Nuwellis Inc (NUWE) 2022 Q4 法說會逐字稿

Good morning and welcome to the Nuwellis fourth quarter and full-year 2022 earnings conference call. (Operator Instructions) Please note that this event is being recorded.

早上好，歡迎來到 Nuwellis 第四季度和 2022 年全年收益電話會議。 （操作員說明）請注意，正在記錄此事件。

Now I'd like to turn the call over to Ms. Vivian Cervantes, Investor Relations. Please go ahead.

現在我想把電話轉給投資者關係部的 Vivian Cervantes 女士。請繼續。

Thank you, operator. Hi, everyone. Thank you for joining us in today's conference call to discuss Nuwellis's corporate developments and financial results for the fourth quarter and full year ended December 31, 2022. In addition to myself, with us today are Nestor Jaramillo, Nuwellis's President and CEO; and Lynn Blake, CFO. At 8:00 AM Eastern today, Nuwellis released financial results for the quarter and year ended December 31, 2022. If you have not received Nuwellis's earnings release, please visit the investors page on the company's website.

謝謝你，運營商。大家好。感謝您參加今天的電話會議，討論 Nuwellis 截至 2022 年 12 月 31 日的第四季度和全年的企業發展和財務業績。除了我自己，今天和我們在一起的還有 Nuwellis 總裁兼首席執行官 Nestor Jaramillo；和首席財務官 Lynn Blake。美國東部時間今天上午 8 點，Nuwellis 發布了截至 2022 年 12 月 31 日的季度和年度財務業績。如果您還沒有收到 Nuwellis 的收益發布，請訪問公司網站上的投資者頁面。

During this conference 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, and could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

在本次電話會議期間，公司將作出前瞻性陳述。在今天的電話會議中所做的所有前瞻性陳述都將受到 1995 年《私人證券訴訟改革法案》的保護。任何與對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業績相關的陳述都是前瞻性陳述.所有前瞻性陳述均基於我們當前的估計和各種假設。這些陳述涉及重大風險和不確定性，並可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件存在重大差異。

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 SEC, including the latest 10-K and subsequent reports.

所有前瞻性陳述均基於當前可獲得的信息，公司不承擔更新這些陳述的義務。因此，您不應過分依賴這些陳述。請參閱公司向美國證券交易委員會提交的文件中的警告聲明和風險討論，包括最新的 10-K 和後續報告。

With that, I now would like to turn the call over to Nestor.

有了這個，我現在想把電話轉給內斯特。

Thank you, Vivian, and good morning, everyone. Welcome to Nuwellis's fourth-quarter 2022 earnings conference call. On today's call, I will provide an overview of our fourth quarter and full-year performance and give an update on our strategic initiatives. Our Chief Financial Officer, Lynn Blake, will then provide detailed financial results before opening the call for questions, followed by my closing remarks.

謝謝你，Vivian，大家早上好。歡迎來到 Nuwellis 的 2022 年第四季度收益電話會議。在今天的電話會議上，我將概述我們第四季度和全年的業績，並介紹我們戰略計劃的最新情況。我們的首席財務官 Lynn Blake 將在開始提問之前提供詳細的財務結果，然後是我的結束語。

2022 proved to be a year of growth for Nuwellis, with 42% year-over-year revenue growth in the fourth quarter, a revenue increase of 13% sequential, and an 8% revenue growth for the full year. Revenue growth in the quarter was led by our pediatric segment, which increased 92% year over year. This was followed by 47% growth in our heart failure segment and 24% growth in our critical care segment.

事實證明，2022 年是 Nuwellis 增長的一年，第四季度收入同比增長 42%，環比增長 13%，全年收入增長 8%。本季度的收入增長由我們的兒科部門引領，同比增長 92%。其次是我們的心力衰竭部門增長了 47%，重症監護部門增長了 24%。

Our momentum continues to be fueled by the execution of two key growth strategies that we have mentioned in the past. First, our expansion in the field organizations, especially with our clinical education specialists, or CESs. Our CESs has played an important role supporting our account managers within the inpatient and outpatient facilities. And I will provide more detail later in the call.

我們過去提到的兩項關鍵增長戰略的執行繼續推動著我們的發展勢頭。首先，我們在現場組織中的擴展，尤其是我們的臨床教育專家或 CES。我們的 CES 在支持住院和門診設施內的客戶經理方面發揮了重要作用。我將在稍後的通話中提供更多詳細信息。

The second initiative that fuel our momentum in Q4 is the growing body of clinical evidence in the last seven months supporting the use of the Aquadex in all the three segments of our business.

