Nuwellis Announces Termination of REVERSE-HF Clinical Trial to Focus on Strategic Growth in Outpatient Heart Failure Care
Nuwellis (NASDAQ:NUWE) announced the termination of its REVERSE-HF clinical trial, which was evaluating ultrafiltration versus IV loop diuretic therapy for fluid management in hospitalized heart failure patients. The company will redirect its focus toward outpatient heart failure care, pediatric, and critical care markets.
The trial, which began in 2022, had enrolled 167 patients before termination. This strategic decision is expected to save $4.0 million over 2.5 years. The company plans to analyze existing data for potential clinical publications. Importantly, the termination was not due to device performance or safety concerns, and the Nuwellis SmartFlow® remains FDA-cleared for fluid overload treatment.
Nuwellis (NASDAQ:NUWE) ha annunciato la sospensione del suo studio clinico REVERSE-HF, che confrontava l'ultrafiltrazione con la terapia diuretica endovenosa a base di diuretici dell'ansa per la gestione dei fluidi nei pazienti ospedalizzati con insufficienza cardiaca. L'azienda si concentrerà ora sui mercati dell'assistenza ambulatoriale per l'insufficienza cardiaca, pediatrica e delle cure critiche.
Lo studio, iniziato nel 2022, aveva arruolato 167 pazienti prima della sua interruzione. Questa decisione strategica dovrebbe consentire un risparmio di 4,0 milioni di dollari in 2,5 anni. L'azienda intende analizzare i dati raccolti per eventuali pubblicazioni cliniche. È importante sottolineare che la sospensione non è stata causata da problemi di prestazioni o sicurezza del dispositivo, e il Nuwellis SmartFlow® rimane autorizzato dalla FDA per il trattamento del sovraccarico di liquidi.
Nuwellis (NASDAQ:NUWE) anunció la finalización de su ensayo clínico REVERSE-HF, que evaluaba la ultrafiltración frente a la terapia con diuréticos en bolo intravenoso para el manejo de líquidos en pacientes hospitalizados con insuficiencia cardíaca. La empresa redirigirá su enfoque hacia la atención ambulatoria de insuficiencia cardíaca, así como a los mercados pediátrico y de cuidados críticos.
El ensayo, iniciado en 2022, había reclutado a 167 pacientes antes de su finalización. Esta decisión estratégica se espera que ahorre 4,0 millones de dólares en 2,5 años. La empresa planea analizar los datos existentes para posibles publicaciones clínicas. Es importante destacar que la finalización no se debió a problemas de rendimiento o seguridad del dispositivo, y el Nuwellis SmartFlow® sigue estando aprobado por la FDA para el tratamiento de la sobrecarga de líquidos.
Nuwellis (NASDAQ:NUWE)는 입원 심부전 환자의 체액 관리를 위해 초여과법과 정맥 내 루프 이뇨제 치료를 비교 평가하던 REVERSE-HF 임상시험을 종료했다고 발표했습니다. 회사는 앞으로 외래 심부전 치료, 소아 및 중환자 치료 시장에 집중할 계획입니다.
2022년에 시작된 이 임상시험은 종료 시점까지 167명의 환자를 등록했습니다. 이번 전략적 결정으로 2.5년간 400만 달러를 절감할 것으로 예상됩니다. 회사는 기존 데이터를 분석하여 임상 논문으로 발표할 예정입니다. 중요한 점은 이번 종료가 장치 성능이나 안전성 문제 때문이 아니며, Nuwellis SmartFlow®는 체액 과부하 치료를 위해 FDA 승인을 계속 유지하고 있다는 것입니다.
Nuwellis (NASDAQ:NUWE) a annoncé l'arrêt de son essai clinique REVERSE-HF, qui évaluait l'ultrafiltration par rapport à la thérapie diurétique intraveineuse par diurétiques de l'anse pour la gestion des fluides chez les patients hospitalisés en insuffisance cardiaque. L'entreprise va désormais se concentrer sur les soins ambulatoires en insuffisance cardiaque, ainsi que sur les marchés pédiatrique et des soins critiques.
L'essai, débuté en 2022, avait inclus 167 patients avant son arrêt. Cette décision stratégique devrait permettre d'économiser 4,0 millions de dollars sur 2,5 ans. L'entreprise prévoit d'analyser les données existantes en vue de publications cliniques potentielles. Il est important de souligner que l'arrêt n'est pas lié à des problèmes de performance ou de sécurité du dispositif, et le Nuwellis SmartFlow® reste approuvé par la FDA pour le traitement de la surcharge hydrique.
Nuwellis (NASDAQ:NUWE) gab die Beendigung der REVERSE-HF-Studie bekannt, die Ultrafiltration mit intravenöser Schleifendiuretika-Therapie zur Flüssigkeitskontrolle bei hospitalisierten Herzinsuffizienzpatienten verglich. Das Unternehmen wird seinen Fokus auf die ambulante Herzinsuffizienzversorgung sowie auf pädiatrische und intensivmedizinische Märkte verlagern.
