Nuwellis Inc (NUWE) 2024 Q3 法說會逐字稿

Good day everyone and welcome to Nuwellis third quarter, 2024 earnings conference call.

大家好，歡迎參加 Nuwellis 2024 年第三季財報電話會議。

At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing star one on your telephone keypad. You may withdraw yourself from the queue by pressing star two. Please note this call may be recorded. I'll be standing by if you should need any assistance. It is now my pleasure to turn the program over for forward-looking statements. Vivian Cervantes, Investor Relations.

此時，所有參與者都處於只聽模式。稍後，您將有機會在問答環節中提問。您可以隨時按下電話鍵盤上的星號一號註冊提問。您可以按二號星退出佇列。請注意，此通話可能會被錄音。如果您需要任何幫助，我會隨時待命。現在我很高興將該計劃轉交給前瞻性陳述。維維安·塞萬提斯，投資者關係。

Thank you. Good morning, everyone and welcome to Nuwellis earnings conference call for the third quarter ended September 30, 2024. All participants will be in listen-only mode. Should you need assistance. Please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions to ask the questions. You may press star on your Touchtone pad.

謝謝。大家早安，歡迎參加 Nuwellis 截至 2024 年 9 月 30 日的第三季財報電話會議。所有參與者將處於僅聽模式。如果您需要協助。請按星號鍵，然後按零，向會議專家發出訊號。今天的演講結束後，將有機會提問。您可以按下觸控板上的星號。

Thank you for joining today's conference call to discuss Nuwellis corporate developments and financial results for the third quarter ended September 30, 2024, in addition to myself with us today are Nestor Jaramillo Nuwellis Inc President and CEO, Director, John Jefferies, Our Chief Medical Officer, as well as Rob Scott, Our CFO at 8 AM Eastern Time today. No released financial results for the third quarter, 2024. If you have not received no earnings release, please visit the investors page on the company's website during today's call, the company will be making forward-looking statements all forward-looking statements made during today's call will be protected under the private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends as well as our estimated results or performance are forward-looking statements. All forward-looking statements 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.

感謝您參加今天的電話會議，討論Nuwellis 公司發展和截至2024 年9 月30 日的第三季度財務業績，今天與我們在一起的除了我本人之外，還有Nestor Jaramillo Nuwellis Inc 總裁兼首席執行官、董事、我們的首席醫療官John Jefferies ，以及我們的財務長 Rob Scott，東部時間今天上午 8 點。尚未發布 2024 年第三季財務業績。如果您沒有收到任何收益發布，請在今天的電話會議期間訪問公司網站上的投資者頁面，該公司將做出前瞻性聲明，今天電話會議期間做出的所有前瞻性聲明將受到《私人證券訴訟改革法》的保護1995 年。任何與未來事件和市場趨勢的預期或預測以及我們的估計結果或績效相關的陳述均為前瞻性陳述。所有前瞻性陳述均基於我們目前的估計和各種假設。這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。

All forward-looking statements are based upon current available information and the company assumes no obligation to update these statements accordingly. You should not place undue reliance on these statements. Please refer to the cautionary statements and discussion of risks in the company's filings with the securities and exchange commission including the latest 10-K with that. I now would like to turn the call over to Nestor.

所有前瞻性陳述均基於當前可用信息，本公司不承擔相應更新這些陳述的義務。您不應過度依賴這些陳述。請參閱該公司向美國證券交易委員會提交的文件（包括最新的 10-K 報告）中的警示性聲明和風險討論。我現在想把電話轉給內斯特。

Thank you Vivian, and good morning, everyone. Welcome to Nuwellis third quarter, 2024 earnings conference call on today's call. I will provide an overview of our third quarter performance and give an update on our strategic initiatives. Followed by Dr. Jefferies, Our Chief Medical Officer who will provide a summary of the recent publication on the efficacy of new. Well in a real world community hospital setting.

