BioCardia Inc (BCDA) 2026 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the BioCardia 2026 first quarter financial results and business update conference call. (Operator Instructions) Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately 1 hour after the end of the call.

各位女士、先生，感謝您稍候。下午好，歡迎參加 BioCardia 2026 年第一季財務業績與業務更新電話會議。(接線員指示) 提醒各位與會者，本次電話會議的音訊正透過網際網路進行即時直播，並同時錄音以供回放。本次電話會議的網路重播將於會議結束後約 1 小時提供。

I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda.

現在我想把電話交給 BioCardia 投資人關係部的 Miranda Peto。Miranda，請開始。

Thank you very much. Good afternoon, and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, President and Chief Executive Officer; and David McClung, the company's Chief Financial Officer.

非常感謝。下午好，感謝各位參加今天的電話會議。與我一同出席的 BioCardia 管理團隊成員包括：總裁兼執行長 Peter Altman，以及公司財務長 David McClung。

During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management's intentions, beliefs, projections, outlook, analyses and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies and obtaining regulatory approvals.

在本次電話會議中，管理層將作出前瞻性陳述，包括涉及 BioCardia 對未來表現與營運結果之預期的陳述，以及對管理層意圖、信念、預測、展望、分析與目前預期的提及。此類因素包括但不限於：開發新產品與新技術以及取得監管核准所固有的不確定性。

Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-K filed with the SEC on March 24, 2026. The content of this call contains time-sensitive information that is accurate only as of today, May 15, 2026. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

前瞻性陳述涉及風險及其他因素，可能導致實際結果與該等陳述存在重大差異。關於這些風險的更多資訊，請參閱 BioCardia 於 2026 年 3 月 24 日向美國證券交易委員會（SEC）提交之 Form 10-K 報告中所述的風險因素與警示性聲明。本次電話會議內容包含具時效性的資訊，僅截至今日（2026 年 5 月 15 日）為準且為正確。除法律要求外，公司不承擔任何公開更新或修訂任何資訊以反映本次電話會議後發生之事件或情況的義務。

It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead.

現在我很高興把電話交給 BioCardia 總裁兼執行長 Peter Altman 醫師。Peter，請開始。

Dr. Altman, this is the operator. Perhaps your line is muted?

Altman 醫師，我是接線員。您的線路可能被靜音了？

Thank you. Thank you, Miranda, and good afternoon to everyone on the call. We have had significant accomplishments this last quarter for our CardiAMP Cell Therapy for the treatment of ischemic heart failure. This is a significant unmet clinical need for which we have FDA breakthrough designation and Medicare reimbursement at $20,000 per treatment procedure today.

謝謝。謝謝你，Miranda，也向所有參與本次電話會議的各位致上下午好。在上一季度，我們在用於治療缺血性心衰竭的 CardiAMP 細胞療法方面取得了重大成果。這是一項重大的未被滿足臨床需求；我們目前已獲得 FDA 突破性療法認定，且 Medicare 對每次治療程序的給付為 20,000 美元。

I'm going to share these accomplishments as they happen, so you can appreciate the dynamics of the recent developments. First, the blinded echocardiography data from the CardiAMP Heart Failure trial presented at the Technology and Heart Failure Therapeutics Conference in Boston in early March was excellent. We described this data readout in our last call, but it bears repeating as the clinical data underlies the value we are creating in the regulatory meetings that have been happening in parallel.

我將按事情發生的順序分享這些成果，讓各位能理解近期發展的動態。首先，3 月上旬在波士頓舉行的 Technology and Heart Failure Therapeutics Conference 上所發表之 CardiAMP 心衰竭試驗的盲性超音波心動圖數據非常出色。我們在上次電話會議中已說明這次數據解讀，但值得再次強調，因為臨床數據是我們在同步進行的監管會議中所創造價值的基礎。

This echocardiography data analyzed by the world-class Echo Core Laboratory at Yale University is data which few, if any, advanced therapies for heart failure have in their trials, and it is long-term, truly blinded, contrast-enhanced echocardiography. The CardiAMP Heart Failure echocardiography results showed compelling signals of enhanced heart function in the treated patients relative to the control patients over time.

