子奧斯卡」的醫療科技創新獎。兩項醫療器材網路卓越獎，一項是產品創新獎，這是一個驚喜，另一項是產品發布獎，真正結合了兩個團隊共同努力所能取得的成就。

And then lastly, our Innovator in Chief, Dr. Michelle Williams, won Medical Device Innovator of the Year award, and we think that was certainly well deserved.

最後，我們的首席創新者米歇爾威廉斯博士榮獲年度醫療器材創新者獎，我們認為這是她當之無愧的。

Okay, turning to the scoreboard. Really, the numbers say it all. First-half performance, BioEnvelope revenue for the quarter up 33% year over year. That puts us at about a $14 million run rate now. Why is that? Well, that's really being driven by EluPro growth, almost exclusively by EluPro growth, up 49% sequentially for the quarter. EluPro now makes up 68% of our BioEnvelope revenue and it continues to grow. Why is that? Well, that's all driven by our VAC approvals. So we now have over 160 hospitals that we've gotten through the VAC process.

好的，轉到記分板。確實，數字說明了一切。上半年業績方面，BioEnvelope 本季營收年增 33%。這使得我們現在的營運成本約為 1,400 萬美元。這是為什麼？嗯，這實際上是由 EluPro 的成長推動的，幾乎完全是由 EluPro 的成長推動的，本季環比成長 49%。EluPro 目前占我們 BioEnvelope 營收的 68%，而且還在持續成長。這是為什麼？嗯，這一切都是由我們的 VAC 批准推動的。因此，現在已有超過 160 家醫院通過了 VAC 流程。

When we say through the VAC process, we don't just mean on contract and able to order. We don't actually count these hospitals until they are actively ordering and we are shipping them the product. So that breaks down sort of at a high level what's going on with the product.

當我們說通過 VAC 流程時，我們不僅僅意味著簽訂合約和能夠訂購。直到這些醫院主動訂購並且我們向他們運送產品時，我們才真正統計這些醫院的數量。這樣，我們就可以從高層次分析出產品的運作。

Let's get in little drive a little bit more detail here. So looking at the revenue, it's kind of amazing. We sold the first unit of EluPro last September, and we experienced some very modest revenue recognition in the third quarter of 2024. But since then, this product has been on a tear. You can see the quarterly growth continues. We now expect to end the year at a revenue rate approaching $20 million. And that really is due to the tremendous work the commercial team is doing.

讓我們在這裡更詳細地了解一下小驅動器。所以從收入來看，這有點令人驚訝。我們在去年 9 月售出了第一台 EluPro，並在 2024 年第三季實現了非常適中的收入確認。但自此以後，該產品一直暢銷。您可以看到季度成長仍在持續。我們現在預計今年年底的收入將接近 2000 萬美元。這確實要歸功於商業團隊所做的大量工作。

Dig in here and see what's really going on though. It's really driven by our sales per account. So as we said before, if we can get on contract with the hospital, what we're seeing is 130% higher revenue in those accounts for EluPro than we're seeing with CanGaroo, and this is reflecting greater utilization of the product.

深入研究一下，看看到底發生了什麼事。這實際上是由我們每個帳戶的銷售額所推動的。因此，正如我們之前所說，如果我們能夠與醫院簽訂合同，我們看到 EluPro 在這些帳戶中的收入比 CanGaroo 高出 130%，這反映了該產品的利用率更高。

CanGaroo is a great biologic envelope, it was able to hold the pacemaker in place, keep it stable, prevent erosion from taking place and migration from taking place and ultimately a fibrotic capsule forming. But if you add the powerful protection of rifampin and minocycline, you really get the full benefit of a drug-eluting biologic. And that's why we're seeing this 130% higher utilization rate with EluPro than with CanGaroo.

CanGaroo 是一種出色的生物包膜，它能夠將起搏器固定到位，保持其穩定，防止侵蝕和移位，並最終形成纖維化囊。但如果加上利福平和米諾環素的強力保護，您就能真正獲得藥物洗脫生物製劑的全部益處。這就是為什麼我們看到 EluPro 的利用率比 CanGaroo 高出 130%。

We couldn't do this not only without our own direct sales team, which is doing a great job, but also with our 1,099 distributor network, which is now making up about 33% of our total sales, enabling us to very efficiently move across the country and gain new territories, but also with our partnership with Boston Scientific.

我們之所以能做到這一點，不僅得益於我們自己的直銷團隊（他們的工作非常出色），也得益於我們擁有 1,099 個分銷商網絡（目前占我們總銷售額的 33% 左右），這使我們能夠非常高效地在全國範圍內開展業務並開拓新市場，同時也得益於我們與波士頓科學公司的合作。

Now, Boston actively involved in EluPro sales in 98 distinct hospitals ordering. They are currently facilitating and participating in about 30% of EluPro cases. So if you just start, just do the math and you sort of extrapolate this out, we're targeting something along the lines of 1,600 or so hospital centers that would ultimately use EluPro that are active in planners of pacemakers. That, if it just sort of scales the way it's going, makes this $150 million product in just the US, in just pacemakers alone. And we think the neuro market is at least as big of an opportunity for us there. So from a revenue standpoint, really strong work so far.

目前，波士頓積極參與EluPro在98家不同醫院的銷售訂購。他們目前正在協助和參與約 30% 的 EluPro 案件。因此，如果您剛開始，只需進行計算並推斷出來，我們的目標是最終有大約 1,600 個醫院中心使用 EluPro，這些醫院中心積極參與起搏器規劃。如果以目前的方式擴大規模，光是在美國，光是起搏器一項產品的價值就將達到 1.5 億美元。我們認為神經市場對我們來說至少是一個巨大的機會。因此從收入角度來看，到目前為止我們的工作確實非常出色。

Again, we've said all along, our revenue, if you want to know what our revenue is going to do, look at what our VAC approvals are doing. And here, this just shows the great work of our team continuing to grind out those approvals. 161 institutions, you can see there the monthly progress we're making. We add somewhere between 12 to 15 new institutions a month. We have something along the lines of 90 submissions in progress, and we have about a 95% success rate. So when we submit to a VAC, we have a very, very strong likelihood of gaining approval.