在第四季度推動我們發展勢頭的第二項舉措是，在過去七個月中，越來越多的臨床證據支持在我們所有三個業務部門中使用 Aquadex。

I'd now like to turn to the business update and our key strategic initiatives, starting with growing our clinical body of evidence. A key area for us and investment at Nuwellis is having a robust clinical evidence. In doing so, we have more leverage to change practice guidelines towards making Aquadex the standard of care for fluid overload and further driving clinical adoption. We are pleased to be able to announce many new publications, poster presentations at medical conferences, and peer-reviewed data, further reinforcing Nuwellis technology in cardiac surgery, heart failure, and pediatrics throughout 2022 and thus far in 2023.

我現在想談談業務更新和我們的關鍵戰略計劃，從增加我們的臨床證據開始。我們和 Nuwellis 投資的一個關鍵領域是擁有強有力的臨床證據。通過這樣做，我們有更多的影響力來改變實踐指南，使 Aquadex 成為體液超負荷的護理標準，並進一步推動臨床採用。我們很高興能夠在整個 2022 年和 2023 年期間宣布許多新出版物、醫學會議上的海報展示和同行評審數據，進一步加強 Nuwellis 在心臟手術、心力衰竭和兒科方面的技術。

As previously mentioned, cardiac surgery, we had two peer-review publications. On August 31st, we announced the publication of a new peer-review clinical data, demonstrating 100% survival at 30 days following the use of ultrafiltration in high-risk postoperative coronary artery bypass grafting for CABG patients. In January of this year, The Annals of Thoracic Surgery, the authors commented on a key turn order set or hospital protocol for cardiac surgery-associated acute kidney injury that included a recommendation to use ultrafiltration for proposed cardiac surgery patients that are unresponsive to diuretics.

如前所述，心臟外科，我們有兩篇同行評審出版物。 8 月 31 日，我們宣布發布一項新的同行評審臨床數據，證明在 CABG 患者的高風險術后冠狀動脈旁路移植術中使用超濾後 30 天的生存率為 100%。今年 1 月，The Annals of Thoracic Surgery，作者評論了心臟手術相關急性腎損傷的關鍵輪流指令集或醫院方案，其中包括對對利尿劑無反應的擬進行心臟手術的患者使用超濾的建議。

These recommendations validate our Aquadex therapy to improve outcomes post-cardiac surgery and is supportive of our goal to leverage our body of clinical evidence to change practice guidelines for ultrafiltration.

這些建議證實了我們的 Aquadex 療法可以改善心臟手術後的結果，並支持我們利用我們的臨床證據來改變超濾實踐指南的目標。

In the heart failure segment, we highlighted the multicenter, controlled, randomized clinical trial called AVOID-HF that was analyzed under the newly favored statistical analysis called win ratio. This new analysis, presented at the 2022 Heart Failure Society of America Scientific Meeting, showed the strong benefit of ultrafiltration over diuretics in reducing cardiovascular mortality and heart failure events at 30 and 90 days in fluid-overload heart failure patients who are unresponsive to diuretics.

在心力衰竭部分，我們重點介紹了名為 AVOID-HF 的多中心、對照、隨機臨床試驗，該試驗是在新近流行的稱為勝率的統計分析下進行分析的。這項在 2022 年美國心力衰竭學會科學會議上發表的新分析表明，對於利尿劑無反應的液體超負荷心力衰竭患者，超濾在降低 30 天和 90 天的心血管死亡率和心力衰竭事件方面優於利尿劑。

In addition, in the fourth quarter, we announced a peer-review publication of a single center, 10-year, real-world retrospective study of 355 consecutive patients supporting lower heart failure hospitalizations and readmissions in a year after using the Aquadex. These data demonstrated 81% lower heart failure hospitalizations per year, and a 48% decrease in rehospitalizations from the national average of 30 days. We are now actively leveraging this data to educate providers and facilities of the economic benefit and cost savings Nuwellis can provide with the use of the Aquadex system in both inpatient and outpatient settings, as well as the improved quality of life in patients.

此外，在第四季度，我們宣布了一份同行評審出版物，該研究發表了一項為期 10 年的單中心、真實世界回顧性研究，該研究對 355 名支持下心力衰竭住院和使用 Aquadex 一年內再入院的連續患者進行了回顧性研究。這些數據表明每年心力衰竭住院率降低 81%，再住院率比全國平均 30 天降低 48%。我們現在正在積極利用這些數據來教育供應商和設施，讓他們了解 Nuwellis 可以在住院和門診環境中使用 Aquadex 系統，以及改善患者的生活質量。

We also continued to make progress in our pivotal REVERSE-HF trial. As a reminder, the primary effectiveness endpoint of REVERSE-HF will evaluate mortality and heart failure events within 30 and 90 days as a comparison between Aquadex therapy and intravenous loop diuretics. To date, we have activated nine clinical study sites, and we are on track to achieve our Q1 2023 milestone of 12 sites enrolled by the end of the first quarter. We expect to present the results of the study to the medical societies responsible for establishing medical guidelines.

