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What changed in Nuwellis, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Nuwellis, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+495 added−401 removedSource: 10-K (2026-03-11) vs 10-K (2025-03-11)

Top changes in Nuwellis, Inc.'s 2025 10-K

495 paragraphs added · 401 removed · 277 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

102 edited+33 added−35 removed58 unchanged
Biggest changePatient treatment was guided with the continuous hematocrit monitoring function built within the Aquadex System, supporting safe and effective fluid removal in critically ill pediatric patients. 78 In December 2022, a third-party, single-center, real-world retrospective study of 335 consecutive patients treated with the Aquadex FlexFlow ® System, “ Ten Year Real World Experience with Ultrafiltration for the Management of Acute Decompensated Heart Failure, ” compared previous randomized controlled clinical trials with ultrafiltration and demonstrated that ultrafiltration compares favorably in reducing heart failure rehospitalizations (2.14 hospitalizations per year before Aquadex versus 0.4 hospitalizations per year one year after Aquadex), renal function response, and weight/volume loss. 75 The study found ultrafiltration to be safe with regard to renal function despite the cohort in this study being sicker than those studied in other clinical trials, and that Ultrafiltration can be a safe and effective strategy for decongestion in clinical practice wherein the benefits outweigh the potential risks of kidney dysfunction requiring hemodialysis and major bleeding events. 79 In February 2022, a third party retrospectively reviewed and concluded, “The Use of Ultrafiltration as a fluid management strategy for High-Risk Coronary Artery Bypass Grafting,” that ultrafiltration is a safe and effective modality to manage fluid balance in a patient population with relatively high Society of Thoracic Surgery (“STS”) scores, but a prospective multicenter study would be warranted in this patient cohort. 76 Additionally, another peer-reviewed publication advocates for early clinical application of ultrafiltration in diuretic resistant patients 80 and a cost analysis demonstrated that compared to diuretics, ultrafiltration resulted in a total cost savings of 14.4% at 90 days due to reduced readmissions. 81 Jain et al. pooled data from seven randomized controlled trials of ultrafiltration with a total of 771 patients and concluded that extracorporeal ultrafiltration is associated with more efficient fluid and sodium removal compared with medical therapy, hence leading to a reduction in readmission rates and a potential salutary impact on financial burden associated with the care of heart failure patients. 82 Wobbe et al pooled data from eight randomized controlled trials enrolling 801 participants and studied the effectiveness of ultrafiltration compared to diuretics, demonstrating ultrafiltration increases fluid removal (difference in means 1372.5 mL; p p p = 0.022) and rehospitalization for heart failure (OR 0.54; p = 0.003) suggesting ultrafiltration is a safe and effective treatment option for volume-overloaded heart failure. 83 12 Table of Contents One 2019 peer-reviewed paper reported on a multicenter, retrospective case series of children who received kidney replacement therapy (“KRT”) with an ultrafiltration device. 84 Patients were grouped according to weight and primary disease state (e.g. kidney, cardiac or other) and received one of three treatment modalities.
Biggest changePatient treatment was guided with the continuous hematocrit monitoring function built within the Aquadex System, supporting safe and effective fluid removal in critically ill pediatric patients. 78 In December 2022, a third-party, single-center, real-world retrospective study of 335 consecutive patients treated with the Aquadex FlexFlow ® System, “ Ten Year Real World Experience with Ultrafiltration for the Management of Acute Decompensated Heart Failure, ” compared previous randomized controlled clinical trials with ultrafiltration and demonstrated that ultrafiltration compares favorably in reducing heart failure rehospitalizations (2.14 hospitalizations per year before Aquadex versus 0.4 hospitalizations per year one year after Aquadex), renal function response, and weight/volume loss. 75 The study found ultrafiltration to be safe with regard to renal function despite the cohort in this study being sicker than those studied in other clinical trials, and that ultrafiltration can be a safe and effective strategy for decongestion in clinical practice wherein the benefits outweigh the potential risks of kidney dysfunction requiring hemodialysis and major bleeding events. 79 In February 2022, a third-party retrospectively reviewed study, “The Use of Ultrafiltration as a fluid management strategy for High-Risk Coronary Artery Bypass Grafting,” concluded that ultrafiltration is a safe and effective modality to manage fluid balance in a patient population with relatively high Society of Thoracic Surgery (“STS”) scores, but a prospective multicenter study would be warranted in this patient cohort. 76 Additionally, another peer-reviewed publication advocates for early clinical application of ultrafiltration in diuretic resistant patients 80 and a cost analysis demonstrated that compared to diuretics, ultrafiltration resulted in a total cost savings of 14.4% at 90 days due to reduced readmissions. 81 73 Pinney et al.
However, possible signs and symptoms of fluid overload include pulmonary edema/pleural effusion, peripheral edema, anasarca (swelling of the skin) ascites, jugular vein distention and dyspnea. 2 Medical conditions or diseases where excess fluid accumulates in the body are heart failure, kidney failure, nephrotic syndrome, cirrhosis, or burn injuries/trauma.
However, possible signs and symptoms of fluid overload include pulmonary edema/pleural effusion, peripheral edema, anasarca (swelling of the skin) ascites, jugular vein distention and dyspnea. 2 Medical conditions or diseases where excess fluid accumulates in the body are heart failure, kidney failure, nephrotic syndrome, cirrhosis, and burn injuries/trauma.
Ann Thorac Surg. 2014; 98(4): 1274-80. 4 Table of Contents The condition of fluid overload is often observed in patients with heart failure and secondary oliguric states, 7 although in pediatric patients, fluid overload is associated with significant increases in mortality. 8 9 Congestion or fluid overload, the hallmark of decompensated heart failure (HF), is the primary reason for hospitalization in 90% of these patients. 10 11 For this reason, diuretics have been the cornerstone of heart failure treatment for more than 50 years. 12 Over the past 20 years, approaches to treatment have changed dramatically. 13 These dramatic improvements include new medications and new technologies, such as ultrafiltration, to help treat fluid overload.
Ann Thorac Surg. 2014; 98(4): 1274-80. 7 Table of Contents The condition of fluid overload is often observed in patients with heart failure and secondary oliguric states, 7 although in pediatric patients, fluid overload is associated with significant increases in mortality. 8 9 Congestion or fluid overload, the hallmark of decompensated heart failure (HF), is the primary reason for hospitalization in 90% of these patients. 10 11 For this reason, diuretics have been the cornerstone of heart failure treatment for more than 50 years. 12 Over the past 20 years, approaches to treatment have changed dramatically. 13 These dramatic improvements include new medications and new technologies, such as ultrafiltration, to help treat fluid overload.
This WR analysis also yielded results favoring ultrafiltration, demonstrating that AUF is safe and more effective than ALD in reducing CV mortality and subsequent HF events for hospitalized heart failure patients. 75 In June 2024, analysis of an Aquadex program, Outcomes of Ultrafiltration in community-based hospitals , showed diuretic refractory acute decompensated heart failure (ADHF) patients benefited from significant volume loss and weight reduction along with stable renal function and remarkable clinical benefit. 76 All 30 patients treated over the first-year cohort were included in a retrospective analysis that demonstrated Aquadex therapy provided a statistically significant reduction in heart failure rehospitalization rate at 60 days (p=0.013) and numerically fewer ADHF readmissions at 30 days from UF initiation compared to the pre-UF era. 76 The study demonstrated that a successful Aquadex program is reproducible and can be coordinated by general cardiologists without the need for a dedicated heart failure unit. 76 In November 2023, a retrospective case series and literature review conducted by The Mount Sinai Hospital, “ Utilization of aquapheresis among hospitalized patients with end-stage liver disease: A case series and literature review,” utilization of ultrafiltration from January 2020 through July 2023 in patients with decompensated cirrhosis in the intensive care unit (ICU) found that the introduction of ultrafiltration earlier in a patient’s hospital course may reduce the risk of kidney injury and diuretic-induced electrolyte derangement and reduce the risk of development of sequential organ failures in patients with decompensated cirrhosis. 77 In September 2023, a third-party, single-center case study review of pediatric patients showed the Aquadex System successfully treated small patients without hemodynamic instability or other complications, demonstrating that therapy is an effective treatment option for fluid overload.
This WR analysis also yielded results favoring ultrafiltration, demonstrating that AUF is safe and more effective than ALD in reducing CV mortality and subsequent HF events for hospitalized heart failure patients. 75 In June 2024, analysis of an Aquadex program, Outcomes of Ultrafiltration in community-based hospitals , showed diuretic refractory acute decompensated heart failure (ADHF) patients benefited from significant volume loss and weight reduction along with stable renal function and remarkable clinical benefit. 76 All 30 patients treated over the first-year cohort were included in a retrospective analysis that demonstrated Aquadex therapy provided a statistically significant reduction in heart failure rehospitalization rate at 60 days (p=0.013) and numerically fewer ADHF readmissions at 30 days from UF initiation compared to the pre-UF era. 76 The study demonstrated that a successful Aquadex program is reproducible and can be coordinated by general cardiologists without the need for a dedicated heart failure unit. 76 In a November 2023 retrospective case series and literature review conducted by The Mount Sinai Hospital, “ Utilization of aquapheresis among hospitalized patients with end-stage liver disease: A case series and literature review,” utilization of ultrafiltration from January 2020 through July 2023 in patients with decompensated cirrhosis in the intensive care unit (ICU) found that the introduction of ultrafiltration earlier in a patient’s hospital course may reduce the risk of kidney injury and diuretic-induced electrolyte derangement and reduce the risk of development of sequential organ failures in patients with decompensated cirrhosis. 77 In September 2023, a third-party, single-center case study review of pediatric patients showed the Aquadex System successfully treated small patients without hemodynamic instability or other complications, demonstrating that therapy is an effective treatment option for fluid overload.
In addition, on January 1, 2025, the CPT code was associated with a level II Ambulatory Payment Code (APC) code that provides higher reimbursement for therapeutic ultrafiltration administered in the outpatient setting per day and will facilitate the migration of the therapy to this setting for a subset of the patient population, which may relieve some of the growing pressure on hospital systems and improve hospital economics and patient quality of life.
In addition, on January 1, 2025, the CPT code was associated with a level II Ambulatory Payment Code (APC) code that provides higher reimbursement per day for therapeutic ultrafiltration administered in the outpatient setting and will facilitate the migration of the therapy to this setting for a subset of the patient population, which may relieve some of the growing pressure on hospital systems and improve hospital economics and patient quality of life.
These payers, which include federal healthcare programs (e.g., Medicare and Medicaid), state healthcare programs, private health insurance companies, and managed care organizations, then reimburse our customers based on established payment formulas that consider part or all of the costs associated with these devices and the related procedures performed.
These payers, which include federal healthcare programs (e.g., Medicare and Medicaid), state healthcare programs, private health insurance companies, and managed care organizations, then reimburse our customers based on established payment formulas that consider part or all of the costs associated with the devices and related procedures performed.
While the agency responsible for administering the Medicare program, the Centers for Medicare and Medicaid Services, has not issued a formal national coverage determination for ultrafiltration using the Aquadex System, there is established CMS reimbursement in absence of the policy.
While the agency responsible for administering the Medicare program, the Centers for Medicare and Medicaid Services (CMS), has not issued a formal national coverage determination for ultrafiltration using the Aquadex System, there is established CMS reimbursement in absence of the policy.
Following the acquisition of the business associated with the Aquadex System (the “Aquadex Business”) from Baxter in August 2016, our direct salesforce was focused initially on re-engaging hospital accounts that had ordered Aquadex blood sets in prior years, re-educating customers on the therapy, and assessing each hospital’s use of the Aquadex System to gain additional opportunity for increased utilization, primarily in heart failure.
Following the acquisition of the business associated with the Aquadex System (the “Aquadex Business”) from Baxter in August 2016, our direct salesforce was focused initially on re-engaging hospital accounts that had ordered Aquadex blood sets in prior years, re-educating customers on ultrafiltration therapy, and assessing each hospital’s use of the Aquadex System to gain additional opportunity for increased utilization, primarily in heart failure.
Additionally, between 10-40% of heart failure patients are refractory to diuretics, 17 with diuretic resistance associated with a higher risk of in-hospital worsening of heart failure, increase mortality after discharge, and a 3-fold increase in rehospitalization rates. 18 In addition, patients with heart failure and cardiorenal syndrome have diminished response to loop diuretics, making these agents less effective at relieving congestion. 19 Also, long-term use of diuretics has been associated with kidney damage. 20 One study found that approximately 40% of heart failure patients have poor diuretic response. 21 This poor response is possibly due to noncompliance or high intake of salt, poor drug absorption, insufficient kidney response to drug, and reduced diuretic secretion. 22 Despite treatment with loop diuretics, patients are frequently hospitalized and treated for recurrent symptoms and signs of fluid overload. 7 Ronco C, Costanzo MR, Bellomo R, et al.
Additionally, between 10-40% of heart failure patients are refractory to diuretics, 17 with diuretic resistance associated with a higher risk of in-hospital worsening of heart failure, increase mortality after discharge, and a three-fold increase in rehospitalization rates. 18 In addition, patients with heart failure and cardiorenal syndrome have diminished response to loop diuretics, making these agents less effective at relieving congestion. 19 Also, long-term use of diuretics has been associated with kidney damage. 20 One study found that approximately 40% of heart failure patients have poor diuretic response. 21 This poor response is possibly due to noncompliance or high intake of salt, poor drug absorption, insufficient kidney response to drug, and reduced diuretic secretion. 22 Despite treatment with loop diuretics, patients are frequently hospitalized and treated for recurrent symptoms and signs of fluid overload. 7 Ronco C, Costanzo MR, Bellomo R, et al.
Product Development Activities As we expand our commercialization efforts in the pediatric market, we are developing a CRRT device, branded Vivian, to address the unmet and specific needs of pediatric patients weighing 2.5kg and above who do not have functioning kidneys and who need kidney replacement therapy for survival.
Product Development Activities As we expand our commercialization efforts in the pediatric market, we are developing a dedicated CRRT device, branded Vivian, to address the unmet and specific needs of pediatric patients weighing 2.5kg and above who do not have functioning kidneys and who need kidney replacement therapy for survival.
Approximately 10,300 children suffer from AKI, of these, over 1800 are neonates. 85 Funded in part by a $1.7 million grant from the National Institute of Health, the Company completed preliminary engineering testing for its dedicated pediatric system in the fourth quarter of 2023.
Approximately 10,300 children suffer from AKI, of these, over 1800 are neonates. 85 Funded in part by a $1.7 million grant from the National Institute of Health, (“NIH”) the Company completed preliminary engineering testing for its dedicated pediatric system in the fourth quarter of 2023.
The study found that of the 72 patients who weighed less than 10 kg, 43 or 60% survived to the end of therapy or transitioned to another modality of kidney support. 23 or 32% survived to hospital discharge. Among patients who weighed between 10-20 kg, 13 or 100% survived to the end of KRT treatment.
The study found that of the 72 patients who weighed less than 10 kg, 43 or 60% survived to the end of therapy or transitioned to another modality of kidney support, and 23 or 32% survived to hospital discharge. Among patients who weighed between 10-20 kg, 13 or 100% survived to the end of KRT treatment.
Nat Rev Dis Primers . 2020; 6(16):1-15. 49 Fonarow et al. Rev Cardiovasc Med . 2003;4: Suppl 7:S21-30. 450 Costanzo MR, et al. J Am Coll Cardiol . 2017 May 16;69(19):2428-2445. 51 Sax D, et al. J Card Fail. 2022: 28(10): 1545-59. 52 Voigt J, et al. Clin Cardiol . 2014;37(5): 312-321. 53 Heidenreich PA, et al.
Nat Rev Dis Primers . 2020; 6(16):1-15. 49 Fonarow et al. Rev Cardiovasc Med . 2003;4: Suppl 7:S21-30. 50 Costanzo MR, et al. J Am Coll Cardiol . 2017 May 16;69(19):2428-2445. 51 Sax D, et al. J Card Fail. 2022: 28(10): 1545-59. 52 Voigt J, et al. Clin Cardiol . 2014;37(5): 312-321. 53 Heidenreich PA, et al.
If the FDA believes that we or any of our contract manufacturers or regulated suppliers are not in compliance with these requirements, it can shut down our manufacturing operations, require recall of our products, refuse to clear or approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.
If the FDA believes that we or any of our contract manufacturers or regulated suppliers are not in compliance with applicable requirements, it can shut down our manufacturing operations, require recall of our products, refuse to clear or approve new marketing applications, institute legal proceedings to detain or seize products, enjoin future violations or assess civil and criminal penalties against us or our officers or other employees.
