Nuwellis Announces 92% Survival in Children with Acute Kidney Injury (AKI), Fluid Overload or Congenital Kidney Failure Following Treatment with Aquadex®
Nuwellis (Nasdaq: NUWE) announced groundbreaking results from their ULTRA-Peds registry study evaluating the Aquadex System in pediatric patients with kidney conditions. The multi-center study, involving 91 pediatric patients across 8 U.S. centers, demonstrated remarkable outcomes with a 92% survival rate during treatment and 66% survival to hospital discharge.
The study included patients with congenital heart disease (30%), end-stage renal disease (25%), and malignancy (14%). The Aquadex therapy showed strong procedural success, with 86% of circuits completing treatment without interruption. Building on these results, Nuwellis is developing Vivian, a dedicated pediatric CRRT system for infants weighing 2.5-20kg, supported by a $3 million NIH grant.
Nuwellis (Nasdaq: NUWE) ha annunciato risultati innovativi dallo studio di registro ULTRA-Peds che valuta il sistema Aquadex in pazienti pediatrici con condizioni renali. Lo studio multicentrico, che coinvolge 91 pazienti pediatrici in 8 centri negli Stati Uniti, ha mostrato esiti notevoli con una sopravvivenza del 92% durante il trattamento e sopravvivenza al ricovero ospedaliero del 66%.
Lo studio comprendeva pazienti con malattie cardiache congenite (30%), insufficienza renale terminale (25%) e neoplasie (14%). La terapia Aquadex ha evidenziato un forte successo procedurale, con l'86% dei circuiti che hanno completato il trattamento senza interruzioni. Basandosi su questi risultati, Nuwellis sta sviluppando Vivian, un sistema CRRT dedicato ai pediatri per neonati che pesano 2,5-20 kg, supportato da una sovvenzione NIH di 3 milioni di dollari.
Nuwellis (Nasdaq: NUWE) anunció resultados innovadores del registro ULTRA-Peds que evalúa el Sistema Aquadex en pacientes pediátricos con condiciones renales. El estudio multicéntrico, que incluyó 91 pacientes pediátricos en 8 centros de EE. UU., mostró resultados notables con una tasa de supervivencia del 92% durante el tratamiento y 66% de supervivencia hasta el alta hospitalaria.
El estudio incluyó pacientes con enfermedad cardíaca congénita (30%), enfermedad renal terminal (25%) y malignidad (14%). La terapia Aquadex mostró un fuerte éxito procedimental, con 86% de los circuitos que completaron el tratamiento sin interrupciones. A partir de estos resultados, Nuwellis está desarrollando Vivian, un sistema CRRT pediátrico dedicado para lactantes que pesan entre 2,5 y 20 kg, respaldado por una beca NIH de 3 millones de dólares.
뉴웨리스(Nasdaq: NUWE)가 소아 신장 질환 환자를 대상으로 한 Aquadex 시스템의 ULTRA-Peds 레지스트리 연구에서 혁신적인 결과를 발표했습니다. 다기관 연구로 미국 8개 센터에서 총 91명의 소아 환자를 포함했고, 치료 중 생존율 92%, 입원 시점 생존율 66%의 주목할 만한 결과를 보였습니다.
연구에는 선천성 심장질환(30%), 말기 신부전(25%), 악성종양(14%)이 포함되었습니다. Aquadex 치료는 절차적 성공이 강력했고 회로의 86%가 중단 없이 치료를 완료했습니다. 이러한 결과에 바탕해 Nuwellis는 체중 2.5-20kg의 영아를 위한 소아 CRRT 전용 시스템인 Vivian을 개발 중이며, 미국 국립보건원 NIH 보조금 300만 달러의 지원을 받고 있습니다.
Nuwellis (Nasdaq: NUWE) a annoncé des résultats révolutionnaires issus de l’étude ULTRA-Peds évaluant le système Aquadex chez les patients pédiatriques atteints de troubles rénaux. L’étude multicentrique, impliquant 91 patients pédiatriques dans 8 centres américains, a montré des résultats remarquables avec un taux de survie de 92% pendant le traitement et 66% de survie jusqu’à la sortie de l’hôpital.
L’étude comprenait des patients avec maladie cardiaque congénitale (30%), maladie rénale terminale (25%) et malignité (14%). La thérapie Aquadex a démontré un fort succès procédural, avec 86% des circuits ayant terminé le traitement sans interruption. Fort de ces résultats, Nuwellis développe Vivian, un système CRRT pédiatrique dédié aux nourrissons pesant entre 2,5 et 20 kg, soutenu par une subvention NIH de 3 millions de dollars.
