Nuwellis Completes FDA Meeting, Plans Label Expansion for Aquadex SmartFlow System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Nuwellis announced the completion of a recent pre-submission meeting with the FDA regarding the proposed label expansion of the Aquadex SmartFlow System to support pediatric patients weighing 5 kg and above. The currently cleared indication is for patients weighing 20 kg and above. The company said, "The pre-submission meeting provided constructive feedback on the Company's proposed regulatory strategy, including a pathway toward a 510(k) submission supported by targeted bench testing, toxicological assessments, and pediatric clinical evidence. The feedback provides important clarity as Nuwellis advances its regulatory and clinical plans in this high-need patient population. The Company anticipates submitting to the FDA by the end of 2026."
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About NUWE
Nuwellis, Inc. is a commercial-stage medical technology company. The Company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex FlexFlow and the Aquadex SmartFlow systems (collectively the Aquadex System). The Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. The Aquadex System is designed to remove excess fluid from patients suffering from fluid overload who have failed diuretic therapy. The Aquadex System consists of a console, which is a piece of equipment containing electromechanical pumps and a liquid crystal display (LCD) screen; a one-time disposable blood circuit set, which is an integrated collection of tubing, filters, sensors, and connectors that contain and deliver the blood from and back to the patient, and a disposable catheter.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Nuwellis Expands Aquadex Labeling to Pediatric Patients
- Successful FDA Meeting: Nuwellis has successfully completed a pre-submission meeting with the FDA regarding the proposed label expansion of the Aquadex SmartFlow® System to pediatric patients weighing 5 kg and above, indicating positive progress in addressing market needs.
- Clinical Demand Response: The real-time monitoring capability of the Aquadex system for fluid management in low-weight pediatric patients provides crucial support for clinical decision-making, which is expected to significantly enhance treatment safety and efficacy for this patient group.
- Clear Regulatory Strategy: Constructive feedback obtained during the meeting clarifies the pathway for Nuwellis's 510(k) submission, supported by targeted bench testing and clinical evidence, thereby strengthening the company's competitive position in this high-need patient population.
- Significant Market Potential: Nuwellis anticipates submitting to the FDA by the end of 2026, aiming to address fluid overload issues in low-weight pediatric patients, further expanding its influence in the rapidly growing pediatric healthcare market.
See More
Nuwellis Q1 Earnings Beat Expectations with Revenue Growth
- Earnings Performance: Nuwellis reported a Q1 GAAP EPS of -$2.09, missing expectations by $1.09, indicating ongoing challenges in achieving profitability.
- Revenue Growth: The company achieved revenue of $2.4 million, a 26.3% year-over-year increase, beating market expectations by $0.31 million, reflecting strong product demand and market performance.
- Gross Margin Improvement: Gross margin improved to 70.1%, driven by successful pricing strategies, optimized product mix, and a transition to contract manufacturing, enhancing the company's profitability.
- Financial Health: As of March 31, 2026, the company reported no debt and approximately $2.2 million in cash, cash equivalents, and restricted cash, indicating strong liquidity and financial stability.
See More
Nuwellis Showcases New Research at International Heart and Lung Transplantation Conference
- Research Presentation: At the 2026 International Society for Heart and Lung Transplantation meeting, the University of Iowa showcased a case study on using ultrafiltration to treat pediatric heart failure, emphasizing its significance in managing complex pediatric cardiorenal patients, which may drive standardization in clinical practice.
- Clinical Application Potential: The case study demonstrated that Aquadex ultrafiltration therapy effectively managed fluid overload in patients with chemotherapy-induced dilated cardiomyopathy, improving pre-operative clinical status and enhancing post-transplant outcomes, indicating its potential in pediatric settings.
- Technology Promotion Strategy: Nuwellis CEO John Erb stated that the company will continue collaborating with practitioners to promote the adoption of Aquadex for pediatric indications, addressing fluid management challenges and enhancing patient care quality.
- Industry Exchange Platform: The ISHLT conference provided a vital opportunity for clinicians and researchers to share emerging data and engage in scientific dialogue, with Nuwellis' participation further solidifying its leadership position in heart and lung disease treatment.