再說一次，我們一直在說，我們的收入，如果你想知道我們的收入將會如何，看看我們的 VAC 批准情況。這只是展示了我們團隊的出色工作，繼續努力獲得這些批准。 161 個機構，您可以在那裡看到我們每月的進展。我們每月增加 12 至 15 家新機構。我們有大約 90 份提交正在進行中，成功率約為 95%。因此，當我們提交 VAC 時，我們獲得批准的可能性非常高。

Facilitating that great work with the VACs is the work we've done with our GPO contracts. And so we are on contract now with seven major GPOs, including Premier, S3P, Advantus, and we have several others under the work and believe we will be reporting on a few more successes there as the year concludes as we get through this second half.

我們透過 GPO 合約進行的工作是為了促進 VAC 的出色工作。因此，我們目前已與七家主要的 GPO 簽訂了合同，其中包括 Premier、S3P、Advantus，並且我們還有其他幾家公司正在合作，我們相信，隨著今年下半年的到來，我們將報告更多成功案例。

So all in all, what an incredible first year for Elu crew. And I want to thank the entire Elutia crew. It really was a team effort from science to operations to commercial everybody working together the way our culture says that we should.

總而言之，對於 Elu 團隊來說，這是令人難以置信的第一年。我還要感謝整個 Elutia 團隊。這確實是一個團隊的努力，從科學到營運到商業，每個人都按照我們的文化所要求的方式共同努力。

Okay. EluPro has a tremendous amount of fun and it's a great commercial success, but we are just getting started. Our mission is to humanize medicine so that patients can thrive without compromise and there is no bigger need than in the breast reconstruction space.

好的。EluPro 充滿了樂趣，並取得了巨大的商業成功，但我們才剛剛起步。我們的使命是使醫療人性化，以便患者能夠健康成長，而乳房重建領域正是我們最大的需求。

This year alone, 317,000 women will be told that they have an invasive form of breast cancer. Many of those are going to go on and require mastectomies and need reconstruction, and a staggering 1 in 3 women going through breast reconstruction are going to suffer serious complications from that reconstruction procedure, and that is something we can fix and that is something that we have resolved to change.

光是今年，就有 317,000 名女性被告知罹患侵襲性乳癌。其中許多人將繼續接受乳房切除術和重建手術，而接受乳房重建的女性中，有三分之一的人將在重建手術中遭受嚴重的併發症，這是我們可以解決的問題，也是我們決心要改變的問題。

Taking a look at the breast reconstruction market, it is a very big market. And it is a very big market that already has a dominance of biologics in it. So biologics represents a $1.5 billion addressable market in the US alone and biologics accounts for 65% of the device-related spend in reconstruction.

縱觀乳房重建市場，這是一個非常大的市場。這是一個非常大的市場，生物製劑已經佔據主導地位。因此，光是在美國，生物製劑就代表著 15 億美元的潛在市場，而生物製劑佔重建中與設備相關的支出的 65%。

Breaking down the numbers, there are 151,000 mastectomies annually in the United States. Two-thirds of those involve bilateral procedures. That generates somewhere between 200,000 to 225,000 individual breasts that are being reconstructed.

具體數字來看，美國每年有 151,000 例乳房切除手術。其中三分之二涉及雙邊程序。這就產生了大約 200,000 到 225,000 個需要重建的乳房。

Biologics account for 80% of the reconstruction cases at a cost of somewhere between $7,500 and $9,500 per case. Therefore, biologics are about 65% of the implant-related costs, but they do not address the primary cause of implant failure. So this is a market where we see biologics as the standard of care, and that standard of care is currently failing.

生物製劑佔重建病例的 80%，每例費用在 7,500 美元至 9,500 美元之間。因此，生物製劑約佔植入物相關成本的 65%，但它們並不能解決植入物失敗的主要原因。因此，在這個市場上，我們將生物製劑視為治療標準，而這種治療標準目前正在失敗。

Despite the high costs, biologics alone don't address the problem. And these numbers don't lie. As I said, 1 in 3 women going through the breast reconstruction procedure suffer a serious complication. Why is this? It's driven almost exclusively by persistent bacterial contamination. So 10% to 14% of women will experience a significant infection, 19% to 29% will suffer capsular contracture, which is most often a direct result of the inflammatory process from colonization of bacteria, and up to 21% of women will actually have an implant loss.

儘管成本很高，但單靠生物製劑並不能解決問題。這些數字不會說謊。正如我所說，三分之一接受乳房重建手術的女性會遭受嚴重的併發症。這是為什麼呢？其幾乎完全是由持續的細菌污染引起的。因此，10% 至 14% 的女性會出現嚴重感染，19% 至 29% 的女性會出現包膜攣縮，這通常是細菌定植引起的發炎過程的直接結果，而實際上多達 21% 的女性會出現植入物流失。

And there's significant and very real economic costs associated with these two. We're looking at almost $50,000 an economic burden to the hospital, which because it's a post-operative infection, the hospital must bear alone. These are not insured costs.

這兩項措施都會產生龐大且實質的經濟成本。我們認為這將給醫院帶來近 5 萬美元的經濟負擔，因為這是術後感染，所以醫院必須獨自承擔。這些不是保險費用。

So if you think about this, and just about everyone I know knows a woman going through a procedure like this. You've been diagnosed with breast cancer. Horrible news. You have the courage to go and face a mastectomy. Radiation oftentimes very frequently, chemotherapy and instead, what do you face? You face multiple surgeries, delays in your underlying cancer treatment, and the pain and suffering of a failed reconstructive procedure. This is something that the drug-eluting biologic technology that we've developed was made to fix.

