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Nuwellis Expands Aquadex® for Pediatric Fluid Management to Two New Hospital Systems

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Nuwellis (NASDAQ: NUWE) has expanded its Aquadex SmartFlow® therapy to two additional pediatric centers in the Southeastern United States, bringing the total to 47 pediatric centers using their fluid management solution. The Aquadex system is designed for controlled fluid removal in patients weighing 20 kg and above, offering a nurse-managed, bedside-compatible therapy for children facing fluid overload. This expansion represents growing recognition of early, precise fluid management as crucial for better outcomes in pediatric care. The technology provides care teams with a gentle approach to managing fluid overload in critically ill children, where the margin for error is particularly narrow.
Nuwellis (NASDAQ: NUWE) ha ampliato la sua terapia Aquadex SmartFlow® a due ulteriori centri pediatrici nel Sud-Est degli Stati Uniti, portando a 47 il numero totale di centri pediatrici che utilizzano la loro soluzione per la gestione dei fluidi. Il sistema Aquadex è progettato per la rimozione controllata dei fluidi in pazienti con un peso di almeno 20 kg, offrendo una terapia gestita dall'infermiere e compatibile a letto per bambini con sovraccarico di liquidi. Questa espansione riflette il crescente riconoscimento dell'importanza di una gestione precoce e precisa dei fluidi per migliorare i risultati nella cura pediatrica. La tecnologia offre ai team di assistenza un approccio delicato per gestire il sovraccarico di liquidi nei bambini gravemente malati, dove il margine di errore è particolarmente ridotto.
Nuwellis (NASDAQ: NUWE) ha ampliado su terapia Aquadex SmartFlow® a dos centros pediátricos adicionales en el sureste de Estados Unidos, alcanzando un total de 47 centros pediátricos que utilizan su solución para el manejo de líquidos. El sistema Aquadex está diseñado para la eliminación controlada de líquidos en pacientes que pesen 20 kg o más, ofreciendo una terapia manejada por enfermería y compatible para uso en la cama en niños con sobrecarga de líquidos. Esta expansión representa un creciente reconocimiento de la importancia de un manejo temprano y preciso de líquidos para mejorar los resultados en la atención pediátrica. La tecnología proporciona a los equipos de cuidado un enfoque suave para manejar la sobrecarga de líquidos en niños críticamente enfermos, donde el margen de error es especialmente estrecho.
Nuwellis(NASDAQ: NUWE)는 미국 남동부 지역의 두 개 추가 소아 센터에 Aquadex SmartFlow® 치료법을 확장하여, 총 47개 소아 센터에서 이 체액 관리 솔루션을 사용하게 되었습니다. Aquadex 시스템은 20kg 이상의 환자에서 체액을 조절하여 제거하도록 설계되었으며, 간호사가 관리하고 침상에서 사용할 수 있는 치료법으로 체액 과부하에 직면한 어린이들에게 적합합니다. 이번 확장은 조기이면서 정밀한 체액 관리가 소아 치료에서 더 나은 결과를 위한 핵심임을 점점 더 인정받고 있음을 의미합니다. 이 기술은 중증 아동의 체액 과부하를 관리하는 데 있어 오류 허용 범위가 매우 좁은 상황에서 의료진에게 부드러운 접근법을 제공합니다.
Nuwellis (NASDAQ : NUWE) a étendu sa thérapie Aquadex SmartFlow® à deux centres pédiatriques supplémentaires dans le sud-est des États-Unis, portant le total à 47 centres pédiatriques utilisant leur solution de gestion des fluides. Le système Aquadex est conçu pour l’élimination contrôlée des fluides chez les patients pesant 20 kg et plus, offrant une thérapie gérée par les infirmières et compatible au chevet des enfants souffrant de surcharge liquidienne. Cette expansion reflète une reconnaissance croissante de l’importance d’une gestion précoce et précise des fluides pour améliorer les résultats en soins pédiatriques. La technologie offre aux équipes soignantes une approche douce pour gérer la surcharge liquidienne chez les enfants gravement malades, où la marge d’erreur est particulièrement étroite.
Nuwellis (NASDAQ: NUWE) hat seine Aquadex SmartFlow® Therapie auf zwei weitere pädiatrische Zentren im Südosten der Vereinigten Staaten ausgeweitet und damit insgesamt 47 pädiatrische Zentren erreicht, die ihre Flüssigkeitsmanagement-Lösung nutzen. Das Aquadex-System ist für die kontrollierte Flüssigkeitsentfernung bei Patienten ab einem Gewicht von 20 kg konzipiert und bietet eine von Pflegepersonal gesteuerte, bettkompatible Therapie für Kinder mit Flüssigkeitsüberladung. Diese Erweiterung zeigt die zunehmende Anerkennung der frühen und präzisen Flüssigkeitskontrolle als entscheidend für bessere Ergebnisse in der pädiatrischen Versorgung. Die Technologie ermöglicht den Pflegeteams einen schonenden Ansatz zur Behandlung von Flüssigkeitsüberladung bei kritisch kranken Kindern, bei denen der Fehlerraum besonders gering ist.
Positive
  • Expansion to two new pediatric centers in the Southeastern US
  • Growing adoption with 47 total pediatric centers now using Aquadex therapy
  • Product offers unique advantages for pediatric care with nurse-managed, bedside-compatible therapy
Negative
  • Limited to patients weighing 20 kg and above
  • No specific revenue or financial impact disclosed

