Nuwellis Announces the First Successful Outpatient Application of the Aquadex Smartflow庐 System Under New CMS Code
Nuwellis (Nasdaq: NUWE) has achieved a significant milestone with the first successful treatment of patients using its Aquadex SmartFlow庐 ultrafiltration therapy in a hospital-based outpatient setting. This advancement follows the recent CMS decision to increase outpatient reimbursement from $413 to $1,639 per treatment day.
The treatment, performed at a leading healthcare institution in the southeastern United States, demonstrates Nuwellis's progress in expanding access to fluid management therapy. The outpatient model allows for treatment using existing venous access and care teams without requiring hospitalization, potentially reducing hospital readmissions while maintaining the same trusted clinical protocols used in inpatient settings.
Nuwellis (Nasdaq: NUWE) ha raggiunto un importante traguardo con il primo trattamento riuscito di pazienti utilizzando la sua terapia di ultrafiltrazione Aquadex SmartFlow庐 in un contesto ambulatoriale ospedaliero. Questo progresso segue la recente decisione del CMS di aumentare il rimborso per i trattamenti ambulatoriali da 413 a 1.639 dollari per giorno di trattamento.
Il trattamento, eseguito in una struttura sanitaria di primo piano nel sud-est degli Stati Uniti, dimostra i progressi di Nuwellis nell'ampliare l'accesso alla terapia di gestione dei fluidi. Il modello ambulatoriale consente di effettuare il trattamento utilizzando l'accesso venoso esistente e il personale di cura senza necessit脿 di ricovero, riducendo potenzialmente le riammissioni ospedaliere e mantenendo gli stessi protocolli clinici affidabili utilizzati nei reparti.
Nuwellis (Nasdaq: NUWE) ha alcanzado un hito significativo con el primer tratamiento exitoso de pacientes utilizando su terapia de ultrafiltraci贸n Aquadex SmartFlow庐 en un entorno ambulatorio hospitalario. Este avance sigue a la reciente decisi贸n del CMS de aumentar el reembolso ambulatorio de $413 a $1,639 por d铆a de tratamiento.
El tratamiento, realizado en una instituci贸n sanitaria l铆der en el sureste de Estados Unidos, demuestra el progreso de Nuwellis en ampliar el acceso a la terapia de manejo de l铆quidos. El modelo ambulatorio permite realizar el tratamiento utilizando el acceso venoso existente y los equipos de atenci贸n sin necesidad de hospitalizaci贸n, lo que podr铆a reducir las readmisiones hospitalarias manteniendo los mismos protocolos cl铆nicos confiables usados en entornos hospitalarios.
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氙戈淡 雮彊攵�鞚� 欤检殧 鞚橂旮瓣磤鞐愳劀 鞁滍枆霅� 鞚� 旃橂電� Nuwellis臧� 觳挫暋 甏�毽� 旃橂 鞝戧芳靹膘潉 頇曤寑頃橂姅 雿� 鞛堨柎 歆勳爠鞚� 氤挫榾鞚岇潉 鞛呾頃╇媹雼�. 鞕鸽灅 氇嵏鞚� 旮办〈鞚� 鞝曤Д 鞝戧芳氩曣臣 鞚橂歆勳潉 頇滌毄頃橃棳 鞛呾洂鞚� 頃勳殧 鞐嗢澊 旃橂毳� 臧�電ロ晿瓴� 頃橂┌, 鞛呾洂 頇橃瀽 旃橂鞐� 靷毄霅橂姅 鞁犽氚涬姅 鞛勳儊 頂勲韱犾綔鞚� 鞙犾頃橂┐靹� 氤戩洂 鞛瀰鞗愳潉 欷勳澕 靾� 鞛堨姷雼堧嫟.
Nuwellis (Nasdaq : NUWE) a franchi une 茅tape importante avec le premier traitement r茅ussi de patients utilisant sa th茅rapie d鈥檜ltrafiltration Aquadex SmartFlow庐 en milieu ambulatoire hospitalier. Cette avanc茅e fait suite 脿 la r茅cente d茅cision du CMS d鈥檃ugmenter le remboursement ambulatoire de 413 脿 1 639 dollars par jour de traitement.
Le traitement, r茅alis茅 dans un 茅tablissement de sant茅 de premier plan dans le sud-est des 脡tats-Unis, t茅moigne des progr猫s de Nuwellis dans l鈥櫭﹍argissement de l鈥檃cc猫s 脿 la th茅rapie de gestion des fluides. Le mod猫le ambulatoire permet de traiter les patients en utilisant l鈥檃cc猫s veineux existant et les 茅quipes soignantes, sans n茅cessiter d鈥檋ospitalisation, ce qui pourrait r茅duire les r茅admissions hospitali猫res tout en maintenant les m锚mes protocoles cliniques fiables utilis茅s en milieu hospitalier.
