Spectral AI Inc (MDAI) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day, and welcome to the Spectral AI Inc. Q1 2026 financial results conference call. (Operator Instructions) Please note, this event is being recorded.

    各位好,歡迎參加 Spectral AI Inc. 2026 年第一季財務業績電話會議。(接線員指示)請注意,本活動將被錄音。

  • I would now like to turn the conference over to Devin Sullivan from The Equity Group. Please go ahead.

    現在我想把會議交給 The Equity Group 的 Devin Sullivan。請開始。

  • Devin Sullivan - Investor Relations

    Devin Sullivan - Investor Relations

  • Thank you, Nick. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2026 first-quarter financial results conference call. Our speakers for today will be Vincent Capone, the company's Chief Executive Officer; and David McGuire, the company's Chief Financial Officer.

    謝謝你,Nick。各位下午好,感謝各位參加 Spectral AI 2026 年第一季財務業績電話會議。今天的講者包括公司執行長 Vincent Capone,以及公司財務長 David McGuire。

  • Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategies, plans, objectives, initiatives, and financial outlook. When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose, and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the company's control that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements.

    在開始之前,我想提醒各位,本次電話會議中所作的某些陳述屬於《1995 年美國私人證券訴訟改革法案》安全港條款所界定的前瞻性陳述,包括有關公司策略、計畫、目標、倡議與財務展望的陳述。在本次電話會議中使用「估計(estimates)」、「預測(projected)」、「預期(expects)」、「預料(anticipates)」、「預報(forecasts)」、「計畫(plans)」、「打算(intends)」、「相信(believes)」、「尋求(seeks)」、「可能(may)」、「將(will)」、「應(should)」、「未來(future)」、「提議(propose)」以及上述詞語的變化形式或類似表述,或其否定形式,均旨在識別前瞻性陳述。這些前瞻性陳述並非對未來表現、狀況或結果的保證,且涉及多項已知與未知的風險、不確定性、假設及其他重要因素,其中許多因素不在公司控制範圍內,可能導致實際結果或結果與前瞻性陳述中討論的內容存在重大差異。

  • As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and other risks and uncertainties as described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

    因此,提醒聽眾不要過度依賴任何前瞻性陳述。投資人應仔細考量前述因素,以及公司向美國證券交易委員會(SEC)提交之文件(包括註冊聲明及公司提交的其他文件)中「風險因素」章節所述的其他風險與不確定性。這些申報文件識別並說明了其他重要風險與不確定性,可能導致實際事件與結果與前瞻性陳述所載內容存在重大差異。

  • With that said, I would now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vince, please go ahead.

    話不多說,現在我想把電話會議交給 Spectral AI 執行長 Vincent Capone。Vince,請開始。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Thanks, Devin, and thank you all for joining us today. We issued our earnings release this afternoon, which contains additional details of our operating results, and we will also file our Form 10-Q with the SEC this evening as well.

    謝謝你,Devin,也感謝各位今天加入。我們今天下午發布了財報新聞稿,其中包含我們營運結果的更多細節;我們也將於今晚向 SEC 提交 Form 10-Q。

  • I'd like to start the call by welcoming David McGuire to his first earnings call as our new Chief Financial Officer. David joined us last week and has been quickly getting up to speed. He brings to MDAI more than 20 years of experience across a variety of accounting and finance functions. Needless to say, we're thrilled to have him join the leadership team.

    我想先歡迎 David McGuire 以新任財務長身分首次參加我們的財報電話會議。David 上週加入我們,並迅速熟悉業務。他在多元的會計與財務職能領域擁有超過 20 年的經驗。不用說,我們非常高興他加入領導團隊。

  • It has been just a short time since we last spoke, so I will keep my remarks fairly brief. As previously announced, we submitted our de novo application to the FDA in June of 2025. Since then, we have replied to additional requests for information and have maintained an active dialogue with the agency. We continue to anticipate a response from the FDA before the end of the second quarter of this year, after which time we hope to move quickly to commercialize our DeepView System by the end of 2026.