這些由耶魯大學世界級 Echo Core Laboratory 分析的超音波心動圖數據，是少數（若有的話）心衰竭先進療法在其試驗中所能取得的資料；而且這是長期、真正盲性、對比增強的超音波心動圖。CardiAMP 心衰竭試驗的超音波心動圖結果顯示，與對照組患者相比，接受治療的患者隨時間推移呈現出心功能改善的有力訊號。

More specifically, the heart volumes of both full heart relaxation and maximum heart contraction did not increase over time in the treated subjects, but did increase in the control subjects who did not receive therapy. Increased heart volumes is the normal course for these patients and results in the heart becoming more spherical and losing its pumping efficiency.

更具體而言，接受治療受試者在心臟完全舒張與最大收縮時的心臟容積並未隨時間增加；但未接受治療的對照組受試者則出現增加。心臟容積增加是此類患者的常見病程，會導致心臟變得更球形並喪失其泵血效率。

Increased volumes have long been known to be correlated with poor long-term outcomes. In CardiAMP-HF, the treated patients did not experience this negative remodeling. In the subgroup having elevated biomarkers of heart stress, these heart function benefits for both full relaxation and full contraction were statistically significant and aligned with the 3 tiers of the composite outcome of: one, living longer without heart replacement therapy such as LVAD or transplant; two, having fewer major adverse events such as heart attacks, strokes and hospitalizations; and three, having a better quality of life.

長期以來已知，容積增加與不良的長期預後相關。在 CardiAMP-HF 中，接受治療的患者未出現這種負向重塑。在具有升高之心臟壓力生物標記的亞組中，無論在完全舒張或完全收縮方面的心功能效益皆達統計顯著，並與複合結局的三個層級一致：第一，在未接受如 LVAD 或移植等心臟替代治療的情況下存活更久；第二，較少發生重大不良事件，如心肌梗塞、中風與住院；第三，生活品質更佳。

This composite endpoint also achieved statistical significance. All of the patients were on maximum guideline-directed medical therapy. And these benefits seen with CardiAMP Cell Therapy were in addition to those provided by the established therapy. This underlines that the CardiAMP Cell Therapy is likely driving a new mechanism of action of microvascular repair, promoting new capillary growth and reducing tissue fibrosis in the heart.

該複合終點亦達到統計顯著。所有患者均接受最大化的指南導向藥物治療。而在既有治療所提供的效益之外，CardiAMP 細胞療法仍展現出額外的益處。這凸顯 CardiAMP 細胞療法很可能正在驅動一種新的作用機轉：微血管修復，促進新的毛細血管生長，並降低心臟組織纖維化。

This is the data we have been discussing with Japan's Pharmaceutical and Medical Devices Agency regarding potential for approval with a rigorous post-marketing study to collect further evidence with respect to both safety and efficacy. I am delighted today to share that in our formal clinical consultation with Japan's Pharmaceutical and Medical Devices Agency, they have said that they are inclined to accept this data as the basis for regulatory submission and approval in Japan for an initial indication aligned closely with the trial results.

這些就是我們一直與日本醫藥品醫療機器綜合機構（PMDA）討論的數據，探討在嚴謹的上市後研究下收集更多安全性與有效性證據，以支持核准的可能性。我很高興在今天分享：在我們與日本 PMDA 的正式臨床諮詢中，對方表示傾向接受這些數據作為在日本進行監管申請與核准的基礎，且初始適應症將與試驗結果高度一致。

They have noted that there is an unmet need in Japan that the CardiAMP Cell Therapy may address. In our 10-Q report today, we also detail that we have received the draft written advisory record from the agency, and it is in alignment with this meeting. BioCardia is already actively preparing for the formal Shonin premarket application for approval in Japan, which we expect will take approximately 7 months to prepare and submit to the agency for review.

他們指出，日本存在 CardiAMP 細胞療法可能可滿足的未被滿足需求。在我們今天的 10-Q 報告中，我們也詳述已收到該機構的書面諮詢紀錄草案，內容與本次會議一致。BioCardia 已在積極準備於日本申請核准的正式 Shonin 上市前申請，我們預期準備並提交供該機構審查約需 7 個月。

We will provide additional updates on this time line ahead. This is excellent news for patients, BioCardia and our investors. We also completed a Q-Sub meeting with FDA Center for Biologics Evaluation and Research on this CardiAMP heart failure data. This discussion focused on our already FDA-approved CardiAMP cell processing platform to extend existing labeling from in vitro diagnostic indication to a therapeutic indication for ischemic heart failure of reduced ejection fraction.