謝謝維維安，大家早安。歡迎參加今天召開的 Nuwellis 2024 年第三季財報電話會議。我將概述我們第三季的業績，並介紹我們策略舉措的最新情況。接下來是我們的首席醫療官 Jefferies 博士，他將提供最近發表的有關新藥功效的摘要。在現實世界的社區醫院環境中。

Our Chief Financial Officer Rob Scott will then provide detailed commentary on our financial results before opening up the call for questions followed by my closing remarks.

然後，我們的財務長 Rob Scott 將在開始提問之前對我們的財務業績提供詳細的評論，然後是我的結束語。

Nuwellis has generated 2.4 million in revenue for the third quarter of 2024. A 2% decrease year over year. However, sequentially, we grew 8% over Q2.

Nuwellis 2024 年第三季的營收為 240 萬美元。年減2%。然而，環比第二季度增長了 8%。

While the adult category of our business saw a lower volume of patients treated during the summer month. Our pediatric customer category experienced a surge in revenue of 28% compared to the same quarter of last year driven by three new pediatric accounts opened this quarter including one of the largest hospital networks in Florida.

雖然我們業務的成人類別在夏季接受治療的患者數量有所減少。與去年同期相比，我們的兒科客戶類別收入猛增 28%，這得益於本季度開設的三個新兒科帳戶，其中包括佛羅裡達州最大的醫院網絡之一。

We also experienced a sequential improvement in pediatric senses.

我們也經歷了兒科感官的連續改善。

In addition to the pediatric account, we also opened two additional adult accounts.

除了兒童帳戶外，我們還另外開設了兩個成人帳戶。

We are excited to continue to drive market penetration of our differentiated aqueduct ultrafiltration therapy as we leverage our body of clinical evidence.

我們很高興利用我們的臨床證據繼續推動我們差異化導水管超濾療法的市場滲透。

For the reminder of our customer category, critical care and heart failure were down 25% and 36% respectively on lower consumable utilization and consult sales reflecting the generally lower volume of patients treated during the summer months.

提醒我們的客戶類別，由於消耗品利用率和諮詢銷售下降，重症監護和心臟衰竭分別下降了 25% 和 36%，這反映出夏季治療的患者數量普遍較低。

One of our key initiatives for the last three years have been to build our body of clinical evidence in order to make this therapy standard of care and get into the medical society guidelines.

過去三年我們的關鍵舉措之一是建立我們的臨床證據體系，以使這種療法成為護理標準並進入醫學會指南。

In support of this initiative, I would like now to turn it over to Dr. Jefferies to discuss the latest addition to our growing body of clinical evidence and the impact that this clinical information may have in broad day to day clinical practice. Dr.Jefferies.

為了支持這項倡議，我現在想將其交給 Jefferies 博士，討論我們不斷增長的臨床證據中的最新內容，以及這些臨床資訊可能對廣泛的日常臨床實踐產生的影響。傑弗里斯博士。

Thank you, Nestor and good morning everyone in August, we announced the publication of a new study and current problems in cardiology demonstrating the effectiveness of aqueducts and significantly reducing 60 day hospital readmission rates for patients with acutely compensated heart failure who are otherwise resistant to diuretic treatment in a community hospital setting.

謝謝內斯特，八月大家早安，我們宣布發表一項新的研究和當前心臟病學的問題，證明導水管的有效性，並顯著降低對利尿劑有抵抗力的急性代償性心力衰竭患者的60 天再入院率在社區醫院接受治療。

As a senior author on this paper, I was pleased to see the analysis of an Aquadex program and community based regional hospitals showing how refractory acute decompensated heart failure patients benefited from significant volume loss and weight reduction along with stable renal function and remarkable clinical benefit.

作為本文的資深作者，我很高興看到Aquadex 計劃和社區地區醫院的分析顯示難治性急性失代償性心臟衰竭患者如何從顯著的體積減少和體重減輕以及穩定的腎功能和顯著的臨床獲益中受益。

I would like to highlight that the outcomes of community based hospital setting trial demonstrate the broader applicability and effectiveness of the Aquadex therapy. Real world data in some ways is often more powerful than randomized controlled trials because it uses everyday patients that need to be treated rather than a cohort of pre selected patients which typically occurs as a certain group of academic institutions.