Heart Failure Out-Patients : Further, we intend to expand the use of the Aquadex System with heart failure patients in the outpatient setting, such as an infusion clinic or hospital outpatient department (e.g., observation unit). On January 1, 2022, the American Medical Association granted a new and dedicated Category III Current Procedural Terminology (CPT) code, 0692T, for Therapeutic Ultrafiltration.
Heart Failure Outpatients : Further, we intend to expand the use of the Aquadex System with heart failure patients in the outpatient setting, such as an infusion clinic or hospital outpatient department (e.g., observation unit). On January 1, 2022, the American Medical Association granted a new and dedicated Category III Current Procedural Terminology (CPT) code, 0692T, for Therapeutic Ultrafiltration.
Am J Kidney Dis . 2017;69(1):136-142. 5 Table of Contents Nearly one-half of hospitalized patients with heart failure are discharged with residual fluid excess after receiving conventional diuretic therapies. 23 Additionally, one study found that 24% of such patients were readmitted to the hospital within 30 days of their discharge, and up to 42-50% were readmitted at 90 days and 6 months respectively. 24 25 Regardless of diuretic strategy, 42% of acutely decompensated heart failure subjects in the DOSE (Diuretic Optimization Strategies Evaluation) trial reached the composite endpoint of death, rehospitalization, or emergency department visit at 60 days. 26 We believe that there is an association of chronic loop diuretic therapy and greater resource utilization at hospitals. 27 Therefore, an alternative therapy to help stabilize or improve patient care is needed.
Am J Kidney Dis . 2017;69(1):136-142. 8 Table of Contents Nearly one half of hospitalized patients with heart failure are discharged with residual fluid excess after receiving conventional diuretic therapies. 23 Additionally, one study found that 24% of such patients were readmitted to the hospital within 30 days of their discharge, and up to 42-50% were readmitted at 90 days and six months respectively. 24 25 Regardless of diuretic strategy, 42% of acutely decompensated heart failure subjects in the DOSE (Diuretic Optimization Strategies Evaluation) trial reached the composite endpoint of death, rehospitalization, or emergency department visit at 60 days. 26 We believe that there is an association of chronic loop diuretic therapy and greater resource utilization at hospitals. 27 Therefore, an alternative therapy to help stabilize or improve patient care is needed.
Ultrafiltration has been a well-documented technique in the treatment of fluid overload in heart failure patients for over 20 years. 28 We believe that ultrafiltration is a safe and effective therapy to treat fluid overload and congestion by removing the overload of fluid and congestion by removing extra fluid and salt. 29 With ultrafiltration, medical practitioners can specify and control the amount of fluid to be extracted at a safe, predictable, and effective rate.
Ultrafiltration has been a well-documented technique in the treatment of fluid overload in heart failure and critical care patients for over 20 years. 28 We believe that ultrafiltration is a safe and effective therapy to treat fluid overload and congestion by removing the overload of fluid and congestion by removing extra fluid and salt. 29 With ultrafiltration, medical practitioners can specify and control the amount of fluid to be extracted at a safe, predictable, and effective rate.
One hospital cost analysis demonstrated a total cost savings of $3,975 per patient when using ultrafiltration as compared to diuretic therapy over 90 days. 30 The Aquadex System The Aquadex System is designed and clinically proven to simply, safely, and precisely remove excess fluid (primarily excess salt and water) from patients suffering from fluid overload who have failed diuretic therapy.
One hospital’s cost analysis demonstrated a total cost savings of $3,975 per patient when using ultrafiltration as compared to diuretic therapy over 90 days. 30 The Aquadex System The Aquadex System is designed and clinically proven to simply, safely, and precisely remove excess fluid (primarily excess salt and water) from patients suffering from fluid overload who have failed diuretic therapy.
Two-thirds of procedures lasted for the intended duration, and very few patients could not tolerate the Aquadex ® procedure. 71, 72 In January 2023, we began designing an IDE clinical study for the Company’s dedicated pediatric device currently under development. The design was reviewed with FDA in May 2023 and the study is anticipated to begin enrollment in 2026.
Two thirds of procedures lasted for the intended duration, and very few patients could not tolerate the Aquadex ® procedure. 71, 72 In January 2023, we began designing an IDE clinical study for the Company’s dedicated pediatric device currently under development. The design was reviewed with FDA in May 2023 and the study is anticipated to begin enrollment in 2027.
AUF won in 71.0% of the HF event-related paired comparisons (versus 29.0% for ALD) and in 53.4% of quality of life comparisons (versus 46.6% for ALD), resulting in a WR = 1.43 (p=0.056) favoring ultrafiltration. 73 This updated evidence further suggests that AUF may be more effective than ALD at reducing HF events and HF rehospitalizations and shows a clear trend towards a sustained clinical benefit when evaluating a holistic composite outcome including CV mortality, HF events and quality of life. 73 The re-analysis was also presented as a Late Breaking Clinical Trial podium presentation at the Technology and HF Therapeutics Conference in March 3-5, 2024, in Boston. 74 A former reanalysis of the original AVOID-HF dataset, using a similar WR composite method, was presented at the Annual Scientific Session of the Heart Failure Society of America in September 2022 , “Revisiting The Aquapheresis Versus Intravenous Diuretics And Hospitalizations For Heart Failure (AVOID-HF) Trial: Further Evidence Supporting Aquapheresis To Reduce Heart Failure Events,” exploring CV mortality within 90 days and HF events within 30 days.
AUF won in 71.0% of the HF event-related paired comparisons (versus 29.0% for ALD) and in 53.4% of quality-of-life comparisons (versus 46.6% for ALD), resulting in a WR = 1.43 (p=0.056) favoring ultrafiltration. 73 This updated evidence further suggests that AUF may be more effective than ALD at reducing HF events and HF rehospitalizations and shows a clear trend toward a sustained clinical benefit when evaluating a holistic composite outcome including CV mortality, HF events and quality of life. 73 The re-analysis was also presented as a Late Breaking Clinical Trial podium presentation at the Technology and HF Therapeutics Conference in March 2024. 74 A former reanalysis of the original AVOID-HF dataset, using a similar WR composite method, was presented at the Annual Scientific Session of the Heart Failure Society of America in September 2022 , “Revisiting The Aquapheresis Versus Intravenous Diuretics And Hospitalizations For Heart Failure (AVOID-HF) Trial: Further Evidence Supporting Aquapheresis To Reduce Heart Failure Events,” exploring CV mortality within 90 days and HF events within 30 days.
J Am Coll Cardiol . 2005; 46(11): 2043-2046. 6 Table of Contents Benefits of the Aquadex System The Aquadex System offers a safe approach to treating fluid overload and: • In a single center, retrospective analysis of 335 consecutive patients, patients in whom there was follow-up for 12 months, there were 1.74 fewer rehospitalizations for HF in the year following UF when compared to the 12 months preceding UF; 33 • Analysis of an Aquadex program in community-based regional hospitals with 30 patients showed refractory acute decompensated heart failure (ADHF) patients benefited from significant volume loss (mean loss of 9.40 + 4.55L) and weight reduction (mean decrease of 7.40kg) along with stable renal function and remarkable clinical benefit as well as a statistically significant reduction in the ADHF rehospitalization rate at 60 days (p=0.013). 34 • In a re-appraisal of the AVOID-HF trial (n=224 patients), including an additional 31 adjudicated events to complete the dataset, demonstrated that patients treated with AUF had a 60% reduction in heart failure events at 30 days compared to intravenous diuretics (p=0.014) and significantly fewer HF hospitalizations at 30 days (p=0.032). 35 • Rehospitalizations at 30 days with Aquadex were 12.4% compared with the national average at 30 days of 24%; • Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%); 36 • Stabilizes or improves cardiac hemodynamics; 37 38 • Safe, easy-to-use, and flexible in application; • Provides complete control over rate and total volume of fluid removed by allowing a medical practitioner to specify the amount of fluid to be removed from each individual patient; • Can be performed via peripheral or central venous access; • Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of electrolyte abnormalities); 38 40 • No significant changes to kidney function; 41 • The use of continuous hematocrit monitoring and SvO2 sensor provides guided-therapy ultrafiltration. 42 • Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored; 43 • Provides highly automated operation with only one setting required to begin therapy; • Utilizes a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up; and • Has a built-in console that guides the medical practitioner through the setup and operational process.
J Am Coll Cardiol . 2005; 46(11): 2043-2046. 9 Table of Contents Benefits of the Aquadex System The Aquadex System offers a safe approach to treating fluid overload and: • In a single center, retrospective analysis of 335 consecutive patients in whom there was follow-up for 12 months, there were 1.74 fewer rehospitalizations for HF in the year following UF when compared to the 12 months preceding UF; 33 • Analysis of an Aquadex program in community-based regional hospitals with 30 patients showed refractory acute decompensated heart failure (ADHF) patients benefited from significant volume loss (mean loss of 9.40 + 4.55L) and weight reduction (mean decrease of 7.40kg) along with stable renal function and remarkable clinical benefit as well as a statistically significant reduction in the ADHF rehospitalization rate at 60 days (p=0.013). 34 • A re-appraisal of the AVOID-HF trial (n=224 patients), including an additional 31 adjudicated events to complete the dataset, demonstrated that patients treated with adjustable ultrafiltration ( AUF ) had a 60% reduction in heart failure events at 30 days compared to intravenous diuretics (p=0.014) and significantly fewer HF hospitalizations at 30 days (p=0.032). 35 • Rehospitalizations at 30 days with Aquadex were 12.4% compared with the national average at 30 days of 24%; • Reduces length of hospital stay when initiated early, resulting in average savings of $3,975 (14%); 3 6 • Stabilizes or improves cardiac hemodynamics; 3 7 3 8 • Is safe, easy-to-use, and flexible in application; • Provides complete control over rate and total volume of fluid removed by allowing a medical practitioner to specify the amount of fluid to be removed from each individual patient; • Can be performed via peripheral or central venous access; • Predictably removes excess isotonic fluid (extracts water and sodium while sparing potassium and magnesium; decrease risk of electrolyte abnormalities); 3 8 40 • Results in no significant changes to kidney function; 41 • Uses continuous hematocrit monitoring and SvO2 sensors to provide guided-therapy ultrafiltration, 42 • Following ultrafiltration, neurohormonal activation is reset toward a more physiological condition and diuretic efficacy is restored; 4 3 • Provides highly automated operation with only one setting required to begin therapy; • Utilizes a single-use, disposable auto-loading blood filter circuit that facilitates easy set-up; and • Has a built-in console that guides the medical practitioner through the setup and operational process.
Other systems, such as Baxter’s Prismaflex, a filter-based device that is approved for continuous renal replacement therapy for patients weighing 20kg or more with acute renal failure and/or fluid overload, represent indirect competitors, as they can only be used to conduct ultrafiltration with significant limitations.
Other systems, such as Baxter’s Prismaflex, a filter-based device that is approved for continuous renal replacement therapy for patients weighing 20kg or more with acute renal failure and/or fluid overload, represent indirect competition, as they can only be used to conduct ultrafiltration with significant limitations.
While the Aquadex System is only FDA cleared for the treatment of pediatric patients weighing 20 kg or more, the Company is aware that many children’s hospitals in the U.S. are modifying the way that the Aquadex System is used in a manner that is deemed to be off-label by the Company and FDA in order to provide dialysis to neonates and other premature infants who weigh less than 20 kg and who were born either without kidneys or without normal kidney function.
While the Aquadex System is only FDA-cleared for the treatment of pediatric patients weighing 20 kg or more, the Company is aware that many children’s hospitals in the U.S. are modifying the way that the Aquadex System is used in a manner that is deemed to be off-label by the Company and the FDA in order to provide dialysis to neonates and other premature infants who weigh less than 20 kg and who were born either without kidneys, inborn errors of metabolism or without normal kidney function.
Please note that selected authors in the citations below are either current consultants to the Company or were previously compensated consultants. Each author typically is required to disclose any actual or potential conflicts of interests at the time they submitted their written manuscript to the potential publication. Dr.
Please note that selected authors in the citations below are either current consultants to the Company or were previously compensated consultants. Each author typically is required to disclose any actual or potential conflicts of interest at the time they submitted their written manuscript to the potential publication. Dr.
Each year there are over 1 million heart failure hospitalizations in the United States, and 90% of those hospitalizations are due to symptoms of fluid overload. 14 These patients are hospitalized on average for 8 days at a cost of approximately $24,000, as to which reimbursement does not cover the full cost. 15 Treatments for Fluid Overload Diuretics Treatment for fluid overload has traditionally been achieved through use of oral or loop diuretics which may be accompanied by use of other categories of medications, such as angiotensin-converting enzyme (ACE) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors, Aldosterone receptor antagonists (MRAs), beta-blockers, and inotropic drugs.
Each year there are over one million heart failure hospitalizations in the United States, and 90% of those hospitalizations are due to symptoms of fluid overload. 14 These patients are hospitalized on average for eight days at a cost of approximately $24,000, for which reimbursement typically does not cover the full cost. 15 Treatments for Fluid Overload Diuretics Treatment for fluid overload has traditionally been achieved through use of oral or loop diuretics which may be accompanied by use of other categories of medications, such as angiotensin-converting enzyme (ACE) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors, Aldosterone receptor antagonists (MRAs), beta-blockers, and inotropic drugs.
These reports are also available on the SEC’s website, www.sec.gov. The information on, or that may be accessed through, any websites noted herein is not incorporated by reference into and should not be considered a part of this Annual Report on Form 10-K. 21 Table of Contents We are a “smaller reporting company” under federal securities laws.
These reports are also available on the SEC’s website, www.sec.gov. The information on, or that may be accessed through, any websites noted herein is not incorporated by reference into and should not be considered a part of this Annual Report on Form 10-K. We are a “smaller reporting company” under federal securities laws.
In addition, we need to distinguish the Aquadex System from the indirect competition of other devices that can also be used to conduct ultrafiltration. 17 Table of Contents Third-Party Reimbursement In the United States, our products are purchased primarily by customers such as hospitals or other healthcare providers. Customers bill various third-party payers for covered services provided to patients.
In addition, we need to distinguish the Aquadex System from the indirect competition of other devices that can also be used to conduct ultrafiltration. Third-Party Reimbursement In the United States, our products are purchased primarily by customers such as hospitals or other healthcare providers. Customers bill various third-party payers for covered services provided to patients.
As long as we remain a smaller reporting company and non-accelerated filer, we are exempt from the attestation requirement in the assessment of our internal control over financial reporting by our independent auditors pursuant to section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) but are required to make our own internal assessment of the effectiveness of our internal controls over financial reporting.
As long as we remain a smaller reporting company and non-accelerated filer, we are exempt from the attestation requirement in the assessment of our internal control over financial reporting by our independent auditors pursuant to section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”) but are required to make our own internal assessment of the effectiveness of our internal controls over financial reporting. 24 Table of Contents
The Company estimates it has treated more than 30,000 patients across all three (3) of our customer categories, since it reintroduced the Aquadex System to the U.S. market in 2016. 23 Orso D, et al. Eur Rev Med Pharmacol Sci . 2021 Apr;25(7):2971-2980. 24 Costanzo MR, et al. J Am Coll Cardiol . 2017;69(19):2428- 2445. 25 Thandra A, et al.
The Company estimates it has treated more approximately 15,000 patients across all three (3) of our customer categories since it reintroduced the Aquadex System to the U.S. market in 2016. 23 Orso D, et al. Eur Rev Med Pharmacol Sci . 2021 Apr;25(7):2971-2980. 24 Costanzo MR, et al. J Am Coll Cardiol . 2017;69(19):2428- 2445. 25 Thandra A, et al.
We intend to focus on the acute needs of fluid overloaded patients in cardiac surgery and other areas of critical care, while continuing to support heart failure patients in the inpatient setting, and the outpatient setting.
We intend to focus on the acute needs of fluid overloaded patients in cardiac surgery and other areas of critical care, while continuing to support heart failure patients in the inpatient setting, as well as the outpatient setting.
We believe that our technology will provide a competitive advantage in the fluid management market by providing improved clinical benefits and reducing the cost of care relative to other treatment alternatives. Our strategic focus is to demonstrate a strong business model by driving revenue growth.
We believe that our technology will provide a competitive advantage in the fluid management market by providing improved clinical benefits and reducing the cost of care relative to other treatment alternatives. 16 Table of Contents Our strategic focus is to demonstrate a strong business model by driving revenue growth.
Similar to adult patients, these conditions and procedures may lead to fluid overload. While incidence data is not readily available, it is estimated that there are approximately 10,000 to 14,000 pediatric patients with heart failure. 67 Fluid overload drives pediatric morbidity and mortality risk in critically ill patients.