所以，如果你考慮這一點，我認識的幾乎每個人都知道有女人正在經歷這樣的手術。您被診斷出患有乳癌。可怕的消息。您有勇氣去接受乳房切除手術。放射治療通常非常頻繁，而化療則相反，您面臨什麼？您將面臨多次手術、潛在癌症治療的延遲以及重建手術失敗的痛苦和折磨。我們開發的藥物洗脫生物技術就是為了解決這個問題。

You might be wondering, how bad is it? Well, how's this for bad company? Breast reconstruction ranks among the riskiest procedures in medicine despite being performed over 150,000 times a year. It falls just between major limb amputation and colorectal resection with an ostomy for serious complications. So it's not really surprising that women, when faced with the option for breast reconstruction, 60% of women opt to not have their breast reconstruction.

您可能想知道，情況有多糟？那麼，這對壞人來說怎麼樣呢？儘管每年進行超過 15 萬次乳房重建手術，但它仍然是醫學上最危險的手術之一。對於嚴重併發症，其治療費用介於主要肢體截肢和結腸直腸切除造口術之間。因此，當女性面臨乳房重建的選擇時，60% 的女性選擇不進行乳房重建，這並不奇怪。

Friends, this is a market that needs a revolution and that is exactly what Elutia is bringing to the table. We have built on our award-winning technology from EluPro to bring you what's next.

朋友們，這個市場需要一場革命，而這正是 Elutia 所帶來的。我們以 EluPro 屢獲殊榮的技術為基礎，為您帶來最新的產品。

NXT-41x is a fully engineered next-generation biological matrix that brings both the handling and the biological remodeling of a biologic matrix. But to that, we've added powerful antibiotics with sustained antibiotic release to prevent infection that is associated with these types of procedures. Our team have been hard at work on this for the past three years, and we are in a position now to where it's actually just around the corner.

NXT-41x 是一種完全工程化的下一代生物基質，它帶來了生物基質的處理和生物重塑。但除此之外，我們還添加了強效抗生素並持續釋放抗生素，以防止與此類手術相關的感染。我們的團隊在過去三年裡一直致力於此，現在我們已處於一個接近成功的時刻。

So we've been hard at work leveraging our proven development experience both from a technological standpoint, as well as a regulatory standpoint to rapidly gain market access. And so as you guys know, we've submitted and gotten approval for EluPro, but we haven't talked about, we spent a tremendous amount of time during those last three years developing and perfecting a great base biological matrix. And our development of that matrix is complete.

因此，我們一直在努力利用我們在技術角度和監管角度上經過驗證的開發經驗來快速獲得市場准入。正如你們所知，我們已經提交並獲得了 EluPro 的批准，但我們還沒有談論過，我們在過去三年中花費了大量的時間來開發和完善一個偉大的基礎生物基質。我們對此矩陣的開發已經完成。

Our animal data supporting the use of that matrix is complete. We have already held pre-submission meetings with the Food and Drug Administration, and our teams are now preparing submissions for approval. So we anticipate having the NXT-41 base matrix approved now and launching in the second half of 2026 and the antibiotic matrix in the first half of '27.

支持使用此矩陣的動物數據是完整的。我們已經與食品藥物管理局舉行了提交前的會議，我們的團隊現在正在準備提交批准。因此，我們預計 NXT-41 基礎基質現在將獲得批准並於 2026 年下半年推出，抗生素基質將於 2027 年上半年推出。

We will obviously providing more detail on this in the coming months, but I wanted to give you a good sense of not just where we are in the development program, but more importantly, why the NXT-41 program for breast reconstruction has been so high on the development teams priority list for the last three years.

我們顯然會在接下來的幾個月裡提供更多關於此的細節，但我想讓您不僅了解我們在開發計劃中所處的位置，更重要的是，為什麼 NXT-41 乳房重建計劃在過去三年中一直在開發團隊的優先事項列表中名列前茅。

With that, I will conclude my comments and turn the call over to Matt, who will discuss where we are from a litigation standpoint and then do his financial review.

至此，我將結束我的評論並將電話轉給馬特，他將從訴訟的角度討論我們的現狀，然後進行財務審查。

Okay. Thank you, Randy. So first off, the litigation update, which is a new section for our conference calls, but it's not a new situation that that we have been working on here. As a little bit of background, this stems from a product recall that we had over four years ago and it was in a part of the company that we actually sold two years ago. So it really relates to history of the company as opposed to anything that we're doing right now.

好的。謝謝你，蘭迪。首先，訴訟更新是我們電話會議的一個新部分，但這不是我們一直在處理的新情況。簡單介紹一下背景，這源自於我們四年前的一次產品召回，而該產品屬於我們兩年前出售的一部分。因此，它實際上與公司的歷史有關，而不是與我們現在正在做的任何事情有關。

But what we have been left with based on that product recall is quite a large number of lawsuits, and many of you are aware of that already. But we had 110 individual lawsuits that stemmed from this event in the long ago. It has been a really a substantial weight on the company, both from a value point of view and from a personal point of view. And I'm glad to say that we are now very close to the end of that process. We've made really substantial progress recently, and it has been a real focus for a small number of people in the company for some time.