我們還在關鍵的 REVERSE-HF 試驗中繼續取得進展。提醒一下，REVERSE-HF 的主要有效性終點將評估 30 天和 90 天內的死亡率和心力衰竭事件，作為 Aquadex 療法和靜脈內袢利尿劑之間的比較。迄今為止，我們已經啟動了 9 個臨床研究站點，我們有望在第一季度末實現 2023 年第一季度 12 個站點註冊的里程碑。我們希望將研究結果提交給負責制定醫學指南的醫學協會。

Further, in pediatrics, the fastest growing segment of our business, we announced peer-reviewed data demonstrating 71% survival in kidney replacement therapy using Aquadex in low-birth-weight, pre-term neonates.

此外，在我們業務增長最快的兒科領域，我們公佈的同行評審數據表明，使用 Aquadex 對低出生體重的早產新生兒進行腎臟替代治療後，存活率為 71%。

Finally, completing our clinical programs, I would like to extend my warm welcome to Dr. John Jefferies, our new Chief Medical Officer. Dr. Jefferies brings with him over two decades of cardiology and heart failure expertise, both adult and pediatric patients, and we are excited to have him in our team as we continue to build our clinical body of evidence.

最後，在完成我們的臨床項目後，我要熱烈歡迎我們的新任首席醫療官 John Jefferies 博士。 Jefferies 博士帶來了他超過二十年的心髒病學和心力衰竭專業知識，包括成人和兒科患者，我們很高興他能加入我們的團隊，因為我們將繼續建立我們的臨床證據。

Our second strategic initiative involves the targeted expansion of our commercial footprint to drive penetration. This includes both expansion of our commercial team and of installed base of active accounts. As of the end of Q4, we are pleased to be able to say that we have now filled all open sales leadership, account management, and clinical education positions.

我們的第二個戰略舉措涉及有針對性地擴大我們的商業足跡以推動滲透。這包括擴大我們的商業團隊和活躍賬戶的安裝基礎。截至第四季度末，我們很高興地宣布，我們現在已經填補了所有空缺的銷售領導、客戶管理和臨床教育職位。

As previously noted, our clinical education specialists, or CES -- all of whom are trained nurses -- directly partner with the patient's care team on the optimal use of our ultrafiltration system. In so doing, they facilitate not only successful patient outcomes, but also support increased use of our therapy across multiple specialty units in a hospital in addition to helping drive adoption at new targeted facilities.

如前所述，我們的臨床教育專家或 CES——他們都是訓練有素的護士——直接與患者護理團隊合作，以優化我們的超濾系統。通過這樣做，它們不僅有助於患者取得成功，而且還支持在醫院的多個專業部門增加我們的療法的使用，此外還有助於推動新目標設施的採用。

As for our expansion of our installed base console placements, the razor in our razor/razorblade model increased more than six times in the fourth quarter compared to the year-ago period, and increased 44% in 2022 versus prior year, with focused expansion in key geographic locations and high-volume centers. We achieved record US console sales in Q4 with 20 consoles sold. To date, we have established a strong foot in the East Coast and in the US.

至於我們已安裝的基本控制台展示位置的擴展，我們的剃須刀/剃須刀刀片模型中的剃須刀在第四季度比去年同期增長了六倍多，並且在 2022 年比上一年增長了 44%，重點擴展在關鍵地理位置和高流量中心。我們在第四季度取得了創紀錄的美國遊戲機銷量，售出了 20 台遊戲機。迄今為止，我們已經在東海岸和美國站穩了腳跟。

Turning now to our third strategic initiative of targeting outpatient clinics treating heart failure patients. Through our research, we have found many real-world case studies that suggest the current standard of care for managing fluid overload for heart failure patients is extremely costly for both patients and hospitals due to higher cost of care and high hospital readmission rates. According to the data, it costs over $24,000 per patient per encounter to treat a heart failure patient hospitalized for average of eight days, in addition to the unreimbursed cost of hospital readmissions within 30 days.

現在轉向我們針對治療心力衰竭患者的門診診所的第三個戰略計劃。通過我們的研究，我們發現了許多真實世界的案例研究，這些研究表明，由於較高的護理成本和較高的醫院再入院率，目前管理心力衰竭患者體液超負荷的護理標準對患者和醫院來說都是極其昂貴的。根據數據，治療一名平均住院 8 天的心力衰竭患者，每位患者每次就診的費用超過 24,000 美元，此外還包括 30 天內再次入院的未報銷費用。

As mentioned before, we now have the clinical evidence demonstrating that Aquadex reduces heart failure hospitalizations by 81%, and lower heart failure readmission rates by over 50%, thereby decreasing both the total cost of care and unreimbursed cost of the hospitalizations.