Similar to adult patients, these conditions and procedures may lead to fluid overload. While incidence data is not readily available, it is estimated that there are approximately 10,000 to 14,000 pediatric patients with heart failure. 6 7 Fluid overload drives pediatric morbidity and mortality risk in critically ill patients.
It is because of this unmet medical need the Company has undertaken the development of a dedicated Continuous Renal Replacement Therapy (“CRRT”) device intended for patients weighing between 2.5 and above kg. See - Product Development Activities below. 67 Jayaprasad, N. Heart Views . 2016; 17(3): 92-99. 68 Sutherland SM, et al.
It is because of this unmet medical need that the Company has undertaken the development of a dedicated Continuous Renal Replacement Therapy (“CRRT”) device intended for patients weighing above 2.5 kg and under 20 kg. See - Product Development Activities below. 67 Jayaprasad, N. Heart Views . 2016; 17(3): 92-99. 68 Sutherland SM, et al.
The results indicated that the Aquadex ® device can provide both standard ultrafiltration and modified continuous veno-venous hemofiltration (CVVH) in children with end stage renal disease (ESRD) or acute kidney injury (AKI) across a wide weight spectrum.
The results indicated that the Aquadex ® device can provide both standard ultrafiltration and modified continuous veno-venous hemofiltration (CVVH) in children with end-stage renal disease (ESRD) or acute kidney injury (AKI) and Fluid Overload (FO) across a wide weight spectrum.
Positive research has been recently published demonstrating the value of ultrafiltration in high-risk coronary artery bypass grafting surgery. 64 It is also encouraging to see ultrafiltration being recommended for cardiac surgery patients who are unresponsive to diuretics in a recently published turnkey order set proposed by the Enhanced Recovery After Surgery (“ERAS”) Society consensus guidelines. 62 The Company believes it can expand use cases for the Aquadex System, without any additional clinical trial or other labeling changes at the U.S.
Research has been recently published demonstrating the value of ultrafiltration in high-risk coronary artery bypass grafting surgery. 6 4 It is also encouraging to see ultrafiltration being recommended for cardiac surgery patients who are unresponsive to diuretics in a recently published turnkey order set proposed by the Enhanced Recovery After Surgery (“ERAS”) Society consensus guidelines. 6 2 The Company believes it can expand use cases for the Aquadex System without any additional clinical trial or other labeling changes at the U.S.
We expanded our commercialization efforts to include pediatrics, following receipt of 510(k) clearance of the Aquadex system to include pediatric patients who weigh 20kg or more in February 2020. In the United States, our target customers for the Aquadex System include healthcare systems and academic hospitals specializing in advanced treatment of chronic heart failure and/or critical care patients.
We expanded our commercialization efforts to include pediatrics, following receipt of FDA 510(k) clearance of the Aquadex System to include pediatric patients who weigh 20 kg or more in February 2020. In the United States, our target customers for the Aquadex System include healthcare systems and academic hospitals specializing in advanced treatment of chronic heart failure and/or critical care patients.
We and our contract manufacturers are also required to manufacture our products in compliance with Current Good Manufacturing Practice requirements set forth in the QSR.
We and our contract manufacturers are also required to manufacture our products in compliance with current Good Manufacturing Practice requirements set forth in the QMSR.
The severity of heart failure depends on how well a person’s heart pumps blood throughout the body. 48 According to a nationwide study of over 140,000 patients suffering from acute decompensated heart failure, over 38% of patients discharged were still symptomatic and about half of the patients were discharged with less than five pounds of lost fluid. 49 This clinical evidence from the ADHERE registry shows patients are discharged too early, while still showing evidence of fluid overload.
The severity of heart failure depends on how well a person’s heart pumps blood throughout the body. 4 8 According to a nationwide study of over 140,000 patients suffering from acute decompensated heart failure, over 38% of patients discharged were still symptomatic and about half of the patients were discharged with less than five pounds of lost fluid. 4 9 This clinical evidence from the ADHERE registry shows patients are discharged too early, while still showing evidence of fluid overload.
Additionally, Medtronic and DaVita have recently formed a joint venture, called Mozarc Medical, to pursue a variety of kidney applications across each of our customer categories. Our ability to compete effectively depends upon our ability to demonstrate the advantages of ultrafiltration as compared to diuretics, a pharmacological treatment that is currently the standard of care.
Additionally, Medtronic and DaVita have recently formed a joint venture, Mozarc Medical, to pursue a variety of kidney applications across each of our customer categories. 20 Table of Contents Our ability to compete effectively depends upon our ability to demonstrate the advantages of ultrafiltration as compared to diuretics, a pharmacological treatment that is currently the standard of care.
As a result of not fully having their fluid imbalance properly addressed prior to discharge from the hospital, patients are frequently being readmitted, with one study showing 30-day readmissions of 24% and 6-month readmissions of 44%. 50 51 Heart failure often requires inpatient treatment, and it carries a huge economic burden in the United States, costing the nation an estimated $60.2 billion each year, with hospital costs accounting for 62% of the economic burden. 52 As the population ages, healthcare expenditures are expected to increase substantially. 53 Therefore, therapies aimed at treating congestion and fluid overload are essential from a patient care and healthcare economics perspective.
As a result of not fully having their fluid imbalance properly addressed prior to discharge from the hospital, patients are frequently being readmitted, with one study showing 30-day readmission rates of 24% and six-month readmission rates of 44%. 50 51 Heart failure often requires inpatient treatment, and it carries a huge economic burden in the United States, costing the nation an estimated $60.2 billion each year, with hospital costs accounting for 62% of the economic burden. 52 As the population ages, healthcare expenditures are expected to increase substantially. 5 3 Therefore, therapies aimed at treating congestion and fluid overload are essential from a patient care and healthcare economics perspective.
In December 2021, we launched the REVERSE-HF prospective, multicenter, randomized controlled trial (RCT) to evaluate ultrafiltration compared to IV diuretics in patients with heart failure (HF). Seventeen clinical sites nationwide have been activated to enroll patients in this RCT and fourteen sites have contributed to patient enrollment, which began in June 2022.
In December 2021, we launched the REVERSE-HF prospective, multicenter, randomized controlled trial (RCT) to evaluate ultrafiltration compared to IV diuretics in patients with heart failure (HF). Seventeen clinical sites nationwide were activated to enroll patients in this RCT and fifteen sites have contributed to patient enrollment, which began in June 2022.
As we expand our commercialization efforts in the pediatric market, we are developing a CRRT console to address the unmet and specific needs of pediatric patients who do not have functioning kidneys and need kidney replacement therapy for survival. 86 Elliott MJ. Ann Thorac Surg . 1993;56:1518-22. 87 Selewski DT, et al.
As we expanded our commercialization efforts in the pediatric market, we developed a CRRT console to address the unmet and specific needs of pediatric patients who do not have functioning kidneys and need kidney replacement therapy for survival. 86 Elliott MJ. Ann Thorac Surg . 1993;56:1518-22. 87 Selewski DT, et al.
According to the National Center for Health Sciences, over 7.3 million cardiovascular operations are performed each year in the United States, including an estimated 340,000 coronary-artery bypass grafting (“CABG”) procedures, 56 Cardiac surgery is associated with a degree of fluid overload due to cardiopulmonary bypass. 57 Intravenous fluid therapy is an integral treatment for patients undergoing surgery and in critical care units. 58 Fluid overload in post-cardiac surgery can readily occur because surgery can affect the pumping actions of the heart, leading to postoperative hemodynamic instability. 59 The condition often remains symptomless for several days until clinical symptoms become apparent, when treatment is almost always too late and ineffective. 60 Major complications after cardiac operations are associated with an increased risk for operative death, longer hospital length of stay, and higher rates of discharge to a location other than home. 61 As many as 80% of cardiac surgery patients may have stage 1 or greater cardiac-surgery-associated acute kidney injury (CSA-AKI). 62 In the recent publication A Turnkey Order Set for Prevention of CSA-AKI the new CSA-AKI Guidelines suggest the avoidance of other nephrotoxic agents including loop diuretics. 62 Hospital readmissions are a common problem in cardiac surgery and remain high.
According to the National Center for Health Sciences, over 7.3 million cardiovascular operations are performed each year in the United States, including an estimated 340,000 coronary-artery bypass grafting (“CABG”) procedures. 5 6 Cardiac surgery is associated with a degree of fluid overload due to cardiopulmonary bypass. 5 7 Intravenous fluid therapy is an integral treatment for patients undergoing surgery and in critical care units. 5 8 Fluid overload in post-cardiac surgery can readily occur because surgery can affect the pumping actions of the heart, leading to postoperative hemodynamic instability. 5 9 The condition often remains symptomless for several days until clinical symptoms become apparent, when treatment is almost always too late and ineffective. 60 Major complications after cardiac operations are associated with an increased risk for operative death, longer hospital length of stay, and higher rates of discharge to a location other than home. 61 As many as 80% of cardiac surgery patients may have stage one or greater cardiac-surgery-associated acute kidney injury (CSA-AKI). 6 2 In the recent publication A Turnkey Order Set for Prevention of CSA-AKI the new CSA-AKI Guidelines suggest the avoidance of nephrotoxic agents including loop diuretics and considering the use of ultrafiltration during post-surgery recovery. 62 Hospital readmissions are a common problem in cardiac surgery and remain high.
In totality, AVOID-HF recapitulated the results of both UNLOAD and CARRESS while providing evidence that had AVOID-HF been followed to completion, it is our belief that the trial would likely have met its primary endpoint of improved outcome in acute decompensated heart failure patients. 89 Costanzo MR, et al.
In totality, AVOID-HF recapitulated the results of both UNLOAD and CARRESS while providing evidence that had AVOID-HF been followed to completion, it is our belief that the trial would likely have met its primary endpoint of improved outcome in acute decompensated heart failure patients.
The FDA enforces the QSR through periodic announced and unannounced inspections that may include the manufacturing facilities of subcontractors.
The FDA enforces the QMSR through periodic announced and unannounced inspections that may include the manufacturing facilities of subcontractors.
AKI & CRRT meeting; March 2025, San Deigo, CA. 11 Table of Contents In February 2025, a re-appraisal of the complete dataset, including an additional 31 adjudicated events, from the AVOID-HF trial, demonstrated that patients treated with adjustable ultrafiltration (AUF) had a 60% reduction in heart failure events (HF) at 30 days (p=0.014) compared to adjustable intravenous diuretics (ALD) and significantly fewer HF hospitalizations at 30 days (p=0.032). 73 Additionally, a hierarchical composite endpoint of 30-day cardiovascular (CV) mortality, HF events (including HF rehospitalization, unscheduled outpatient or emergency room treatment with intravenous loop diuretics, vasoactive drugs, or ultrafiltration) and change in quality of life was evaluated using the Finkelstein-Schoenfeld win ratio (WR) method.
Clin Nephrol. 2025 Dec 11. 14 Table of Contents In February 2025, a re-appraisal of the complete dataset, including an additional 31 adjudicated events, from the AVOID-HF trial, demonstrated that patients treated with adjustable ultrafiltration (AUF) had a 60% reduction in heart failure events (HF) at 30 days (p=0.014) compared to adjustable intravenous diuretics (ALD) and significantly fewer HF hospitalizations at 30 days (p=0.032). 73 Additionally, a hierarchical composite endpoint of 30-day cardiovascular (CV) mortality, HF events (including HF rehospitalization, unscheduled outpatient or emergency room treatment with intravenous loop diuretics, vasoactive drugs, or ultrafiltration) and change in quality of life was evaluated using the Finkelstein-Schoenfeld win ratio (WR) method.
In one pediatric study, a 3% increase in mortality was observed for every 1% increase in fluid overload, and children who are more than 20% fluid overloaded have an odds ratio for mortality of 8.5 compared to children who are less than 20% fluid overloaded. 68 69 The Company believes that the total U.S. pediatric market for fluid overload is approximately $130 million. 70 In 2024, the Company derived approximately 40% of its revenue from the treatment of pediatric patients.
In one pediatric study, a 3% increase in mortality was observed for every 1% increase in fluid overload, and children who are more than 20% fluid overloaded have an odds ratio for mortality of 8.5 compared to children who are less than 20% fluid overloaded. 6 8 6 9 The Company believes that the total U.S. pediatric market for fluid overload is approximately $160 million. 70 In 2025, the Company derived approximately 40% of its revenue from the treatment of pediatric patients.
Crit Care Med . 2012; 40(9): 2694-2699. 88 Riley AA. BMC Nephrology . 2018; 19:268-80. 14 Table of Contents Sales and Marketing As of December 31, 2024, we had 19 full-time employees in sales and marketing. We have 9 sales territories in the United States.
Crit Care Med . 2012; 40(9): 2694-2699. 88 Riley AA. BMC Nephrology . 2018; 19:268-80. 17 Table of Contents Sales and Marketing As of December 31, 2025, we had 24 full-time employees in sales and marketing. We have ten sales territories in the United States.
With the FDA 510(k) clearance of the Aquadex SmartFlow® system for patients weighing over 20kg, we are also targeting pediatric hospitals. Our largest customer represented 14.4% of our 2024 annual revenue. The loss of this customer would have a material adverse effect on our revenue.
With the FDA 510(k) clearance of the Aquadex SmartFlow® system for patients weighing over 20kg, we are also targeting pediatric hospitals. Our largest customer represented 13.7% of our 2025 annual revenue. The loss of this customer would have a material adverse effect on our revenue.
Sean Pinney for example, is the principal investigator under the Company’s current REVERSE-HF heart failure clinical study. Additionally, Dr. Maria Rosa Costanzo, joined the Company’s Board of Directors in September, 2019, though many of her cited publications preceded her membership on the Board of Directors. Since joining the Company’s Board, Dr.
Sean Pinney for example, was the principal investigator under the Company’s former REVERSE-HF heart failure clinical study. Additionally, Dr. Maria Rosa Costanzo, joined the Company’s Board of Directors in September 2019, though many of her cited publications preceded her membership on the Board of Directors.
In the composite outcome, there were 2 CV deaths within 30-days.
In the composite outcome, there were two CV deaths within 30 days.
The Company launched the registry in November 2020 and conducted the registry at seven clinical sites prior to closure in October 2023 with 97 patients enrolled.
The Company launched the registry in November 2020 and conducted the registry at seven clinical sites prior to closure in October 2023 with one patient enrolled.
Given the strategic refocus away from the C-Pulse System and toward the Aquadex System, we have chosen to limit the maintenance of issued C-Pulse System related patents to those innovations that are of high value. In addition, we have four pending patent applications in the United States unrelated to our dedicated pediatric device in development.
Given the strategic refocus away from the C-Pulse System and toward the Aquadex System, we have chosen to limit the maintenance of issued C-Pulse System. In addition, we have four pending patent applications in the United States unrelated to our dedicated pediatric device in development.
We are also investing in the development of a new dedicated pediatric device, to further address the needs of the pediatric population, and in clinical studies supporting the use of this device. Heart Failure In-Patients : Heart failure patients suffering from fluid overload may be treated in an inpatient setting, such as a hospital, extended care facility or nursing home.
We are also investing in the development of a new dedicated pediatric CRRT device, to further address the needs of the pediatric population, and in clinical studies supporting the use of this device. Heart Failure Inpatients : Heart failure patients suffering from fluid overload may be treated in an inpatient setting, such as a hospital cardiology clinic or ICU.
The QSR requires a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing and record keeping.
The QMSR (which replaces the prior Quality System Regulation (“QSR”)) requires medical device establishments to maintain a quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of marketed devices, and includes extensive requirements with respect to quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling controls, device evaluation, distribution, installation, complaint handling, servicing and record keeping.
The Company expects this sensor effort to be completed in 2025. In 2021, we also initiated a product development project to develop a pediatric continuous renal replacement therapy (CRRT) device. We successfully completed functional system prototypes in 2022 and preliminary engineering testing in 2023.
In 2021, we also initiated a product development project to develop a pediatric continuous renal replacement therapy (CRRT) device. We successfully completed functional system prototypes in 2022 and preliminary engineering testing in 2023.
The Aquadex SmartFlow incorporates diagnostic tools for physicians to use during an Aquadex therapy to more precisely determine the amount of excess fluid to be removed, the rate of ultrafiltration, and when to stop therapy as dry weight is approached. Clinical Trials. To obtain FDA clearance to market certain devices, clinical trials may be required to support a 510(k) application.
The Aquadex SmartFlow incorporates functions for physicians to use during an Aquadex therapy to more precisely determine the amount of excess fluid to be removed, the rate of ultrafiltration, and when to stop therapy as dry weight is approached. Clinical Trials. Clinical trials may be required to support a marketing application for certain device.