但該產品召回事件為我們帶來了大量的訴訟，你們中的許多人已經意識到了這一點。但很久以前我們就有 110 起因該事件而引發的個人訴訟。無論從價值角度或從個人角度來看，這都為公司帶來了巨大的負擔。我很高興地說，我們現在已經非常接近這一進程的尾聲了。我們最近取得了實質的進展，並且一段時間以來，這一直是公司少數人真正關注的焦點。

So what has happened, we've really started making a concerted effort, at least a couple of quarters ago to get these cases behind us, to get them all settled. And just in the last quarter, we settled 27 of these cases. And cumulatively now, we've settled 97 out of that original 110. And with the remaining 13 cases, they -- on any individual basis, they should actually be easier to settle than much of what we've had to deal with over the last few years and even in the last quarter. No single trial attorney is handling more than three of those. So in a lot of ways, that actually makes it a little bit easier for us to deal with them one by one.

那麼，發生的事情是，我們至少在幾個季度前就開始齊心協力地解決這些案件。僅在上個季度，我們就解決了 27 起此類案件。現在累計起來，我們已經解決了最初 110 個案件中的 97 個。而對於剩下的 13 起案件，無論從哪個角度來看，它們實際上都應該比我們過去幾年甚至上個季度處理的大部分案件更容易解決。沒有一位出庭律師能夠處理超過三起此類案件。因此，從很多方面來說，這實際上使我們更容易逐一處理這些問題。

The implications of this for the company are -- they're two big ones. One is that it substantially reduces the expense that we incur going forward. And then the other one is that it really removes an overhang that made it very difficult. We've been talking to other companies about any kind of strategic transaction. And I think we have really addressed their concerns now. And like I said, I think we're very close to putting this entirely behind us.

這對公司來說有兩大影響。一是它大大減少了我們今後產生的費用。另一個是，它確實消除了造成困難的懸而未決的問題。我們一直在與其他公司討論任何類型的策略交易。我認為我們現在確實已經解決了他們的擔憂。正如我所說的，我認為我們已經快要把這件事完全拋在腦後了。

So with that, I will move on to the financial update. And there, it really integrates very directly with everything that Randy talked about. I won't go through all of the bullet points on this page, but just hitting a few highlights really at the top of the list is the performance of EluPro.

因此，我將繼續介紹財務更新。而且，它確實與蘭迪談論的一切直接融合。我不會詳細介紹本頁上的所有要點，但只需介紹幾個亮點，其中排在首位的是 EluPro 的性能。

We saw 49% growth on a sequential basis for EluPro from Q1 of this year to Q2 of this year. That drove really substantial growth even in the overall BioEnvelope business, even though a fair amount of that business is still CanGaroo. So we saw $3.5 million in sales in the BioEnvelope business versus $2.6 million from a year ago. And as Randy indicated, we expect that growth to continue, and we expect more accounts to convert over to EluPro and to bring on new accounts based on having this really exciting product in our portfolio right now.

我們看到 EluPro 從今年第一季到第二季連續成長了 49%。儘管其中相當一部分業務仍屬於 CanGaroo，但這仍然推動了整個 BioEnvelope 業務的大幅成長。因此，我們看到 BioEnvelope 業務的銷售額為 350 萬美元，而去年同期為 260 萬美元。正如蘭迪所說，我們預計這種增長將會持續下去，我們預計更多的帳戶將轉換到 EluPro，並且基於我們目前產品組合中這款非常令人興奮的產品，將帶來新的帳戶。

Just touching briefly on our other two main product areas in the cardiovascular patch products. We took control back of those products from an exclusive distributor last quarter -- in Q2. We only have them for a portion of the quarter, but even just in that portion of the quarter, we were able to generate over $700,000 of revenue from those products, and that's more than double what we were able to do through the distributor just the quarter before, and we expect to also see continued growth there.

簡單介紹一下心血管貼片產品的另外兩個主要產品領域。上個季度，也就是第二季度，我們從獨家經銷商手中收回了這些產品的控制權。我們只在本季度的一部分時間裡擁有這些產品，但即使只是在本季度的這一部分時間裡，我們也能夠從這些產品中獲得超過 70 萬美元的收入，這比上一季我們透過分銷商獲得的收入增加了一倍多，我們預計這些產品還將繼續增長。

And then for SimpliDerm, which is a product with a lot of opportunity, we didn't do as well last quarter, and we generated $2 million of revenue there versus what we had done previously, which was higher. I do believe that there are multiple ways that we can generate value from that franchise, whether it's by driving additional sales or by partnering with another company in order to bring value to our shareholders.

然後對於 SimpliDerm，這是一個有很多機會的產品，我們上個季度的表現不太好，我們在那裡創造了 200 萬美元的收入，而我們之前的收入則更高。我確實相信，我們可以透過多種方式從該特許經營權中創造價值，無論是透過推動額外的銷售還是與其他公司合作來為我們的股東帶來價值。

So overall, those three things add up to sales of $6.3 million for the quarter, which we expect to see growing going forward. That was essentially comparable to what we did in the year ago quarter.

因此總體而言，這三項加起來本季的銷售額為 630 萬美元，我們預計未來銷售額還會成長。這與我們去年同期的表現基本相當。

The other areas I'd like to touch on are gross margin where we're seeing really nice efficiency in terms of our operations, and we saw a substantial improvement in our adjusted gross margin reaching 62.4% for Q2, about 4 full percentage points or more than 4 full percentage points from a year ago. And we're seeing that largely based on the efficiency that we're getting in the BioEnvelope business as we start to scale that up a little bit more.

我想談的其他領域是毛利率，我們的營運效率非常好，調整後的毛利率大幅提高，第二季達到 62.4%，比去年同期高出約 4 個百分點或超過 4 個百分點。我們看到這一點很大程度上是基於我們在 BioEnvelope 業務中獲得的效率，因為我們開始進一步擴大該業務的規模。

And then also with the really high margins that we generate in cardiovascular. Those gross margins are actually over 80% for that business. And that does a nice job of dropping money towards our bottom line.