我想強調的是，基於社區的醫院環境試驗的結果證明了 Aquadex 療法更廣泛的適用性和有效性。在某些方面，真實世界的數據通常比隨機對照試驗更有效，因為它使用的是需要治療的日常患者，而不是通常作為某個學術機構群體出現的一組預先選定的患者。

The outcome of this study shows that ultra filtration can be very effective for these real world types of patients.

這項研究的結果表明，超濾對於這些現實世界類型的患者非常有效。

This is vital for new wells strategy as we now have the data to leverage as we expand the use of this therapy to these therapy, to these hospitals in a non academic center setting.

這對於新的油井策略至關重要，因為我們現在擁有可以利用的數據，因為我們將這種療法的使用擴展到這些療法，並擴展到非學術中心環境中的這些醫院。

Going deeper into the study's findings, it showed that favorable Aquadex therapy programs can result and achieved early is shown in this hospital system in the form of reduced acute decompensated heart failure readmissions.

更深入研究研究結果表明，有利的 Aquadex 治療方案可以在該醫院系統中以減少急性失代償性心臟衰竭再入院的形式儘早產生和實現。

There were numerically fewer 30 day acute decompensated heart failure readmissions after aqueduct program initiation compared to pre program initiation with a statistical P value of 0.351. However, at 60 days, there were significantly fewer acute decompensated heart failure readmissions with a statistically significant P value of 0.013.

與計畫啟動前相比，導水管計畫啟動後 30 天急性失代償性心臟衰竭再入院的數量較少，統計 P 值為 0.351。然而，60 天時，急性失代償性心臟衰竭再入院人數顯著減少，統計學顯著 P 值為 0.013。

Additionally, patients experienced significant B reduction with a mean food loss of 9.4 L and a significant weight loss with a mean decrease of 7.4 kg. Notably, ALL 30 patients had stable renal function and no significant change in serum creatinine. A test used to measure kidney function is 72 hours of ultrafiltration therapy.

此外，患者的維生素 B 顯著減少，平均食物損失 9.4 公升，體重顯著減輕，平均減少 7.4 公斤。值得注意的是，ALL 30 例患者腎功能穩定，血清肌酸酐無明顯變化。用於測量腎功能的測試是 72 小時的超濾治療。

Finally, the study had important practical implications for heart failure clinics demonstrating that a successful Aquadex program is reproducible and can be coordinated by general cardiologists without the need for a dedicated heart failure unit.

最後，該研究對心臟衰竭診所具有重要的實際意義，表明成功的 Aquadex 計劃是可重複的，並且可以由普通心臟病專家進行協調，而無需專門的心臟衰竭科室。

We continue to enroll patients in the reverse HF trial which is designed to help increase awareness and provide the data to support becoming standard of care. The study has enrolled over third of the patients contemplated by the protocol.

我們繼續招募患者參加反向心臟衰竭試驗，該試驗旨在幫助提高認識並提供數據以支持成為護理標準。該研究已招募了超過三分之一的方案預期患者。

I welcome any questions on this new evidence during the Q&A session. And now I'd like to turn to Rob to discuss our third quarter financial results.

我歡迎在問答環節中就這項新證據提出任何問題。現在我想請羅布討論我們第三季的財務表現。

Thank you Dr. Jefferies. And good morning everyone turning to the Q3 financial results revenue for the third quarter was $2.4 million representing an 8% sequential growth and a 2% decline over the prior year period.

謝謝杰弗里斯博士。大家早安，大家都在關注第三季的財務業績，第三季的營收為 240 萬美元，比上年同期成長 8%，比上年同期下降 2%。

Our pediatric customer category surged with a 28% increase compared to a year ago as we expanded our Aquadex offerings to three new pediatric centers. One of which is within is within one of the largest hospital networks in Florida.