Die Studie, die 2022 begann, hatte vor der Beendigung 167 Patienten eingeschlossen. Diese strategische Entscheidung soll 4,0 Millionen US-Dollar über 2,5 Jahre einsparen. Das Unternehmen plant, die vorhandenen Daten für mögliche klinische Veröffentlichungen auszuwerten. Wichtig ist, dass die Beendigung nicht auf Leistungs- oder Sicherheitsbedenken des Geräts zurückzuführen ist, und das Nuwellis SmartFlow® bleibt von der FDA für die Behandlung von Flüssigkeitsüberladung zugelassen.
- Expected cost savings of $4.0M over 2.5 years from trial termination
- Strategic focus shift to higher-potential outpatient market
- Increasing demand in hospital-based outpatient heart failure programs
- SmartFlow device maintains FDA clearance with no safety concerns
- Early termination of major clinical trial REVERSE-HF
- Incomplete trial data with only 167 patients enrolled
- Potential loss of opportunity to generate comprehensive clinical evidence
Insights
Nuwellis terminates REVERSE-HF trial to save $4M and redirect focus to outpatient settings where growth potential appears stronger.
Nuwellis' decision to terminate the REVERSE-HF clinical trial represents a strategic pivot in their business approach. The company is shifting resources away from inpatient heart failure treatment validation toward hospital-based outpatient settings, which they've identified as offering superior growth potential. This redirection will save the company approximately
The trial had enrolled 167 patients since 2022, and while the press release frames this as a strategic decision rather than a clinical failure, it's notable that the company chose not to continue to full enrollment. Nuwellis indicates they may still extract publishable data from the partial enrollment, potentially salvaging some clinical value from the investment already made.
From a business perspective, this pivot toward outpatient care aligns with broader healthcare trends. The outpatient setting offers several advantages: lower treatment costs, potentially higher volume, and alignment with value-based care initiatives. The decision to focus on areas showing "increasing demand" suggests Nuwellis is pursuing a data-driven approach to resource allocation.
The company's emphasis that this decision was "not related to device performance or patient safety concerns" is important for maintaining confidence in their SmartFlow® technology, which remains FDA-cleared for fluid overload treatment. By redirecting resources to outpatient, pediatric, and critical care segments, Nuwellis appears to be concentrating on market segments where their ultrafiltration technology can potentially gain faster adoption with less resource-intensive validation requirements.
| WHO | WHAT | WHEN | WHY |
| Nuwellis, Inc. | Termination of the REVERSE-HF clinical trial | July 17, 2025 | To redirect resources toward outpatient markets where scalable impact is highest. |
MINNEAPOLIS, July 17, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. today announced the termination of its REVERSE-HF clinical trial, a randomized post-market trial evaluating ultrafiltration vs. IV loop diuretic therapy for fluid management in hospitalized heart failure patients. This decision reflects the company’s strategic commitment to prioritize resources in areas demonstrating the greatest potential for patient impact and business growth—namely, outpatient heart failure, pediatric, and critical care.
“We’re incredibly grateful to the hospitals, investigators, and clinical teams who contributed their time and expertise to REVERSE-HF,” said John Erb, CEO of Nuwellis. “The trial was thoughtfully designed, and we remain confident in the role of ultrafiltration as a vital therapy for fluid management in heart failure. However, as we evaluate where we can make the most meaningful and scalable impact, it’s clear that the hospital-based outpatient setting presents the strongest opportunity in heart failure— for patients, our hospital customers, and for our business.”
Nuwellis is seeing increasing demand and interest of its ultrafiltration therapy in hospital-based outpatient heart failure programs. Redirecting investment from REVERSE-HF allows the company to accelerate progress in this high-potential area, while continuing to support ongoing strong growth in its pediatric and critical care customer categories. The company anticipates it will save approximately
The REVERSE-HF Trial collected valuable data that may be helpful in informing clinical practice. The trial began enrolling patients in 2022, and at the time of its termination, it had enrolled 167 patients. The company intends to work with the steering committee, investigators, and biostatisticians to identify what statistical value can be derived from the existing data to support potential future clinical publications or podium presentations.
The decision to terminate the post-market clinical study was not related to device performance or patient safety concerns. The Nuwellis SmartFlow® remains on the market as an FDA cleared treatment for patients suffering from fluid overload. For more information, visit www.nuwellis.com.
About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device 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 www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.
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.
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 2025 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 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.
For further information, please contact:
Investor Relations:
Robert Scott
Chief Financial Officer
ir@nuwellis.com
Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com
FAQ
Why did Nuwellis (NUWE) terminate the REVERSE-HF clinical trial?
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How many patients were enrolled in the NUWE REVERSE-HF trial before termination?
Is the Nuwellis SmartFlow device still FDA approved after the trial termination?
What markets will Nuwellis (NUWE) focus on after terminating REVERSE-HF?