而且我們在心血管領域也獲得了非常高的利潤。該業務的毛利率實際上超過 80%。這確實能幫助我們節省資金，並實現獲利。

So on a bottom-line basis, there are different ways of looking at it, whether it's an operating or a net or an EBITDA basis. Really, I think the most instructive metric is adjusted EBITDA here, which takes out the nonrecurring and noncash expenses. There, we had a $3.8 million loss for the quarter.

因此，從底線角度來看，有不同的看法，無論是營業利潤、淨利潤或 EBITDA 基礎。確實，我認為這裡最有指導意義的指標是調整後的 EBITDA，它剔除了非經常性支出和非現金支出。本季我們虧損了 380 萬美元。

But when I think about that for where the company is with a really high growth, top-line franchise in form of EluPro, and then also with the product development investments that we've been making, which are going to yield really exciting results in the near future, I'm actually really pleased with the efficiency that we're seeing there and the ability to move this company towards profitability.

但當我想到公司現在擁有真正高成長、以 EluPro 形式佔據頂級特許經營權的公司，以及我們一直在進行的產品開發投資時，這些投資將在不久的將來產生真正令人興奮的結果，我對我們所看到的效率以及推動公司盈利的能力感到非常滿意。

And then lastly, I just mentioned that we ended Q2 with $8.5 million of cash. And I think the important thing to mention there is that we do have a number of business development transactions that we are evaluating. And we won't say too much more about that here, but we do expect to be able to say more in the very near future. And we do expect those to have an impact in a very positive way on our cash position.

最後，我剛才提到，我們在第二季結束時擁有 850 萬美元的現金。我認為值得一提的重要一點是，我們確實正在評估一些業務發展交易。我們不會在這裡透露太多，但我們確實希望在不久的將來能夠透露更多。我們確實希望這些會對我們的現金狀況產生非常正面的影響。

With that, I will turn it back to Randy.

說完這些，我就把它交還給蘭迪。

Thank you, Matt. Okay, so let's just conclude the call here with providing you some guidance and clarity on where it is we are going as a company. It's probably not going to come as a surprise to anyone to find out that a lot of our focus is dedicated exactly where it should be to EluPro.

謝謝你，馬特。好的，讓我們在這裡結束這通通話，為您提供一些指導和說明，讓您了解我們作為一家公司的發展方向。大家可能不會對我們將大量精力集中於 EluPro 這一事實感到驚訝。

EluPro is now at the stage where it's about scaling. We know exactly how to grow revenue in EluPro. It's simply to get more VACs on contracts. So we are going to continue to scale revenue in EluPro by expanding the number of VACs and GPO coverage that we have. We're going to be leveraging both the momentum that we've developed with our own direct sales channel, as well as our partners at Boston Scientific to help drive this process. And those two things really shouldn't come as a surprise to anyone.

EluPro 目前正處於擴展階段。我們確切地知道如何增加 EluPro 的收入。這只是為了獲得更多的合約 VAC。因此，我們將透過擴大 VAC 數量和 GPO 覆蓋範圍來繼續擴大 EluPro 的收入。我們將利用我們自己的直銷管道以及波士頓科學公司的合作夥伴所開發的勢頭來推動這一進程。這兩件事確實不應該讓任何人感到驚訝。

Third, we're going to continue to increase the production capacity and continue to lower COGS. We've already seen a tremendous job being done in our gross margin by our operations team. And as we like to say, that product doesn't make itself. The team in Roswell, Georgia does a phenomenal job growing with this product and continuing to meet product orders, and we're incredibly proud of the work that they do. So you can expect to see more of that going on.

第三，我們將持續提高生產能力並持續降低銷售成本。我們已經看到我們的營運團隊在毛利率方面做出了巨大的貢獻。正如我們常說的，產品不是自己生產的。喬治亞州羅斯威爾的團隊在開發該產品和持續滿足產品訂單方面做得非常出色，我們對他們的工作感到無比自豪。因此你可以期待看到更多這樣的事情發生。

Fourth, you've heard about it now, our NXT-41 platform is now just about here. It is proven technology, drug-eluting biologics technology, through a proven regulatory pathway, going into a much bigger market with a much bigger unmet medical need. And we are really excited to not just bring that to market from a business standpoint, but also, when you're in this business, being able to develop a product like that for people and for an indication where there is such an outstanding medical need. We are not only excited, but we are passionately pursuing that and driving that forward at full speed.

第四，您現在已經聽說了，我們的 NXT-41 平台即將推出。這是一項經過驗證的技術，即藥物洗脫生物製劑技術，透過經過驗證的監管途徑，進入更大的市場，滿足更大的未滿足的醫療需求。我們真的很高興，不僅從商業角度將其推向市場，而且當你從事這個行業時，能夠為人們開發這樣的產品，並滿足如此突出的醫療需求。我們不僅感到興奮，而且我們正滿懷熱情地追求這一目標並全速推動它向前發展。

And then lastly, as Matt said, and as I said at the beginning into my conference, we are working on a number of strategic opportunities and expect to drive one or more of those to conclusion in the relatively near future, and we'll have more on that when developments warrant.

最後，正如馬特所說，正如我在會議開始時所說的那樣，我們正在研究一些戰略機遇，並期望在不久的將來推動其中一個或多個戰略機會取得成果，當事態發展需要時，我們將對此有更多的了解。

With that, I will conclude my comments and turn the call over to the operator for your questions.

至此，我將結束我的意見，並將電話轉給接線員回答您的問題。

(Operator Instructions) Frank Takkinen, Lake Street Capital Markets.

（操作員指示）弗蘭克·塔基寧 (Frank Takkinen)，Lake Street Capital Markets。

Thanks for the questions, and congrats on all of the exciting progress. I wanted to start first with one on EluPro.