See More
Nuwellis Receives Patent Allowance for Dual-Lumen Catheter
- Patent Progress: Nuwellis announced it received a Notice of Allowance from the USPTO for its dual-lumen catheter used in ultrafiltration therapy, aimed at improving blood flow and reducing treatment complications, which is expected to enhance its product lineup.
- Enhanced Design Flexibility: The catheter features an adjustable, flexible design that allows doctors to customize it during treatment, ensuring smoother usage and improved treatment outcomes across various patients.
- Market Expansion Potential: Once the patent is officially approved, it is anticipated to support Nuwellis in promoting ultrafiltration therapy in hospitals and outpatient settings, thereby expanding market share and enhancing competitive positioning.
- Stock Price Reaction: Despite the positive patent news, Nuwellis' stock is trading approximately 3% lower at around $1.13, reflecting market caution regarding its future growth potential.
See More
Nuwellis Announces Aquadex Software Update for Enhanced Clinical Workflow
- Software Update Enhancement: Nuwellis' release of the Aquadex SmartFlow® software update reduces ultrafiltration adjustment step size from 10 mL/hr to 5 mL/hr, which is particularly crucial in pediatric care, significantly improving clinical outcomes related to small-volume fluid shifts and enhancing patient safety and treatment efficacy.
- User Experience Optimization: The update aims to streamline clinical workflows and enhance device usability, especially providing better therapy visibility for nursing staff, which is expected to improve nursing efficiency and reduce operational errors, thereby elevating overall care quality.
- Key Algorithm Improvements: The update includes a refined blood flow algorithm designed to reduce nuisance alarms and improve flow stability, which will help clinicians detect potential filter clotting earlier, thus increasing the safety and effectiveness of treatments.
- No-Cost Update: This software update is available at no cost to existing customers and can be deployed through standard update processes, with support from Nuwellis' field and service teams ensuring a smooth transition to the new system, further solidifying customer relationships.
See More
Nuwellis Welcomes Back Three Key Team Members
- Team Restructuring: Nuwellis announces the return of three former team members, Liby Cielo, Meredith Stein, and Scott Campbell, reflecting the company's ongoing efforts to strengthen its commercial and clinical capabilities to support hospitals treating complex cardiorenal conditions.
- Market Expansion: Cielo will focus on hospital engagement and clinical education in South Texas, leveraging her experience in promoting Aquadex therapy across multiple hospital systems to further drive market acceptance of the therapy.
- Enhanced Clinical Education: Stein, with over 30 years of nursing experience and a history of establishing the Aquadex program, will bolster Nuwellis' clinical education capabilities in cardiovascular and critical care, improving patient treatment outcomes.
- Strengthened Sales Leadership: Campbell, as Area Vice President of Sales for the western U.S., will utilize his over 20 years of medical device experience to drive the adoption of Aquadex therapy in both adult and pediatric patients, particularly in emerging outpatient settings, aiding the company's further development in the healthcare market.
See More
Nuwellis Expands Aquadex Labeling to Pediatric Patients
- Successful FDA Meeting: Nuwellis has successfully completed a pre-submission meeting with the FDA regarding the proposed label expansion of the Aquadex SmartFlow® System to pediatric patients weighing 5 kg and above, indicating positive progress in addressing market needs.
- Clinical Demand Response: The real-time monitoring capability of the Aquadex system for fluid management in low-weight pediatric patients provides crucial support for clinical decision-making, which is expected to significantly enhance treatment safety and efficacy for this patient group.
- Clear Regulatory Strategy: Constructive feedback obtained during the meeting clarifies the pathway for Nuwellis's 510(k) submission, supported by targeted bench testing and clinical evidence, thereby strengthening the company's competitive position in this high-need patient population.
- Significant Market Potential: Nuwellis anticipates submitting to the FDA by the end of 2026, aiming to address fluid overload issues in low-weight pediatric patients, further expanding its influence in the rapidly growing pediatric healthcare market.
See More
Nuwellis Q1 Earnings Beat Expectations with Revenue Growth
- Earnings Performance: Nuwellis reported a Q1 GAAP EPS of -$2.09, missing expectations by $1.09, indicating ongoing challenges in achieving profitability.
- Revenue Growth: The company achieved revenue of $2.4 million, a 26.3% year-over-year increase, beating market expectations by $0.31 million, reflecting strong product demand and market performance.