    距離我們上次通話時間不長,因此我會讓發言相對簡短。如先前所宣布,我們已於 2025 年 6 月向 FDA 提交 de novo 申請。此後,我們已回覆更多資訊要求,並與主管機關保持積極對話。我們仍預期在今年第二季結束前收到 FDA 的回覆,之後希望能迅速推進,並於 2026 年底前將 DeepView System 商業化。

  • We are executing our strategic priorities with a well-capitalized balance sheet that includes approximately $11.4 million of cash at the end of this quarter. With that as our backdrop, the first quarter was defined really by two words: progress and preparation. Progress as it relates to advancing the development of our DeepView System and continuing to highlight its attributes to physicians and clinicians around the world. And preparation to continue our primary goal of commercializing the DeepView System for the burn indication.

    我們在資本充足的資產負債表支持下執行策略優先事項,本季末現金約為 1,140 萬美元。在此背景下,第一季可用兩個詞來定義:進展與準備。「進展」體現在推進 DeepView System 的開發,並持續向全球醫師與臨床人員展示其特性;「準備」則是為了持續達成我們的主要目標——將 DeepView System 針對燒燙傷適應症推向商業化。

  • Progress was demonstrated when we announced our $31.7 million advanced funding from BARDA in March of 2026. This award included a no-cost extension of the base phase of our contract and the immediate acceleration of the second phase of our contract, which included funding to support and accelerate additional feature design and aspects of the DeepView System and the procurement of up to 30 devices for burn centers, Level 1 trauma centers, and emergency departments.

    「進展」的具體展現是我們於 2026 年 3 月宣布獲得 BARDA 提供的 3,170 萬美元預先資金。該獎助包含我們合約基礎階段的免成本延長,以及第二階段的立即加速推進;其中包括用於支持並加速 DeepView System 額外功能設計與相關面向的資金,以及採購最多 30 台設備,供燒燙傷中心、第一級創傷中心與急診部門使用。

  • Preparation was demonstrated by expanding our leadership team. As noted, we've added the new CFO, we have expanded our Chief Commercial Officer search, and we are working towards completing that in the near term, and we can continue with the engagement with Deloitte Consulting to finalize our commercialization strategy.

    「準備」則體現在擴充我們的領導團隊。如前所述,我們新增了新任財務長,並擴大了首席商務長(Chief Commercial Officer)的招募範圍,正朝近期完成該任命努力;同時,我們也持續與 Deloitte Consulting 合作,以完成商業化策略的定案。

  • Lastly, the finalization of our protocol of our outcome study is also in the works. This outcome study will focus on the benefits derived from the use of the DeepView System across clinician workflows and patients' journeys with an intended scope of approximately 240 patients, spread across 12 clinical sites. The outcome study is designed to demonstrate the surgical precision that results from a wound assessment made by the DeepView System, and how improving time to treatment decisions through the use of the DeepView System will beneficially impact a patient's overall care journey and, therefore, reduce the overall length of stay.

    最後,我們也正在推進結局研究(outcome study)方案(protocol)的定案。該結局研究將聚焦於在臨床人員工作流程與病患就醫旅程中使用 DeepView System 所帶來的效益,預計納入約 240 名病患,分布於 12 個臨床據點。此研究旨在證明 DeepView System 進行傷口評估所帶來的手術精準度,以及透過使用 DeepView System 改善治療決策時間將如何對病患整體照護旅程產生正面影響,進而縮短整體住院天數。

  • We are also working to advance our international sales strategy. As we touched on at our 2025 year-end earnings call in March, upon FDA clearance, we will update our UKCA burn assessment approval, which we secured in 2024 to reflect the improved algorithm, hardware and software included in our FDA submitted DeepView System. We continue to expect to begin initial sales in late 2026, pending such expanded UKCA labeling that will either take place in the UK, Australia, or in the Gulf Cooperation Council countries.

    我們也正推進國際銷售策略。如同我們在 3 月的 2025 年度年終財報電話會議中提到的,在取得 FDA 核准後,我們將更新於 2024 年取得的 UKCA 燒燙傷評估核准,以反映我們提交 FDA 的 DeepView System 中所包含的改良演算法、硬體與軟體。我們仍預期在 2026 年下半年開始初期銷售,但須視該擴充後的 UKCA 標示(labeling)完成情況而定;相關標示更新可能在英國、澳洲或海灣合作委員會(GCC)國家進行。

  • I'd also like to take a moment to provide an update on our handheld device, which we are developing as part of our Department of Defense contract through the contracting consortium called MTEC. On our 2025 year-end earnings call, just this recent March, I noted that we expected to deliver a fully functioning prototype of the device by the end of the second quarter of this year. I'm pleased to announce that we delivered a prototype to MTEC just last week. We hope to be asked to bid on the Phase 3 of that contract later this year and we would anticipate pursuing a 510(k) approval of our handheld device by utilizing our cart-based DeepView System as its predicate.

