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Nuwellis to Exit International Operations to Accelerate U.S. Revenue Growth and Strategic Focus

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Nuwellis (Nasdaq: NUWE), a medical technology company focused on fluid management solutions, has announced its strategic decision to exit international operations to concentrate exclusively on the U.S. market. The company is making this move to capitalize on strong growth and clinical demand in U.S. cardiac surgery and pediatric programs, as well as expanding opportunities in hospital-based outpatient settings.

Led by CEO John Erb, Nuwellis will implement a structured wind-down of international operations while intensifying its focus on high-acuity and hospital-based outpatient settings in the U.S. market. The strategic realignment aims to prioritize investment in areas showing the strongest momentum and growth potential, particularly in cardiac surgery, pediatrics, and outpatient models.

Nuwellis (Nasdaq: NUWE), un'azienda di tecnologia medica specializzata in soluzioni per la gestione dei fluidi, ha annunciato la sua decisione strategica di uscire dalle operazioni internazionali per concentrarsi esclusivamente sul mercato statunitense. L'azienda compie questa scelta per sfruttare la forte crescita e la domanda clinica nei programmi di chirurgia cardiaca e pediatrica negli Stati Uniti, oltre a cogliere le opportunità in espansione negli ambulatori ospedalieri.

Sotto la guida del CEO John Erb, Nuwellis attuerà una chiusura strutturata delle operazioni internazionali intensificando al contempo il focus sui contesti ospedalieri ad alta complessità e ambulatoriali nel mercato USA. Il riallineamento strategico mira a dare priorità agli investimenti nelle aree con maggior slancio e potenziale di crescita, in particolare nella chirurgia cardiaca, pediatria e nei modelli ambulatoriali.

Nuwellis (Nasdaq: NUWE), una empresa de tecnología médica centrada en soluciones de gestión de fluidos, ha anunciado su decisión estratégica de salir de las operaciones internacionales para enfocarse exclusivamente en el mercado estadounidense. La compañía realiza este movimiento para aprovechar el fuerte crecimiento y la demanda clínica en los programas de cirugía cardíaca y pediátrica en EE. UU., así como las oportunidades en expansión en entornos ambulatorios hospitalarios.

Bajo la dirección del CEO John Erb, Nuwellis implementará un cierre estructurado de las operaciones internacionales mientras intensifica su enfoque en entornos hospitalarios de alta complejidad y ambulatorios en el mercado estadounidense. La realineación estratégica busca priorizar la inversión en áreas con mayor impulso y potencial de crecimiento, especialmente en cirugía cardíaca, pediatría y modelos ambulatorios.

Nuwellis (나스닥: NUWE)는 체액 관리 솔루션에 중점을 둔 의료 기술 회사로, 국제 사업에서 철수하고 미국 시장에만 전념하기로 전략적 결정을 발표했습니다. 이 회사는 미국 심장 수술 및 소아과 프로그램에서 강력한 성장과 임상 수요를 활용하고, 병원 기반 외래 진료 분야에서 확장되는 기회를 잡기 위해 이 같은 조치를 취했습니다.

CEO John Erb의 주도 아래 Nuwellis는 국제 사업을 체계적으로 축소하는 한편, 미국 시장 내 고위험군 및 병원 기반 외래 진료에 집중할 예정입니다. 이번 전략적 재조정은 심장 수술, 소아과, 외래 진료 모델 등에서 가장 강력한 성장 동력과 잠재력을 보이는 분야에 투자를 우선시하는 것을 목표로 합니다.

Nuwellis (Nasdaq : NUWE), une entreprise de technologie médicale spécialisée dans les solutions de gestion des fluides, a annoncé sa décision stratégique de se retirer des opérations internationales pour se concentrer exclusivement sur le marché américain. L'entreprise prend cette décision pour tirer parti de la forte croissance et de la demande clinique dans les programmes de chirurgie cardiaque et pédiatrique aux États-Unis, ainsi que des opportunités croissantes dans les soins ambulatoires hospitaliers.

