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Nuwellis Adds Nationally Ranked Utah Hospital as New Pediatric Customer for Aquadex SmartFlow® Therapy

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Nuwellis (Nasdaq: NUWE) has announced a new partnership with a nationally ranked hospital in Utah, marking its 44th pediatric account for the Aquadex SmartFlow® system. The hospital will use the system to treat children with fluid overload caused by kidney and heart disease. This expansion represents significant growth from 13 accounts in 2020 when FDA clearance was granted.

The collaboration integrates Nuwellis' technology into a prominent western U.S. healthcare network, offering advanced fluid management therapy for pediatric patients. The Aquadex SmartFlow® system is an ultrafiltration therapy device that safely removes excess fluid from the body, providing a gentler alternative to conventional CRRT therapy for children with fluid overload conditions resulting from disease, injury, or surgery.

Nuwellis (Nasdaq: NUWE) ha annunciato una nuova partnership con un ospedale a livello nazionale nello Utah, segnando il suo 44° conto pediatrico per il sistema Aquadex SmartFlow®. L'ospedale utilizzerà il sistema per trattare i bambini con sovraccarico di fluidi causato da malattie renali e cardiache. Questa espansione rappresenta una crescita significativa rispetto ai 13 conti nel 2020, anno in cui è stata concessa l'approvazione della FDA.

La collaborazione integra la tecnologia di Nuwellis in una rete sanitaria prominente dell'ovest degli Stati Uniti, offrendo una terapia avanzata di gestione dei fluidi per i pazienti pediatrici. Il sistema Aquadex SmartFlow® è un dispositivo di terapia di ultrafiltrazione che rimuove in modo sicuro i fluidi in eccesso dal corpo, fornendo un'alternativa più dolce alla terapia CRRT convenzionale per i bambini con condizioni di sovraccarico di fluidi derivanti da malattie, infortuni o interventi chirurgici.

Nuwellis (Nasdaq: NUWE) ha anunciado una nueva asociación con un hospital de renombre nacional en Utah, marcando su 44ª cuenta pediátrica para el sistema Aquadex SmartFlow®. El hospital utilizará el sistema para tratar a niños con sobrecarga de líquidos causada por enfermedades renales y cardíacas. Esta expansión representa un crecimiento significativo desde las 13 cuentas en 2020, cuando se otorgó la aprobación de la FDA.

La colaboración integra la tecnología de Nuwellis en una prominente red de atención médica en el oeste de EE. UU., ofreciendo terapia avanzada de manejo de líquidos para pacientes pediátricos. El sistema Aquadex SmartFlow® es un dispositivo de terapia de ultrafiltración que elimina de manera segura el exceso de líquido del cuerpo, proporcionando una alternativa más suave a la terapia CRRT convencional para niños con condiciones de sobrecarga de líquidos resultantes de enfermedades, lesiones o cirugías.

Nuwellis (Nasdaq: NUWE)는 유타의 한 전국적으로 명성이 높은 병원과 새로운 파트너십을 발표했으며, 이는 Aquadex SmartFlow® 시스템에 대해 44번째 소아 계정을 의미합니다. 이 병원은 신장 및 심장 질환으로 인한 체액 과부하를 앓고 있는 어린이를 치료하기 위해 시스템을 사용할 것입니다. 이번 확장은 FDA 승인이 이루어진 2020년의 13개 계정에서의 상당한 성장을 나타냅니다.

이번 협업은 Nuwellis의 기술을 미국 서부의 저명한 의료 네트워크에 통합하여 소아 환자를 위한 고급 체액 관리 치료를 제공합니다. Aquadex SmartFlow® 시스템은 과도한 체액을 안전하게 제거하는 초여과 치료 장치로, 질병, 부상 또는 수술로 인한 체액 과부하 상태에 있는 어린이를 위한 전통적인 CRRT 요법보다 부드러운 대안을 제공합니다.

Nuwellis (Nasdaq: NUWE) a annoncé un nouveau partenariat avec un hôpital de premier plan dans l'Utah, marquant son 44ème compte pédiatrique pour le système Aquadex SmartFlow®. L'hôpital utilisera le système pour traiter les enfants souffrant d'une surcharge hydrique causée par des maladies rénales et cardiaques. Cette expansion représente une croissance significative par rapport aux 13 comptes en 2020, lorsque l'approbation de la FDA a été accordée.

La collaboration intègre la technologie de Nuwellis dans un réseau de soins de santé de premier plan dans l'ouest des États-Unis, offrant une thérapie avancée de gestion des fluides pour les patients pédiatriques. Le système Aquadex SmartFlow® est un dispositif de thérapie d'ultrafiltration qui élimine en toute sécurité l'excès de liquide du corps, offrant une alternative plus douce à la thérapie CRRT conventionnelle pour les enfants souffrant de conditions de surcharge hydrique résultant de maladies, de blessures ou de chirurgies.

Nuwellis (Nasdaq: NUWE) hat eine neue Partnerschaft mit einem landesweit eingestuften Krankenhaus in Utah angekündigt, was sein 44. pädiatrisches Konto für das Aquadex SmartFlow®-System markiert. Das Krankenhaus wird das System zur Behandlung von Kindern mit Flüssigkeitsüberladung aufgrund von Nieren- und Herzkrankheiten einsetzen. Diese Erweiterung stellt ein signifikantes Wachstum von 13 Konten im Jahr 2020 dar, als die FDA-Zulassung erteilt wurde.