- Gross Margin Improvement: Gross margin improved to 70.1%, driven by successful pricing strategies, optimized product mix, and a transition to contract manufacturing, enhancing the company's profitability.
- Financial Health: As of March 31, 2026, the company reported no debt and approximately $2.2 million in cash, cash equivalents, and restricted cash, indicating strong liquidity and financial stability.
See More
Nuwellis Showcases New Research at International Heart and Lung Transplantation Conference
- Research Presentation: At the 2026 International Society for Heart and Lung Transplantation meeting, the University of Iowa showcased a case study on using ultrafiltration to treat pediatric heart failure, emphasizing its significance in managing complex pediatric cardiorenal patients, which may drive standardization in clinical practice.
- Clinical Application Potential: The case study demonstrated that Aquadex ultrafiltration therapy effectively managed fluid overload in patients with chemotherapy-induced dilated cardiomyopathy, improving pre-operative clinical status and enhancing post-transplant outcomes, indicating its potential in pediatric settings.
- Technology Promotion Strategy: Nuwellis CEO John Erb stated that the company will continue collaborating with practitioners to promote the adoption of Aquadex for pediatric indications, addressing fluid management challenges and enhancing patient care quality.
- Industry Exchange Platform: The ISHLT conference provided a vital opportunity for clinicians and researchers to share emerging data and engage in scientific dialogue, with Nuwellis' participation further solidifying its leadership position in heart and lung disease treatment.
See More
Nuwellis Receives Patent Allowance for Dual-Lumen Catheter
- Patent Progress: Nuwellis announced it received a Notice of Allowance from the USPTO for its dual-lumen catheter used in ultrafiltration therapy, aimed at improving blood flow and reducing treatment complications, which is expected to enhance its product lineup.
- Enhanced Design Flexibility: The catheter features an adjustable, flexible design that allows doctors to customize it during treatment, ensuring smoother usage and improved treatment outcomes across various patients.
- Market Expansion Potential: Once the patent is officially approved, it is anticipated to support Nuwellis in promoting ultrafiltration therapy in hospitals and outpatient settings, thereby expanding market share and enhancing competitive positioning.
- Stock Price Reaction: Despite the positive patent news, Nuwellis' stock is trading approximately 3% lower at around $1.13, reflecting market caution regarding its future growth potential.
See More
Nuwellis Announces Aquadex Software Update for Enhanced Clinical Workflow
- Software Update Enhancement: Nuwellis' release of the Aquadex SmartFlow® software update reduces ultrafiltration adjustment step size from 10 mL/hr to 5 mL/hr, which is particularly crucial in pediatric care, significantly improving clinical outcomes related to small-volume fluid shifts and enhancing patient safety and treatment efficacy.
- User Experience Optimization: The update aims to streamline clinical workflows and enhance device usability, especially providing better therapy visibility for nursing staff, which is expected to improve nursing efficiency and reduce operational errors, thereby elevating overall care quality.
- Key Algorithm Improvements: The update includes a refined blood flow algorithm designed to reduce nuisance alarms and improve flow stability, which will help clinicians detect potential filter clotting earlier, thus increasing the safety and effectiveness of treatments.
- No-Cost Update: This software update is available at no cost to existing customers and can be deployed through standard update processes, with support from Nuwellis' field and service teams ensuring a smooth transition to the new system, further solidifying customer relationships.
See More
Nuwellis Welcomes Back Three Key Team Members
- Team Restructuring: Nuwellis announces the return of three former team members, Liby Cielo, Meredith Stein, and Scott Campbell, reflecting the company's ongoing efforts to strengthen its commercial and clinical capabilities to support hospitals treating complex cardiorenal conditions.
- Market Expansion: Cielo will focus on hospital engagement and clinical education in South Texas, leveraging her experience in promoting Aquadex therapy across multiple hospital systems to further drive market acceptance of the therapy.
- Enhanced Clinical Education: Stein, with over 30 years of nursing experience and a history of establishing the Aquadex program, will bolster Nuwellis' clinical education capabilities in cardiovascular and critical care, improving patient treatment outcomes.
- Strengthened Sales Leadership: Campbell, as Area Vice President of Sales for the western U.S., will utilize his over 20 years of medical device experience to drive the adoption of Aquadex therapy in both adult and pediatric patients, particularly in emerging outpatient settings, aiding the company's further development in the healthcare market.
See More