Sous la direction du PDG John Erb, Nuwellis mettra en œuvre une réduction structurée de ses opérations internationales tout en intensifiant son attention sur les environnements hospitaliers à haute intensité et les soins ambulatoires aux États-Unis. Ce réalignement stratégique vise à prioriser les investissements dans les domaines présentant le plus fort élan et potentiel de croissance, notamment la chirurgie cardiaque, la pédiatrie et les modèles ambulatoires.

Nuwellis (Nasdaq: NUWE), ein Medizintechnikunternehmen, das sich auf Flüssigkeitsmanagementlösungen spezialisiert hat, hat seine strategische Entscheidung bekannt gegeben, sich aus den internationalen Geschäften zurückzuziehen, um sich ausschließlich auf den US-Markt zu konzentrieren. Das Unternehmen trifft diese Entscheidung, um vom starken Wachstum und der klinischen Nachfrage in den US-amerikanischen Programmen für Herzchirurgie und Pädiatrie sowie von den wachsenden Möglichkeiten in ambulanten Krankenhausbereichen zu profitieren.

Unter der Leitung von CEO John Erb wird Nuwellis eine strukturierte Abwicklung der internationalen Geschäfte durchführen und gleichzeitig den Fokus auf hochakute und ambulante Krankenhausbereiche im US-Markt verstärken. Die strategische Neuausrichtung zielt darauf ab, Investitionen in Bereiche mit dem stärksten Wachstumspotenzial zu priorisieren, insbesondere in der Herzchirurgie, Pädiatrie und ambulanten Modellen.

Positive
  • Strategic focus on U.S. market where company sees strongest growth
  • Expanding traction in cardiac surgery and pediatric programs
  • Rising opportunities in hospital-based outpatient space
  • Operational streamlining to improve resource allocation
Negative
  • Loss of international market presence and revenue streams
  • Reduction in geographic diversification
  • Potential costs associated with international operations wind-down

MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced its decision to exit international operations in order to focus exclusively on the U.S. market—where the company is seeing the strongest growth and clinical demand.

This strategic realignment supports Nuwellis’ core business strategy: investing in the markets driving revenue growth. With expanding traction in U.S. cardiac surgery and pediatric programs, and a rising opportunity in the hospital-based outpatient space, the company is streamlining to prioritize investment in markets where it can have the most immediate and long-term impact.

“This move allows us to fully align our operations where the fastest growth is happening,” said John Erb, CEO of Nuwellis. “We’re investing in the areas that are showing momentum—and that means doubling down on the U.S. market. Our focus is on delivering results for patients and providers in high-acuity and hospital-based outpatient settings.”

Cardiac surgery, pediatrics, and outpatient models are emerging as the strongest growth drivers for Nuwellis, offering faster intervention, better patient outcomes, and more efficient resource use. This strategic pivot positions the company to lead in this evolving care landscape.

The company will continue to support its international partners through a structured wind-down period. This shift underscores Nuwellis’ broader strategy to align operations with market demand and deliver shareholder value through operational discipline and customer focus.

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 is Nuwellis (NUWE) exiting international operations?

Nuwellis is exiting international operations to focus exclusively on the U.S. market where it's seeing the strongest growth and clinical demand, particularly in cardiac surgery and pediatric programs.

What are the main growth areas for Nuwellis (NUWE) in the U.S. market?

The main growth areas are cardiac surgery, pediatrics, and hospital-based outpatient settings, which are emerging as the strongest growth drivers for the company.

How will Nuwellis (NUWE) handle its existing international business?

The company will support its international partners through a structured wind-down period while focusing resources on the U.S. market.

What is Nuwellis's (NUWE) core business strategy for 2025?

Nuwellis's core strategy is investing in markets driving revenue growth, specifically focusing on the U.S. market where it can have the most immediate and long-term impact.

Who is leading Nuwellis's (NUWE) strategic realignment?

The strategic realignment is being led by CEO John Erb, who emphasizes focusing on areas showing the strongest momentum in the U.S. market.
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