Insights

Nuwellis expands pediatric fluid management technology to two new hospital systems, showing steady market penetration in a specialized niche.

Nuwellis has expanded its Aquadex SmartFlow therapy to two additional pediatric centers in the Southeastern US, bringing their total to 47 pediatric centers adopting this specialized technology. This represents incremental but meaningful commercial progress in the pediatric fluid management market.

The Aquadex system addresses a critical clinical challenge where precision matters significantly. Pediatric patients experiencing fluid overload have minimal margin for error due to their smaller body mass and physiological constraints. The technology's design for patients weighing 20kg and above defines its specific addressable market within pediatrics.

From a commercial perspective, each hospital system adoption typically follows a methodical evaluation process and represents both potential equipment sales and ongoing revenue through disposables. The company appears to be executing a focused strategy targeting the pediatric segment, where specialized requirements create opportunities for market differentiation.

The technology's positioning as nurse-managed and bedside-compatible addresses operational efficiency needs, an increasingly decisive factor in hospital purchasing decisions amid healthcare staffing challenges. While no financial metrics or implementation timelines are disclosed, this announcement demonstrates continued commercial traction in what appears to be a strategic market segment for Nuwellis.

For tracking purposes, the concrete metric of 47 pediatric centers provides investors with a baseline to measure future adoption rates and assess the company's execution in this specialized market. This expansion in the Southeastern US suggests systematic regional growth that could potentially build momentum through clinical networks.

The Company has 47 Pediatric Centers utilizing Aquadex

MINNEAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for patients with fluid overload, today announced a meaningful step forward for children facing fluid overload with the recent expansion of its Aquadex SmartFlow® therapy into two additional pediatric centers across the Southeastern United States. The company now has 47 pediatric centers that have adopted Aquadex therapy as part of their fluid management approach.

Even in well-managed care settings, fluid overload can be a turning point in recovery for pediatric patients—who often have a narrow margin for error. When alternative therapies fall short, the patient risks can escalate quickly. More hospitals are now turning to Aquadex to support pediatric life-saving intervention, helping teams act before fluid overload drives complications and, in some cases, mortality.

“Pediatric patients require an added level of precision. The margin for error is narrow, and the clinical stakes are often immediate,” said John Jefferies, MD, MPH, FACC, FHFSA, Chief Medical Officer of Nuwellis. “That is why this expansion matters—it provides care teams with an additional therapeutic option for managing fluid overload in critically ill children.”

Aquadex is a nurse-managed, bedside-compatible therapy that allows for controlled, gentle fluid removal. Designed for use in adults and pediatric patients weighing 20 kg and above, it offers an approach that supports stability without the need for aggressive intervention—especially important in pediatric care.

For Nuwellis, the expansion is not just a number. It is a signal that more clinical teams are rethinking how and when they intervene. Early, precise fluid management is increasingly viewed as a path to better outcomes, and fewer setbacks, for this vulnerable population.

“Every new hospital that brings in Aquadex is one more team empowered to act with confidence and control,” said John Erb, Interim Chief Executive Officer of Nuwellis. “We are immensely proud to support that shift.”

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:
Louisa Smith
Gilmartin Group
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com


FAQ

How many pediatric centers now use Nuwellis (NUWE) Aquadex therapy?

Nuwellis has 47 pediatric centers that have adopted Aquadex therapy as part of their fluid management approach.

What is the minimum weight requirement for Nuwellis Aquadex SmartFlow therapy?

The Aquadex SmartFlow therapy is designed for use in adults and pediatric patients weighing 20 kg and above.

What are the key features of Nuwellis' Aquadex therapy for pediatric patients?

Aquadex is a nurse-managed, bedside-compatible therapy that allows for controlled, gentle fluid removal, specifically designed to support stability without aggressive intervention in pediatric care.

Where did Nuwellis (NUWE) expand its pediatric Aquadex therapy in 2025?

Nuwellis expanded its Aquadex SmartFlow therapy to two additional pediatric centers across the Southeastern United States.
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