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Here are two brief analogies for Nuwellis (NUWE):

• Like Baxter International for advanced fluid management in critical care.
• Like Fresenius Medical Care for specialized fluid removal therapy beyond traditional dialysis.

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• Aquadex SmartFlow System: A medical device used for therapeutic ultrafiltration to remove excess fluid from patients with fluid overload.
• Aquadex SmartFlow Consumables: Disposable kits, including blood circuit sets and cartridges, designed for single-patient use with the Aquadex SmartFlow System.

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Nuwellis (symbol: NUWE) sells primarily to other companies. Its customer base consists of healthcare providers that utilize its Aquadex SmartFlow system for ultrafiltration therapy.

The company's primary customers are:

• Hospitals
• Healthcare Systems
• Specialized clinics (e.g., cardiology, critical care, nephrology)

Based on Nuwellis's publicly available financial disclosures, including its annual report (10-K filing for the year ended December 31, 2023), no single customer accounted for 10% or more of its total revenue during 2023 or 2022. Consequently, Nuwellis does not disclose specific major customer companies by name or symbol, as there are no individually identifiable customers meeting a typical "major customer" threshold in its public filings.

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John Erb, President and Chief Executive Officer, interim Chief Financial Officer

Mr. Erb has served as Nuwellis's chief executive officer and president since November 2015, and was appointed interim Chief Financial Officer on October 8, 2025. He has over 40 years of experience in the medical device industry. Previously, Mr. Erb was chief executive officer of NuAx, Inc. (2007 to 2018) and also served as chief executive officer (2001 to 2006) of the previous owner of the Aquadex FlexFlow System, then known as CHF Solutions, Inc. He also served as a director and chief executive officer of NeuroMedic, Inc. from 2010 to 2020, when NeuroMedic was acquired by ReCor Medical, Inc. Mr. Erb has served on the Board of Directors for companies that were acquired, including Vascular Solutions (acquired by Teleflex in 2017), SenoRx, Inc. (acquired by CR Bard in 2010), and CryoCath Technologies (acquired by Medtronic in 2008).

Neil P. Ayotte, Esq., Senior Vice President, General Counsel, Secretary, and Chief Compliance Officer

Mr. Ayotte joined Nuwellis in June 2021. He has over 30 years of experience as a lawyer and business leader, with more than 16 years dedicated to the medical device industry. Prior to Nuwellis, Mr. Ayotte was Executive Vice President, Secretary, and General Counsel of Bluestem Group, Inc., a publicly-traded online retailer. He also served as Chief Legal Counsel for the Integration Management Office during Medtronic's $49 billion acquisition of Covidien plc.

David Lerner, Chief Technology Officer

Mr. Lerner has held executive leadership roles in product, technology, and organizational development within the med tech sector. He co-founded start-up firms including CorRen. Before joining Nuwellis, he was the Vice President of Engineering at Senseonics, Inc., focusing on an implantable glucose sensing system. He also served as Chief Technology Officer at Biomedix, where he was a co-founder and board member, and served as VP of Engineering from 1997 to 2002.

Ryan Marthaler, Vice President of Product Marketing and Business Development

Mr. Marthaler joined Nuwellis in February 2023 as a Senior Director of Product Marketing and was appointed to Vice President of Product Marketing and Business Development in March 2025. He brings over 20 years of experience in healthcare marketing and product management, with most of his career spent in the medical device industry.

Kim, Vice President of Operations

Kim (last name not publicly available in search results) has been working with Nuwellis as a product development consultant for over seven years and was recently appointed Vice President of Operations. She is responsible for overseeing daily production, supply chain management, and customer service. She has over 30 years of experience in the medical device industry, focusing on bringing new products to market, managing product improvements, and driving quality initiatives.

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The key risks to Nuwellis's business include its ongoing struggle to maintain its Nasdaq listing and overall financial viability, significant share dilution from capital-raising activities, and intense competition within a complex regulatory environment.

1. Nasdaq Delisting Risk and Financial Distress: Nuwellis has repeatedly faced the risk of delisting from Nasdaq due to its common stock failing to maintain the minimum bid price requirement of $1.00 per share. The company has executed multiple reverse stock splits to regain compliance, indicating persistent underlying financial challenges. Delisting could severely impede its ability to raise additional financing. The company is experiencing rapid cash burn, is currently unprofitable, and has seen declining revenue, which further highlights its precarious financial health.
2. Share Dilution from Capital-Raising Activities: To address its financial needs and maintain its Nasdaq listing, Nuwellis has undertaken significant dilutive actions. This includes frequent reverse stock splits and public offerings with ultra-low-priced shares and pre-funded warrants. These measures lead to immediate dilution for existing shareholders and may deprive the company of future proceeds, as some warrants allow for zero-cash exercise.
3. Competition and Regulatory Environment: Nuwellis operates in the highly competitive healthcare sector, facing established players with substantial resources and experience. The company's ability to innovate and differentiate its offerings is crucial, as failure to do so can lead to declining investor confidence. Furthermore, the healthcare industry is subject to complex regulatory frameworks, and changes or increased scrutiny can create significant hurdles for product development and market entry, potentially impacting the company's performance.

