New Evidence on Aquadex Ultrafiltration Therapy to Be Presented at HFSA 2024 Conference
New Evidence on Aquadex Ultrafiltration Therapy to Be Presented at HFSA 2024 Conference
MINNEAPOLIS, July 09, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce that new clinical evidence demonstrating the efficacy of its Aquadex system will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place September 27-30, 2024, in Atlanta, Georgia.
2024年7月9日,明尼阿波利斯(美國環球新聞)-- Nuwellis, Inc.Nuwellis,醫療技術公司,致力於通過科學、合作和創新來改變患有液體過載的患者的生活(Nasdaq: NUWE)。該公司專注於將Aquadex SmartFlow系統用於超濾治療。該研究由Wayne Old博士進行,他是一位先進的心臟衰竭心臟病學家,工作地點位於Sentara Norfolk General醫院。研究強調了Aquadex超濾療法治療在傳統利尿劑治療無效的心力衰竭患者中緩解液體過載的益處。該研究結果表明,Aquadex可以有效地管理液體水平,爲這種具有挑戰性的患者人口提供了一個關鍵的治療選擇。
The study, conducted by Dr. Wayne Old, MD, an advanced heart failure cardiologist at Sentara Health, based out of Sentara Norfolk General Hospital in Norfolk, Va., highlights the benefits of Aquadex ultrafiltration therapy for heart failure patients experiencing fluid overload who have not responded to traditional diuretic treatments. The research underscores Aquadex's ability to effectively manage fluid levels, providing a critical therapeutic alternative for this challenging patient population.
這項由Wayne Old博士進行的研究,他是Sentara Health的一名先進心臟衰竭心臟病專家,工作地點在弗吉尼亞州諾福克市的Sentara Norfolk General醫院。該研究強調了Aquadex超濾療法治療在傳統利尿劑治療無效的心力衰竭患者中緩解液體過載的益處。該研究結果表明,Aquadex可以有效地管理液體水平,爲這種具有挑戰性的患者人口提供了一個關鍵的治療選擇。
"We are excited to share our findings at the upcoming HFSA conference," said Dr. Wayne Old. "Our research demonstrates the efficacy of Aquadex in improving patient outcomes where diuretics have failed. This data supports the integration of ultrafiltration therapy via the Aquadex system into standard practice for managing fluid overload in heart failure patients, providing a new therapy option for patients needing decongestion."
"我們很高興在即將舉行的HFSA會議上分享我們的研究結果。"Wayne Old博士說。"我們的研究表明,在利尿劑無效的情況下,Aquadex的有效性在改善患者預後方面得到了證明。這些數據支持將Aquadex超濾療法集成到治療心力衰竭患者液體過載的標準實踐中,爲需要脫水的患者提供了一種新的治療選擇。"
Nestor Jaramillo, President and CEO of Nuwellis, expressed his gratitude to Dr. Old and his team for their dedicated research efforts. "We extend our deepest appreciation to Dr. Old and his research team for their invaluable work in validating the effectiveness of Aquadex," said Jaramillo. "Nuwellis is committed to providing robust clinical data to support the use of our therapy. There are many heart failure patients hospitalized due to the symptoms of fluid overload who continue to be treated with diuretics despite their known inefficacy. Aquadex not only offers a more effective solution but also presents significant economic savings to hospitals by reducing the length of hospital stays and associated healthcare costs."
Nuwellis的總裁兼CEO Nestor Jaramillo對Old博士和他的團隊爲他們的研究工作表示感激。"我們最深切地感謝Old博士和他的研究團隊在驗證Aquadex有效性方面的寶貴工作。"Jaramillo說。"Nuwellis致力於提供有力的臨床數據來支持我們的治療方案。許多心力衰竭患者因液體過載症狀住院,儘管已知利尿劑治療的無效性。 Aquadex不僅提供了一種更有效的解決方案,而且通過減少住院時間和相關醫療費用,爲醫院帶來了顯著的經濟節省。"
Sentara Health is also actively participating in REVERSE-HF, a pivotal clinical study on ultrafiltration using Aquadex. REVERSE-HF (Ultrafiltration Versus IV Diuretics in Worsening Heart Failure) is evaluating the clinical outcomes and economic value of Aquadex ultrafiltration therapy in comparison to intravenous (IV) diuretics for the treatment of fluid overload in patients with worsening heart failure.
Sentara Health也積極參與REVERSE-HF計劃(一項關於使用Aquadex的超濾的重要臨床研究)。REVERSE-HF(透析對比靜脈輸注利尿劑治療進展的心力衰竭)正在評估Aquadex超濾療法與靜脈(IV)利尿劑治療在治療液體過載患者的心力衰竭患者中的臨床結果和經濟價值。
Dr. Amin Yehya, MD, MS, FACC, FHFSA is the site principal investigator for the REVERSE-HF trial, the medical director of the durable mechanical circulatory support at Sentara Health, and an advanced heart failure and transplant cardiologist. "We are excited to participate in REVERESE-HF and examine Aquadex SmartFlow therapy in our heart failure patients experiencing fluid overload," stated Dr. Yehya. "We are looking forward to confirming the efficacy of ultrafiltration for our patients who do not respond to diuretics. Currently, diuretics are the sole treatment available for the acute relief of heart failure congestion with over 40% of the patients unresponsive to the therapy. Simplified ultrafiltration has demonstrated that it has the potential to change that and offer long-term benefits for heart failure management. REVERSE-HF is set to provide the evidence."