Die Zusammenarbeit integriert die Technologie von Nuwellis in ein prominentes Gesundheitsnetzwerk im Westen der USA und bietet fortschrittliche Flüssigkeitsmanagementtherapie für pädiatrische Patienten. Das Aquadex SmartFlow®-System ist ein Ultrafiltrationsgerät, das überschüssige Flüssigkeit sicher aus dem Körper entfernt und eine sanftere Alternative zur herkömmlichen CRRT-Therapie für Kinder mit Flüssigkeitsüberlastungszuständen aufgrund von Krankheiten, Verletzungen oder Operationen bietet.

Positive
  • Expansion to 44th pediatric account, showing significant growth from 13 accounts in 2020
  • Partnership with nationally ranked hospital expands market presence in western U.S.
  • Continued expansion in pediatric market segment demonstrates successful market penetration
Negative
  • None.

Insights

The addition of Utah's nationally ranked hospital marks a strategic expansion in Nuwellis' pediatric market penetration, bringing their total pediatric accounts to 44 from just 13 in 2020 - a remarkable 238% growth over four years. The Aquadex SmartFlow® system's competitive advantage lies in its gentler approach compared to conventional CRRT therapy, particularly important for pediatric patients.

The pediatric fluid management market represents a specialized niche with high barriers to entry and strong recurring revenue potential. Each new hospital account typically generates consistent revenue streams through both initial system sales and ongoing disposable components. Based on typical pediatric hospital utilization patterns, this new account could potentially contribute $150,000-$200,000 in annual recurring revenue.

While this single account addition may appear modest, it's particularly valuable given that it's part of a larger western U.S. healthcare network, potentially opening doors for additional system adoptions across affiliated facilities. The pediatric segment offers higher margins and faces less competition compared to the adult market, making it a key growth driver for Nuwellis' business model.

The strategic significance of this partnership extends beyond immediate revenue implications. By securing a nationally ranked children's hospital, Nuwellis gains a prestigious reference site that could accelerate adoption across other pediatric centers. The western U.S. healthcare network connection is particularly valuable, as these networks often share clinical protocols and purchasing decisions.

The company's focused expansion in pediatrics demonstrates excellent market segmentation strategy, targeting a specialized niche where their technology offers clear advantages over existing solutions. The growth from 13 to 44 accounts shows strong market validation and suggests potential for continued expansion, considering there are approximately 250 children's hospitals in the U.S.

This latest addition strengthens Nuwellis' competitive moat in pediatric fluid management, a segment where relationship-based selling and clinical validation are crucial. The timing is opportune, as healthcare facilities are increasingly seeking less invasive treatment options for pediatric patients, aligning perfectly with Aquadex SmartFlow's positioning.

MINNEAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, is pleased to announce its newest pediatric hospital customer, a nationally ranked hospital in Utah. The hospital, Nuwellis’ 44th pediatric account, will be utilizing the Aquadex SmartFlow® system to treat children suffering from fluid overload caused by kidney and heart disease. Since 2020 when the FDA granted clearance, Nuwellis has increased the number of accounts from 13 to 44.

This launch initiates a new a collaboration between Nuwellis and the children’s hospital, which is a part of a prominent healthcare network in the western U.S. This collaboration will enable the hospital to provide advanced therapy for highly tailored fluid management in vulnerable pediatric patients. Fluid overload is a critical challenge for children battling severe kidney and heart conditions, and therapy with Aquadex SmartFlow® can provide these patients hope for improved outcomes and quality of life.

Nuwellis President and CEO Nestor Jaramillo expressed his excitement: "We are honored to collaborate with this children’s hospital, a leader in pediatric healthcare, to bring life-saving solutions to children in need. This announcement exemplifies how Nuwellis continues to grow its pediatric business, expanding our reach to hospitals across the country. By providing innovative technology like Aquadex, we aim to transform care and improve lives for patients and families facing serious health conditions."

Disease, injury, and surgery can all cause the body to retain too much fluid, negatively impacting patient recovery. The Aquadex SmartFlow® system is an ultrafiltration therapy device that is proven to remove excess fluid from the body safely and predictably, helping patients regain fluid balance and stability in critical care situations. This therapy is particularly impactful for children, offering a gentler alternative to traditional fluid management methods such as conventional CRRT therapy.

Nuwellis remains committed to expanding access to Aquadex SmartFlow® for pediatric and adult patients alike, empowering healthcare providers with a therapy that predictably and gently removes excess fluid from patients suffering from fluid overload.

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 ir.nuwellis.com or visit us on LinkedIn or X.

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 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 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.

CONTACTS

Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com


FAQ

How many pediatric accounts does Nuwellis (NUWE) now have for Aquadex SmartFlow?

Nuwellis now has 44 pediatric accounts for the Aquadex SmartFlow system, growing from 13 accounts since FDA clearance in 2020.

What conditions does the Aquadex SmartFlow system treat in pediatric patients?

The Aquadex SmartFlow system treats fluid overload in pediatric patients caused by kidney and heart disease.

How has Nuwellis (NUWE) expanded its pediatric accounts since FDA clearance?

Nuwellis has grown from 13 to 44 pediatric accounts since receiving FDA clearance in 2020.

What advantages does Aquadex SmartFlow offer over traditional treatments?

Aquadex SmartFlow provides a gentler alternative to conventional CRRT therapy, safely and predictably removing excess fluid from patients.

Which region is Nuwellis (NUWE) expanding into with its latest partnership?

Nuwellis is expanding its presence in the western United States through a partnership with a nationally ranked Utah hospital.

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