如前所述，我們現在有臨床證據表明，Aquadex 可將心力衰竭住院率降低 81%，並將心力衰竭再入院率降低 50% 以上，從而降低總護理成本和未報銷的住院費用。

Another major milestone of Nuwellis in 2022 was the assignment by the American Medical Association of a new dedicated Category III CPT code for therapeutic ultrafiltration. We have been leveraging this code in our conversations to reactivate outpatient clinics who have previously been using Aquadex, but later discontinue use due to the lack of reimbursement. We continue to believe that there is a line of sight toward our goal of achieving a Category I CPT code in two to three years, which will allow Nuwellis to further leverages the benefit of Aquadex for providers and facilities alike.

Nuwellis 在 2022 年的另一個重要里程碑是美國醫學會分配了一個新的用於治療性超濾的專用 III 類 CPT 代碼。我們一直在對話中利用此代碼來重新激活以前使用過 Aquadex 但由於缺乏報銷而後來停止使用的門診診所。我們仍然相信，我們的目標是在兩到三年內實現 I 類 CPT 代碼，這將使 Nuwellis 能夠進一步利用 Aquadex 為提供商和設施帶來的好處。

Turning now to our fourth strategic initiative, which is on the product-development front, as well as strategic partnerships.

現在轉向我們的第四個戰略計劃，即產品開發方面以及戰略合作夥伴關係。

I will begin with an update on our recent-announced exclusive US licensing and distribution agreement for SeaStar Medical's selective cytopheretic device, or CS -- SCD, for preventing pediatric acute kidney injury. Clinical studies have demonstrated that SCD's potential to eliminate dialysis dependency, shorten ICU time, and restore the lives of critical field pediatric patients. This agreement further reinforces our previously communicated decision to focus on the pediatric segment and also further expand our product portfolio, enabling us to save more lives in this underserved patient population.

我將首先更新我們最近宣布的美國獨家許可和分銷協議，用於 SeaStar Medical 的選擇性細胞分離裝置，或 CS -- SCD，用於預防小兒急性腎損傷。臨床研究表明，SCD 具有消除透析依賴、縮短 ICU 時間和恢復重症領域兒科患者生命的潛力。該協議進一步加強了我們之前傳達的專注於兒科領域的決定，並進一步擴大了我們的產品組合，使我們能夠在這個服務不足的患者群體中挽救更多生命。

SeaStar Medical expects the FDA to complete its review of a humanitarian device exemption, or HDE, for the use of its SCD in children in the first half of this year. We look forward to keeping you updated on the progress in the coming weeks and months.

SeaStar Medical 預計 FDA 將在今年上半年完成對兒童使用其 SCD 的人道主義器械豁免 (HDE) 的審查。我們期待在未來幾周和幾個月內讓您了解最新進展。

On the product development front, we are on track with progress on our pediatric continuous renal replacement therapy device and continue to anticipate IDE submission by early 2024. Early feedback from physicians, and pediatric nephrologists in particular, have been enthusiastic, noting how our technology uniquely addresses the unmet need of this patient population and could potentially be a game changer in pediatric treatment.

在產品開發方面，我們的兒科連續性腎臟替代治療裝置正在取得進展，並繼續預計 IDE 將在 2024 年初提交。醫生，尤其是兒科腎病學家的早期反饋非常熱情，注意到我們的技術如何獨特解決了這一患者群體未滿足的需求，並可能成為兒科治療的遊戲規則改變者。

In conclusion, I want to reiterate how excited I am for the future of Nuwellis. Our goal of making Aquadex therapy the standard of care for restoring fluid balance remains intact. We believe we are approaching an inflection point towards reaching this goal. The work that we did in 2020 advanced us down this path, and I look forward to continue a strong execution in 2023 and beyond.

最後，我想重申我對 Nuwellis 的未來感到多麼興奮。我們的目標是使 Aquadex 療法成為恢復體液平衡的護理標準，這一目標保持不變。我們相信我們正在接近實現這一目標的拐點。我們在 2020 年所做的工作推動我們走上了這條道路，我期待在 2023 年及以後繼續強有力的執行。

Now, I would like to turn the call over to our Chief Financial Officer, Lynn Blake, to discuss our Q4 and full-year 2022 results.