隨著我們將 Aquadex 產品擴展到三個新的兒科中心，我們的兒科客戶類別與一年前相比激增了 28%。其中之一位於佛羅裡達州最大的醫院網絡之一內。

Our critical care and heart failure, customer categories were down 25% and 36% year over year respectively. These declines are due to lower consumables utilization in the summer months and also because of console sales, gross margin was 70% for the third quarter compared to gross margin of 57.3% in the prior year quarter. The margin improvement was primarily driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses selling general and administrative expenses were $2.7 million in the third quarter.

我們的重症監護和心臟衰竭客戶類別較去年同期分別下降 25% 和 36%。這些下降是由於夏季消耗品利用率較低以及控制台銷售所致，第三季的毛利率為 70%，而去年同期的毛利率為 57.3%。利潤率的提高主要是由於消耗品製造量的增加以及固定間接製造費用的降低，第三季銷售一般和管理費用為 270 萬美元。

A decrease of approximately 21% as compared to $3.4 million in the third quarter of 2023.

與 2023 年第三季的 340 萬美元相比，減少約 21%。

The decrease in SG&A was primarily realized through efficiency initiatives enacted in the second half of 2023.

SG&A 的減少主要是透過 2023 年下半年頒布的效率措施實現的。

Third quarter, research and development expense was $486,000 compared to $1.1 million in the prior year period.

第三季研發費用為 486,000 美元，去年同期為 110 萬美元。

The decrease in R&D expense was primarily due to reduce consulting fees and compensation related expenses.

研發費用減少主要是因為諮詢費和薪資相關費用減少。

Total operating expenses were $3.2 million in the quarter. A decrease of approximately $1.4 million or 30% as compared to the third quarter of 2023. As we continue to realize savings from operating efficiency initiatives enacted in the second half of 2023 operating loss in the third quarter was $1.5 million compared to an operating loss of $3.2 million in the prior year period, resulting in a $1.7 million period over period improvement, net income attributable to common shareholders in the third quarter was $2.4 million or a gain of a $74 per share compared to a net loss attributable to common shareholders of $3.4 million or a loss of $63.27 per share for the same period in 2023 third quarter, net income improvement was primarily the result of the revaluation of a prior period, warrant liability resulting in a $3.9 million benefit.

該季度的總營運費用為 320 萬美元。與 2023 年第三季相比減少約 140 萬美元，即 30%。隨著我們繼續透過 2023 年下半年實施的營運效率措施實現節省，第三季的營運虧損為 150 萬美元，而上年同期的營運虧損為 320 萬美元，導緻同期改善 170 萬美元，第三季度歸屬於普通股股東的淨利為240 萬美元，即每股收益74 美元，而2023 年第三季歸屬於普通股股東的淨虧損為340 萬美元，即每股虧損63.27 美元收入改善主要是由於對上期認股權證負債進行重估，帶來了390 萬美元的收益。

We ended the third quarter with $1.9 million in cash and cash equivalents and with no debt on the balance sheet.

第三季末，我們擁有 190 萬美元的現金和現金等價物，資產負債表上沒有債務。

Our cash balance in the third quarter includes the August and July registered direct offerings priced at the market under NASDAQ rules with gross proceeds of approximately $892,000*$2million respectively.

我們第三季的現金餘額包括根據納斯達克規則在市場上定價的 8 月和 7 月註冊直接發行，總收益分別約為 892,000 美元 * 200 萬美元。

As we previously disclosed, we mutually terminated our license and distribution agreement with [Csar] Medical resulting in a settlement in October whereby they agreed to pay Nuwellis $900,000. By the end of the calendar year, we received approximately $500,000 in the month of October.

正如我們先前所揭露的，我們共同終止了與 [Csar] Medical 的許可和分銷協議，最終於 10 月達成和解，他們同意向 Nuwellis 支付 90 萬美元。到年底，我們在 10 月收到了大約 50 萬美元。

This concludes our prepared remarks. Operator. We would now like to open the call to questions.

我們準備好的演講到此結束。操作員。我們現在要開始提問。

At this time. If you would like to ask a question, please press star one. Now on your telephone keypad once again to ask a question that is star 1 one moment. While we queue.