    我也想花點時間更新我們的手持式裝置進度;該裝置是我們透過名為 MTEC 的承包聯盟、作為國防部合約的一部分所開發。在我們今年 3 月的 2025 年度年終財報電話會議上,我曾提到我們預期在今年第二季末交付一台可完全運作的原型機。我很高興宣布,我們就在上週已向 MTEC 交付原型機。我們希望今年稍晚能受邀就該合約第三階段(Phase 3)投標,並預期以我們的推車式 DeepView System 作為比對器械(predicate),推進手持式裝置的 510(k) 核准。

  • We had a great showing at this year's Annual Meeting of the American Burn Association, which was held in Orlando in April. The conference provided a welcome platform to showcase the DeepView System to more than 2,200 clinicians, researchers, and burn care leaders from around the world. The DeepView System was prominent in a number of podium and poster presentations and Dr. Christopher Lewis presented an overview of the technology, including his real-world experience and results to attendees at the ABA Innovation Theater. These types of events continue to accelerate the awareness of our DeepView System.

    我們在今年 4 月於奧蘭多舉行的美國燒燙傷協會(American Burn Association)年會上表現亮眼。該會議提供了一個良好平台,向來自全球超過 2,200 名臨床人員、研究人員與燒燙傷照護領導者展示 DeepView System。DeepView System 在多場口頭與海報發表中皆相當醒目,Christopher Lewis 醫師也在 ABA 創新劇場(Innovation Theater)向與會者介紹該技術概述,包括其實際臨床經驗與成果。此類活動持續加速市場對我們 DeepView System 的認知。

  • Lastly, we just recently received the Small Business Innovator Award at the inaugural Texas Innovation Conference, which was held April 22 and 23 at the campus of TCU. The award highlights the years of disciplined research, close collaboration with clinicians, and our commitment towards developing a technology with a real-world clinical need that can genuinely improve patient outcomes for burn victims.

    最後,我們最近在於4月22日與23日於TCU校園舉辦的首屆德州創新大會(Texas Innovation Conference)上,獲頒小型企業創新者獎(Small Business Innovator Award)。該獎項彰顯了我們多年來嚴謹自律的研究、與臨床醫師的緊密合作,以及我們致力於開發一項具備真實世界臨床需求、能夠真正改善燒燙傷患者治療結果之技術的承諾。

  • Our commitment goes beyond simply launching our DeepView System into the market. We are focused on delivering this innovative technology in the market in a way that drives real value for patients, clinicians, payers, and of course, our shareholders.

    我們的承諾不僅止於將DeepView System推向市場。我們專注於以能為患者、臨床醫師、支付方,當然也包括我們股東,帶來真正價值的方式,將這項創新技術導入市場。

  • With that, I'll now turn things over to David for a review of our first quarter financial results.

    接下來,我將把時間交給David,請他回顧我們第一季的財務結果。

  • David McGuire - Chief Financial Officer

    David McGuire - Chief Financial Officer

  • Thanks, Vince. I'm excited to join Spectral at this pivotal time in its history, I spent my career helping public companies build scalable financial organizations, drive capital efficiencies, and navigate funding opportunities. After meeting my new colleagues and getting an up-close look at the DeepView System and its underlying technology, I believe Spectral is well positioned to capitalize on a significant market opportunity.

    謝謝你,Vince。我很高興能在Spectral歷史上的這個關鍵時刻加入公司。我職涯一直在協助上市公司建立可擴展的財務組織、提升資本效率,並掌握融資機會。在與新同事會面並近距離了解DeepView System及其底層技術後,我相信Spectral已具備良好定位,可把握一個重大的市場機會。

  • To echo what Vince said, my focus will be on ensuring we have the right financial infrastructure and processes to execute on our strategy. As Vince noted, we delivered a solid start to the year. We remain confident in our ability to continue our R&D efforts and evolve in the commercial business.