現在，我想將電話轉給我們的首席財務官 Lynn Blake，討論我們的第四季度和 2022 年全年業績。

Thank you, Nestor, and good morning, everyone. Since joining Nuwellis last October, I continue to be increasingly excited about the company's future. Our Q4 revenue growth of 42% is attribute to the success of our commercial team expansion, advancements in our clinical evidence development, and our tenacity in increasing market awareness of treatment options for patients with fluid overload.

謝謝你，內斯特，大家早上好。自去年 10 月加入 Nuwellis 以來，我對公司的未來越來越感到興奮。我們第四季度的收入增長了 42%，這歸功於我們的商業團隊擴張的成功、我們臨床證據開發的進步，以及我們在提高市場對體液超負荷患者治療方案意識方面的堅韌。

Turning to the Q4 financial results. Revenue for the fourth quarter was $2.3 million, representing 42% year-over-year growth and a 13% sequential increase from the third quarter of 2022. Our pediatric products segment once again had the strongest growth in the quarter with a 92% increase year over year. This was followed by 47% growth in our heart failure segment and 24% growth in critical care.

轉向第四季度的財務業績。第四季度收入為 230 萬美元，同比增長 42%，比 2022 年第三季度環比增長 13%。我們的兒科產品部門在本季度再次實現最強勁增長，同比增長 92%超過一年。其次是我們的心力衰竭部門增長了 47%，重症監護增長了 24%。

Gross margin for the quarter was 56.9% of sales, an increase of 250 basis points compared to gross margin of 54.4% in the prior year. This increase was primarily driven by increased sales volume in the quarter.

本季度毛利率為銷售額的 56.9%，與去年同期的毛利率 54.4% 相比增長了 250 個基點。這一增長主要是由於本季度銷量增加所致。

Selling, general and administrative expenses were $4.7 million in the fourth quarter. Compared to the fourth quarter of 2021, SG&A expenses increased approximately $570,000 or 14%. Compared to the third quarter of 2022, SG&A expenses increased by approximately $413,000 or 10%, reflecting increased variable compensation expenses and professional fees in the fourth quarter.

第四季度的銷售、一般和管理費用為 470 萬美元。與 2021 年第四季度相比，SG&A 費用增加了約 570,000 美元或 14%。與 2022 年第三季度相比，SG&A 費用增加了約 413,000 美元或 10%，反映了第四季度可變薪酬費用和專業費用的增加。

Fourth-quarter research and development expense was $1.2 million, an increase of $70,000 or 6% relative to the fourth quarter of 2021. On a sequential-quarter basis, research and development costs increased $273,000 or 29%, all related to the planned development of our new pediatric-dedicated sites.

第四季度研發費用為 120 萬美元，較 2021 年第四季度增加 70,000 美元或 6%。按季度計算，研發費用增加 273,000 美元或 29%，均與計劃開發相關我們新的兒科專用站點。

Total operating expenses were $5.9 million in the quarter, an increase of approximately $640,000 compared to the fourth quarter of 2021. Total operating expenses for the full year were $21.9 million, a decrease of approximately $2.1 million or 9% year over year as we focused on conserving cash flow, while, at the same time, funding our top strategic [objective]. Our 2022 full-year cash utilization decreased 15% year over year, reflecting continued expense vigilance.

本季度總運營費用為 590 萬美元，比 2021 年第四季度增加約 640,000 美元。全年總運營費用為 2190 萬美元，同比減少約 210 萬美元或 9%，因為我們專注於保存現金流，同時為我們的首要戰略[目標]提供資金。我們 2022 年全年現金使用率同比下降 15%，反映出持續的費用警惕。

The net loss in the fourth quarter was $1.9 million or a loss of $5 per share, compared to a net loss of $4.3 million or $41.09 per share for the same period in 2021. The current period net loss includes non-recurring other income of $2.6 million related to recognition and revaluation of the warrants issued in conjunction with our October financing. Additionally, these loss-per-share amounts reflect the company's reverse stock split that was effected in December 2022. Prior year earnings per share have been adjusted to reflect the impact of the reverse stock split as well.

第四季度淨虧損為 190 萬美元或每股虧損 5 美元，而 2021 年同期為淨虧損 430 萬美元或每股虧損 41.09 美元。本期淨虧損包括非經常性其他收入 2.6 美元萬美元與我們 10 月份融資時發行的認股權證的確認和重估有關。此外，這些每股虧損數額反映了公司於 2022 年 12 月生效的反向股票分割。上一年的每股收益已經過調整，以反映反向股票分割的影響。

At December 31, 2022, we had approximately 536,000 outstanding common shares. On January 4 of this year, our stockholders approved A proposal allowing holders of the warrants issued in the October financing to exercise those warrants. To date, 99% of the warrants have now been exercised, substantially clearing our warrant overhang. And as a result, we currently have approximately 1.2 million shares of common stock outstanding.