我們將在此時間表之前提供更多更新。這對患者、BioCardia 以及我們的投資人而言都是極佳的消息。我們也已就這些 CardiAMP 心衰竭數據，與 FDA 生物製品評估與研究中心（CBER）完成了一場 Q-Sub 會議。本次討論聚焦於我們已獲 FDA 核准的 CardiAMP 細胞處理平台，如何將既有標示由體外診斷（IVD）適應症延伸至治療性適應症，用於治療射血分率降低之缺血性心衰竭。

FDA made clear that they view the appropriate approval pathway as a premarket approval. FDA had no concerns on the safety of the CardiAMP Cell Therapy and the conversation focused on the efficacy results, which FDA found intriguing. We discussed the potential of advancing to a premarket application based on this data. FDA encouraged BioCardia to complete the ongoing CardiAMP HF II trial to provide support for the premarket application. FDA did also agree to engage on certain elements of the study statistical analysis based on nuances of our composite endpoint and has provided other meaningful advice to BioCardia on the study.

FDA 明確表示，他們認為適當的核准途徑為上市前核准（PMA）。FDA 對 CardiAMP 細胞治療的安全性沒有疑慮，對話重點放在療效結果，而 FDA 認為這些結果相當引人關注。我們討論了基於這些數據推進至上市前申請的可能性。FDA 鼓勵 BioCardia 完成正在進行的 CardiAMP HF II 試驗，以為上市前申請提供支持。FDA 也同意就研究統計分析的某些要素進行交流（基於我們複合終點的細微差異），並向 BioCardia 就該研究提供了其他具實質意義的建議。

The 4 activated centers in the ongoing CardiAMP Heart Failure II study have continued to enroll patients. The trial is designed as a 250-patient study where 160 patients are needed to have 80% power. We have additional centers interested in participating that we are onboarding and have plans to expand as fast as resources allow. Completing the CardiAMP Shonin premarket application for approval in Japan and enrolling CardiAMP Heart Failure II are our top priorities.

正在進行的 CardiAMP Heart Failure II 研究中，已啟動的 4 個中心持續招募患者。該試驗設計為 250 名患者的研究，其中需要 160 名患者以達到 80% 的檢定力。我們還有其他有意參與的中心正在導入中，並計畫在資源允許的情況下盡快擴增。完成 CardiAMP Shonin 上市前申請以取得日本核准，以及推進 CardiAMP Heart Failure II 的招募，是我們的首要優先事項。

Results also from our second clinical program of the CardiAMP Cell Therapy in chronic myocardial ischemia have been accepted for oral presentation next week at the prestigious EuroPCR meeting. We expect these results will be available on Wednesday. We have also completed the pre-submission meeting with FDA on the approval of the Helix Transendocardial Delivery System in recent weeks. FDA agreed that there are 2 pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance or compatibility with general classes of agents.

我們第二個臨床計畫——CardiAMP 細胞治療用於慢性心肌缺血——其結果也已獲接受，將於下週在享有盛名的 EuroPCR 會議進行口頭報告。我們預期這些結果將於週三公布。此外，我們在近期也已就 Helix 經心內膜遞送系統（Helix Transendocardial Delivery System）的核准，與 FDA 完成了提交前（pre-submission）會議。FDA 同意 Helix 的上市許可有兩條途徑，並且對 Helix 的安全性數據、裝置性能或與一般類別藥劑的相容性均未提出疑慮。

FDA's preferred route of Helix approval was simultaneous with the approval of the CardiAMP Cell Therapy system for the treatment of heart failure. FDA also suggested a follow-on presubmission incorporating agency advice could enable Helix approval via the de novo pathway as a stand-alone delivery system. We have delivered now on all four catalysts detailed on our last call, having 3 positive regulatory interactions and are very pleased with the outcomes.