感謝您的提問，並祝賀所有令人興奮的進展。我想先從 EluPro 開始。

Obviously, you've had very strong market receptivity. And just curious when -- obviously, when a product is launching as quickly and successfully as EluPro has, there's always bottlenecks along the way. So just curious what those bottlenecks are, whether that's still VACs and just the process there and the variability of timing, inventory, or anything like that and anything you need to address to continue this growth trajectory.

顯然，您的市場接受度非常高。只是很好奇——顯然，當一款產品像 EluPro 一樣快速而成功地推出時，總是會遇到瓶頸。所以我只是好奇這些瓶頸是什麼，是否仍然是 VAC，以及那裡的流程和時間、庫存或諸如此類的變化，以及任何你需要解決的問題，以繼續這種增長軌跡。

Yeah. Thanks, Frank. So bottlenecks, I would say at first, the commercial team really did give the operations team a run for their money. There were some people sweating being able to keep up with production as we first got that started. They have done that. They have really mastered that. You're starting to see that efficiency show up in the gross margin.

是的。謝謝，弗蘭克。因此，首先我想說的是，商業團隊確實為營運團隊帶來了瓶頸。當我們剛開始生產時，有些人為能否跟上生產進度而緊張。他們已經這麼做了。他們確實掌握了這一點。您開始看到效率體現在毛利率中。

We don't like any good company. We don't like to build crazy amounts of inventory. But we have the inventory in place there to be able to have 100% service level. That's our goal, deliver exactly what the customer wants, exactly when the customer expects to receive it. And they've done a great job there.

我們不喜歡任何好公司。我們不喜歡建立大量的庫存。但我們有庫存，能夠達到 100% 的服務水準。這就是我們的目標：在客戶期望的時間內準確地交付他們想要的東西。他們在那裡做得很好。

I wish it were more exciting, and maybe I don't wish it was more exciting, than the opportunity that we see. But really, it's about scaling back. The ordering is now so predictable.

我希望它比我們看到的機會更令人興奮，也許我不希望它更令人興奮。但實際上，這只是縮減規模而已。現在的排序是如此可預測。

When we turn a hospital on, they order and they're ordering at this really significant rate over what they won, 130% of what they were ordering, CanGaroo, a good account for us. We'll do some, actually, we expect actually just an average account for us to do about $100,000 a year. So those accounts are just scaling.

當我們開通醫院時，他們就會下訂單，而且他們的訂單量比他們贏得的訂單量高出很多，是他們之前訂單量的 130%，對於我們來說，CanGaroo 是一個很好的客戶。我們會做一些，實際上，我們預計平均每個帳戶每年的收入約為 100,000 美元。所以這些帳戶只是在擴大規模。

So as we get through the VAC process, revenue scale. So I don't know if you call it a bottleneck or just the work we have to do. But we have 160, we have 160 VACs through approval right now. It's kind of interesting it lines up. We have 1,600 centers that we are targeting in total. It takes us on average about six months to do that. We always keep a really strong number of those accounts in the pipeline.

因此，當我們完成 VAC 流程時，收入規模就會擴大。所以我不知道你是否稱之為瓶頸或只是我們必須做的工作。但我們現在有 160 個 VAC 已經通過批准。排列起來很有趣。我們總共計劃涵蓋 1,600 個中心。我們平均需要大約六個月的時間來完成這項工作。我們始終保留大量此類帳戶。

Like I said, I think right now we happen to have 90, because actually we had a lot pull through, but we add new filings every day, and our partners at Boston Scientific are being tremendously helpful in opening up those new doors. They certainly have accounts that they have high interest in, high need in.

就像我說的，我認為現在我們恰好有 90 個，因為實際上我們已經完成了很多工作，但我們每天都會增加新的文件，而我們在波士頓科學公司的合作夥伴在打開這些新大門方面提供了極大的幫助。他們肯定擁有自己非常感興趣、非常需要的帳號。

So it's not really much of a mystery anymore what drives the revenue with EluPro. really is, if we get through the back, We're seeing that ordering just scale.

因此，EluPro 的收入驅動因素已不再是什麼秘密。事實上，如果我們深入了解，就會發現訂單規模正在擴大。

Great. That's a good color. Maybe one on the NXT-41, exciting to hear that advancing along. First, maybe just a little clarification and help us understand kind of the two-step process. I think we read in the press release that the first one's expected second half of '26 and then the drug-eluting version in the first half of '27. So some additional background there would be interesting to understand.

偉大的。這顏色不錯。也許是 NXT-41 上的一個，很高興聽到它正在取得進展。首先，也許只是一點澄清，幫助我們理解這個兩步驟過程。我想我們在新聞稿中看到，第一個預計將於 26 年下半年推出，然後藥物洗脫版本將於 27 年上半年推出。因此，了解一些額外的背景資訊將會很有趣。

And then just a clarification, is there any linkage to NXT-41 to SimpliDerm as you think about business development activities?

然後澄清一下，當您考慮業務發展活動時，NXT-41 與 SimpliDerm 之間是否存在任何關聯？

Sure. So the first centers around regulatory strategy, right? So and you know, Dr. Williams, she doesn't just deliver great science. She also knows that the product won't help people until it can get through the FDA. And we're taking what you might call a conservative or a de-risk by uncoupling the regulatory clearances of first the matrix by itself and then the matrix with the antibiotic attached to it.

當然。那麼首先要圍繞著監管策略，對嗎？所以你知道，威廉斯博士，她不僅僅提供偉大的科學成果。她也知道，該產品只有在通過 FDA 的審核後才能對人們有所幫助。我們採取了一種所謂的保守或降低風險的方法，即首先分離基質本身的監管許可，然後再分離基質及其附著的抗生素的監管許可。

And so the first approval that you'll see is the matrix by itself. This is not a derivative of SimpliDerm. This is a brand new matrix for a lot of different reasons. We went with what we call a fully engineered matrix. And so this is a -- it starts with a porcine extracellular matrix base that we treat with a number of different procedures that chemical and enzymatic that Michelle and her team have developed.