此時。如果您想提問，請按星號一。現在，再次在電話鍵盤上詢問一個問題，即星號 1 一會兒。當我們排隊的時候。

If you've press star one before, please press star one. Now star one to ask a question.

如果您之前按過星號一，請按星號一。現在加星號來提問。

We'll take a question from Jonathan Soff. Overall, your line is open.

我們將回答喬納森·索夫的問題。總體而言，您的線路是開放的。

Thank you guys. Good morning. I would like to ask you to walk us through an economic comparison of the now profitable, given the heightened reimbursement, the now profitable way that hospitals can use aqueduct in the outpatient setting. And the money they would make, you know, versus the money they would make doing ultra filtration a different way for these same outpatients.

謝謝你們。早安.我想請您向我們介紹一下目前盈利的經濟比較，考慮到報銷的增加，醫院在門診環境中使用渡槽的目前盈利方式。你知道，他們會賺到的錢，與他們為這些相同的門診病人以不同的方式進行超濾所賺到的錢相比。

Very good question, Jonathan. This may take a little long this explanation. Right now, the only way that ultrafiltration is provided is in the inpatient and patients get hospitalized and it takes anywhere from 3 to 5 days to remove the fluid of these patients. If you and then the reimbursement is there are 3DRGs that reimburses the inpatient treatment of heart failure. Any one of those 3DRGs, the hospital incurs a loss because the cost of a patient to be treated for heart failure, for decompensated heart failure in the hospital is about $24,000 and the highest DRG is probably $12,000. So the hospital incurs a loss with this reimbursement. Now, the hospitals can provide ultra situation in the outpatient setting. It could be in an observation unit or even in the and the patient doesn't need to be I admitted in the hospital.

很好的問題，喬納森。這個解釋可能要花一點時間。目前，提供超濾的唯一方法是在住院患者中進行，患者住院後需要 3 到 5 天才能清除這些患者的體液。如果您報銷的是 3DRG，可以報銷心臟衰竭的住院。對於這些 3DRG 中的任何一項，醫院都會遭受損失，因為患者因心臟衰竭、失代償性心臟衰竭在醫院接受治療的費用約為 24,000 美元，最高的 DRG 可能為 12,000 美元。所以這筆報銷讓醫院蒙受了損失。現在，醫院可以在門診提供超情境服務。它可能在觀察室，甚至在醫院，病人不需要住院。

Secondly, the reimbursement now is $1639 per day. So, if the patient needs three days to remove the fluid that the physician recommends, then it would be that amount every day.

其次，現在的報銷是每天1639美元。因此，如果患者需要三天來排出醫生建議的液體，那麼每天的量就是這個量。

So the hospital now given our cost of the circuit, which is $900 the hospital can make $700 a day for treating these patients. And again, the patient can take anywhere from 33 days treating the patient coming in and out of the out of the observation unit. And so therefore the hospital would be, would have more profit from the therapy.

因此，醫院現在考慮到我們的線路成本為 900 美元，醫院每天可以為治療這些患者賺取 700 美元。同樣，患者可以在 33 天內對進出觀察室的患者進行治療。因此，醫院將從治療中獲得更多利潤。

Right. So you would see this totally replacing the impatient population, you know, for those that don't have to be there for some other reason.

正確的。所以你會看到這完全取代了那些不耐煩的人群，你知道，對於那些因其他原因不必在那裡的人來說。

Right? We envision exactly it could replace admitting the patient in the hospital, decongesting the patient in the or in the observation unit, not needing to admit the patient in the ICU or in the hospital, therefore, will replace the inpatient treatment of using ultra Patient.

正確的？我們準確地設想，它可以取代將患者收治入院，減輕患者在觀察室或觀察室的擁塞，不需要將患者收治在 ICU 或醫院，因此，將取代使用 ultra Patient 的住院治療。

Okay. So then, I mean, is there any difference in actual outpatient medical benefit between, you know, these two procedures, meaning Aquadex versus you know, some sort of dialysis machine they might use, you know, because as long as the hospital can justify doing no harm, it's always going to make more money if it can.