    呼應Vince所說,我的重點將放在確保我們具備正確的財務基礎設施與流程,以落實我們的策略。如Vince所提,我們今年開局穩健。我們仍對持續推進研發工作並推動商業化業務的演進充滿信心。

  • Starting with the top line. R&D revenue for Q1 of 2026 was $4 million compared to $6.7 million. The year over year decline was anticipated, primarily driven by the completion of work under the base phase of the company's Project BioShield contract with BARDA. This decline was partially offset by increased activity under other US government contracts including work on the handheld device that Vince referenced earlier.

    先從營收端來看。2026年第一季研發(R&D)營收為400萬美元,相較於去年同期的670萬美元。這項年對年下滑在預期之內,主要原因是公司與BARDA簽訂之Project BioShield合約基礎階段(base phase)工作已完成。此下滑部分被其他美國政府合約活動增加所抵銷,其中包括Vince先前提到的手持式裝置相關工作。

  • Gross margin for Q1 of 2026 improved by 360 bps to 50.8%, driven largely by a higher concentration of direct labor as a component of overall revenue. General and administrative expenses were down slightly to $4.0 million from $4.1 million in the prior period, reflecting continued cost discipline, partially offset by some increased public company infrastructure costs.

    2026年第一季毛利率提升360個基點至50.8%,主要受惠於直接人工在整體營收組成中的占比提高。一般及行政費用由前期的410萬美元小幅下降至400萬美元,反映我們持續的成本紀律,但部分被上市公司基礎設施成本增加所抵銷。

  • Other expense for Q1 2026 was $1.5 million compared to other income of $3.9 million in the prior year period. The change was primarily driven by the noncash fair value adjustments related to our warrant liability.

    2026年第一季其他費用為150萬美元,相較於去年同期其他收入390萬美元。變動主要來自與我們認股權證負債(warrant liability)相關的非現金公允價值調整。

  • Net loss for Q1 2026 was $3.4 million or $0.11 per diluted share compared to net income of $2.9 million or $0.11 per diluted share. Excluding the impact of the warrant fair value adjustments in both periods, the underlying operating performance was generally in line with our expectations.

    2026年第一季淨損為340萬美元,或每股稀釋後虧損0.11美元;相較之下,去年同期為淨利290萬美元,或每股稀釋後盈餘0.11美元。若排除兩期認股權證公允價值調整的影響,基礎營運表現整體上大致符合我們的預期。

  • With respect to our financial condition, as of March 31, 2026, cash was $11.7 million compared to $15.4 million as of December 31, '25. Cash usage during the quarter reflected continued investment in R&D and commercialization initiatives. We remain focused on disciplined capital allocation as we advance towards commercialization.

    就財務狀況而言,截至2026年3月31日,現金為1,170萬美元,較2025年12月31日的1,540萬美元下降。本季現金使用反映我們持續投資於研發與商業化推進計畫。隨著我們邁向商業化,我們仍專注於嚴謹的資本配置。

  • As of March 31, 2026, total debt was $8.5 million with 31.8 million shares outstanding. Overall, we believe we are well positioned to support the next phase of growth, and I look forward to engaging with many of you in the quarters ahead.

    截至2026年3月31日,總負債為850萬美元,流通在外股數為3,180萬股。整體而言,我們認為公司已具備良好條件以支持下一階段的成長,我也期待在未來幾季與各位中的許多人交流。

  • With that, I'll turn the call over to Vince.

    接下來,我把電話會議交回給Vince。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Thanks, David. Before turning things over for questions, I want to address our 2026 revenue outlook. For this year, we are reiterating our revenue guidance of approximately $18.5 million which includes the effect of the accelerated BARDA funding. This guidance does not include any significant contributions from the sale of the DeepView System.

    謝謝你,David。在進入提問之前,我想先說明我們對2026年營收展望。今年我們重申營收指引約為1,850萬美元,其中包含BARDA加速撥款的影響。此指引未納入DeepView System銷售所帶來的任何重大貢獻。

  • With that, I'll open the floor to any questions.

    接下來,我開放現場提問。

  • Operator

    Operator

  • (Operator Instructions) Ryan Zimmerman, BTIG.

    (接線員指示)Ryan Zimmerman,BTIG。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Good afternoon and thanks for taking our questions. And David, welcome. Maybe to start just because FDA clearance is so close, potentially. Vince, it'd be good to expand a little bit on kind of the tenor of your conversations or what you're comfortable saying that gives you confidence that these time lines will stick for 2Q? And then if you talk about some of the commercial activities that you're doing in preparation for the commercial launch of DeepView? And then I have a follow-up.