Nuwellis (Nasdaq: NUWE) hat einen bedeutenden Meilenstein erreicht: die erste erfolgreiche Behandlung von Patienten mit seiner Aquadex SmartFlow庐 Ultrafiltrationstherapie in einem ambulanten Krankenhausumfeld. Dieser Fortschritt folgt auf die k眉rzliche Entscheidung des CMS, die ambulante Verg眉tung von 413 auf 1.639 US-Dollar pro Behandlungstag zu erh枚hen.
Die Behandlung, durchgef眉hrt in einer f眉hrenden Gesundheitseinrichtung im S眉dosten der USA, zeigt den Fortschritt von Nuwellis bei der Erweiterung des Zugangs zur Fl眉ssigkeitsmanagement-Therapie. Das ambulante Modell erm枚glicht die Behandlung unter Verwendung des bestehenden ven枚sen Zugangs und der Pflegeteams, ohne eine Krankenhausaufnahme zu ben枚tigen, was potenziell Krankenhauswiederaufnahmen reduziert und gleichzeitig die bew盲hrten klinischen Protokolle aus der station盲ren Versorgung beibeh盲lt.
- CMS reimbursement rate increased significantly from $413 to $1,639 per treatment day
- Successful expansion into outpatient settings, broadening market opportunities
- Potential reduction in hospital readmissions through outpatient treatment model
- More efficient resource management for healthcare systems
- None.
Insights
Nuwellis' outpatient Aquadex ultrafiltration marks strategic expansion with 4x higher reimbursement, potentially increasing adoption and revenue streams.
This announcement represents a significant strategic development for Nuwellis that could substantially expand their market opportunity. The company has successfully implemented their Aquadex ultrafiltration therapy in a hospital-based outpatient setting, marking a critical operational milestone backed by a recent CMS reimbursement code change.
The most compelling aspect is the dramatic increase in reimbursement rates鈥攆rom approximately
This shift addresses several critical market dynamics simultaneously:
- Allows treatment of fluid overload patients without requiring full hospitalization, reducing costs while maintaining revenue
- Creates a new revenue stream for Nuwellis by expanding into the outpatient setting
- Aligns with healthcare systems' goals to reduce readmissions and manage complex patients more cost-effectively
- Maintains the clinical protocol continuity that physicians already trust
From a business perspective, this enables Nuwellis to penetrate the market more deeply by offering their technology across more care settings. The increased reimbursement substantially improves the value proposition for healthcare facilities, which historically has been a major adoption barrier for specialized medical technologies.
As hospitals face growing pressure to reduce inpatient stays while managing complex patients with conditions like heart failure, this outpatient application provides a pragmatic solution that works within existing clinical workflows while potentially improving the standard of care. The company appears well-positioned to support implementation through training and protocol development, which will be critical for widespread adoption.
Supported by the recent CMS decision to increase the reimbursement rate, which facilitates broader use of the therapy in outpatient settings
MINNEAPOLIS, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming fluid management, today announced that the first patients have been successfully treated with Aquadex庐 ultrafiltration therapy in a hospital-based outpatient setting. This milestone reflects a major advancement in the company鈥檚 mission to improve access to fluid management and support better care across the continuum.
The treatments were performed at a leading healthcare institution in the southeastern United States using the same Aquadex SmartFlow庐 system and clinical protocols trusted in inpatient environments. By enabling therapy in a hospital-based outpatient setting, Nuwellis is helping to reimagine how and where patients with fluid overload can be supported鈥攐ffering a potential new model for earlier, more proactive care.
鈥淔or patients struggling with fluid overload, access to consistent, effective therapy can make a life-changing difference,鈥� said John Erb, CEO of Nuwellis. 鈥淭his milestone represents more than just a shift in setting鈥攊t reflects our vision for expanding how care is delivered and making fluid management more flexible, scalable, and patient-centered.鈥�
In addition to the clinical benefits, hospitals may also realize significant economic advantages by transitioning appropriate therapies to outpatient care. With outpatient reimbursement increasing from approximately
The hospital-based outpatient setting provides an opportunity to treat patients using existing venous access and care teams, without requiring hospitalization. This approach may offer significant advantages to patients who are repeatedly admitted due to volume challenges, while also helping healthcare systems manage resources more efficiently.
Nuwellis continues to work closely with providers to support hospital-based outpatient program development, including training, protocols, and workflow integration. The company sees this as a foundational step in building sustainable access to ultrafiltration therapy鈥攁nd a key part of its long-term strategy to expand the impact of Aquadex.
For more information, please visit and to learn more about the Company鈥檚 reimbursement for outpatient, please visit the .
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庐 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 Twitter.
About the Aquadex SmartFlow庐 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
Media Contact:
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Director of Communications
FAQ
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