截至 2022 年 12 月 31 日，我們擁有約 536,000 股已發行普通股。今年 1 月 4 日，我們的股東批准了一項提案，允許 10 月份融資中發行的認股權證持有人行使這些認股權證。迄今為止，99% 的認股權證現已行權，大大清除了我們的認股權證積壓。因此，我們目前擁有大約 120 萬股已發行普通股。

From a liquidity perspective, we ended the fourth quarter with $18.3 million in cash, cash equivalents, and marketable securities, and we have no debt on the balance sheet.

從流動性的角度來看，我們在第四季度結束時擁有 1830 萬美元的現金、現金等價物和有價證券，資產負債表上沒有債務。

This concludes our prepared remarks. Operator, we would now like to open the call for questions.

我們準備好的發言到此結束。接線員，我們現在想打開問題電話。

Thank you. (Operator Instructions) Jeffrey Cohen, Ladenburg Thalmann.

謝謝。 （操作員說明）Jeffrey Cohen，Ladenburg Thalmann。

So a few questions from [Aaron]. Firstly, can you talk about SeaStar's SCD for pediatric AKI? It sounds like their submission is in and you would anticipate being able to commercialize their unit in 2023. Could you talk about timeline there? And could you talk about commercialization specific to your three channels?

[Aaron] 提出了幾個問題。首先，您能談談SeaStar 用於小兒AKI 的SCD 嗎？聽起來他們的提交已經提交，你預計能夠在 2023 年將他們的單位商業化。你能談談那裡的時間表嗎？您能否談談針對您的三個渠道的商業化？

Yes, Jeff, we'll be glad to answer that question. SeaStar, the approval -- they are applying for a humanitarian device exemption. And as you know, FDA can be unpredictable. But we expect that they would receive the HDE sometime in the first half of this year.

是的，傑夫，我們很樂意回答這個問題。 SeaStar，批准——他們正在申請人道主義設備豁免。如您所知，FDA 可能無法預測。但我們預計他們會在今年上半年的某個時候收到 HDE。

The second part of your question was about the commercialization. We're going to do that in a staged approach. We're going to start with our key users of the SCD device -- which happens to be many of them, our top users of Aquadex -- in pediatrics. So we see a very strong strategic fit there. So we hope to be very successful once we can start commercializing the device.

你問題的第二部分是關於商業化的。我們將分階段進行。我們將從 SCD 設備的主要用戶開始——恰好是他們中的許多人，我們的 Aquadex 的主要用戶——在兒科領域。因此，我們在那裡看到了非常強大的戰略契合度。因此，我們希望一旦我們可以開始將該設備商業化，就會非常成功。

Okay, got it. And then a financial question: you talked about 47% increase in cardiac and 24% in critical care. What was the peds number?

好，知道了。然後是一個財務問題：你談到心髒病增加了 47%，重症監護增加了 24%。 peds 號碼是多少？

Peds number was 92% for the fourth quarter, year over year.

第四季度的 Peds 數量同比為 92%。

It's Q4 year over year. Okay, got it. Do you think you'll break that out next year, or this year by segment?

這是去年第四季度。好，知道了。你認為你會在明年或今年按細分細分嗎？

I think we'll continue to provide that color in our commentary. It is not official segment reporting from a financial standpoint, but that's how we think about our call points and our market size.

我想我們會繼續在我們的評論中提供這種顏色。從財務角度來看，這不是官方的細分報告，但這就是我們對呼叫點和市場規模的看法。

Okay, got it. When you talk about the unit that you're working, on the pediatric extension, you talked about IDE, early '24. What's left to do between now and submitting the IDE?

好，知道了。當你談論你正在工作的單位時，在兒科擴展方面，你談到了 24 年初的 IDE。從現在到提交 IDE 之間還剩下什麼？

Well, two things. One, we need to complete the development, which is very far advanced. And then also most important is test the performance of the device from safety and efficacy, 100%. We want to make sure that this product has the highest quality possible when we do the launch of this -- we start the IDE study.

好吧，有兩件事。第一，我們需要完成開發，這是非常先進的。然後也是最重要的是從安全性和有效性上測試設備的性能，100%。我們希望在發布此產品時確保該產品具有最高質量——我們開始 IDE 研究。

The next step that we have, the immediate next step, is our pre-submission to the FDA. And this is basically a formality where we inform the FDA of what our plans are, and then we have a conversation directly with them to see what is their opinion about our plans.