To remove the excess fluid, patients suffering from heart failure may receive ultrafiltration therapy in two settings: (i) inpatient care: provided to a patient admitted to a hospital, extended care facility, nursing home or other longer-term care facility; and (ii) outpatient care: provided to a patient who is not admitted to a facility, but receives treatment at a doctor’s office, clinic, or hospital outpatient department. 44 Shah, K, et al.
To remove the excess fluid, patients suffering from heart failure may receive ultrafiltration therapy in two settings: (i) inpatient care: provided to a patient admitted to a hospital; and (ii) outpatient care: provided to a patient who is not admitted to a facility but receives treatment at a clinic or hospital outpatient department.
We estimate that the last expiring patent licensed from Baxter has a term to mid-2025. We estimate that most of our currently issued U.S. patents will expire by 2027. In addition to the licensed patents, Nuwellis has ten (10) company-owned patents, including two (2) patents issued within the last two years.
We estimate that most of our currently issued U.S. patents will expire by 2027. In addition to the licensed patents, we have ten (10) company-owned patents, including two (2) patents issued within the last two years.
Medical devices and their manufacturers are also subject to inspection by the FDA. The FDC Act, supplemented by other federal and state laws, also provides civil and criminal penalties for violations of its provisions. We manufacture and market medical devices that are regulated by the FDA, comparable state agencies and regulatory bodies in other countries.
Medical devices and their manufacturers are also subject to inspection by the FDA. The FDC Act, supplemented by other federal and state laws, also provides civil and criminal penalties for violations of its provisions.
As part of the Patient Protection and Affordable Care Act of 2012, as amended (the “Affordable Care Act”), Medicare instituted the Hospital Readmissions Reduction Program, which penalizes hospitals with high 30-day readmission rates for heart failure and other common diseases and procedures. This penalty can be as high as 3% of reimbursement for all Medicare admissions.
Hospitals in the United States also face potential penalties for heart failure readmissions. As part of the Patient Protection and Affordable Care Act of 2012, as amended (the “Affordable Care Act”), Medicare instituted the Hospital Readmissions Reduction Program, which penalizes hospitals with high 30-day readmission rates for heart failure and other common diseases and procedures.
Unless an exemption applies, each medical device we intend to commercially distribute in the U.S. will require 510(k) clearance. 510(k) Clearance. To obtain 510(k) clearance for a medical device, an applicant must submit a premarket notification to the FDA demonstrating that the device is “substantially equivalent” to a predicate device legally marketed in the United States.
To obtain 510(k) clearance for a medical device, an applicant must submit a premarket notification to the FDA demonstrating that the device is “substantially equivalent” to a predicate device legally marketed in the United States.
In addition, the FDA may require a company to conduct post-market studies or order it to establish and maintain a system for tracking its products through the chain of distribution to the patient level. 19 Table of Contents Failure to comply with applicable regulatory requirements, including those applicable to the conduct of clinical trials, can result in enforcement action by the FDA, which may lead to any of the following sanctions: • warning letters or untitled letters; • fines, injunctions and civil penalties; • product recall or seizure; • unanticipated expenditures; • delays in clearing or refusal to clear products; • withdrawal or suspension of FDA clearance; • orders for physician notification or device repair, replacement or refund; • operating restrictions, partial suspension or total shutdown of production or clinical trials; or • criminal prosecution.
Failure to comply with applicable regulatory requirements, including those applicable to the conduct of clinical trials, can result in enforcement action by the FDA, which may lead to any of the following sanctions: • Warning letters or Untitled letters; • fines, injunctions and civil penalties; • product recall or seizure; • civil fines and penalties; • delays in clearing or refusal to clear products; • import alerts or refusals; • withdrawal or suspension of FDA clearance; • orders for physician notification or device repair, replacement or refund; • operating restrictions, partial suspension or total shutdown of production or clinical trials; or • criminal prosecution.
Growing revenue is the key metric employees, stockholders and potential investors will use to judge our performance. Our field-based employees include both sales representatives and clinical education specialists in 9 sales territories in the United States. We also have distribution agreements in several countries in Europe, South America, the Middle East, and Asia.
Growing revenue is the key metric employees, stockholders and potential investors will use to judge our performance. Our field-based employees include both sales representatives and clinical education specialists in ten sales territories in the United States.
J Am Coll Cardiol . 2007; 49(6):675-683 86 Urban S, et al. Adv Clin Exp Med . 2021;30(7):737-746. 90 Grodin JL, et al. Eur J of Heart Fail . 2018;20(7):1148-1156. 91 Rao VS, et al. Circ Heart Fail . 2019;12 (6):e005552. 92 Costanzo MR, et al.
Thus, we believe that a change in creatinine should not dissuade the use of ultrafiltration. 89 Costanzo MR, et al. J Am Coll Cardiol . 2007; 49(6):675-683 86 Urban S, et al. Adv Clin Exp Med . 2021;30(7):737-746. 90 Grodin JL, et al. Eur J of Heart Fail . 2018;20(7):1148-1156. 91 Rao VS, et al.
Technologies that help reduce readmissions, such as the Aquadex System, can help hospitals mitigate these penalties. 54 The Company believes the total U.S. heart failure market is approximately $1 billion 55 and that roughly 20% of its revenue is derived from the treatment of heart failures patients.
Technologies that help reduce readmissions, such as the Aquadex System, can help hospitals mitigate these penalties. 5 4 The Company believes the total U.S. heart failure market is approximately $1 billion for inpatient therapy and is approximately $770 million for outpatient therapy. 55 Roughly 17% of its 2025 revenue was derived from the treatment of heart failure patients. 44 Shah, K, et al.
The results of clinical trials may be unfavorable or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant clearance of a product. The commencement or completion of any clinical trial may be delayed or halted or be inadequate to support clearance of a 510(k) application for numerous reasons.
The results of clinical trials may be unfavorable or, even if the intended safety and effectiveness success criteria are achieved, may not be considered sufficient for the FDA to grant clearance of a product.
These include: • establishment registration and device listing upon the commencement of manufacturing; • the Quality System Regulation (“QSR”), which requires manufacturers, including third-party manufacturers, to follow the FDA design control regulations; • labeling regulations, which prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling and promotional activities; • medical device reporting regulations, which require that manufacturers report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if malfunctions were to recur; • corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections; and • product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDC Act caused by the device that may present a risk to health.
These include: • establishment registration and device listing upon the commencement of any activity defined as “manufacturing”; • the Quality Management System Regulation (“QMSR”), which imposes requirements for risk management, design/document controls, purchasing, traceability, and production/process controls on manufacturers, including third-party manufacturers; • labeling regulations, which (among other requirements and restrictions) prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling and promotional activities; 22 Table of Contents • medical device reporting (“MDR”), per which manufacturers must report to the FDA if a device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if malfunctions were to recur; • mandatory reporting of corrections and removals taken to reduce a risk to health or remedy a violation of the Food, Drug, and Cosmetic Act caused by the device which may present a risk to health; and • voluntary recalls of devices.
With our “FDA 510(k) clearance for use in pediatric patients weighing 20kg or more, we have expanded our commercialization efforts to treatments for pediatric patients. 13 Table of Contents Critical Care : We have launched a marketing campaign focused on the benefits of the Aquadex System in treating patients suffering from fluid overload following cardiac surgery procedures, such as CABG surgery, valve repairs and replacements procedures, VAD implants and other cardiac surgical procedures.
Critical Care : We have launched a marketing campaign focused on the benefits of the Aquadex System in treating patients suffering from fluid overload following cardiac surgery procedures, such as CABG surgery, valve repairs and replacements procedures, VAD implants and other cardiac surgical procedures.
These patients typically have very few other treatment options given the large extracorporeal blood volume required by standard dialysis machines the need for blood priming of the dialysis circuit and the use of large catheters. By comparison, the Aquadex extracorporeal blood volume is only 35 ml.
These patients typically have very few other treatment options given the large extracorporeal blood volume required by standard dialysis machines (58ml for Baxter HF20 device), the need for blood priming of the dialysis circuit, vasoactive medications to support hemodynamics, and the use of large bore dialysis catheters.
Thus, we believe that a change in creatinine should not dissuade the use of ultrafiltration. Disparate results between UNLOAD and CARRESS led to initiation of the AVOID-HF trial, designed to prospectively address the question of patient outcomes when treated with ultrafiltration versus intravenous diuretics for acute decompensated heart failure (HF), was initiated by Baxter International, Inc.
JACC: Heart Failure . 2016;4(2):95-105. 18 Table of Contents Disparate results between UNLOAD and CARRESS led to initiation of the AVOID-HF trial, designed to prospectively address the question of patient outcomes when treated with ultrafiltration versus intravenous diuretics for acute decompensated heart failure (HF), which was initiated by Baxter International, Inc.
On February 4, 2020, we received 510(k) clearance of the Aquadex SmartFlow® system for use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management.
The Aquadex FlexFlow system was first granted FDA 510(k) clearance for commercial use on June 3, 2002. On February 24, 2020, we received 510(k) clearance of the Aquadex FlexFlow System 2.0 (“SmartFlow®”) (K192756) system for use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics.
Costanzo has declined any equity ownership in the Company, although she has accepted cash remuneration for her Board and Committee participation. Fluid Overload Fluid overload, also known as hypervolemia, is a condition in which there is too much fluid in the blood, vital organs, and interstitial space, and generally refers to the expansion of the extracellular fluid volume.
Fluid Overload Fluid overload, also known as hypervolemia, is a condition in which there is too much fluid in the blood, vital organs, and interstitial space, and generally refers to the expansion of the extracellular fluid volume.
J Am Coll Cardiol . 2005; 46(11): 2047-51. 7 Table of Contents Our Market Opportunity The Aquadex System is used for the treatment of patients suffering from fluid overload who have failed medical therapy including diuretics. We are currently focusing our commercial activities in three primary clinical areas where fluid overload is prevalent: heart failure, critical care, and pediatrics.
J Am Coll Cardiol . 2005; 46(11): 2047-51. 10 Table of Contents Our Market Opportunity The Aquadex System is used for the treatment of patients suffering from fluid overload who have failed medical therapy including diuretics.
We will make such design changes as needed based on proactive and reactive mechanisms. Research and development costs also include expenses related to our clinical research. In 2021 we initiated a product development project designed to enhance the functionality of the hematocrit sensor that is part of the Aquadex console.
Research and development costs also include expenses related to our clinical research. In 2021 we initiated a product development project designed to enhance the functionality of the hematocrit sensor that is part of the Aquadex console. The sensor effort was completed in 2025 and will move into production consoles in 2026.
The 510(k) clearance process cannot exceed 90 days from the date the FDA accepts the 510(k) submission After a device has received 510(k) clearance for a specific indication for use, any modification to that device that could “significantly affect its safety or effectiveness,” such as a significant change in the design, materials, method of manufacture or which results in “major change” to the product performance, may require a new 510(k) clearance.
After a device has received 510(k) clearance for a specific indication for use, any modification to that device that “could significantly affect its safety or effectiveness,” such as a significant change in the design, materials, or method of manufacture, or which represents a “major change” to the intended use of the device, requires a new 510(k) clearance prior to being implemented.
Good Clinical Practices include, but is not limited to, the FDA’s IDE regulations, which describe the conduct of clinical trials with medical devices. They also prohibit promotion, test marketing or commercialization of an investigational device and any representation that such a device is safe or effective for the purposes being investigated.
They also prohibit promotion, test marketing or commercialization of an investigational device and any representation that such a device is safe or effective for the purposes being investigated.
The heart becomes weak or stiff and enlarges over time, making it harder for the heart to pump the blood needed for the body to function properly.
Patients with heart failure and fluid overload commonly experience shortness of breath, fatigue, difficulty exercising and swelling of the legs. The heart becomes weak or stiff and enlarges over time, making it harder for the heart to pump the blood needed for the body to function properly.
Food and Drug Administration (“FDA”) to support its use in the applications identified immediately above. The Company believes the total U.S. critical care failure market is approximately $900 million. 65 In 2024, the Company derived approximately 40% of its revenue from the treatment of critical care patients. 54 McIlvennan C et al.
Food and Drug Administration (“FDA”) to support its use in the applications identified immediately above. The Company believes the total U.S. critical care failure market is approximately $900 million. 6 5 In 2025, the Company derived approximately 32% of its revenue from the treatment of critical care patients. 56 https://idataresearch.com/new-study-shows-approximately-340000-cabg-procedures-per-year-in-the-united-states/. 57 Kruger A et al.
The determination as to whether new 510(k) is needed is initially left to the manufacturer; however, the FDA may review this determination to evaluate the regulatory status of the modified product at any time and may require the manufacturer to cease marketing the modified device until 510(k) clearance is received. 18 Table of Contents The Aquadex FlexFlow system was granted FDA 510(k) clearance for commercial use on June 3, 2002.
The determination as to whether a new 510(k) is needed is initially left to the manufacturer; however, the FDA may evaluate the regulatory status of the modified at any time and, if it disagrees with the sponsor’s determination that a new 510(k) was not needed, may require the manufacturer to cease marketing the modified device until 510(k) clearance is received.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeSubsequently, on May 23, 2024, we received a letter from the Listing Qualifications Staff (the “Staff”) informing the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq, under Listing Rule 5550(b)(1) (the “Stockholder’s Equity Requirement”), because the Company’s stockholders’ equity of $885,000, as reported in the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, was below the required minimum of $2.5 million, and because, as of May 23, 2024, the Company did not meet the alternative compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.
Biggest changeAs a result of the above, the Company’s stockholders’ equity as of June 30, 2025, as reported in the interim financial statements included in the Company’s Quarterly Report on Form 10-Q, was below the amount required to be in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq, under Listing Rule 5550(b)(1) (the “Stockholder’s Equity Requirement”) .
Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System. We face significant challenges in expanding market acceptance of the Aquadex System, which could adversely affect our potential sales. Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System, and we have no other commercial products at this time.
We face significant challenges in expanding market acceptance of the Aquadex System, which could adversely affect our potential sales. Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System, and we have no other commercial products at this time.
Additionally, we may acquire development-stage companies that are not yet profitable and which require continued investment, which could decrease our future earnings or increase our futures losses. Any of these outcomes could prevent us from realizing the anticipated benefits of an acquisition. To pay for an acquisition, we might use stock or cash.
Additionally, we may acquire development-stage companies that are not yet profitable and which require continued investment, which could decrease our future earnings or increase our future losses. Any of these outcomes could prevent us from realizing the anticipated benefits of an acquisition. To pay for an acquisition, we might use stock or cash.
These payers, which include federal health care programs (e.g., Medicare and Medicaid), state health care programs, private health insurance companies and managed care organizations, then reimburse our customers based on established payment formulas that consider part or all of the cost associated with these devices and the related procedures performed.
These payers, which include federal health care programs (e.g., Medicare and Medicaid), state healthcare programs, private health insurance companies and managed care organizations, then reimburse our customers based on established payment formulas that consider part or all of the cost associated with these devices and the related procedures performed.
Moreover, the Physician Payment Sunshine Act (the “Sunshine Act”), which was enacted as part of the Affordable Care Act, requires applicable medical device companies to track and publicly report, with limited exceptions, all payments and other transfers of value to physicians and teaching hospitals in the U.S.
Moreover, the federal Physician Payment Sunshine Act (the “Sunshine Act”), which was enacted as part of the Affordable Care Act, requires applicable medical device companies to track and publicly report, with limited exceptions, all payments and other transfers of value to physicians and teaching hospitals in the U.S.
The FCPA prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The U.K.
The FCPA prohibits any U.S. individual or business from paying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business.
In addition, the interpretation and application of consumer, health-related, and data protection laws in the United States, Europe and elsewhere are often uncertain, contradictory, and in flux. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices.
In addition, the interpretation and application of consumer, health-related, and data protection laws in the United States, and elsewhere are often uncertain, contradictory, and in flux. It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices.
We will rely on third-party suppliers, including single-source suppliers, to provide us with certain components of the Aquadex System. We have no long-term contracts with the majority of our third-party suppliers that guarantee volume or the continuation of payment terms.
We rely on third-party suppliers, including single-source suppliers, to provide us with certain components of the Aquadex System. We have no long-term contracts with the majority of our third-party suppliers that guarantee volume or the continuation of payment terms.