FDA 對 Helix 核准的偏好路徑，是與 CardiAMP 細胞治療系統用於治療心衰竭的核准同步進行。FDA 也建議，後續可依據主管機關建議再進行一次提交前會議，或可使 Helix 透過 de novo 途徑，以獨立遞送系統的身分獲得核准。我們已達成上次電話會議所詳述的四項催化劑中的全部，完成了 3 次正向的法規互動，並對結果非常滿意。

For the second quarter of 2026, looking ahead, we expect to complete one or more transactions that will fund Japan PMDA submission for approval and the CardiAMP Heart Failure II trial. I will now pass the call to David McClung, our CFO, who will review our first quarter 2026 financial results. David?

展望 2026 年第二季，我們預期將完成一項或多項交易，以資助日本 PMDA 的核准申請提交，以及 CardiAMP Heart Failure II 試驗。接下來我將把電話交給我們的財務長 David McClung，他將回顧我們 2026 年第一季的財務結果。David？

Thank you, Peter. Good afternoon, everyone. Here are the highlights of our financial results for the quarter ended March 31, 2026. Total expense decreased by $460,000 quarter-over-quarter to $2.3 million in the first quarter of 2026 compared to $2.7 million in the same quarter of 2025. The primary driver of this change, research and development expense decreased $295,000 to $1.2 million in the first quarter of 2026 versus $1.5 million in the first quarter of 2025.

謝謝你，Peter。各位下午好。以下為截至 2026 年 3 月 31 日止季度的財務結果重點。2026 年第一季總費用較前一季減少 46 萬美元至 230 萬美元，相較於 2025 年同季為 270 萬美元。此變動的主要原因在於研發費用減少 29.5 萬美元，2026 年第一季為 120 萬美元，而 2025 年第一季為 150 萬美元。

The decrease relates primarily to the closeout of the CardiAMP Heart Failure trial, partially offset by expenses for early enrollment in the CardiAMP Heart Failure II trial and regulatory activities to advance CardiAMP in Japan. Selling, general and administrative expenses decreased to $1.0 million for the 3 months ended March 2026 as compared to $1.2 million in the quarter ended March 2025, primarily due to lower professional service fees.

此下降主要與 CardiAMP Heart Failure 試驗結案相關，但部分被 CardiAMP Heart Failure II 試驗早期招募費用，以及推進 CardiAMP 在日本法規活動的費用所抵銷。截至 2026 年 3 月止三個月的銷售、一般及行政費用降至 100 萬美元，相較於截至 2025 年 3 月止季度為 120 萬美元，主要由於專業服務費用較低。

Our net loss was $2.3 million for the first quarter of 2026 compared to $2.7 million in Q1 2025. Net cash used in operations was $1.7 million for the first quarter of 2026 compared to $1.6 million in the same quarter in 2025, with the change relating primarily to the timing of supplier payments. The company ended the quarter with cash and cash equivalents totaling $951,000. We will continue to carefully manage our use of capital while still delivering our milestones and objectives.

2026 年第一季淨損為 230 萬美元，相較於 2025 年第一季為 270 萬美元。2026 年第一季營運活動使用之淨現金為 170 萬美元，相較於 2025 年同季為 160 萬美元；此變動主要與供應商付款時點有關。公司於本季末的現金及約當現金合計為 95.1 萬美元。我們將持續審慎管理資本使用，同時仍推進我們的里程碑與目標。

This concludes management's prepared comments. We're now ready to take questions from attendees.

以上為管理層預先準備的發言。我們現在準備接受與會者提問。

(Operator Instructions)

（接線員指示）

Jim Molloy, Alliance Global Partners.

Jim Molloy，Alliance Global Partners。

Hello, this is Laura on for Jim Molloy. So maybe just provide a bit more insight into the regulatory process in Japan? Like what additional work do you think you might need to do alongside the Shonin application that you mentioned from now until submission this year? And also, what's the timing of when you'll hear back from the agency after filing?

你好，我是代替 Jim Molloy 的 Laura。能否請你再多提供一些關於日本法規流程的見解？例如，從現在到今年提交你提到的 Shonin 申請之間，你認為還需要同步完成哪些額外工作？另外，提交後大概何時會收到主管機關的回覆？

Laura, thank you for the question. The dynamics in Japan for submission are rather extensive. So we have already prepared a large STED document, which they've already been reviewing as part of this process, which is essentially a template for the actual submission. But the process ahead will involve auditing our clinical data, auditing our manufacturing and literally going through every thread associated with the submission process.