因此，您看到的第一個批准就是矩陣本身。這不是 SimpliDerm 的衍生物。由於許多不同的原因，這是一個全新的矩陣。我們採用了所謂的完全工程矩陣。所以這是——它從豬細胞外基質開始，我們用米歇爾和她的團隊開發的多種不同的化學和酶程序進行處理。

We optimized it not just for handling, but we also optimized it for incorporation. And because this is an engineered matrix, what we were looking to do there, Frank, was one of the knocks on sort of biologics and particularly human tissue that's used in biologics is the donor-to-donor variability. And we wanted to take that out. We wanted to make a base matrix where the physician would say, I know exactly how this thing is going to perform. And I know this base matrix is engineered in such a way to where it's going to incorporate biologically in an absolutely optimal state. And so that's what we did with that base matrix.

我們不僅針對處理進行了最佳化，還針對合併進行了最佳化。因為這是一個工程基質，弗蘭克，我們想要做的就是對生物製劑，特別是用於生物製劑的人體組織進行敲擊，即捐贈者與捐贈者之間的差異。我們想把它去掉。我們想要製作一個基礎矩陣，讓醫生能夠說，我確切地知道這個東西將如何發揮作用。我知道這個基礎基質經過精心設計，能夠以絕對最佳的狀態進行生物結合。這就是我們對該基礎矩陣所做的。

And so that will -- you'll see that come on the market in the second half of '26 now. And then shortly after that, the antibiotics delivery version attached and that we've been able to develop really, we think, the expertise from the process with EluPro and what the FDA wants to see from a drug-eluting standpoint.

因此，您將會在 26 年下半年看到該產品上市。此後不久，抗生素輸送版本就附加上了，我們認為，我們已經能夠真正開發出 EluPro 流程中的專業知識以及 FDA 希望從藥物洗脫的角度看到的東西。

We are using the same drugs, different delivery system, but we really actually love rifampin and minocycline in this space. We'll have more to talk about that, but we actually have some really powerful, not just anti-microbial effects, but actually pro-regenerative effects that we've been able to prove out in the lab with that. So we're really excited about that.

我們使用的是相同的藥物，不同的輸送系統，但我們確實很喜歡這個領域的利福平和米諾環素。我們將會對此進行更多討論，但實際上我們確實具有一些非常強大的作用，不僅僅是抗菌作用，而且實際上還具有促再生作用，我們已經能夠在實驗室中證明這一點。所以我們對此感到非常興奮。

And then your second question sort of centered around how this related to SimpliDerm. This is going into the same markets as SimpliDerm is obviously using a biologic mesh in breast reconstruction. But we think really with a second generation sort of technology. And so what we like about having SimpliDerm is we have our key accounts, we have our KOLs established, these great surgeon relationships. And SimpliDerm is, as we say, simply a great product. Physicians love SimpliDerm. We think it is the best biologic on the market today.

然後你的第二個問題集中在這與 SimpliDerm 有何關係。這與 SimpliDerm 進入的市場相同，SimpliDerm 顯然在乳房重建中使用生物網片。但我們確實認為這是第二代技術。我們喜歡 SimpliDerm 的原因是，我們擁有關鍵客戶，建立了關鍵意見領袖 (KOL)，與外科醫生建立了良好的關係。正如我們所說，SimpliDerm 是一款非常棒的產品。醫生都很喜歡 SimpliDerm。我們認為它是目前市面上最好的生物製劑。

But ultimately, where we're going is we think that NXT-41 really gives a more complete solution than any human-derived matrix could give.

但最終，我們認為 NXT-41 確實提供了比任何人工矩陣更完整的解。

Perfect, helpful. And then maybe just one last one, and I'm guessing you can't say too much on it, but related to the comments of very soon when we should hear some business development commentary. Would you characterize very soon as weeks, months, or quarters?

完美，很有幫助。然後也許只是最後一個，我猜你不能說太多，但與我們很快就會聽到的一些業務發展評論有關。您會很快描述為幾週、幾個月還是幾季？

It's nothing's done, Frank, until it's done. And so I would expect it to be in weeks or quarters. It's just one of those things. It's like reminds me of that, Billy Crystal's line in Princess Bride, you rush miracles, you get lousy miracles. Well, you rush business development and you get lousy business development.

弗蘭克，在事情完成之前，什麼都不算完成。因此我預計它會在幾週或幾個季度內發生。這只是其中之一。這讓我想起了《公主新娘》中比利·克里斯託的台詞，你急於創造奇蹟，你得到的只是一個糟糕的奇蹟。好吧，你急於發展業務，結果卻得到糟糕的業務發展。

And so we have a number of transactions that we're contemplating right now. We would expect at least one of them to come to fruition, but nothing's done until it's done. So I don't want to really provide any more time for them. I don't want to have to negotiate against ourselves with regards to time. And if I set an unrealistic expectation, really, it's only us that would bear the consequence of that.

因此，我們目前正在考慮多項交易。我們期望其中至少有一個能夠實現，但在實現之前什麼都不算完成。所以我真的不想再提供他們任何時間。我不想在時間問題上與我們自己進行談判。如果我設定了不切實際的期望，那麼實際上，只有我們才能承擔其後果。

Perfect. Fair enough. Thanks for taking the questions.

完美的。很公平。感謝您回答這些問題。

Ross Osborn, Cantor Fitzgerald.

羅斯奧斯本、康托費茲傑拉。

Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions. I guess just starting with gross margin, I was good step up this quarter with cardiovascular coming back in the mix. As we think about the path forward, how should we frame your ability to not just maintain but potentially expand gross margins from here?