Furthermore, the stock market is subject to significant price and volume fluctuations, and the price of our common stock could fluctuate widely in response to several factors, including: • our quarterly or annual operating results; • changes in our earnings estimates; • investment recommendations by securities analysts following our business or our industry; • additions or departures of key personnel; • changes in the business, earnings estimates or market perceptions of our competitors; • our failure to achieve operating results consistent with securities analysts’ projections; • future announcements concerning us, including our clinical and product development strategy, or our competitors; • regulatory developments, disclosure regarding completed, ongoing or future clinical studies and enforcement actions bearing on advertising, marketing or sales; • acquisition or loss of significant manufacturers, distributors or suppliers or an inability to obtain sufficient quantities of materials needed to manufacture our system; • fluctuations of investor interest in the medical device sector; • changes in industry, general market or economic conditions; and • announcements of legislative or regulatory changes.
Furthermore, the stock market is subject to significant price and volume fluctuations, and the price of our common stock could fluctuate widely in response to several factors, including: • our quarterly or annual operating results; • changes in our earnings estimates; • investment recommendations by securities analysts following our business or our industry; 45 Table of Contents • additions or departures of key personnel; • changes in the business, earnings estimates or market perceptions of our competitors; • our failure to achieve operating results consistent with securities analysts’ projections; • future announcements concerning us, including our clinical and product development strategy, or our competitors; • regulatory developments, disclosure regarding completed, ongoing or future clinical studies and enforcement actions bearing on advertising, marketing or sales; • acquisition or loss of significant manufacturers, distributors or suppliers or an inability to obtain sufficient quantities of materials needed to manufacture our system; • fluctuations of investor interest in the medical device sector; • changes in industry, general market or economic conditions; and • announcements of legislative or regulatory changes.
Additionally, President Trump has directed various federal agencies to further evaluate key aspects of U.S. trade policy and there has been ongoing discussion and commentary regarding potential significant changes to U.S. trade policies, treaties and tariffs.
Additionally, President Trump has directed various federal agencies to further evaluate key aspects of U.S. trade policy and there have been ongoing discussion and commentary regarding potential significant changes to U.S. trade policies, treaties and tariffs.
Approval or clearance of our products could be withdrawn, delayed, or denied by the EU, the FDA and the relevant authorities of other countries if our manufacturing facilities do not comply with their respective manufacturing requirements.
Approval or clearance of our products could be withdrawn, delayed, or denied by the FDA and the relevant authorities of other countries if our manufacturing facilities do not comply with their respective manufacturing requirements.
The physician self-referral laws, commonly referred to as the Stark law, is a strict liability statute that generally prohibits physicians from making referrals for the furnishing of any “designated health services,” for which payment may be made under the Medicare or Medicaid programs, to any entity with which the physician (or an immediate family member) has an ownership interest or compensation arrangement, unless an applicable exception applies.
The federal physician self-referral law, commonly referred to as the Stark Law, is a strict liability statute that generally prohibits physicians from making referrals for the furnishing of any “designated health services,” for which payment may be made under the Medicare or Medicaid programs, to any entity with which the physician (or an immediate family member) has an ownership interest or compensation arrangement, unless an applicable exception applies.
To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. 34 Table of Contents Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products.
To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. 38 Table of Contents Our products could infringe patent rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages or limit our ability to commercialize our products.
Other pending patent applications involve an extracorporeal blood filtration machine that includes flexible source line connection, open vs. closed loop fluid collection controls, a self-emptying bag, improved density measurement techniques, algorithm to ensure reliable auto clamp safety engagement, a blood leak detector that can detect hemolyzed blood, and mechanical cartridge design to ease manufacturing assembly and user setup.
Other pending patent applications involve an extracorporeal blood filtration machine that includes flexible source line connection, open versus closed loop fluid collection controls, a self-emptying bag, improved density measurement techniques, an algorithm to ensure reliable auto clamp safety engagement, a blood leak detector that can detect hemolyzed blood, and mechanical cartridge design to ease manufacturing assembly and user setup.
If we violate the FDC Act or other regulatory requirements at any time during or after the product development and/or approval process, we could be subject to enforcement actions by the FDA or other agencies, including: fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of the production of our products, withdrawal of any existing approvals or pre-market clearances of our products, refusal to approve or clear new applications or notices relating to our products, recommendations that we not be allowed to enter into government contracts and criminal prosecution.
If we violate the FDC Act or other regulatory requirements at any time during or after the product development and/or approval process, we could be subject to enforcement actions by the FDA or other agencies, including: Warning or Untitled letters, fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspension of the production of our products, withdrawal of any existing approvals or pre-market clearances of our products, refusal to approve or clear new applications or notices relating to our products, recommendations that we not be allowed to enter into government contracts and criminal prosecution.
Our distribution arrangements outside the U.S. presents some risk under these laws. Our distributors may sell our products to healthcare providers that are owned, controlled or managed by a foreign government and its employees, including healthcare providers may be deemed to be a foreign official under the FCPA. We could be held liable for the actions of our distributors.
Our distribution arrangements outside the U.S. present some risk under these laws. Our distributors may sell our products to healthcare providers that are owned, controlled or managed by a foreign government and its employees, including healthcare providers may be deemed to be a foreign official under the FCPA. We could be held liable for the actions of our distributors.
On September 29, 2016, we announced a strategic refocus of our strategy that included halting all clinical evaluations of the C-Pulse System to fully focus our resources on commercializing our Aquadex System, taking actions to reduce our cash burn in connection with such strategic refocus and reviewing potential strategic alliances and financing alternatives.
On September 29, 2016, we announced a strategic refocus of our strategy that included halting all clinical evaluations of the C-Pulse System to fully focus our resources on commercializing our Aquadex System, taking actions to reduce our cash utilization in connection with such strategic refocus and reviewing potential strategic alliances and financing alternatives.
We face four primary risks relative to protecting this critical information, including: loss of access risk; inappropriate disclosure risk; inappropriate modification risk; and the risk of our being unable to adequately monitor our controls over the first three risks. 35 Table of Contents The secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy.
We face four primary risks relative to protecting this critical information, including: loss of access risk; inappropriate disclosure risk; inappropriate modification risk; and the risk of our being unable to adequately monitor our controls over the first three risks. 39 Table of Contents The secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy.
Our business is dependent upon the FDA and the FDA’s ability to timely respond to our drug development activities. On January 20, 2025, President Trump signed an executive order creating an advisory commission, the “Department of Government Efficiency” to reform federal government processes and reduce expenditures.
Our business is dependent upon the FDA and the FDA’s ability to timely respond to our product development activities. On January 20, 2025, President Trump signed an executive order creating an advisory commission, the “Department of Government Efficiency” to reform federal government processes and reduce expenditures.
Risks Related to Our Common Stock Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and subject us to additional trading restrictions. Our common stock is listed on the Nasdaq Capital Market under the symbol “NUWE”.
Risks Related to Our Common Stock Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and subject us to additional trading restrictions. Our common stock is listed on the Nasdaq Capital Market under the symbol “NUWE.
Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other adverse consequences. We are subject to the Foreign Corrupt Practices Act (“FCPA”), the U.K. Bribery Act and other anti-corruption, anti-bribery and anti-money laundering laws in various jurisdictions both domestic and abroad.
Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws could subject us to penalties and other adverse consequences. We are subject to the Foreign Corrupt Practices Act (“FCPA”) and other anti-corruption, anti-bribery and anti-money laundering laws in various jurisdictions both domestic and abroad.
The established market or customer base for our Aquadex System is limited and our success depends on our ability to increase adoption and utilization of the Aquadex System. Acceptance of our product in the marketplace by health care providers is uncertain, and our failure to achieve sufficient market acceptance will significantly limit our ability to generate revenue and be profitable.
The established market or customer base for our Aquadex System is limited and our success depends on our ability to increase adoption and utilization of the Aquadex System. Acceptance of our product in the marketplace by healthcare providers is uncertain, and our failure to achieve sufficient market acceptance will significantly limit our ability to generate revenue and be profitable.
To market our products in the European Community, the United States and other countries, where approved, manufacturers of such products must continue to comply or ensure compliance with the relevant manufacturing requirements.
To market our products in the United States and other countries, where approved, manufacturers of such products must continue to comply or ensure compliance with the relevant manufacturing requirements.
In addition, our business strategy depends in part on our ability to grow our business by establishing an effective sales force and selling our products to hospitals and other healthcare facilities while controlling costs. In addition to heart failure, we have expanded our commercialization efforts into critical care and post-cardiac surgery.
In addition, our business strategy depends in part on our ability to grow our business by establishing an effective salesforce and selling our products to hospitals and other healthcare facilities while controlling costs. In addition to heart failure, we have expanded our commercialization efforts into critical care and post-cardiac surgery.
We may not be able to build key relationships with health care providers to drive further sales in the United States or sell the Aquadex System outside the United States. Product orders may be cancelled, patients or customers currently using our products may cease to do so and patients or customers expected to begin using our products may not.
We may not be able to build key relationships with healthcare providers to drive further sales in the United States or sell the Aquadex System outside the United States. Product orders may be cancelled, patients or customers currently using our products may cease to do so and patients or customers expected to begin using our products may not do so.
In addition, we need to distinguish Aquadex System from the indirect competition of other devices that can also be used to conduct ultrafiltration. 27 Table of Contents Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales.
In addition, we need to distinguish the Aquadex System from the indirect competition of other devices that can also be used to conduct ultrafiltration. Significant additional governmental regulation could subject us to unanticipated delays which would adversely affect our sales.
Moreover, changes that result in our failure to comply with the requirements of applicable laws and regulations could result in the types of enforcement actions by the FDA and/or other agencies as described above, all of which could impair our ability to have manufactured and to sell the affected products.
Moreover, changes that result in our failure to comply with the requirements of applicable laws and regulations could result in the types of enforcement actions by the FDA and/or other agencies as described above, all of which could impair our ability to manufacture and to sell the affected products.
However, in the United States and international markets, we expect that both government and third-party payers will continue to attempt to contain or reduce the costs of health care by challenging the prices charged, or deny coverage, for health care products and services.
However, in the United States and international markets, we expect that both government and third-party payers will continue to attempt to contain or reduce the costs of healthcare by challenging the prices charged, or deny coverage, for healthcare products and services.
We compete against many companies, some of which have longer operating histories, more established products and greater resources than we do, which may prevent us from achieving further market penetration or improving operating results. Competition from medical device companies and medical device divisions of health care companies, pharmaceutical companies and gene- and cell-based therapies is intense and expected to increase.
We compete against many companies, many of which have longer operating histories, more established products and greater resources than we do, which may prevent us from achieving further market penetration or improving operating results. Competition from medical device companies and medical device divisions of healthcare companies, pharmaceutical companies and gene- and cell-based therapies is intense and expected to increase.
In the United States, the products included in the Aquadex System are purchased primarily by customers, such as hospitals or other health care providers. Customers bill various third-party payers for covered therapies involving the Aquadex System provided to patients.
In the United States, the products included in the Aquadex System are purchased primarily by customers, such as hospitals or other healthcare providers. Customers bill various third-party payers for covered therapies involving the Aquadex System provided to patients.
In addition, any healthcare reforms enacted in the future may, like the Affordable Care Act, be phased in over a number of years, but if enacted, could reduce our revenue, increase our costs, or require us to revise the ways in which we conduct business or put us at risk for loss of business.
However, any healthcare reforms enacted in the future may, like the Affordable Care Act, be phased in over a number of years, but if enacted, could reduce our revenue, increase our costs, or require us to change the ways in which we conduct business or put us at risk for loss of business.
We have identified a material weakness in connection with our internal control over financial reporting which, if not remediated, could adversely affect our business, reputation and stock price. We review and update our internal controls, disclosure controls and procedures, and corporate governance policies as our Company continues to evolve.
We have identified two material weaknesses in connection with our internal control over financial reporting which, if not remediated, could adversely affect our business, reputation and stock price. We review and update our internal controls, disclosure controls and procedures, and corporate governance policies as our Company continues to evolve.
Market acceptance will require substantial marketing efforts and the expenditure of significant funds by us to inform health care providers of the benefits of using the Aquadex System and to provide further training on its use.
Market acceptance will require substantial marketing efforts and the expenditure of significant funds by us to inform healthcare providers of the benefits of using the Aquadex System and to provide further training on its use.
In some circumstances, such adverse events could also cause delays in new product approvals. 28 Table of Contents We may be held liable if any product we develop or commercialize causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or consumer use.
In some circumstances, such adverse events could also cause delays in new product approvals. We may be held liable if any product we develop or commercialize causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or consumer use.
Legislative proposals can substantially change the way health care is financed by both governmental and private insurers and may negatively impact payment rates for our system.
Legislative proposals can substantially change the way healthcare is financed by both governmental and private insurers and may negatively impact payment rates for our system.
Federal Reserve Board to address inflation, the Ukraine-Russia and Israel-Hamas conflicts, the continuing effects of the COVID-19 pandemic and supply chain disruptions. These factors could lead to further disruption, instability, and volatility in global markets, continue to increase inflation, disrupt supply chains, adversely affect consumer confidence and disposable income levels and have other impacts on our business.
Federal Reserve Board to address inflation, the Ukraine-Russia and Israel-Hamas conflicts and supply chain disruptions. These factors could lead to further disruption, instability, and volatility in global markets, continue to increase inflation, disrupt supply chains, adversely affect consumer confidence and disposable income levels and have other impacts on our business.
While the agency responsible for administering the Medicare program, the Centers for Medicare and Medicaid Services, has not issued a favorable national coverage determination under its Investigational Device Exception Studies Program for ultrafiltration using the Aquadex System, a number of private insurers have approved reimbursement for the products included in the Aquadex System for specific indications and points of service.
While the agency responsible for administering the Medicare program, the CMS, has not issued a favorable national coverage determination under its Investigational Device Exemption Studies Program for ultrafiltration using the Aquadex System, a number of private insurers have approved reimbursement for the products included in the Aquadex System for specific indications and points of service.
For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
We are a “smaller reporting company” under federal securities laws. For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies, including reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
In addition, the risk that we may not be able to continue as a going concern may make it more difficult to obtain necessary additional funding on terms favorable to us, or at all.
Additional financing may not be available when we need it or may not be available on terms that are favorable to us. In addition, the risk that we may not be able to continue as a going concern may make it more difficult to obtain necessary additional funding on terms favorable to us, or at all.
Additionally, the company did not prepare and retain contemporaneous documentation to evidence the implementation and operation of controls, including controls related to the review of balance sheet reconciliations, the preparation and recording of journal entries, the review of period-end financial reporting checklists and controls over user access.
Additionally, the Company did not prepare and retain contemporaneous documentation to evidence the implementation and operation of controls, including controls related to the review of balance sheet reconciliations, the preparation and recording of journal entries and controls over user access.
These resulted in four (4) issued patents, 1 abandoned application, and five (5) pending patent applications. The first issued patent involves a mechanical design for the therapy bags to allow easy load/unload by the user. The second issued patent involves transport mode operation on battery power, enabling patient mobility.
These resulted in eight (8) issued patents, one abandoned application, and one pending patent applications. The first issued patent involves a mechanical design for the therapy bags to allow easy load/unload by the user. The second issued patent involves transport mode operation on battery power, enabling patient mobility.
When an entity is determined to have violated the federal FCA, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Various states have also enacted laws modeled after the federal FCA.
When an entity is determined to have violated the federal FCA, it may be required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim.
Investors should consider the specific risk factors discussed below, together with the “Cautionary Note Regarding Forward-Looking Statements” and the other information contained in this Annual Report on Form 10-K and the other documents that we will file from time to time with the SEC. Summary of Risk Factors Our business is subject to a number of risks.
Investors should consider the specific risk factors discussed below, together with the “Cautionary Note Regarding Forward-Looking Statements” and the other information contained in this Annual Report on Form 10-K and the other documents that we will file from time to time with the SEC.
The recall was conducted with the knowledge of the U.S. Food and Drug Administration which has characterized the Class of the recall as Class 1. We may face significant risks associated with international operations, which could have a material adverse effect on our business, financial condition and results of operations. We market our products globally.
The recall was conducted with the knowledge of the U.S. FDA which has classifed the recall as Class 1. We may face significant risks associated with international operations, which could have a material adverse effect on our business, financial condition and results of operations. We have historically marketed our products globally.
The company does not have any foreign tax loss carryovers. 40 Table of Contents We believe the Company may have experienced additional ownership changes under Section 382 of the Internal Revenue Code in the current and earlier years further limiting the NOL carryforwards that may be utilized. We have not yet completed a formal Section 382 analysis.
We believe the Company may have experienced additional ownership changes under Section 382 of the Internal Revenue Code in the current and earlier years further limiting the NOL carryforwards that may be utilized. We have not yet completed a formal Section 382 analysis.
Historically, the market price of our common stock has fluctuated over a wide range. There has been relatively limited trading volume in the market for our common stock, and a more active, liquid public trading market may not develop or may not be sustained.
There has been relatively limited trading volume in the market for our common stock, and a more active, liquid public trading market may not develop or may not be sustained.