Amin Yehya醫生是REVERSE-HF試驗的現場主要研究員,也是Sentara Health耐久性機械循環支持的醫學主任,先進心臟衰竭和移植心臟病學家。"我們很高興參加REVERESE-HF試驗,並研究Aquadex SmartFlow療法治療我們的心力衰竭患者液體過載的情況。"Yehya博士說。"我們期待證實超濾療法對那些對利尿劑無效的患者具有療效。目前,利尿劑是可用於緩解心力衰竭充血的唯一治療方法,但超過40%的患者對該治療方法無反應。簡化超濾療法已經證明具有改變這種情況併爲心力衰竭治療提供長期益處的潛力。REVERSE-HF試驗將提供相關證據。"
Additional details on Dr. Old's research will be forthcoming from HFSA. Nuwellis invites attendees of the HFSA 2024 Annual Scientific Meeting to attend the presentation and learn more about the clinical advancements and benefits of Aquadex ultrafiltration therapy. Neither Dr. Old nor Sentara Health received any financial support from Nuwellis in support of his research initiatives. The REVERSE-HF clinical study is sponsored by Nuwellis.
來自HFSA的關於Old博士研究的更多詳細信息即將公佈。 Nuwellis邀請HFSA 2024年年會的與會者參加這個演示,並了解Aquadex超濾療法的臨床進展和好處。Old博士和Sentara Health均未因研究倡議而收到Nuwellis的任何財務支持。REVERSE-HF臨床研究由Nuwellis贊助。
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit or visit us on LinkedIn or X.
DaVita(紐約證券交易所股票代碼:DVA)是一家以改善全球患者生活質量爲重點的醫療保健提供商。該公司是美國最大的腎臟護理服務提供商之一,並已經是臨床質量和創新的領導者超過20年。DaVita爲腎臟健康旅程中每個階段和場所的患者提供護理,從減緩腎臟疾病的進展到幫助支持移植,從急性住院護理到家庭透析。截至2022年12月31日,DaVita在美國的2724個門診透析中心爲20萬名患者提供服務。該公司還在全球其他11個國家運營350個門診透析中心。DaVita減少了住院、改善了死亡率,並通過合作推動腎臟護理行業爲所有患者實現公平且高質量的醫療標準。欲了解更多信息,請訪問www.davita.com /關於。
Nuwellis Inc.(納斯達克證券代碼:Nuwe)是一家醫療技術公司,致力於通過科學、合作和創新來改變因液體過載而生的患者的生活。該公司專注於將Aquadex SmartFlow系統用於超濾治療。Nuwellis總部位於明尼阿波利斯,擁有在愛爾蘭的全資子公司。欲了解更多信息,請訪問網站或在LinkedIn 或X上關注我們。
About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
關於Aquadex SmartFlow系統
Aquadex SmartFlow系統可通過簡單、靈活、智能的方法從患有高容量負荷(液體過多)的患者中移除過多的液體,提供經臨床驗證的治療。 Aquadex SmartFlow系統適用於20千克或更重的成人和兒童,可臨時(長達8小時)或長期(超過8小時接受住院治療的患者)使用,用於治療不反應於藥物管理(包括利尿劑)的液體過多患者。所有治療必須由醫療保健專業人員在門診或住院臨床設置中進行,並且都是在醫生開具處方後使用,醫生和患者均接受體外循環治療的培訓。
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the impact of the COVID-19 pandemic, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
前瞻性聲明
在本新聞發佈中,某些陳述可被視爲1995年私人證券訴訟改革法規定下的前瞻性陳述,包括但不限於關於2024年及以後市場新機會和預期增長的聲明。前瞻性陳述是關於未來事件的預測、投影和其他陳述,它們基於當前的預期和假設,因此,受到風險和不確定性的影響。許多因素可能導致本新聞發佈中的前瞻性陳述與實際未來事件有所不同,包括但不限於我們執行商業化戰略的能力、COVID-19大流行的影響、我們可能無法籌集足夠的資金以支持預期的運營、我們的後市場臨床數據收集活動、我們的產品對患者的益處、我們的產品開發和商業化努力,我們提高市場及醫生對我們產品的接受程度、潛在的競爭性產品、知識產權保護、合併收購的能力、我們預期收購的協同效益及業務增益、以及其他在我們提交給美國證券交易委員會的備案文件中描述的風險和不確定性。前瞻性陳述僅作爲發表之日的預測,Nuwellis不承擔任何公開更新或修訂前瞻性陳述的義務,無論是因爲新信息、未來事件或其他原因。
CONTACTS
聯繫方式
Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
投資者:
Vivian Cervantes
吉爾馬汀集團
ir@nuwellis.com