嘿，大家好。今天由馬特帕克 (Matt Park) 代替羅斯上場。感謝您回答這些問題。我想，從毛利率開始，隨著心血管疾病的再次出現，本季我的毛利率有了很大的提高。當我們思考未來的道路時，我們應該如何建立您的能力，不僅要維持毛利率，而且要有可能擴大毛利率？

Hey, Matt. It's Matt Ferguson. Good to talk to you again. I think I got your whole question. I know it's centered around growth margin and opportunities for growth in the future. And I would say absolutely opportunities across really all segments of our business to improve growth margin going forward.

嘿，馬特。我是馬特·弗格森。很高興能再次和你交談。我想我明白你的全部問題了。我知道它圍繞著成長空間和未來的成長機會。我想說的是，我們業務的所有領域都絕對有機會提高未來的成長利潤率。

Certainly, in the case of EluPro, we've got a lot of scaling that we're doing. And we will see the benefits of that over time. And I think you'll see them as pretty substantial and significant, and they shouldn't take too long.

當然，就 EluPro 而言，我們正在進行大量的擴展。隨著時間的推移，我們將會看到其帶來的好處。我認為你會發現它們相當實質和重要，而且它們不會花費太長時間。

In the case of cardiovascular, that's a little more straightforward. We're now selling at a higher growth margin. I mentioned that in the prepared remarks that, that's over 80%. So the more we can grow that business, and I think there's a lot of opportunity there, that will contribute positively to the overall growth margin.

對於心血管來說，這就更簡單一些。我們現在的銷售成長幅度更高。我在準備好的發言中提到過，這個比例超過了 80%。因此，我們越能發展這項業務，我認為這裡就有很多機會，這將對整體成長利潤產生積極的貢獻。

And in the case of SimpliDerm, there are some things that we can do there to improve efficiency as well. So I think there are opportunities there as well. Probably a little less so than the other two, but substantial, nonetheless.

就 SimpliDerm 而言，我們也可以做一些事情來提高效率。所以我認為那裡也有機會。可能比其他兩個少一點，但仍然很重要。

Did I get your entire question there, or was there another?

我是否已經回答了您的全部問題，還是還有其他問題？

Yes, that was great. And then I guess just moving on to NXE-41x. This may have been answered already on the call, but can you kind of just walk us through what level of clinical evidence or study design you believe is needed to support FDA approval for both the base matrix as well as the drug-eluting version?

是的，太棒了。然後我想就轉到 NXE-41x 了。這個問題可能已經在電話中得到解答了，但是您能否向我們簡單介紹一下，您認為需要什麼級別的臨床證據或研究設計才能支持 FDA 批准基礎基質和藥物洗脫版本？

Yeah. So we are taking both the base matrix and the antibiotic delivery matrix through the same regulatory platform that we took EluPro through.

是的。因此，我們將基礎基質和抗生素輸送基質都透過與 EluPro 相同的監管平台進行監管。

From a regulatory standpoint, we will be able to do that with exactly the same playbook that we used for EluPro, with the exception of there are -- when you get into surgical meshes for different things, there are different specific requirements for those that the team will be following the well-established standards on.

從監管的角度來看，我們將能夠使用與 EluPro 完全相同的劇本來做到這一點，但有一點不同——當您進入用於不同事物的手術網片時，對於團隊將遵循的既定標準有不同的具體要求。

From a clinical standpoint, one of the reasons that we're staggering the launch of the base matrix is actually so we can go and generate the clinical data, not from a regulatory standpoint, but actually from a marketing standpoint, because we're looking to win this thing, not in the short term, but actually in the long term.

從臨床角度來看，我們錯開基礎矩陣發佈時間的原因之一實際上是為了能夠產生臨床數據，這不是從監管角度，而是從行銷角度，因為我們希望贏得這場勝利，不是在短期內，而是在長期內。

We think 41x has the opportunity. We actually think we'll be by far the first antibiotic-eluting matrix to market. But we care about the matrix that it's on and so sort of not to pick on overly pick on TYRX, but we were not looking to just rush first with a synthetic or a plastic matrix. But here, really a proven biologics matrix, which the surgeons have gotten used to and frankly expect, and they should expect, a great biologics matrix, and then prove that and then add to that the drug-eluting component.

我們認為 41x 有機會。我們實際上認為我們將是迄今為止第一個進入市場的抗生素洗脫基質。但我們關心的是它所處的基質，因此不會過度挑剔 TYRX，但我們也不想急於採用合成或塑膠基質。但在這裡，確實存在一種經過驗證的生物製劑基質，外科醫生已經習慣了，坦率地說，他們期待，他們應該期待一種偉大的生物製劑基質，然後證明這一點，然後在其中添加藥物洗脫成分。

But from a regulatory standpoint, it's actually pretty, well, I say pretty straightforward, and I know our regulatory team would laugh at me for that, but a pretty straightforward. Combination development pathway that involves the Center for Device and Radiologic Health combined with the Center for Drugs. You put all that together, and you have the same pathway that we got EluPro through, and we feel pretty confident we'll be able to do that expeditiously with 41x.

但從監管的角度來看，這其實相當簡單，我知道我們的監管團隊會因此嘲笑我，但這確實相當簡單。涉及設備和放射健康中心與藥物中心相結合的共同開發途徑。將所有這些放在一起，你就擁有了與我們獲得 EluPro 相同的途徑，我們非常有信心能夠使用 41x 迅速完成這一目標。

Got it, those are super helpful. That's it from me. Congrats on the quarter, and thanks for taking the questions.

明白了，這些都非常有用。我說的就這些。恭喜本季取得的成績，感謝您回答問題。

Thank you so much.

太感謝了。

There are no further questions at this time. This will conclude today's conference. You may disconnect your lines at this time and thank you for your participation.

目前沒有其他問題。今天的會議到此結束。現在您可以斷開您的線路了，感謝您的參與。