We have a large number of authorized but unissued shares of stock, which could negatively impact a potential investor if they purchased our common stock. On June 27, 2024, we effected a 1-for-35 reverse split of our outstanding common stock.
We have a large number of authorized but unissued shares of stock, which could negatively impact a potential investor if they purchased our common stock. On July 3, 2025, we effected a 1-for-42 reverse split of our outstanding common stock.
Noncompliance with these laws could subject us to investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, adverse media coverage and other consequences.
Noncompliance with these laws could subject us to investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, adverse media coverage and other consequences. Any investigations, actions or sanctions could adversely affect our business, operating results and financial condition.
Our board of directors has previously approved, pursuant to this authority, the issuance of preferred stock, and we have 127 shares of Series F Convertible Preferred Stock outstanding and 102 shares of Series J Convertible Preferred Stock outstanding as of December 31, 2024.
Our board of directors has previously approved, pursuant to this authority, the issuance of preferred stock, and we have 27 shares of Series F Convertible Preferred Stock outstanding, 34 shares of Series F-1 Convertible Preferred Stock outstanding and 137 shares of Series J Convertible Preferred Stock outstanding as of December 31, 2025.
As of December 31, 2024, there were 127 shares of Series F Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “Series F Convertible Preferred Stock”) outstanding, convertible into 68,961 shares of common stock.
As of December 31, 2025, there were 27 shares of Series F Convertible Redeemable Preferred Stock, par value $0.0001 per share (the “Series F Convertible Preferred Stock”) outstanding, convertible into 10,719 shares of common stock.
If additional capital is not available, we will have to delay, reduce, or cease operations. We believe that we have sufficient capital to fund our operations through May 31, 2025. We will need to raise additional capital to fund our operations through the end of fiscal year 2025.
Risks Related to Our Business We will need to raise additional capital to fund our operations through the end of fiscal year 2026. If additional capital is not available, we will have to delay, reduce, or cease operations. We believe that we have sufficient capital to fund our operations through the end of the second quarter of 2026.
The expiration of state NOL carryforwards will vary by jurisdiction. In addition, future utilization of NOL carryforwards in the U.S. may be subject to certain limitations under Section 382 of the Internal Revenue Code.
The expiration of state NOL carryforwards will vary by jurisdiction. In addition, future utilization of NOL carryforwards in the U.S. may be subject to certain limitations under Section 382 of the Internal Revenue Code. The Company does not have any foreign tax loss carryovers.
Our ten largest customers represented 49.4% and 50.4% of our revenues in the twelve months ended December 31, 2024, and 2023, respectively, with our largest customer representing 14.4% and 13.9%, respectively, of our revenues during such periods. Customer ordering patterns may vary significantly from quarter.
Our ten largest customers represented 49.3% and 49.4% of our revenues in the twelve months ended December 31, 2025, and 2024, respectively, with our largest customer representing 13.7% and 14.4%, respectively, of our revenues during such periods. Customer ordering patterns may vary significantly from quarter. Customers may discontinue providing therapies using our products.
We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation.
We are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse and false claims laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.
We could use the shares that are available for future issuance in dilutive equity financing transactions, or to oppose a hostile takeover attempt or delay or prevent changes in control or changes in or removal of management, including transactions that are favored by a majority of the stockholders or in which the stockholders might otherwise receive a premium for their shares over then-current market prices or benefit in some other manner. 39 Table of Contents A more active, liquid trading market for our common stock may not develop, and the price of our common stock may fluctuate significantly.
We could use the shares that are available for future issuance in dilutive equity financing transactions, or to oppose a hostile takeover attempt or delay or prevent changes in control or changes in or removal of management, including transactions that are favored by a majority of the stockholders or in which the stockholders might otherwise receive a premium for their shares over then-current market prices or benefit in some other manner.
As of December 31, 2024 our Certificate of Incorporation provides for 100,000,000 shares of authorized common stock and 40,000,000 shares of authorized preferred stock, 30,000 of which are designated Series A Junior Participating Preferred Stock, 18,000 of which are designated Series F Convertible Preferred Stock, 600,000 of which are designated Series J Convertible Redeemable Preferred Stock and we have 4,373,968 shares of common stock outstanding, 5,398,003 shares reserved for issuance upon the conversion, exercise or vesting of outstanding preferred stock, warrants and options, 23,762 Series J Convertible Preferred Stock issuable upon the exercise of 1,920 warrants issued in the October 2023 Offering, and 42,175 shares of common stock reserved for future grant under the Company’s equity incentive plans.
As of December 31, 2025 our Certificate of Incorporation provides for 100,000,000 shares of authorized common stock and 40,000,000 shares of authorized preferred stock, 30,000 of which are designated Series A Junior Participating Preferred Stock, 18,000 of which are designated Series F and Series F-1 Convertible Preferred Stock, 600,000 of which are designated Series J Convertible Redeemable Preferred Stock and we have 1,685,817 shares of common stock outstanding, 1,334,937 shares reserved for issuance upon the conversion, exercise or vesting of outstanding preferred stock, warrants and options, 582 Series J Convertible Preferred Stock issuable upon the exercise of 47 warrants issued in the October 2023 Offering, and 35,124 shares of common stock reserved for future grant under the Company’s equity incentive plans.
Our legacy devices, the Aquadex SmartFlow system, including the console and blood circuit, is considered non-implantable, class IIb device. The EU MDR transition period has been extended from May 26, 2024 to December 31, 2028.
In addition, regulations in individual countries or regions may restrict our ability to sell our products. Our legacy device, the Aquadex SmartFlow system, including the console and blood circuit, is considered non-implantable, class IIb device. The EU MDR transition period has been extended from May 26, 2024 to December 31, 2028.
As of December 31, 2024, we have outstanding warrants to purchase an aggregate of approximately 5,303,254 shares of our common stock, and options to purchase an aggregate of approximately 3,873 shares of our common stock, which, if exercised, may further increase the number of shares of our common stock outstanding and the number of shares eligible for resale in the public market.
As of December 31, 2025, we have outstanding warrants to purchase an aggregate of approximately 1,334,937 shares of our common stock, and options to purchase an aggregate of approximately 4,452 shares of our common stock, which, if exercised, may further increase the number of shares of our common stock outstanding and the number of shares eligible for resale in the public market.
As of December 31, 2024, we had U.S. net operating loss (“NOL”) carryforwards of approximately $220.2 million for U.S. federal income tax purposes. Approximately $119.2 million of NOL carryforwards will expire from 2025 through 2038. Pursuant to the Tax Cuts and Jobs Act of 2017, the NOL carryforwards generated in 2019 through 2024 totaling approximately $101.0 million do not expire.
As of December 31, 2025, we had U.S. net operating loss (“NOL”) carryforwards of approximately $240.4 million for U.S. federal income tax purposes. Approximately $118.9 million of NOL carryforwards will expire from 2026 through 2038. Pursuant to the Tax Cuts and Jobs Act of 2017, the NOL carryforwards generated in 2018 through 2025 totaling approximately $121.5 million do not expire.
Manufacturing or design defects, unanticipated use of a product or inadequate disclosure of risks relating to the use of the product can lead to injury or other adverse events.
The design, manufacture and marketing of medical devices involve certain inherent risks. Manufacturing or design defects, unanticipated use of a product or inadequate disclosure of risks relating to the use of the product can lead to injury or other adverse events.
The FDA also imposes requirements through quality system requirements, or QSR, regulations, which include requirements for good manufacturing practices, or GMP. Failure to comply with these requirements could prevent us from obtaining FDA approval of our products and from marketing such products in the United States. Our manufacturing facilities have not been inspected and certified by a Notified Body.
Failure to comply with these requirements could prevent us from obtaining FDA approval of our products and from marketing such products in the United States. Our manufacturing facilities have not been inspected and certified by a Notified Body.
As of December 31, 2024, there were 102 shares of Series J Convertible Preferred Stock (as defined below) outstanding, convertible into 72 shares of common stock and 23,762 Series J Convertible Preferred Stock issuable upon the exercise of 1,920 warrants issued in the October 2023 Offering (as defined below).
As of December 31, 2025, there were 137 shares of Series J Convertible Preferred Stock (as defined below) outstanding, convertible into 81 shares of common stock and 582 Series J Convertible Preferred Stock issuable upon the exercise of 47 warrants issued in the October 2023 Offering (as defined below).
In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, the minimum stockholders’ equity requirement and the minimum bid price requirement.
In order to maintain that listing, we must satisfy minimum financial and other requirements including, without limitation, the minimum stockholders’ equity requirement and the minimum bid price requirement, both of which are requirements where we have been deficient in recent years.
Our board of directors may issue additional series of preferred stock. As a result, the rights of holders of our capital stock will be subject to, and could be adversely affected by, the rights of holders of any stock that may be issued in the future.
The rights of holders of our capital stock will be subject to, and could be adversely affected by, the rights of holders of our outstanding preferred stock and stock that may be issued in the future.
If we are unable to secure additional funding, our development programs and our commercialization efforts would be delayed, reduced or eliminated, our relationships with our suppliers and manufacturers may be harmed, and we may not be able to continue our operations.
If we are unable to secure additional funding, our development programs and our commercialization efforts would be delayed, reduced or eliminated, our relationships with our suppliers and manufacturers may be harmed, and we may not be able to continue our operations. Our near-term prospects are highly dependent on revenues from a single product, the Aquadex System.
To the extent that we may engage in activities regulated by the Health Insurance Portability and Accountability Act and the Health Information Technology for Clinical and Economic Health Act we may have additional regulatory and reporting obligations. We are also subject to the General Data Protection Regulation (EU) 2016/679 due to our business in the EU.
To the extent that we may engage in activities regulated by the Health Insurance Portability and Accountability Act and the Health Information Technology for Clinical and Economic Health Act we may have additional regulatory and reporting obligations.
On December 7, 2023, we received a notice from Nasdaq (the “Notice”) informing us that because the closing bid price for our Common Stock was below $1.00 for 30 consecutive trading days, we were not in compliance with the minimum bid price requirement for continued listing on Nasdaq, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
On June 18, 2025, the Company received a Deficiency Notice from the Listing Qualifications Department of Nasdaq informing the Company that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company was not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
Any investigations, actions or sanctions could adversely affect our business, operating results and financial condition. 32 Table of Contents If we acquire other businesses, products or technologies, we could incur additional impairment charges and will be subject to risks that could hurt our business. We may pursue acquisitions to obtain complementary businesses, products or technologies.
If we acquire other businesses, products or technologies, we could incur additional impairment charges and will be subject to risks that could hurt our business. We may pursue acquisitions to obtain complementary businesses, products or technologies.
In the year ended December 31, 2017, we recognized impairment charges of $4.0 million related to goodwill and intangibles assets from our acquisition of the Aquadex Business. If we were required to recognize impairment charges related to future acquisitions, those charges could decrease our future earnings or increase our future losses.
In the year ended December 31, 2017, we recognized impairment charges of $4.0 million related to goodwill and intangibles assets from our acquisition of the Aquadex Business.
Sales of a substantial number of shares of our common stock by our stockholders in the public market could cause our stock price to fall. The number of shares of common stock issuable upon conversion of our outstanding preferred stock and exercise of outstanding warrants is significant in relation to the number of shares of our common stock currently outstanding.
The number of shares of common stock issuable upon conversion of our outstanding preferred stock and exercise of outstanding warrants is significant in relation to the number of shares of our common stock currently outstanding.
In pediatrics, the Carpe diem system distributed by Medtronic is indicated for use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy, and Baxter’s HF20 Set is authorized under an Emergency Use Authorization to deliver CRRT to treat patients of low weight (8-20 kg) in an acute care environment during the COVID-19 pandemic.
In pediatrics, the Carpediem system distributed by Medtronic is indicated for use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy, and Baxter’s HF20 Set is authorized under an Emergency Use Authorization to deliver CRRT to treat patients of low weight (8-20 kg) in an acute care environment during and since the COVID-19 pandemic. 28 Table of Contents Our ability to compete effectively depends upon our ability to demonstrate the advantages of ultrafiltration as compared to diuretics, a pharmacological treatment that is currently the standard of care.
There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter.
There can be no assurance that we will be able to maintain compliance or, if we fall out of compliance, regain compliance with any deficiency, or if we implement an option that regains our compliance, maintain compliance thereafter. Nasdaq has proposed enhanced listing standards, which could adversely affect our ability to maintain our Nasdaq listing and access to capital markets.
A material weakness is a deficiency or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company's interim or annual condensed consolidated financial statements will not be prevented or detected on a timely basis.
A material weakness is a deficiency or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company's interim or annual condensed consolidated financial statements will not be prevented or detected on a timely basis. 26 Table of Contents Subject to limitations on liquidity that may prevent or delay additional hirings, the Company is taking steps to remediate these material weaknesses as soon as possible.
We have incurred net losses since our inception, including net losses of $11.2 million as of December 31, 2024. As of December 31, 2024, our accumulated deficit was $298.8 million.
We have incurred net losses since our inception, including net losses of $17.5 million as of December 31, 2025. As of December 31, 2025, our accumulated deficit was $316.3 million.
There may be future sales of our securities or other dilution of our equity, which may adversely affect the market price of our common stock. We are generally not restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that represent the right to receive, common stock.
We are generally not restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that represent the right to receive, common stock.
There can be no assurance that we will succeed in these activities, and we may never generate revenues sufficient to achieve profitability. If we do achieve profitability, we may not be able to sustain it. 24 Table of Contents We will need to raise additional capital to fund our operations through the end of fiscal year 2025.
There can be no assurance that we will succeed in these activities, and we may never generate revenues sufficient to achieve profitability. If we do achieve profitability, we may not be able to sustain it.
We are unable to predict whether we could be subject to actions under any of these laws, or the impact of such actions.
Various states have also enacted laws modeled after the federal FCA. 33 Table of Contents We are unable to predict whether we could be subject to actions under any of these laws, or the impact of such actions.
The price of our common stock could fluctuate based upon factors that have little or nothing to do with us and these fluctuations could materially reduce our stock price. Our ability to use U.S. net operating loss carryforwards might be limited.
The changes often appear to occur without regard to specific operating performance. The price of our common stock could fluctuate based upon factors that have little or nothing to do with us and these fluctuations could materially reduce our stock price.
The approved temporary Therapeutic Ultrafiltration Category III CPT code will be in effect for at least five years and provides additional reimbursement for ultrafiltration administered in the outpatient setting. Product defects, resulting in lawsuits for product liability, could harm our business, results of operations and financial condition. The design, manufacture and marketing of medical devices involve certain inherent risks.
The approved temporary Therapeutic Ultrafiltration Category III CPT code will be in effect for at least five years and provides additional reimbursement for ultrafiltration administered in the outpatient setting. 29 Table of Contents We have experienced and may continue to experience product defects or issues with quality management, which may result in lawsuits for product liability, and could harm our business, results of operations and financial condition.
If applicable in the future, these rules may restrict the ability of brokers-dealers to sell our Common Stock and may affect the ability of investors to sell their shares, until our Common Stock no longer is considered a penny stock. 37 Table of Contents We continue to actively monitor our performance with respect to the listing standards and will consider available options to resolve any deficiency and maintain compliance with the Nasdaq rules.
If applicable in the future, these rules may restrict the ability of brokers-dealers to sell our Common Stock and may affect the ability of investors to sell their shares, until our Common Stock no longer is considered a penny stock.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

7 edited+1 added−1 removed5 unchanged
Biggest changeNuwellis leverages 3rd party IT service provider and specifically their cybersecurity team’s expertise. All employees are required to complete cybersecurity training as part of on-boarding process and on-going training both online and in-person. IT department assigns position specific security level encryption to manage information security.
Biggest changeOur Director of Operations is responsible for developing and implementing our information security program and reporting on cybersecurity matters to the board of directors. Nuwellis leverages third-party IT service provider and specifically their cybersecurity expertise. All employees are required to complete cybersecurity training as part of the onboarding process and ongoing training both online and in-person.
These risks include, among other things: operational risks, intellectual property theft, fraud, extortion, harm to employees or customers and violation of data privacy or security laws. We have a cross-departmental approach to addressing cybersecurity risk, including input from employees from our information technology department, and our board of directors.
These risks include, among other things: operational risks, intellectual property theft, fraud, extortion, harm to employees or customers and violation of data privacy or security laws. We have a cross-departmental approach to addressing cybersecurity risk, including input from our board of directors.
Although such risks have not materially affected us, including our business strategy, results of operations or financial condition, to date, we have, from time to time, experienced threats to and breaches of our data and systems, including malware and computer virus attacks. Such occurrences could negatively impact our business strategy, reputation and results of operation.