我們的下一步，緊迫的下一步，是我們向 FDA 的預提交。這基本上是一種形式，我們告知 FDA 我們的計劃是什麼，然後我們直接與他們對話，看看他們對我們的計劃有何看法。

And does the pre-sub meeting come earlier this year, or latter this year?

pre-sub meeting 是今年早些時候還是今年晚些時候？

Early this year. We're very soon to do that pre-submission.

今年年初。我們很快就會進行預提交。

Got it. And then lastly, Lynn, did you call out cash use, Q4 cash use?

知道了。最後，Lynn，你有沒有提到現金使用，Q4 現金使用？

I didn't call out the Q4 number, but it was in the range of $4 million, Jeff.

我沒有說出第四季度的數字，但它在 400 萬美元的範圍內，傑夫。

Got it. Okay. Perfect. That does it for us. Thanks for taking the questions.

知道了。好的。完美的。這對我們有用。感謝您提出問題。

Thank you. Anthony Vendetti, Maxim Group.

謝謝。 Maxim 集團的 Anthony Vendetti。

Thank you. In terms of the console sales, how many were from new accounts versus existing accounts?

謝謝。就主機銷售而言，新帳戶與現有帳戶有多少？

Good question, Anthony. We have about -- 60% were from existing accounts, and the rest was in new accounts.

好問題，安東尼。我們大約有 60% 來自現有賬戶，其餘來自新賬戶。

Okay, great. And obviously, nice -- really nice progress in the pediatric segment and good growth across the board. Can you talk about the usage rate? I think you did give the -- did you give the percent increase in the single-use consumable piece of that? And if not, I must -- I may have missed it, if you can just repeat it.

好的，太好了。顯然，很好——在兒科領域取得了非常好的進展，並且全面取得了良好的增長。能說說使用率嗎？我想你確實給出了 - 你是否給出了一次性消耗品的百分比增加？如果沒有，我必須——我可能錯過了，如果你能重複一遍的話。

Yeah, no. We did not give a breakdown of the consoles versus disposables. I hear what you're saying, Anthony. It's something that we would be preparing for the future. But I think it would be a good metric for you to understand our growth, especially as we increase the placement of consoles, which is our razor in our razorblade model.

是的，不。我們沒有給出遊戲機與一次性遊戲機的細分。我聽到你在說什麼，安東尼。這是我們要為未來做的準備。但我認為這將是一個很好的衡量標準，可以讓您了解我們的增長，尤其是當我們增加遊戲機的位置時，這是我們剃刀刀片模型中的剃刀。

Okay, great. And I don't know if Dr. Jefferies is on, but I had spoken to him during my due diligence process. If he is on, can he speak to the benefits of Aquadex and then the ability to convince his peers in the benefits of using Aquadex in terms of increasing adoption?

好的，太好了。我不知道 Jefferies 博士是否在場，但我在盡職調查過程中曾與他交談過。如果他上台了，他能談談 Aquadex 的好處，然後說服他的同行相信使用 Aquadex 在提高采用率方面的好處嗎？

Yes. He's not here with us right now, Anthony. But yes, that's one of the key roles that we have for him, is to be able to talk to his peer, but as well as the medical societies [that] influence the guidelines.

是的。他現在不在我們身邊，安東尼。但是，是的，這是我們為他提供的關鍵角色之一，就是能夠與他的同齡人以及影響指南的醫學協會交談。

Okay. And you said the expected timeline for the REVERSE-HF study is -- can you just review that again?

好的。你說 REVERSE-HF 研究的預期時間表是——你能再回顧一下嗎？

Yes, we have -- our goal for this quarter, first quarter of 2023, is to have 12 sites activated. We are at nine right now. So we have communicated in the past that we expect enrollment to be about two years before we close the enrollment and start the statistical analysis.

是的，我們有——我們本季度的目標，即 2023 年第一季度，是激活 12 個站點。我們現在九點鐘。所以我們過去曾溝通過，我們預計在我們關閉招生和開始統計分析之前大約需要兩年的時間。

Okay. So the other three sites, you expect by the end of March?

好的。那麼其他三個站點，您預計到 3 月底？

A precise number of sites? Yes, four sites.

確切數量的網站？是的，四個站點。

Okay. Okay, great. And about two years. Okay. Those are my questions. I'll hop back in the queue. Thanks.

好的。好的，太好了。大約兩年。好的。這些是我的問題。我會跳回到隊列中。謝謝。

Thank you. (Operator Instructions) Brooks O'Neil, Lake Street Capital Markets.

謝謝。 （操作員說明）Brooks O'Neil，Lake Street Capital Markets。

Good morning, everyone. Really nice momentum in Q4. I'm just curious if you see any evidence of continuing momentum as we have entered into 2023.

