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1. A specialized Medtronic focused on devices for removing excess body fluid.

2. Like Baxter International or Fresenius Medical Care, but exclusively for ultrafiltration therapy to treat fluid overload.

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• Aquadex FlexFlow system: A medical device system for ultrafiltration therapy, indicated for patients with fluid overload who have failed diuretics, and includes a console, disposable blood set, and catheter.
• Aquadex SmartFlow system: A medical device system used for ultrafiltration therapy in patients suffering from fluid overload who have failed diuretics.

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Nuwellis (NUWE) sells its products primarily to other companies and institutions. However, the provided background information does not identify specific named major customer companies or their public symbols.

Based on the description, Nuwellis's major customers fall into the following categories:

• Hospitals: These healthcare institutions in the United States purchase the Aquadex systems through Nuwellis's direct salesforce for use in ultrafiltration therapy.
• Clinics: These medical facilities in the United States also acquire Nuwellis's products via its direct salesforce.
• Independent specialty distributors: These companies facilitate sales in various international markets, including but not limited to Austria, Brazil, Czech Republic, Germany, Greece, Hong Kong, India, Israel, Italy, Romania, Singapore, Slovakia, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom.

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• Medical Electronic Devices
• Sonean
• Spectrum Plastics Group
• Biomerics

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John Erb, President and Chief Executive Officer

John Erb is a highly experienced medical technology executive with over 40 years of leadership in med-tech, cardiovascular innovation, and complex healthcare organizations. He currently serves as President and CEO of Nuwellis, marking his second tenure leading the company after previously serving as CEO and as Chairman of the Board. He began his career at Johnson & Johnson, holding operational leadership roles, and has since served as President and CEO of multiple medical device companies, including NuAx, Inc., IntraTherapeutics, Inc., and Schneider Worldwide (a Pfizer division). Erb has extensive experience as a board chairman and director across the medical technology sector.

Carisa Schultz, Chief Financial Officer

Carisa Schultz oversees finance, accounting, treasury, and corporate development at Nuwellis, bringing deep experience in public-company healthcare finance and medical technology. She was appointed CFO effective February 2, 2026. Most recently, she served as Vice President of Finance at NeueHealth (formerly Bright Health Group), a healthcare company previously traded on the New York Stock Exchange, where she led enterprise finance, treasury, and corporate development activities. Her background also includes early career experience at Boston Scientific and Big Four public accounting.

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

Neil Ayotte joined Nuwellis in 2021, bringing over 30 years of legal and business experience, including 16 years in the medical device sector. He possesses deep expertise in corporate governance and regulatory compliance. Previously, he was Executive Vice President, Secretary, and General Counsel of Bluestem Group, Inc., and held multiple leadership positions at Medtronic.

Betsy Riemenschneider, Commercial Leader

Betsy Riemenschneider has more than 20 years of experience in healthcare sales, clinical consulting, and commercial leadership. She joined Nuwellis in 2016 and is responsible for the company's commercial strategy and sales execution, with a focus on growth, team development, and expanding access to ultrafiltration therapy.

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1. Significant Financial Distress and Going Concern Risk: Nuwellis faces substantial financial challenges, evidenced by consistent net losses and negative profitability metrics, including operating and net margins of -118.84% and -176.45%, respectively. The company's Altman Z-Score indicates it is in "financial distress" with a "high risk of bankruptcy." Furthermore, Nuwellis carries a "going concern risk" and has a continued reliance on external financing to support operations.

2. Concentrated Product Portfolio and Market Competition: Nuwellis's business is heavily concentrated on its Aquadex FlexFlow and Aquadex SmartFlow systems for ultrafiltration therapy. While the company holds a "niche-leader position" in this specialized segment, it faces significant competition from larger players like Fresenius Medical Care and Baxter International in the broader fluid management market. The company has experienced overall revenue declines and weaker performance in key segments such as critical care.

3. Regulatory Scrutiny and Product Safety Issues: As a medical device company, Nuwellis is subject to intense regulatory oversight. The FDA has issued alerts concerning "extracorporeal blood circuit issues" with Nuwellis devices, leading to a recall identified by the FDA as the "most serious type," potentially causing "serious injury or death" if affected products are used. Such issues underscore the inherent risks of manufacturing or design defects, which can result in recalls, harm reputation, and lead to increased regulatory scrutiny.

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Nuwellis, Inc. (NUWE) is anticipated to drive future revenue growth over the next 2-3 years through several key strategies and market dynamics:

1. Increased U.S. Console Sales and Consumables Utilization: The company has demonstrated strong adoption of its Aquadex systems in the United States, with a 208% increase in U.S. console sales in Q4 2025 and a fourfold sequential increase in Q3 2025. This growth in console placements is expected to lead to a corresponding increase in the utilization of disposable blood sets and catheters, evidenced by a 4% year-over-year growth in consumables utilization in Q1 2025 and a 15% increase in Q3 2025.
2. Expansion in Targeted Patient Categories: Nuwellis is focusing on deepening its penetration within existing accounts, particularly in the critical care and cardiorenal markets. Significant growth has been observed in specific patient populations, with heart failure revenue increasing 48% year-over-year in Q4 2025 and pediatric revenue growing 38% in Q1 2025 and 16% in Q4 2025. The company is also advancing its Vivian pediatric CRRT system, which could further support growth in the pediatric segment.
3. Favorable Reimbursement and Outpatient Market Growth: A significant driver is the higher CMS reimbursement for Aquadex therapy in outpatient settings. Effective January 1, 2025, CMS reassigned Aquadex to a higher outpatient reimbursement level, nearly quadrupling the facility fee to $1,639 per day. This enhanced reimbursement is expected to drive the expansion of the outpatient opportunity pipeline, particularly for heart failure treatment, as more hospitals explore outpatient use.
4. New Product Launches and Strategic Acquisitions: Nuwellis plans to relaunch its Clarity product mid-year 2026, which is expected to contribute to future revenue. Furthermore, the company executed a definitive agreement to acquire Rendiatech, an acquisition aimed at expanding its cardiorenal portfolio and strengthening its market position. The introduction of a new 24-hour Aquadex circuit for hospital-based outpatient use also offers increased flexibility and consistency in therapy.

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Share Repurchases

No information available regarding share repurchases over the last 3-5 years.

Share Issuance

• In June 2025, Nuwellis announced the pricing of a public offering of 406,755 shares of common stock and pre-funded warrants to purchase 14,085,998 shares, along with Series A and B Warrants. The offering was priced at $0.30 per share for common stock and accompanying warrants, and $0.2999 per pre-funded warrant with accompanying warrants.
• Shareholders approved an increase in the authorized number of common shares from 100,000,000 to 200,000,000 in August 2025.
• Nuwellis completed a one-for-forty-two (1-42) reverse stock split of its Common Stock, effective July 7, 2025, to help comply with Nasdaq Capital Market's continued listing requirements.

Inbound Investments

• In January 2026, Nuwellis closed a $5.0 million private placement and warrant inducement transaction to strengthen its capital position.
• The company completed a $5.0 million gross capital raise during the second quarter of 2025.
• Nuwellis raised approximately $7 million in net proceeds through financing activities during 2025, supporting operations.

Outbound Investments

• Nuwellis executed a definitive stock purchase agreement to acquire Rendiatech in January 2026, aiming to expand its cardiorenal portfolio.

Capital Expenditures

• Nuwellis reported $98K in capital expenditures in Q3 2025.
• Total capital expenditures for the full year 2025 were $90K.