Although such risks have not materially affected us, including our business strategy, results of operations or financial condition, to date, we have, from time to time, experienced threats to and breaches of our data and systems, including malware and computer virus attacks. Such occurrences could negatively impact our business strategy, reputation and results of operations. 49 Table of Contents
The Audit Committee and the full board of directors periodically participate in discussions with management and amongst themselves regarding cybersecurity risks.
The Audit Committee and the full board of directors periodically participate in discussions with management and among themselves regarding cybersecurity risks.
We have continued to expand investments in IT security, including software programs and policies mentioned above. We regularly test defenses by performing simulations and drills at both a technical level (including through penetration tests) and by reviewing our operational policies and procedures with third-party experts.
The IT department assigns position specific security level encryption to manage information security. We have continued to expand investments in IT security, including the software programs and policies mentioned above. We regularly test defenses by performing simulations and drills at both a technical level (including through penetration tests) and by reviewing our operational policies and procedures with third-party experts.
In addition, we have a set of Company-wide policies and procedures concerning cybersecurity matters, which include an employee handbook as well as other policies that directly or indirectly relate to cybersecurity, such as policies related to incident response, confidential information and the use of internet, social media, email and wireless. 42 Table of Contents Our Director of Operations is responsible for developing and implementing our information security program and reporting on cybersecurity matters to the board of directors.
In addition, we have a set of Company-wide policies and procedures concerning cybersecurity matters, which include an employee handbook as well as other policies that directly or indirectly relate to cybersecurity, such as policies related to incident response, confidential information and the use of internet, social media, email and wireless devices.
The board of directors, Audit Committee, and senior and management devote significant resources to cybersecurity and risk management processes to adapt to the changing cybersecurity landscape and respond to emerging threats in a timely and effective manner. Our cybersecurity risk management protocols are comprised of software programs including antivirus protection, end-point threat detection, remote access, multifactor authentication.
The board of directors, Audit Committee, and senior management devote what we believe are appropriate resources to cybersecurity and risk management processes to adapt to the changing cybersecurity landscape and respond to emerging threats in a timely and effective manner.
Removed
For more information about the cybersecurity risks we face, see our risk factors in Item 1A- Risk Factors in this Annual Report on Form 10-K.
Added
Our cybersecurity risk management protocols are comprised of software programs including antivirus protection, end-point threat detection, remote access controls, and multifactor authentication.

Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−0 removed1 unchanged
Biggest changeWe believe that our current facilities are suitable and adequate to meet our current needs, and that suitable additional or substitute space will be available as needed to accommodate expansion of our operations. 43 Table of Contents
Biggest changeWe believe that our current facilities are suitable and adequate to meet our current needs, and that suitable additional or substitute space will be available as needed to accommodate expansion of our operations.
This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including an estimate for property taxes for our headquarters, total approximately $34,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease.
This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including an estimate for property taxes for our headquarters, total approximately $36,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+5 added−3 removed3 unchanged
Biggest changeCommencing February 16, 2012, our shares of common stock began trading on the Nasdaq Capital Market, where it now trades under the symbol “NUWE.” See “Risk Factors—Risks Related to Our Common Stock—Nasdaq may delist our common stock from its exchange which could limit your ability to make transactions in our securities and subject us to additional trading restrictions” under Part I, Item 1A of this Annual Report on Form 10-K.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information. Commencing February 16, 2012, our shares of common stock began trading on the Nasdaq Capital Market, where it now trades under the symbol “NUWE.” Prior to that, there was no public trading market for our common stock. Stockholders of Record.
Stockholders of Record. As of March 7, 2025, we had 4,373,968 shares of common stock issued and outstanding, and 1 holder of record of our common stock. A substantially greater number of stockholders may be “street name” or beneficial holders, whose shares are held of record by banks, brokers and other financial institutions. Dividends.
As of March 6, 2026, we had 2,310,477 shares of common stock issued and outstanding, and one holder of record of our common stock. A substantially greater number of stockholders may be “street name” or beneficial holders, whose shares are held of record by banks, brokers and other financial institutions. Dividends.
Removed
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Market Information.
Added
On June 6, 2025, the Company filed the Certificate of Designation of Preferences, Rights and Limitations of Series F-1 Convertible Preferred Stock (the “F-1 Certificate of Designation”) with the Secretary of State of the State of Delaware, authorizing the issuance of 100 shares of Series F-1 Convertible Preferred Stock (the “Series F-1 Preferred Stock”).
Removed
Except as previously disclosed on our (i) Current Report on Form 8-K dated July 25, 2024, respecting the issuance of warrants to certain purchasers to purchase up to an aggregate of 938,680 shares of common stock of the Company at an exercise price of $3.99 per share, (ii) Current Report on Form 8-K dated August 26, 2024, respecting the issuance of warrants to certain purchasers to purchase up to an aggregate of 483,351 shares of common stock of the Company at an exercise price of $1.72 per share and warrants to Ladenburg Thalmann & Co.
Added
The terms of the Series F-1 Preferred Stock are substantially similar to the terms of the Company’s existing Series F Convertible Preferred Stock (the “Existing Series F Stock”), that were issued pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock that was filed with the Secretary of State of the State of Delaware on November 22, 2017, except that the F-1 Certificate of Designation provides that the Company shall not affect any conversion of the shares of Series F-1 Preferred Stock to the extent that, after giving effect to an attempted conversion, the holder of shares of Series F-1 Preferred Stock (together with such holder’s affiliates and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 19.99% of the shares of common stock then outstanding.
Removed
(“Ladenburg”) to purchase an aggregate of 14,501 shares of common stock of the Company, and (iii) Current Report on Form 8-K dated November 7, 2024, respecting the issuance of warrants to certain investors to purchase up to an aggregate of 3,665,034 shares of common stock of the Company at an exercise price of $1.94 share and warrants to Ladenburg to purchase an aggregate of 54,976 shares of common stock of the Company at an exercise price of 3.465 per share, there have been no sales of unregistered securities during the year ended December 31, 2024.
Added
On June 9, 2025, pursuant to Section 3(a)(9) of the Securities Act of 1933, as amended, the Company entered into a Securities Exchange Agreement (the “Exchange Agreement”) with John L.
Added
Erb, the Company’s Chief Executive Officer and member of the board of directors, pursuant to which the Company agreed to issue 100 shares of the Company’s newly designated Series F-1 Stock in exchange for 100 shares of the Company’s outstanding Existing Series F Stock (the “Exchange”). Following the Exchange, Mr. Erb will own 100% of the Series F-1 Stock.
Added
There were no other unregistered sales of equity securities during the year ended December 31, 2025 that were not reported on a Current Report on Form 8-K. 50 Table of Contents Item 6. [Reserved].

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

55 edited+73 added−36 removed36 unchanged
Biggest changeAdditionally, in 2020, the SEC approved a Nasdaq rule change to expedite delisting of securities of companies that have had one or more reverse stock splits with a cumulative ratio of one for 250 or more shares over the prior two-year period.
Biggest changeThe Deficiency Notice also indicated that the Company was not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A) because the Company effected a reverse stock split over the prior one-year period or has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one; accordingly, the Company was informed that its securities were subject to delisting from Nasdaq unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the “Panel”).
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. The following discussion and analysis of our financial condition and results of operations should be read together with our audited consolidated financial statements and related notes which are included elsewhere in this Annual Report on Form 10-K.
Item 7. Management’s Discussion and Analysis of Financial Conditions and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read together with our audited consolidated financial statements and related notes which are included elsewhere in this Annual Report on Form 10-K.
All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and a half shares of common stock.
All pre-funded warrants were exercised on the date of the offering. Each share of common stock (or prefunded warrant in lieu thereof) was sold together with one warrant to purchase one and one half shares of common stock.
To date, we have been funded by debt and equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate profitably.
To date, we have been funded by equity financings, and although we believe that we will be able to successfully fund our operations, there can be no assurance that we will be able to do so or that we will ever operate profitably.
The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30, 2024, the number of shares underlying the common warrants were adjusted to 2,498,331 shares and the exercise price was adjusted to $2.49 per share.
The Company secured the Warrant Stockholder Approval on June 6, 2024. Subsequent to June 30, 2024, the number of shares underlying the common warrants was adjusted to 2,498,331 shares and the exercise price was adjusted to $2.49 per share.
Because the number of authorized shares of our common stock was not reduced proportionately, the reverse stock split increased our board of directors’ ability to issue authorized and unissued shares without further stockholder action.
Because the number of authorized shares of our common stock was not reduced proportionately, the reverse stock split increased our board of directors’ ability to issue previously authorized and unissued shares without further stockholder action.
Going Concern Our consolidated financial statements have been prepared and presented on a basis assuming we continue as a going concern. During the years ended December 31, 2024 and 2023, we incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively.
Going Concern Our consolidated financial statements have been prepared and presented on a basis assuming we continue as a going concern. During the years ended December 31, 2025, and 2024, we incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively.
The warrants issued in this offering were concluded to be equity classified. Roth Capital Partners, LLC acted as the placement agent in the July 2024 Offering. The gross proceeds to the Company from the registered direct offering and the concurrent private placement were approximately $2.0 million.
The warrants issued in this offering were determined to be equity classified. Roth Capital Partners, LLC acted as the placement agent in the July 2024 Offering. The gross proceeds to the Company from the registered direct offering and the concurrent private placement were approximately $2.0 million.
Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable.
Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. 55 Table of Contents Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable.
See Note 2 to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K. 46 Table of Contents Accounting for Warrants We have issued and may continue to issue warrants to purchase shares of common and convertible preferred stock through our public and private offerings.
See Note 2 to the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K. Accounting for Warrants We have issued and may continue to issue warrants to purchase shares of common and convertible preferred stock through our public and private offerings.
If determined to be classified as a liability, we will initially measure the fair value of the warrants upon issuance and subsequently remeasure the fair value of the warrants at each balance sheet date.
If determined to be classified as a liability, we will initially measure the fair value of the warrants upon issuance and subsequently remeasure the fair value of the warrants at each exercise/transaction date and balance sheet date.
The cash provided by financing activities in the current year period was the result of proceeds received from the April 2024, July 2024, and August 2024 financings and from the exercise of warrants from the October 2023, April 2024, and August 2024 financings.
The cash provided by financing activities in the prior year period was the result of proceeds received from the April 2024, July 2024, and August 2024 financings and from the exercise of warrants from the October 2023 and April 2024 financings.
These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 47 Table of Contents We became a revenue generating company after acquiring the Aquadex Business in August 2016.
These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. We became a revenue-generating company after acquiring the Aquadex Business in August 2016.
The Series II Warrants have an exercise price of $1.94, are exercisable six (6) months from the date of issuance, and have a term of two (2) years from the date of exercisability. The Series I Warrants and Series II Warrants are fixed priced and do not contain any variable pricing features.
The Series II Warrants have an exercise price of $81.48, are exercisable six (6) months from the date of issuance, and have a term of two (2) years from the date of exercisability. The Series I Warrants and Series II Warrants are fixed priced and do not contain any variable pricing features.
We sell primarily in the United States to hospitals and clinics through our direct salesforce. We sell outside the United States to independent specialty distributors who in turn sell to hospitals and clinics in their geographic regions.
We sell primarily in the United States to hospitals and clinics through our direct salesforce. We also sold outside of the United States to independent specialty distributors, who in turn sold to hospitals and clinics in their geographic regions.
In a concurrent private placement the Company also agreed to sell and issue to the Purchasers, warrants to purchase up to 483,351 shares of the Company’s common stock The common warrants have an exercise price of $1.72 per share, were immediately exercisable and expire on the fifth anniversary on the effective date of the registration statement to be filed for the purpose of registering the shares of the Company’s common stock underlying the common warrants.
In a concurrent private placement the Company also agreed to sell and issue to the Purchasers, warrants to purchase up to 11,508 shares of the Company’s common stock The common warrants have an exercise price of $72.24 per share, were immediately exercisable and expire on the fifth anniversary on the effective date of the registration statement to be filed for the purpose of registering the shares of the Company’s common stock underlying the common warrants.
The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 54,976 shares of the Company’s Common Stock as part of the compensation payable to the Placement Agent in connection with the warrant inducement.
The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 1,312 shares of the Company’s Common Stock as part of the compensation payable to the Placement Agent in connection with the warrant inducement.
During 2021 and through December 31, 2024, we closed on underwritten public and other equity offerings for aggregate net proceeds of approximately $49.9 million after deducting the underwriting discounts and commissions or placement agents’ fees and offering expenses, as applicable, and other costs associated with the offerings.
During 2021 and through December 31, 2025, we closed on underwritten public and other equity offerings for aggregate net proceeds of approximately $57.0 million after deducting the underwriting discounts and commissions or placement agents’ fees and offering expenses, as applicable, and other costs associated with the offerings.
Since then, our activities have consisted mainly of expanding our sales and marketing efforts, as well as continued development of clinical evidence and new product development efforts. As of December 31, 2024, we had an accumulated deficit of $298.8 million, and we expect to incur losses for the foreseeable future.
Since then, our activities have consisted mainly of expanding our sales and marketing efforts, as well as continued development of clinical evidence and new product development efforts. As of December 31, 2025, we had an accumulated deficit of $316.3 million, and we expect to incur losses for the foreseeable future.
The Series I Warrants have an exercise price of $1.94, are exercisable six (6) months from the date of issuance, and have a term of five (5) years from the date of exercisability.
The Series I Warrants have an exercise price of $81.48, are exercisable six (6) months from the date of issuance and have a term of five (5) years from the date of exercisability.
In consideration for the immediate exercise of the April 2024 Offering warrants, the Company issued Series I common stock purchase warrants (the “Series I Warrants”) and Series II common stock purchase warrants (the “Series II Warrants”) to purchase up to an aggregate of 3,665,034 shares of common stock.
In consideration for the immediate exercise of the April 2024 Offering warrants, the Company issued Series I common stock purchase warrants (the “Series I Warrants”) and Series II common stock purchase warrants (the “Series II Warrants”) to purchase up to an aggregate of 87,274 shares of common stock.
(the “Placement Agent”) and a securities purchase agreement with certain purchasers pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of 483,351 shares of the Company’s common stock, $0.0001 par value per share, at a purchase price of $1.8450 per Share and accompanying common warrant (the “August 2024 Offering”).
(the “Placement Agent”) and a securities purchase agreement with certain purchasers pursuant to which the Company agreed to sell, in a registered direct offering, an aggregate of 11,508 shares of the Company’s common stock, $0.0001 par value per share, at a purchase price of $77.49 per Share and accompanying common warrant (the “August 2024 Offering”).
We generate minimal amounts of income tax expense in connection with activities incurred by our Irish subsidiary. Liquidity and Capital Resources Sources of Liquidity We have funded our operations primarily through cash on hand and a series of equity and debt issuances. On June 26, 2024, we effected a 1-for-35 reverse split of our outstanding common stock.
We generate minimal amounts of income tax expense in connection with activities incurred by our Irish subsidiary. Liquidity and Capital Resources Sources of Liquidity We have funded our operations primarily through cash on hand and a series of equity issuances. On July 3, 2025, we effected a 1-for-42 reverse split of our outstanding common stock.
No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. We believe that our existing capital resources will be sufficient to support our operating plan through May 31, 2025; however, there can be no assurance of this.
No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. 56 Table of Contents We believe that our existing capital resources will be sufficient to support our operating plan through the end of the second quarter of fiscal 2026; however, there can be no assurance of this.
The warrants are fair valued on the date of exercise and the adjustment to fair value is recorded to Additional Paid in Capital. There were 2,737,816 warrants converted to equity resulting in $5.6 million of net proceeds to Additional Paid in Capital.
During the year, there were 2,737,816 warrants exercised at a weighted average exercise price of $2.23. The warrants are fair valued on the date of exercise and the adjustment to fair value is recorded to Additional Paid in Capital. There were 2,737,816 warrants converted to equity resulting in $5.6 million of net proceeds to Additional Paid in Capital.
As of March 7, 2025 our Certification of Incorporation provides for 100,000,000 shares of authorized common stock and 40,000,000 shares of authorized preferred stock, 30,000 of which are designated Series A Junior Participating Preferred Stock, 18,000 of which are designated Series F Convertible Preferred Stock, and 600,000 of which are designated Series J Convertible Preferred Stock, and we have 4,373,968 shares of common stock outstanding, 5,398,003 shares reserved for issuance upon the conversion, exercise or vesting of outstanding preferred stock, warrants and options, and 42,175 shares of common stock reserved for future grant under the Company’s equity incentive plans.