好的。那麼，我的意思是，這兩種程序之間的實際門診醫療福利是否有任何差異，這意味著 Aquadex 與他們可能使用的某種透析機，你知道，因為只要醫院能夠證明合理不做壞事，如果可以的話，它總是會賺更多的錢。

Correct, we believe that treating patients with decompensated heart failure in the outpatient would be more profitable for the hospitals.

是的，我們相信在門診治療失代償性心臟衰竭患者會為醫院帶來更多利潤。

And I forgot to mention one other aspect of treating patients in the inpatient. If the patient gets readmitted within 30 days, then the hospital doesn't get paid by CMS or most private payers. And also it assumes some penalties. So that's another savings because the patient was not admitted.

我忘了提及住院治療患者的另一個面向。如果患者在 30 天內重新入院，那麼 CMS 或大多數私人付款人就不會向醫院支付費用。而且它還承擔一些處罰。由於患者沒有入院，這又是一項節省。

In terms of the patient, the benefit to the patient. It is well documented that patients that get hospitalized, regardless of what is the condition, the mortality rate goes up.

從患者角度來說，對患者有利。有充分證據表明，住院的患者，無論病情如何，死亡率都會上升。

So therefore, by not having to be admitted, you don't are exposed to those high mortality rates.

因此，不必入院，您就不會面臨如此高的死亡率。

In addition, the treatment would be anywhere from 4 to 6 hours and the patient after that, the patient can just go home and then schedule the next visit.

此外，治療時間為 4 至 6 小時，之後患者可以回家，然後安排下一次就診。

So for the patient, it would be much better and also a better quality of life.

所以對於病人來說，這會好得多，生活品質也會更好。

Okay, so then, you know, what's the crux of what, what went wrong with DaVita? Why that never matured into what it was, you know, hoping to mature into.

好吧，那麼，你知道，達維塔出了什麼問題的癥結所在嗎？為什麼從來沒有成熟到現在的樣子，你知道，希望成熟到什麼程度。

Yeah, Jonathan, that's a, that's a good question, you know, and we have internally debated. What were the reasons when we started the conversations with DaVita? We had a champion in that organization as soon as we signed the agreement that champion got promoted and then we were assigned a different team.

是的，喬納森，這是一個很好的問題，你知道，我們已經在內部進行了辯論。我們開始與 DaVita 對話的原因是什麼？我們一簽署協議，組織就有了冠軍，冠軍就得到了晉升，然後我們被分配到了另一個團隊。

So we lost a little bit of momentum there.

所以我們在那裡失去了一點動力。

Also, at the beginning, we did not target the right centers. We target centers that were good customers of nues and they were happy treating the patients by their staff in the inpatient. They did not need it, the DaVita personnel.

另外，一開始我們並沒有瞄準正確的中鋒。我們的目標中心是 nus 的好客戶，他們很樂意由住院部的工作人員治療患者。他們不需要，達維塔人員。

So then we pivot and then we went to accounts that were familiar with ultra filtration. They had issues with capital budgets and personnel and it just took a little too long for them to get ready to use ultra filtration provided by DaVita.

因此，我們轉向了熟悉超濾的客戶。他們在資本預算和人員方面存在問題，而且他們花了太長時間才準備使用 DaVita 提供的超過濾。

All right, thanks. You know, also when can we expect the reverse HF trial date? I'm sorry, I had con commitment calls. So maybe you said something about the time line and, and enrollment percent already. And if you did, would you please reiterate that.

好的，謝謝。您知道，我們什麼時候可以期待反向 HF 審判日期？抱歉，我接到了詐騙承諾電話。也許你已經說了一些關於時間線和入學率的話。如果您這樣做了，請您重申。

Right at the, at the current rate of enrollment, we expect to finish the enrollment period by the middle of 2026.

目前，按照目前的入學率，我們預計將在 2026 年中期完成入學期。

And then after that, there is a 90 day followup and then we would have the data analyzed and be ready to submit by the end of 2026.