Nuwellis (Nasdaq: NUWE) gab bahnbrechende Ergebnisse aus dem ULTRA-Peds-Register, das das Aquadex-System bei pädiatrischen Patienten mit Nierenerkrankungen bewertet, bekannt. Die multizentrische Studie mit 91 pädiatrischen Patienten in 8 US-Zentren zeigte herausragende Ergebnisse mit einer Überlebensrate von 92% während der Behandlung und einer 66%-igen Überlebensrate bis zur Krankenhausentlassung.
Die Studie umfasste Patienten mit angeborenen Herzfehlern (30%), terminaler Nierenerkrankung (25%) und Malignität (14%). Die Aquadex-Therapie wies einen starken prozeduralen Erfolg auf, da 86% der Schaltungen die Behandlung ohne Unterbrechung abschlossen. Aufbauend auf diesen Ergebnissen entwickelt Nuwellis Vivian, ein dediziertes pädiatrisches CRRT-System für Säuglinge mit einem Gewicht von 2,5–20 kg, unterstützt durch einen NIH-Zuschuss von 3 Millionen Dollar.
نويوليس (ناسداك: NUWE) أعلن عن نتائج رائدة من سجل ULTRA-Peds الذي يقيم نظام Aquadex لدى مرضى الأطفال المصابين بحالات الكلى. الدراسة متعددة المراكز، التي شملت 91 مريضاً من الأطفال عبر 8 مراكز في الولايات المتحدة، أظهرت نتائج ملحوظة بواقع 96% بقاطر أثناء العلاج و< b>66% بقائهم حتى خروجهم من المستشفى.
شملت الدراسة مرضى بمرض قلب خلقي (30%)، ومرض الكلى النهائي (25%)، والسرطان (14%). أظهرت علاج Aquadex نجاحاًإجراءياً قوياً، حيث أكمل 86% من الدارات العلاج دون انقطاع. بناءً على هذه النتائج، تقوم Nuwellis بتطوير Vivian، نظام CRRT مخصص للأطفال الرُّضّع الذي يزن 2.5-20 كغ، بدعم من منحة NIH قدرها 3 ملايين دولار.
Nuwellis（纳斯达克代码：NUWE） 宣布了 ULTRA-Peds 注册研究的突破性结果，该研究评估 Aquadex 系统在患有肾病的儿科患者中的应用。该多中心研究涉及 美国8个中心的91名儿科患者，在治疗中实现了 92% 的生存率，出院时的生存率为 66%。
研究对象包括先天性心脏病患者（30%）、末期肾病（25%）和恶性肿瘤（14%）。Aquadex 治疗显示出较高的程序成功率，86% 的回路在治疗中未被中断。基于这些结果，Nuwellis 正在开发 Vivian，一种专为婴儿（体重 2.5-20 kg）设计的儿科 CRRT 系统，并获得了 300 万美元的 NIH 资助。
- 92% patient survival rate during Aquadex treatment course
- 86% success rate in completing treatment circuits without interruption
- Secured $3 million NIH grant for pediatric CRRT system development
- New patents issued for Vivian pediatric technology
- Strong validation of Aquadex system in critical pediatric cases
- Current Aquadex system limited to pediatric patients weighing 20kg or more
- 34% mortality rate before hospital discharge indicates severity of conditions
Insights
Nuwellis' Aquadex shows impressive 92% survival in critically ill children with kidney issues, validating its efficacy in an underserved population.
The ULTRA-Peds registry results represent a significant advancement in pediatric nephrology. With 91 patients across eight U.S. centers, this multi-center dataset provides compelling evidence for Aquadex's effectiveness in children with acute kidney injury, fluid overload, or congenital kidney failure. The
Beyond survival metrics, the
What makes these results particularly significant is the extreme scarcity of treatment options for pediatric patients with kidney failure. Current technologies are predominantly adapted from adult applications, often making them suboptimal for children's unique physiological needs. The registry's inclusion of patients below the current 20kg FDA-cleared threshold highlights this critical care gap while pointing toward potential expanded indications.
The company's development of the Vivian system for neonates and children weighing between 2.5kg and 20kg directly addresses an unmet clinical need in pediatric nephrology. The
Nuwellis' ULTRA-Peds registry results signal potential market expansion in a specialized but crucial niche. The
What's particularly notable is how this positions Nuwellis in the pediatric renal support market, where competition is limited due to technical challenges and smaller patient populations. The company is building a compelling case for leadership in a specialized segment that lacks purpose-built solutions. Their dual-pronged strategy is noteworthy: leveraging current Aquadex technology while simultaneously developing the Vivian system for even smaller patients.