Laura，謝謝你的提問。在日本的提交作業相當繁複。因此我們已準備了一份大型 STED 文件，他們已在此流程中將其作為審查的一部分；這基本上是正式提交文件的範本。但接下來的流程將包括稽核我們的臨床數據、稽核我們的製造作業，並且逐一檢視與提交流程相關的每一個細節。

They have gone through the data here quite a bit already. So they're pretty sophisticated on what we have. And my expectation is it should go relatively straightforward. This was run under good clinical trial practices. So the submission itself, we have to do some pre-audit work on our own with Japan representatives that will hold our regulatory submission for us under BioCardia's control.

他們已經在這裡相當深入地審閱過資料了。所以他們對我們所擁有的內容相當熟悉、也很成熟。而我的預期是，整體應該會相對順利地推進。這項試驗是在良好臨床試驗規範（GCP）下執行的。因此，就申報本身而言，我們需要先與日本的代表先行進行一些內部的預稽核工作；這些代表將在 BioCardia 的控制之下，替我們持有並提交法規申報資料。

And then we will complete the submission in roughly 7 months, I would expect. And then the process after that is about a year-long review process similar to what's done in the United States for a PMA, where they audit all of the data and the manufacturing and the sterility and all that goes into it. And at the end of the day, we would expect to have approval. Just so everybody on the call is aware, BioCardia, even though we're a small company, we actually have roughly 100 FDA-cleared interventional products here in our Morph platform, and we previously had products approved in Europe.

接著我們預期大約在 7 個月左右完成申報。之後的流程大約是一年的審查期，類似美國的 PMA 審查，他們會稽核所有資料、製造、無菌等所有相關內容。最終我們預期會取得核准。也讓所有與會者了解一下：BioCardia 雖然是小公司，但我們在 Morph 平台上其實約有 100 項已獲 FDA 核准/許可的介入性產品，而且過去也曾有產品在歐洲獲准。

So we have pretty good systems for quality and manufacturing in place, and I don't expect any significant issues. The most significant issue was, of course, the clinical data. That is usually the case. And our expectation is if things go as planned in roughly 19 months, we'll be approved and in the market in Japan. On the other side of that approval, there will be a post-marketing study.

因此我們已建立相當完善的品質與製造系統，我不預期會有任何重大問題。當然，最重要的問題一直都是臨床資料。通常都是如此。我們的預期是，如果一切按計畫進行，大約 19 個月後我們就會在日本獲准並進入市場。在取得核准之後，還會有一項上市後研究。

And the post-marketing study is actually really important, but also valuable for us. We will collect additional procedural safety data. We will establish sort of standard of care outcomes that we track, and this will be done in conjunction with the medical societies in Japan and with Japan's Pharmaceutical and Medical Device Agency.

而這項上市後研究其實非常重要，對我們也很有價值。我們將蒐集更多手術/處置相關的安全性資料。我們也會建立並追蹤某種標準治療（standard of care）的結果指標；這將與日本的醫學會以及日本醫藥品醫療機器綜合機構（PMDA）共同進行。

There will be reimbursement during that post-marketing study. So it will be -- think of it as an early marketing launch, but we'll be doing it with -- under the auspices of all the leading societies in Japan. And these societies are the Japan Circulation Society, The Japan Heart Failure Society and the Cardiovascular Interventional Therapeutics Society. We had leadership from all of those attending our PMDA session and folks on both sides of the table in that session express interest in participating in that post-marketing study, and we're supportive of the efforts ahead. So that's the high level. If you have follow-ups, Laura, that I didn't get anything appropriately, I welcome them.

在該上市後研究期間會有給付（reimbursement）。所以你可以把它想成是一個早期的市場導入，但我們會在日本所有主要學會的支持與監督之下進行。這些學會包括日本循環器學會、日本心不全學會，以及心血管介入治療學會。我們的 PMDA 會議上，這些學會的領導層都有出席；而且在那場會議中，雙方與會者都表達了對參與該上市後研究的興趣，我們也支持接下來的推進工作。以上是高層次的說明。Laura，如果你有我沒有回答到或需要補充的追問，我都很歡迎。

Yes, just as a follow-up, maybe you just talk about more about the market opportunity in Japan. You mentioned how CardiAMP may cover an unmet medical need in the region. So how may you see CardiAMP integrating into the treatment regimen in Japan?