之後，我們將進行 90 天的跟進，然後我們將分析數據並準備在 2026 年底之前提交。

Okay. You mean, okay, to the FDA, you mean.

好的。你的意思是，好吧，FDA，你的意思是。

Correct?

正確的？

Well, not to the FDA. This is not, I'm sorry not to the FDA, to submit to publications and to submit to the medical societies for them to include this therapy in their guidelines.

好吧，不是 FDA。很抱歉，這並不是向 FDA 提交，也不是向出版物提交，也不是向醫學會提交，以便他們將這種療法納入其指南。

Assuming, and we expect the results to be very favorable.

假設，我們預期結果會非常有利。

And did you give an update for Vivian progress?

有更新 Vivian 的進度嗎？

Yes, we continue the development phase of BN and we're estimating that by the end of the 2025 we will be ready to start the inhuman clinical study. It would be an IDE trial that will be an FDA trial and we have already agreed on the protocol with the FDA.

是的，我們將繼續 BN 的開發階段，預計到 2025 年底，我們將準備好開始非人道臨床研究。這將是一項 IDE 試驗，也是一項 FDA 試驗，我們已經與 FDA 就方案達成協議。

Thank you very much, Nestor.

非常感謝你，內斯特。

Thank you, Jonathan.

謝謝你，喬納森。

And once again to ask a question that is star one. Now on your telephone keypad, we'll move next to Anthony Vendetti of Maxim Group.

再問一個明星問題。現在，在您的電話鍵盤上，我們將轉到 Maxim Group 的 Anthony Vendetti 旁邊。

Thanks. Good morning. So, these new rates which are substantially higher for ultra filtration go into effect 1,125 correct? And, and how are you internally preparing the organization to capitalize on this and in all you know, all three phases, right? Pediatric critical care and heart failure, specifically, how are you addressing this with your customers? You know, what's the you know, go forward plan.

謝謝。早安.那麼，這些遠高於超濾的新費率生效 1,125 正確嗎？而且，您如何在內部準備組織利用這一點以及您所知道的所有三個階段，對嗎？特別是兒科重症監護和心臟衰竭，您如何與客戶解決這個問題？你知道，你知道什麼，繼續計劃。

Yes, good question. And good morning Anthony. Well, first of all, we're very excited about this new as assigned code that triples the reimbursement. We are preparing by identifying those hospitals, those centers, those accounts that used to do ultrafiltration in the outpatiet setting. And back in 2012, there were about 12 centers that were doing ultrafiltration in the outpatient setting. And it requires a setup requires patients to be able to come in, sit down in the chair and then get the ultrafiltration therapy performed.

是的，好問題。早安，安東尼。好吧，首先，我們對這個新的分配代碼感到非常興奮，它使報銷金額增加了三倍。我們正在透過確定那些曾經在門診進行超濾的醫院、中心和帳戶來進行準備。早在 2012 年，大約有 12 個中心在門診進行超濾。它需要一個設置，要求患者能夠進來，坐在椅子上，然後進行超濾治療。

And also they need to set up what is called the order set.

他們還需要設定所謂的訂單集。

And also we going to ensure that those hospitals in those territories, do have coverage from either local, CMS, administrators and also private payers. So, we're getting ready on both, helping the hospitals get set up as well as making sure that the reimbursement is a ready to be, filed.

我們還將確保這些地區的醫院確實得到當地、CMS、管理人員和私人付款人的承保。因此，我們正在做好這兩方面的準備，幫助醫院建立並確保報銷準備就緒並提交。

Okay. And do, do you feel like at this point you have all the personnel you need in place or do you believe that with this higher reimbursement? You, you may hire a couple of you know, either clinical people or sales people to try to accelerate the adoption.

好的。您覺得現在您是否已經擁有所需的所有人員，或者您是否相信有了更高的報銷額？您可以聘請一些您認識的人，無論是臨床人員還是銷售人員，以嘗試加速採用。

Yeah, good question. Right now. We have nine territories in place with the sales reps and clinical specialists. So we can start with those in those territories, most of these hospitals that we're doing ultra filtration in the outpatient in the past we haven't covered. So we will not need to add anyone in the field to get started with the ultra filtration in the outpatient. We are going to look into bringing some expertise when it comes to reimbursement inside a in the headquarters.