    各位下午好,感謝讓我們提問。也歡迎David加入。或許先從FDA核准(clearance)可能已非常接近這點開始。Vince,能否請你多談一點你們與FDA溝通的整體氛圍(tenor),或在你方便分享的範圍內,是什麼讓你有信心第二季(2Q)的時程能夠維持?另外,也請談談你們為DeepView商業上市所做的一些商業化準備活動。之後我還有一個追問。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Sure, Ryan, good to hear from you. I guess a few things. I don't -- we have had a number of pre-submission meetings with the FDA prior to the submission of our application in June of 2025. And frankly, I mean we had a number of those. So I felt like our submission was strong.

    當然可以,Ryan,很高興聽到你的聲音。我想有幾點。我們在2025年6月遞交申請之前,已與FDA進行過多次預先提交(pre-submission)會議。坦白說,確實有好幾次,所以我覺得我們的提交內容很扎實。

  • We knew the -- we kind of knew what we needed to provide to the FDA. And I think since our submission date, some of the responses we've had, some of the additional requests for information, we've maintained, as I said earlier, an active dialogue with the FDA. And I don't think -- I think that we're -- I think that we're in a good -- as good a position as we can be. And I think our time line is -- remains solid where we expect a resolution of our application by the end of the second quarter.

    我們知道——我們大致知道需要向FDA提供哪些資料。我認為自提交日起,從我們收到的一些回覆、一些額外資訊的要求來看,我們如同先前所說,持續與FDA保持積極對話。我不認為——我認為我們——我認為我們已處於一個良好——在可達範圍內盡可能良好的位置。而且我認為我們的時程——仍然穩健,我們預期在第二季末前能就申請取得結果。

  • As far as some of the commercial activities that we have been doing in connection with looking to advance sales in 2026, the ABA was a great opportunity for us to meet with some of the participants that have been using our device in the UK and Australia over the last year or so. I continue to think that getting our UKCA expanded labeling to track to what we hope gets approved by the FDA, it will give us a strong balance to place devices in the UK.

    至於我們為推動2026年銷售所進行的一些商業活動,ABA對我們而言是個很好的機會,讓我們能與過去一年左右在英國與澳洲使用我們設備的一些參與者會面。我仍然認為,若我們能取得擴增後的UKCA標示(expanded labeling),並使其與我們希望獲FDA核准的內容一致,將有助於我們在英國更有力地部署設備。

  • We continue to do work with the teams in Australia. I know that a lot of the work that's done with Dr. Fiona Wood out of Perth continues to be strong. I know they continue to use our device and those are great opportunities for us, where we can really drive value towards a disparate group of burn patients to show real value in getting quick treatment decisions for their injuries.

    我們也持續與澳洲的團隊合作。我知道在伯斯(Perth)的Fiona Wood醫師團隊所進行的許多工作仍然很強勁。我知道他們持續使用我們的設備,這些對我們而言都是很好的機會,讓我們能為不同族群的燒燙傷患者創造價值,並展現快速做出傷勢治療決策所帶來的實質效益。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Understood. That's very helpful. And just as a follow-up, that additional BARDA contract that you guys picked up for that $31.7 million in funding. I know you're not going to guide '27 right now, Vince, but is there any conceptual commentary you can give us around kind of the cadence of how you think that contract plays out or whether that's evenly spread, as you begin to use some of that funding? Or is there troughs and valleys, if you will, around how the cadence of development may go with that as we think about our models?

    了解,這非常有幫助。再追問一下,你們新增取得的那份BARDA合約,資金規模為3,170萬美元。我知道你現在不會提供2027年的指引,Vince,但你能否在概念上談談你認為該合約的執行節奏(cadence)會如何展開?例如當你們開始動用部分資金時,是否會較為平均地分布?或是如你所說,會有高低起伏(troughs and valleys),取決於開發節奏,讓我們在建立模型時能更好地理解?

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Yeah. I mean I think you're hitting on a good point on the $31.7 million accelerated funding under Phase 2, we'll see some of that in 2026. I mean revenue recognition is the issue upon why we won't generally see much of it in 2026. But you should see much of that being spread out in 2027, especially with us launching the economic outcome study.