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Nuwellis (symbol: NUWE) develops, manufactures, and commercializes medical devices for ultrafiltration therapy, primarily focusing on managing fluid overload in patients suffering from heart failure, critical care conditions, and pediatric care. The addressable markets for their main products, the Aquadex FlexFlow and Aquadex SmartFlow systems, can be best represented by the broader fluid management and fluid therapy markets, which encompass the treatment of fluid imbalances.

The global fluid management market is a significant addressable market for Nuwellis. In 2025, this market is projected to reach approximately USD 9.52 billion globally. It is anticipated to grow at a compound annual growth rate (CAGR) of 11.50% from 2025 to 2033, potentially reaching over USD 22.75 billion by 2033. North America is a major region within this market, holding a substantial share of over 37% of the global revenue, with an estimated market size of USD 3.52 billion in North America in 2025.

Another related market, the global fluid therapy market, was valued at USD 10.60 billion in 2024 and is expected to grow to USD 14.45 billion by 2030, at a CAGR of 6.4% from 2025 to 2030. North America also leads this market, contributing approximately 38% of the total revenue in 2024.

While specific market sizes for "medical ultrafiltration for fluid overload" are not individually broken out in the same detail as the broader fluid management or fluid therapy markets, Nuwellis's products directly address these needs within these larger contexts. The applications of Nuwellis's devices in heart failure, critical care, and pediatric fluid management contribute to these overall market figures. For instance, the congestive heart failure treatment devices market alone was estimated at USD 6.35 billion globally in 2025 and is projected to reach USD 8.95 billion by 2034. The global critical care devices market, another area Nuwellis serves, was estimated at USD 57.93 billion in 2023 and is anticipated to grow to approximately USD 95.17 billion by 2033. Similarly, the pediatric perfusion market, which involves managing fluid in children, was estimated at USD 579 million globally in 2023 and is expected to reach USD 1.06 billion by 2034.

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Nuwellis (NUWE) anticipates several key drivers to fuel its revenue growth over the next two to three years:

1. Growth in the Pediatric Segment: Nuwellis has demonstrated consistent strength and strategic focus on its pediatric patient population. The company reported a 38% growth in pediatric revenue in the first quarter of 2025 and a 23% increase in the second quarter of 2025 compared to the prior year. This growth is supported by the expansion of Aquadex therapy to new pediatric centers and strong demand from existing hospital customers. Furthermore, Nuwellis has received a new U.S. patent for its Vivian™ Pediatric device, focused on safer and more precise ultrafiltration, and secured a $3 million NIH grant to accelerate its pediatric platform.
2. Expansion into Outpatient Heart Failure Treatment: A significant growth driver is the company's strategic pivot towards outpatient opportunities, particularly in heart failure treatment. This initiative is bolstered by a nearly four-fold increase in CMS reimbursement for Aquadex therapy in outpatient clinics, rising to $1,639 per day, effective January 2025. To support this expansion, Nuwellis introduced a new 24-hour Aquadex™ circuit designed for single-day outpatient sessions.
3. Increased Utilization of Consumables and U.S. Console Sales: Revenue growth is expected from the continued increase in the utilization of consumables and higher U.S. console sales. In the first quarter of 2025, a 4% increase in consumables utilization contributed to overall revenue growth, indicating a growing installed base and increased adoption of the Aquadex SmartFlow® System.
4. Strategic Focus on Core Markets and Operational Efficiencies: Nuwellis is sharpening its focus on high-impact growth areas, specifically pediatrics and cardiac surgery care. Alongside this strategic market focus, the company is transitioning its manufacturing operations to KDI Precision Manufacturing. This move is anticipated to generate operational efficiencies and cost savings over the next 12 months, which can be reinvested into growth initiatives.

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Share Issuance

• In June 2025, Nuwellis completed a public offering that generated approximately $5.0 million in gross proceeds. This offering included 2,580,667 common shares and 14,085,998 pre-funded warrants, along with Series A and Series B Warrants. The common stock and warrants were priced at $0.30 per share, with pre-funded warrants at $0.2999. The net proceeds are intended for working capital, general corporate purposes, and potential acquisition activities.
• In October 2022, Nuwellis priced an underwritten public offering of units, aiming to raise approximately $9.6 million. This offering consisted of Class A Units (common stock and warrants) and Class B Units (Series I convertible preferred stock and warrants), each priced at $0.25.
• Nuwellis stockholders approved an increase in authorized shares from 100 million to 200 million and the issuance of common stock through warrant exercises at a Special Meeting held in August 2025, to enhance financial flexibility.

Inbound Investments

• In September 2025, Nuwellis's development partner, Koronis Biomedical Technologies Corporation (KBT), was awarded a $3 million NIH grant to support the development of Vivian™, a pediatric continuous renal replacement therapy (CRRT) device.

Outbound Investments

• Nuwellis signed a non-binding letter of intent to acquire Rendiatech Ltd., an Israeli medical device company, in August 2025. This proposed acquisition is intended to expand Nuwellis' technology platform into real-time urine flow and acute kidney injury monitoring, with the transaction expected to close in Q4 2025.
• In August 2025, Nuwellis announced its decision to exit international operations to focus exclusively on the U.S. market, aligning its investments with areas of strongest growth such as U.S. cardiac surgery and pediatric programs.

Capital Expenditures

• Net cash used in investing activities was approximately $4,000 in Q2 2025, compared to $53,000 in Q2 2024.
• For the second quarter of 2025, research and development (R&D) expenses totaled $675,000, an increase from $558,000 in the same period of 2024.