是的，好問題。現在。我們在九個地區設有銷售代表和臨床專家。因此，我們可以從這些地區的醫院開始，大多數醫院我們過去都在門診進行超濾，但我們沒有覆蓋。因此，我們不需要在現場增加任何人來開始在門診進行超濾。我們將考慮在總部內部引入一些報銷方面的專業知識。

Okay, great. Thank you very much. I'll back in with you. Appreciate it.

好的，太好了。非常感謝。我會回來和你一起。欣賞它。

And once again, that is star one to ask a question, one moment while we queue and it appears that we have no further questions at this time. I'd be happy to return the conference to our host for any concluding remarks.

再一次，這是提問的明星，在我們排隊的那一刻，看來我們目前沒有其他問題了。我很樂意將會議返回給我們的東道主以供總結發言。

Thank you operator. We continue to see momentum in our business. With new accounts steadily opening on increasing awareness of the efficacy and supporting clinical evidence for all Aquadex ultra filtration in the adult and in the pediatric customer categories. We believe these clinical results as described by Dr. Jefferies will have a positive impact in growing our business and supporting aqueduct in becoming the standard of care for fluid removal when diuretics are ineffective.

謝謝運營商。我們繼續看到我們的業務發展勢頭。隨著新帳戶的不斷開設，人們對所有 Aquadex 超濾在成人和兒科客戶類別中的功效和支持臨床證據的認識不斷提高。我們相信 Jefferies 博士所描述的這些臨床結果將對我們的業務發展產生積極影響，並支持導水管成為利尿劑無效時液體清除的護理標準。

As we reported early last week, we were pleased to announce the company received the notice of the from the center of Medicare and Medicaid services also known as CMS.

正如我們上週早些時候報導的那樣，我們很高興地宣布，該公司收到了來自醫療保險和醫療補助服務中心（也稱為 CMS）的通知。

That the Aquadex ultra filtration code will be reassigned to the outpatient reimbursement level most consistent with the administration of ultrafiltration therapy and cost of treatment.

Aquadex 超濾代碼將重新分配到與超濾治療的實施和治療費用最一致的門診報銷水平。

So effective January 1st, 2025 the facility reimbursement fee will increase 297% from $413 to 1,639 per day.

因此，自 2025 年 1 月 1 日起，設施報銷費用將從每天 413 美元增加到 1,639 美元，增加 297%。

With this increased reimbursement, we are opening a new chapter for Nuwellis. We anticipate seeing accelerated top line growth from this rate increase as a point of clarification. A prior announcement reflected reim the reimbursement increase as 397%.

隨著報銷金額的增加，我們為 Nuwellis 翻開了新的篇章。作為澄清點，我們預期此次升息將導致營收加速成長。先前的公告顯示，報銷金額增加了 397%。

Additionally, as reported early last week, the company raised $5.1 million in gross proceeds from warrant exercises and through a warrant inducement solicitation.

此外，據上週稍早報道，該公司透過認股權證行權和認股權證誘導募集籌集了 510 萬美元的總收益。

I want to thank all the stakeholders as well as employees, stockholders, physicians, nurses and patients and health care workers in the field. Without your support, we would not be able to achieve key advances in transforming the lives of patients suffering from fluid overload.

我要感謝所有利害關係人以及該領域的員工、股東、醫生、護士、病人和醫護人員。如果沒有您的支持，我們將無法在改變液體超負荷患者的生活方面取得重大進展。

Thank you for your participation and support.

感謝您的參與與支持。

This does conclude Nuwellis third quarter, 2024 earnings conference call. You may now disconnect your lines and everyone. Have a great day.

Nuwellis 2024 年第三季財報電話會議到此結束。您現在可以斷開線路和所有人的連接。祝你有美好的一天。