    是的。我是說,我認為你提到了一個很好的重點,關於第二階段(Phase 2)下3,170萬美元的加速資金,我們會在2026年看到其中一部分。我是說,收入認列是我們一般不會在2026年看到太多的原因。但你應該會看到其中很大一部分會在2027年攤開,尤其是我們啟動經濟結果研究之後。

  • We've worked hard on the protocol. That will take some time in 2026, but you should see much of that run through into 2027. So I mean, the cadence I would see would be some of the $31.7 million in 2026, most of it in 2027, and maybe a small component remaining in 2028.

    我們在研究方案(protocol)上投入了很多努力。這在2026年會需要一些時間,但你應該會看到其中很大一部分延續到2027年。所以我的意思是,我預期的節奏會是:2026年會有部分3,170萬美元,2027年是大部分,然後可能在2028年還會剩下一小部分。

  • Ryan Zimmerman - Analyst

    Ryan Zimmerman - Analyst

  • Okay. I'm going to leave it there. I appreciate it. And congrats on all the progress you guys are making.

    好的。我就先到這裡。感謝你。也恭喜你們在各項進展上取得的成果。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Thank you.

    謝謝。

  • Operator

    Operator

  • John Vandermosten, Zacks.

    John Vandermosten,Zacks。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • I'll start out with a question on -- it sounded like you guys had a great participation at the American Burn Association Meeting. And I'm wondering what you were hearing from stakeholders, like medical personnel, hospital administrators and things like that. If there's any anecdotal commentary you have on like your interactions or feedback that they're giving you.

    我先從一個問題開始——聽起來你們在美國燒傷協會(American Burn Association)年會上的參與度很高。我想知道你們從利害關係人那裡聽到了什麼,例如醫護人員、醫院管理者等等。如果你們有任何軼事性的評論,像是互動或他們給你們的回饋。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • John, good to hear from you. Yeah. Look, ABA was good for us. It's an opportunity for us for people to actually touch and feel the device that may have not had the opportunity to do so. I was quite pleased with kind of the wait list that we got of potential installations as we move through the conference.

    John,很高興聽到你的聲音。是的。你看,ABA對我們來說很不錯。這讓一些原本沒有機會的人,能夠實際觸摸並感受這個裝置。我對我們在會議期間獲得的潛在安裝候補名單感到相當滿意。

  • Dr. Chris Lewis' presentation at the innovation theater was well attended and his results spoke very strongly to the benefits of using our technology in diagnosis, assessment of the severity of burn wounds. So for us, it was a great opportunity. And we are, frankly, kind of excited to move through the second, third, and fourth quarter of this year with an opportunity to hopefully commercialize this year.

    Chris Lewis醫師在創新劇場(innovation theater)的簡報出席踴躍,而他的結果非常有力地說明了使用我們技術在診斷、評估燒傷傷口嚴重程度方面的效益。對我們而言,這是個很好的機會。坦白說,我們也很期待在今年第二、第三與第四季持續推進,並希望今年有機會實現商業化。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Got it. And if you win that handheld contract, would you see any additional R&D revenues in 2026? Or would that be pushed out further?

    了解。那如果你們拿下那個手持式合約,你們會在2026年看到任何額外的研發(R&D)收入嗎?還是會再往後延?

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Yeah. No, that's a great question. That contract comes up. We don't expect to hear about whether or not we were selected to participate in Phase 3 of that contract until very late in 2026. I believe the decision time point in that is December of 2026.

    是的。不,這是個很好的問題。那個合約會進入下一步。我們預期要到2026年非常晚的時候,才會知道我們是否被選中參與該合約的第三階段(Phase 3)。我相信那個決策時間點是在2026年12月。

  • So we should see none of that in 2026 and hopefully, if we're lucky enough to be asked to participate in the quote process, we would see some of that in -- most of that in 2027 and 2028. I'm really proud of the work our team has done on our handheld device, our ability to distribute to MTEC, a prototype last week really speaks to the effort of our team to get things done in a timely fashion. And we're just going to continue to plow forward with our goals and our time lines to really -- to see some real success in '26 and '27.