大家，早安。第四季度的勢頭非常好。我只是想知道，隨著我們進入 2023 年，您是否看到任何持續勢頭的證據。

Yes. In the past, we don't give guidelines, Brooks, as you know. But yeah, we're very confident that we're going to have a good quarter in Q1.

是的。過去，我們不提供指導方針，布魯克斯，如你所知。但是，是的，我們非常有信心我們將在第一季度有一個好的季度。

And I think the fact that -- Brooks, we've mentioned that we now have fully staffed and filled all key positions in the field. We have new RVP, critical CES positions, starting year-end. We didn't start quarter that way, so it's a good start to the year from commercial team perspective as well.

而且我認為 - 布魯克斯，我們已經提到我們現在已經配備齊全並填補了該領域的所有關鍵職位。我們有新的 RVP，關鍵的 CES 職位，從年底開始。我們並沒有以這種方式開始季度，因此從商業團隊的角度來看，這也是今年的一個良好開端。

Great. And then, you know, I just did hear in a little bit of amazement thinking about the reality that hospitals are penalized for readmissions. And we know that CHF is one of the key areas in which readmissions are pretty common. And just curious how you sense the customer-based doctors in the hospitals.

偉大的。然後，你知道，我只是有點驚訝地聽到醫院因再入院而受到處罰的現實。我們知道 CHF 是重新入院非常普遍的關鍵領域之一。只是好奇您如何看待醫院中以客戶為基礎的醫生。

Do you -- using Aquadex as a way to both provide superior care to patients and prevent readmission -- is there any sense you have of growing awareness that this a win-win-win situation for the hospital, for the doctors, for the patients -- for everybody?

您是否——使用 Aquadex 作為一種既能為患者提供優質護理又能防止再次入院的方式——您是否意識到這對醫院、醫生和患者來說是一個三贏的局面？ - 為所有人？

That's right, Brooks. We just finished our national sales meeting about two weeks ago. And in that meeting, we did nothing but to train the sales organization on the economics of the cost of treating heart failure and the potential savings that we can provide hospitals and the healthcare system in terms of saving money due to the prevention of unreimbursed readmissions within 30 days.

沒錯，布魯克斯。大約兩週前，我們剛剛結束了全國銷售會議。在那次會議上，我們除了對銷售組織進行培訓，讓他們了解治療心力衰竭的成本經濟學以及我們可以為醫院和醫療保健系統提供的潛在節省，以防止因未報銷的再入院而節省資金。 30天。

And in the past, we have not had the clinical evidence to prove and to show that, indeed, Aquadex can save -- can reduce the number of hospitalizations and the readmission rate. Now that we have that information in the last seven months, now we can aggressively talk about what are the economics of the hospital -- and we have all that information because it's public information. We know exactly that readmission rates by hospitals and we can provide an actual financial number showing the savings, in number of dollars.

過去，我們還沒有臨床證據來證明和證明 Aquadex 確實可以挽救——可以減少住院次數和再入院率。現在我們掌握了過去七個月的信息，現在我們可以積極討論醫院的經濟狀況——我們掌握了所有這些信息，因為它是公開信息。我們確切地知道醫院的再入院率，我們可以提供一個實際的財務數字來顯示節省的金額（以美元為單位）。

Pretty powerful. That's great. With a strong sales organization and all this information, I'm pretty excited about the outlook for you guys this year. So good luck. I hope it plays out.

相當強大。那太棒了。憑藉強大的銷售組織和所有這些信息，我對你們今年的前景感到非常興奮。祝你好運。我希望它發揮出來。

Thank you. We are as well, Brooks.

謝謝。我們也是，布魯克斯。

Thank you. This concludes the question-and-answer session. I would like to turn the conference back over to Mr. Nestor Jaramillo for closing remarks.

謝謝。問答環節到此結束。我想將會議轉回給 Nestor Jaramillo 先生作閉幕詞。

Thank you, operator. I would like to conclude by thanking all of our stakeholders: Nuwellis employees, stockholders, physicians, nurses, patients, and the healthcare workers in the field. Without your support, we would not been able to achieve key advances in transforming the lives of patients suffering from fluid overload. So thank you for your participation and support. Have a nice day.

謝謝你，運營商。最後，我想感謝我們所有的利益相關者：Nuwellis 員工、股東、醫生、護士、患者和該領域的醫護人員。沒有您的支持，我們將無法在改變體液超負荷患者的生活方面取得重大進展。感謝您的參與和支持。祝你今天過得愉快。

The call is now concluded. Thank you for attending today's presentation. You may now disconnect.

現在通話結束。感謝您參加今天的演講。您現在可以斷開連接。