好的，作為追問，也許你可以再多談談日本的市場機會。你提到 CardiAMP 可能可以滿足該地區未被滿足的醫療需求。那麼你如何看待 CardiAMP 在日本的治療流程中會如何整合進去？

Right. So this -- and by the way, Laura, there is an enormous amount of work going through every single drug and therapy that's approved in Japan and demonstrating that there's -- the standard of care there is almost identical to the standard of care here in the United States. There are subtle differences, but nothing that's really that meaningful from our perspective. But from the regulatory perspective, they are meaningful.

好的。所以——順帶一提，Laura，我們做了大量工作，逐一檢視日本核准的每一種藥物與治療方式，並證明那裡的標準治療幾乎與美國的標準治療完全一致。有一些細微差異，但從我們的角度看並沒有真正那麼重要。但從法規角度來看，這些差異是有意義的。

So the market opportunity, I think initially, there's roughly 300,000 patients in Japan with ischemic etiology heart failure who could be appropriate candidates. Initial market though will be much smaller than that. It will be very limited to what we call appropriate use conditions, and we would expect it to be on the order of 20,000 patients. But it's also what we view as a reachable market.

至於市場機會，我認為一開始，日本大約有 30 萬名缺血性病因之心衰竭患者，可能是合適的候選人。不過初期市場會比這個數字小得多。它會非常受限於我們所稱的「適當使用條件」（appropriate use conditions），我們預期規模大約在 2 萬名患者左右。但這也是我們認為可觸及、可實際開發的市場。

And we expect -- historically, in Japan, they have reimbursed a cardiac cell therapy that -- at a reimbursement of around $124,000 per procedure. Now we don't expect that level of reimbursement for what we do because one of the advantages of the CardiAMP Cell Therapy is it can be a cost-effective therapy. But if we use the math of what is our reimbursement today in the United States and what is the expected indication we would have approval for in Japan of 20,000 patients and the $20,000 reimbursement in the United States, that becomes pretty quickly a $400 million market.

而且我們預期——歷史上，日本曾對某種心臟細胞治療給付，每次處置的給付金額約為 124,000 美元。現在我們不預期我們的治療會有那麼高的給付水準，因為 CardiAMP 細胞治療的一個優勢是它可以是一種具成本效益的療法。但如果用我們目前在美國的給付金額來計算，再結合我們預期在日本獲准的適應症所涵蓋的 2 萬名患者，以及美國 20,000 美元的給付水準，那很快就會是一個 4 億美元的市場。

Great. Thank you for taking the questions.

很好。謝謝你回答這些問題。

No problem. I appreciate them, Laura.

不客氣。我很感謝這些問題，Laura。

(Operator Instructions)

（接線員指示）

Showing no further questions, this concludes our question-and-answer session. I would like to turn the conference back over to Peter Altman for any closing remarks.

目前沒有進一步的提問，問答環節到此結束。我想把會議交回給 Peter Altman，請他做結語。

Thank you, Gary. Our efforts advancing cell-based therapies for ischemic heart failure are showing important benefits for patients through the treatment of microvascular dysfunction. The positive regulatory interaction for approval in Japan is a transformative milestone, and we will continue to keep investors current on our progress towards submission and approval. On behalf of our entire BioCardia team, I thank all shareholders for their continued support as you make our efforts possible. Thank you very much.

謝謝你，Gary。我們推進以細胞為基礎的缺血性心衰竭療法的努力，正透過治療微血管功能障礙，為患者帶來重要益處。與日本核准相關的正向法規互動是一個具變革性的里程碑；我們也將持續向投資人更新我們在申報與核准進程上的最新進展。我代表整個 BioCardia 團隊，感謝所有股東持續的支持，因為有你們，我們的努力才得以實現。非常感謝。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

本次電話會議到此結束。感謝各位參加今天的簡報。您現在可以掛線。