    所以我們在2026年應該不會看到任何相關收入;而如果我們夠幸運被邀請參與報價流程(quote process),我們會在——大部分會在2027年和2028年看到。我對我們團隊在手持式裝置上的工作感到非常自豪;我們上週向MTEC交付原型機的能力,確實反映了團隊為了按時完成所付出的努力。我們會持續朝著目標與時間表全力推進,真正——在'26與'27看到實質的成功。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Got it. And how difficult would it be to layer on the Total Body Services -- Surface Area module. You talked about that before as being kind of another investment that you guys might make into the product? How hard it would be to layer that on to the anticipated deployment coming up? And then are there any regulatory hurdles of that or timing hurdles? Or is that just kind of a software upgrade that you could provide?

    了解。那要把全身服務——體表面積(Total Body Services -- Surface Area)模組疊加上去有多困難?你之前提過那算是你們可能會對產品再投入的一項投資。要把它加到即將到來的預期部署上有多難?另外,這在法規上或時程上有任何障礙嗎?還是說那基本上就是你們可以提供的軟體升級?

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • So we do have a TBSA tool included in our FDA submitted device. So we're excited to roll that out if we get FDA approval. Our team has been working hard on an advancement on that. We affectionately call it TBSA 2 internally and that software upgrade should be available in 2027.

    所以,我們在提交給FDA的裝置中已包含TBSA工具。我們很期待在取得FDA核准後推出。我們團隊也一直在努力推進其升級版本。我們內部親切地稱它為TBSA 2,而那個軟體升級應該會在2027年可用。

  • And it should provide even additional support for clinicians and attending physicians to provide a patient with a strong image and analysis for them to understand how much of their body has been burned, what area will heal, what area will not heal. Almost as if you're going to provide a patient with an x-ray for them to see where their bone was broken. I'm excited that we can include TBSA component in the FDA submitted DeepView System. And I'm even more excited with the work that we're doing with the TBSA 2 and ultimately potentially TBSA 3 to really make this feature valuable for clinicians.

    它應該能為臨床醫師與主治醫師提供更多支援,讓他們能向病患提供清晰的影像與分析,協助理解身體有多少部位被燒傷、哪些區域會癒合、哪些區域不會癒合。幾乎就像提供病患一張X光片,讓他們看到骨頭哪裡斷了。我很高興我們能在提交給FDA的DeepView System中納入TBSA組件。我也更期待我們在TBSA 2,以及最終可能的TBSA 3上所做的工作,能真正讓這項功能對臨床人員更有價值。

  • John Vandermosten - Analyst

    John Vandermosten - Analyst

  • Are there any regulatory hoops you have to go through to add that TBSA 2 or 3 on?

    那要加上TBSA 2或3,你們需要走任何法規程序嗎?

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • We should be okay provided that the DeepView System TBSA component is approved as a de novo -- as part of our de novo application. The rest of that may be 510(k), but it's no more complicated than that. It may not even rise to the level of a 510(k), but it will be no more complicated than that.

    只要DeepView System的TBSA組件能以de novo——作為我們de novo申請的一部分獲得核准,我們應該就沒問題。其餘部分可能會走510(k),但不會比這更複雜。甚至可能不需要到510(k)的程度,但不會比那更複雜。

  • Operator

    Operator

  • This concludes our question-and-answer session. I would like to turn the conference back over to Vincent Capone, Chief Executive Officer, for any closing remarks.

    我們的問答環節到此結束。我想把會議交回給執行長Vincent Capone,請他做結語。

  • Vincent Capone - Chief Executive Officer

    Vincent Capone - Chief Executive Officer

  • Great. Thank you. To close, I want to again thank our investors for you supporting our company. I want to reiterate how excited we are about what lies ahead for our company. Our shareholders, patients and clinicians across the country and around the world.

    很好,謝謝。最後,我想再次感謝各位投資人對我們公司的支持。我想重申,我們對公司未來的發展感到非常振奮——對我們的股東、病患,以及全國與全球各地的臨床人員而言。

  • I also would like to remind you to vote your shares at our upcoming annual meeting. Lastly, I want to thank you all for your attendance and interest in our company, and I hope you all have a good evening. Thank you.

    我也想提醒各位,請在即將到來的年度股東大會上為你們的持股投票。最後,感謝各位今天的出席以及對我們公司的關注,祝各位今晚愉快。謝謝。

  • Operator

    Operator

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

    本次會議到此結束。感謝各位參加今天的簡報。您現在可以中斷連線。