The
Nuwellis appears to be executing a strategic pivot toward an integrated cardio-renal care approach, recognizing the interconnection between heart and kidney function. This broader positioning could expand their addressable market beyond pure renal applications, potentially creating additional revenue opportunities across the care continuum.
The registry data effectively de-risks the company's pediatric strategy by providing real-world evidence from multiple centers, addressing one of the key barriers to adoption of new medical technology. With strong clinical data, patent protection, and NIH support, Nuwellis is establishing barriers to entry in this specialized market segment while building the foundation for potential label expansion to patients under 20kg.
ULTRA-Peds Registry, the largest multi-center dataset of its kind, shows Aquadex therapy was well-tolerated in critically ill children, a population with extremely limited treatment options
Results highlight life-threatening gaps in pediatric care and underscore Nuwellis’ commitment to pediatric innovation and integrated cardio-renal care
MINNEAPOLIS, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardio-renal conditions, addressing the critical interplay between the heart and kidneys, today announced findings from the ULTRA-Peds registry, a multi-center observational study examining the real-world use of the Aquadex System in children with acute kidney injury (AKI), fluid overload, or congenital kidney failure.
The ULTRA-Peds registry enrolled 91 pediatric patients across eight U.S. centers, representing a comprehensive real-world dataset to date in this vulnerable population. Diagnoses included congenital heart disease (
Results demonstrated strong survival and procedural success:
92% of patients survived their Aquadex treatment course66% survived to hospital discharge86% of circuits completed their intended treatment course without interruption- Heparin anticoagulation was associated with longer circuit duration compared to bivalirudin
These findings show that Aquadex therapy is both feasible and well tolerated in critically ill children, a population with extremely limited treatment alternatives.
“The ULTRA-Peds registry provides insight into how young children and infants are treated with ultrafiltration and modified dialysis using the Aquadex device,” said Dr. Michelle Starr, Associate Professor of Pediatrics at Indiana University School of Medicine and Riley Hospital for Children’s Division of Pediatric Nephrology and lead investigator of the registry. “Seeing
“ULTRA-Peds registry validates the potential of Aquadex and points us directly toward the future,” said Dr. Stuart Goldstein, Professor of Pediatrics at University of Cincinnati and Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center.
“These results highlight both the resilience of these children and the urgent need for dedicated technology,” said Kelsey Newell, Senior Director of Medical Affairs at Nuwellis. “They also inform our Vivian program, which is supported by NIH funding and new intellectual property. Combined, this positions Nuwellis to transform pediatric kidney support while advancing our broader mission in cardio-renal care.”
The Aquadex System is FDA-cleared for adult patients with fluid overload who have failed diuretic therapy, as well as for pediatric patients weighing 20kg or more. The ULTRA-Peds registry included two distinct arms, one of which was a retrospective review of prior use cases already completed, so included some patients under this weight threshold and the other, which was exclusively prospective and on -label.
The ULTRA-Peds registry is more than a dataset - it highlights a critical gap in care and provides a foundation for Nuwellis’ pediatric and cardio-renal strategy. Building on these findings, Nuwellis is advancing development of Vivian, a dedicated pediatric continuous renal replacement therapy (CRRT) system designed specifically for neonates and small children weighing between 2.5kg and 20kg. Unlike existing technologies adapted from adult use, Vivian is purpose-built to address the delicate physiology of infants and provide clinicians with a safer, more precise tool for kidney support. The program recently received a
The company’s roadmap is designed to move from evidence to innovation to leadership:
- Support evidence generation through registries like ULTRA-Peds to better understand real-world care.
- Advance Vivian development to provide a device designed specifically for infants and small children.
- Lead in cardio-renal care across all ages by addressing the interconnected needs of the heart and kidneys.
The registry was funded by Nuwellis as part of the company’s commitment to advancing knowledge in pediatric kidney support.
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.
About Vivian Vivian is a purpose-built pediatric CRRT system designed for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO₂ sensors for real-time monitoring. Vivian brings three therapies—Ultrafiltration (UF), Continuous Veno-Venous Hemofiltration (CVVH), and Continuous Veno-Venous Hemodialysis (CVVHD)—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.
Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.
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:
Jenene Thomas
Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com
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