As of December 31, 2025 our Certification of Incorporation provides for 100,000,000 shares of authorized common stock and 40,000,000 shares of authorized preferred stock, 30,000 of which are designated Series A Junior Participating Preferred Stock, 18,000 of which are designated Series F Convertible Preferred Stock, 100 of which are designated Series F-1 Convertible Preferred Stock, and 600,000 of which are designated Series J Convertible Preferred Stock, and we have 1,686,217 shares of common stock outstanding, 1,364,221 shares reserved for issuance upon the conversion, exercise or vesting of outstanding preferred stock, warrants and options, and 42,175 shares of common stock reserved for future grant under the Company’s equity incentive plans.
The Aquadex SmartFlow system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20kg or more whose fluid overload is unresponsive to medical management, including diuretics.
The Aquadex SmartFlow system is indicated for temporary (up to eight hours) or extended (longer than eight hours in patients who require hospitalization) use in adult and pediatric patients weighing 20kg or more whose fluid overload is unresponsive to medical management, including diuretics. Recent Developments Nasdaq Compliance On June 18, 2025, Nuwellis, Inc.
As of December 31, 2024, we had an accumulated deficit of $298.8 million and we expect to incur losses for the foreseeable future.
As of December 31, 2025, we had an accumulated deficit of $316.3 million and we expect to incur losses for the foreseeable future.
The warrants issued in this offering were concluded to be equity classified. 52 Table of Contents The gross proceeds from the August 2024 Offering, before deducting the Placement Agent’s fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the common warrants or August Placement Agent Warrants (as defined below), was approximately $631,000.
The gross proceeds from the August 2024 Offering, before deducting the Placement Agent’s fees and expenses and other offering expenses payable by the Company and excluding the net proceeds, if any, from the exercise of the common warrants or August Placement Agent Warrants (as defined below), were approximately $631,000. The August 2024 Offering closed on August 26, 2024.
For non-accelerated filers and smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027, subject to legal challenges and the SEC's voluntary stay of the disclosure requirements.
For non-accelerated filers and smaller reporting companies, disclosure requirements will begin phasing in for fiscal years beginning on or after January 1, 2027, subject to legal challenges and the SEC's voluntary stay of the disclosure requirements. The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures.
The August 2024 Offering closed on August 26, 2024. The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 14,501 shares of the Company’s common stock as part of the compensation payable to the Placement Agent in connection with this offering (the “August Placement Agent Warrants”).
The Company also issued to the Placement Agent, or its designees, warrants to purchase up to 348 shares of the Company’s common stock as part of the compensation payable to the Placement Agent in connection with this offering (the “August Placement Agent Warrants”). The August Placement Agent Warrants were not registered pursuant to the prospectus supplement and the accompanying prospectus.
The warrants offered in this financing were originally classified as a liability on the balance sheet. An independent valuation of the warrants was performed and reviewed with management, and the valuation at issuance was $7.8 million.
The Series A and B warrants offered in this financing were determined to be classified as a liability on the condensed consolidated balance sheet. An independent valuation of the warrants was performed and reviewed with management.
On November 5, 2024, the Company announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company in the April 2024 Offering to purchase up to an aggregate of 1,832,517 shares of the Company’s common stock at their current exercise price of $2.10 per share for total gross proceeds of approximately $3.8 million, prior to deducting inducement agent fees and estimated offering expenses.
The August Placement Agent Warrants have substantially the same terms as the common warrants described above, except that the August Placement Agent Warrants have an exercise price of $127.86 per share and will expire August 23, 2029. 60 Table of Contents On November 5, 2024, the Company announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants issued by the Company in the April 2024 Offering to purchase up to an aggregate of 43,637 shares of the Company’s common stock at their current exercise price of $88.20 per share for total gross proceeds of approximately $3.8 million, prior to deducting inducement agent fees and estimated offering expenses.
Nasdaq Notice On December 7, 2023, we received a notice from Nasdaq (the “Notice”) informing us that because the closing bid price for our Common Stock was below $1.00 for 30 consecutive trading days, we were not in compliance with the minimum bid price requirement for continued listing on Nasdaq, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
(the “Company”) received a letter (the “Deficiency Notice”) from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) informing the Company that because the closing bid price for the Company’s Common Stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company was not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
The Company has contracted with an independent fixed asset appraiser to determine the fair value of the asset groups using a combination of the indirect cost method and income method to value the long-lived assets. There have been no impairment losses recognized for the years ended December 31, 2024 and December 31, 2023.
The Company had contracted with an independent fixed asset appraiser in 2024 to determine the fair value of the asset groups using a combination of the indirect cost method and income method to value the long-lived assets.
Cash Flows from Investing Activities Net cash used in investing activities was $60,000 in 2024. Net cash provided by investing activities was $0.3 million in 2023. The cash used in investing activities in 2024 was for the purchase of property and equipment. The cash provided by investing activities in 2023 represented the proceeds from the sale of marketable securities.
Cash Flows from Investing Activities Net cash used in investing activities was $90,000 and $60,000 in 2025 and 2024, respectively. The cash used in investing activities in 2025 and 2024 was for the purchase of property and equipment. Cash Flows from Financing Activities Net cash provided by financing activities was $6.9 million and $11.0 million in 2025 and 2024, respectively.
Income Tax Expense (in thousands) Year Ended December 31, 2024 Year Ended December 31, 2023 Increase (Decrease) % Change Income tax expense $ 5 $ 8 $ (3 ) (37.5 )% We have not recognized any income tax benefit in our statement of operations related to our U.S. operating losses, as all tax benefits are fully reserved.
Research and Development The decrease in R&D expenses versus the prior year was primarily driven by reduced R&D project spend. 58 Table of Contents Income Tax Expense (in thousands) Year Ended December 31, 2025 Year Ended December 31, 2024 Increase (Decrease) % Change Income tax expense $ 5 $ 5 $ — — % We have not recognized any income tax benefit in our statement of operations related to our U.S. operating losses, as all tax benefits are fully reserved.
Costs and Expenses Our costs and expenses were as follows: (in thousands) Year Ended December 31, 2024 Year Ended December 31, 2023 Increase (Decrease) % Change Cost of goods sold $ 3,064 $ 3,881 $ (817 ) (21.1 )% Selling, general and administrative $ 13,455 $ 17,191 $ (3,736 ) (21.7 )% Research and development $ 3,209 $ 5,422 $ (2,213 ) (40.8 )% Cost of Goods Sold The decrease in costs of goods sold, for the year ended December 31, 2024, compared to the year ended December 31, 2023, was primarily due to higher manufacturing volumes of circuits in the current year and lower fixed overhead manufacturing expenses.
Costs and Expenses Our costs and expenses were as follows: (in thousands) Year Ended December 31, 2025 Year Ended December 31, 2024 Increase (Decrease) % Change Cost of goods sold $ 3,146 $ 3,064 $ 82 2.7 % Selling, general and administrative $ 13,518 $ 13,455 $ 63 0.5 % Research and development $ 2,712 $ 3,209 $ (497 ) (15.5 )% Cost of Goods Sold The increase in costs of goods sold for the year ended December 31, 2025, compared to the year ended December 31, 2024, was primarily due to unfavorable manufacturing variances and under-absorption of fixed overhead because of lower production volumes in the first half of fiscal year 2025.
Capital Resource Requirements As of December 31, 2024, we did not have any material commitments for capital expenditures.
Capital Resource Requirements As of December 31, 2025, we did not have any material commitments for capital expenditures. Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not Applicable
The Company is currently evaluating the impact these rules will have on its consolidated financial statements and related disclosures. 48 Table of Contents Information regarding new accounting pronouncements, when applicable, is included in Note 1 to the consolidated financial statements included in this Annual Report on Form 10-K.
Information regarding new accounting pronouncements, when applicable, is included in Note 1 to the consolidated financial statements included in this Annual Report on Form 10-K. The Company has considered all recent accounting pronouncements issued and their potential effects on its consolidated financial statements.
As the price floor was hit, there was no further down-round protection. The warrants were re-evaluated and classified as equity as of September 30, 2024. During the year, there were 2,737,816 warrants exercised at a weighted average exercise price of $2.23.
At the August 2024 offering, the exercise price of these warrants was adjusted to $2.10, which represented the floor price on these warrants. As the price floor was hit, there was no further down-round protection. The warrants were re-evaluated and reclassified as equity as of September 30, 2024.
The warrants had down-round protection and the price was reset from the June 2024 reverse stock split, which was effective July 8, 2024, and from the July 2024 and the August 2024 offerings. At the August 2024 offering, the exercise price of these warrants was adjusted to $2.10, which represented the floor price on these warrants.
An independent valuation of the warrants was performed and reviewed with management, and the valuation at issuance was $7.8 million. The warrants had down-round protection and the price was reset from the June 2024 reverse stock split, which was effective July 8, 2024, and from the July 2024 and the August 2024 offerings.
We will need to seek additional financing in the future, which, to date, has been through offerings of our equity. We believe that we have sufficient capital to fund our operations through May 31, 2025. Cash Flows from Operating Activities Net cash used in operating activities was $9.6 million and $17.9 million in 2024 and 2023, respectively.
We believe that we have sufficient capital to fund our operations through the end of the second quarter of 2026. 62 Table of Contents Cash Flows from Operating Activities Net cash used in operating activities was $10.8 million and $9.6 million in 2025 and 2024, respectively.
Loss per Share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. For the year ended December 31, 2024, a net gain of $541,000 was included as a deemed dividend from the Series J Convertible Preferred Stock.
Loss per Share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding.
Results of Operations Net Sales (in thousands) Year Ended December 31, 2024 Year Ended December 31, 2023 Increase (Decrease) % Change $ 8,740 $ 8,864 $ (124 ) (1.4 )% Revenue is generated mainly from the sale of disposable blood filters and catheters used in conjunction with the Aquadex System consoles.
Although we believe that we will be able to successfully fund our operations in the future, there can be no assurance that we will be able to do so or that we will ever operate profitably. 57 Table of Contents Results of Operations Net Sales (in thousands) Year Ended December 31, 2025 Year Ended December 31, 2024 Increase (Decrease) % Change $ 8,270 $ 8,740 $ (470 ) (5.4 )% Revenue is generated mainly from the sale of consoles and disposable blood filters and catheters used in conjunction with the Aquadex System.
In no event would the exercise price of the common warrants with respect to either adjustment be reduced below a floor price of $2.10. 51 Table of Contents The gross proceeds to the Company from the April 2024 Offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million.
The gross proceeds to the Company from the April 2024 Offering, before deducting the placement agent fees and other offering expenses were approximately $2.7 million. 59 Table of Contents The warrants offered in this financing were originally classified as a liability on the balance sheet.
In November 2021, the Company entered into a fourth amendment to the lease, extending the term of the lease from March 31, 2022, to March 31, 2027. This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters total approximately $34,000.
This facility serves as our corporate headquarters and houses substantially all our functional areas. Monthly rent and common area maintenance charges, including estimated property tax for our headquarters, total approximately $37,000. The lease contains provisions for annual inflationary adjustments. Rent expense is being recorded on a straight-line basis over the term of the lease.
As of December 31, 2024 and 2023, cash, cash equivalents, and marketable securities were $5.1 million and $3.8 million, respectively. Our business strategy and ability to fund our operations in the future depends in part on our ability to grow the Aquadex Business by expanding our salesforce, selling our products to hospitals and other healthcare facilities, and controlling costs.
Our business strategy and ability to fund our operations in the future depend in part on our ability to grow the Aquadex Business by expanding our salesforce, selling our products to hospitals and other healthcare facilities, and controlling costs. We will need to seek additional financing in the future, which, to date, has been through offerings of our equity.
In December 2024, the Company had a voluntary recall of specific lots of blood circuit units from identified accounts.
In December 2024, the Company had a voluntary recall of specific lots of blood circuit units from identified accounts, and accordingly, the prior year period included a non-recurring expense of approximately $150,000. Selling, General and Administrative Selling, general and administrative expenses increased slightly for the current fiscal year.
Overview We are a commercial-stage medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovative technology. The company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex System.
Overview Nuwellis is dedicated to advancing cardiorenal care by enabling earlier, safer, and more controlled fluid management for patients. The Company is focused on developing, manufacturing, and commercializing medical devices used in ultrafiltration therapy, including the Aquadex System.
The August Placement Agent Warrants were not registered pursuant to the prospectus supplement and the accompanying prospectus. The August Placement Agent Warrants have substantially the same terms as the common warrants described above, except that the August Placement Agent Warrants have an exercise price of $3.04425 per share and will expire August 23, 2029.
The Placement Agent Warrants have substantially the same terms as the January Inducement Warrants described above, except that the Placement Agent Warrants have an exercise price of $5.0985 per share. As of December 31, 2025, and December 31, 2024, cash, cash equivalents, and marketable securities were $1.2 million and $5.1 million, respectively.
Net proceeds were approximately $1.5 million after deducting placement agent fees and commissions and offering expenses payable by the Company. The Company used the net proceeds from the October 2023 Offering for working capital and for general corporate purposes.
The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The guidance requires expanded annual disclosures including the standardization and disaggregation of income tax rate reconciliation categories and the amount of income taxes paid by jurisdiction. The guidance is effective for the Company’s fiscal 2025 Form 10-K.
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures .
Sales during the twelve months ended December 31, 2024 are 1.4% below sales from the prior year, which is attributable to a decrease in console sales and International sales partially offset by a 7% increase in circuit sales and a one-time increase in SeaStar Medical Quelimmune sales.
The decrease in sales in the current year period is primarily due to a 2% decrease in circuit sales, lower console average selling price, lower tech services and international, and one-time prior-year SeaStar Medical Quelimmune sales.
Research and Development The decrease in R&D expense versus the prior year was primarily driven by reduced consulting fees and compensation-related expenses.
This was primarily driven by the addition in headcount and compensation-related expenses and slightly higher professional service fees during fiscal year 2025.
Removed
Recent Developments Executive Transition On February 23, 2025, Nestor Jaramillo, Jr., the President and Chief Executive Officer of the Company, retired from the Company and John Erb was appointed as the Company’s interim President and Chief Executive Officer. In connection with the appointment of John Erb as interim President and Chief Executive Officer of the Company, the Company and Mr.
Added
As previously disclosed, the Company effected the 2024 Reverse Stock Split on June 27, 2024. The Company timely requested a hearing before the Panel, which was scheduled for August 12, 2025.
Removed
Erb entered into an employment letter agreement concerning Mr. Erb’s services which provides that Mr. Erb will receive an annual salary of $300,000.
Added
At its annual meeting held on May 20, 2025, the Company’s stockholders approved a proposal allowing the board of directors of the Company to effect a reverse split in the range of 1-for-5 to 1-for-70. The Company’s board of directors authorized the 2025 Reverse Stock Split to regain compliance with the Minimum Bid Price Requirement.
Removed
In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), we were granted a period of 180 calendar days from December 7, 2023, or until June 4, 2024, to regain compliance with the Minimum Bid Price Requirement.
Added
On July 22, 2025, the Company received formal notice from Nasdaq stating that it had resolved the previously disclosed bid price deficiency.
Removed
Subsequently, on May 23, 2024, we received a letter from the Listing Qualifications Staff (the “Staff”) informing the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq, under Listing Rule 5550(b)(1) (the “Stockholder’s Equity Requirement”), because the Company’s stockholders’ equity of $885,000, as reported in the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2024, was below the required minimum of $2.5 million, and because, as of May 23, 2024, the Company did not meet the alternative compliance standards, relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.
Added
As a result, the hearing previously scheduled with the Nasdaq Hearings Panel for August 12, 2025, was cancelled, and shares of the Company’s Common Stock continue to be listed and traded on the Nasdaq Capital Market under the ticker “NUWE.” 51 Table of Contents Public Offerin gs On June 10, 2025, the Company announced the closing of its public offering of 61,444 shares of its Common Stock, pre-funded warrants to purchase 335,381 shares of Common Stock (all pre-funded warrants were exercised on this date), in each case with accompanying Series A Warrants to purchase up to 1,190,480 shares of Common Stock, Series B Warrants to purchase up to 396,829 shares of Common Stock and Placement Warrants to purchase up to 11,903 shares of Common Stock with gross proceeds of approximately $5.0 million, which included the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants.
Removed
As a result, on June 5, 2024, we received a letter from Nasdaq indicating the Company’s continued non-compliance with Nasdaq Marketplace Rule 5550(a)(2) (the “Letter”). The Letter further informed the Company that the Common Stock would be delisted from Nasdaq unless the Company appeals the Staff's delisting determination by requesting a hearing before the Nasdaq Hearings Panel (the “Panel”).
Added
The public offering price per share of Common Stock and accompanying warrants is $12.60 per share and accompanying warrants, and the public offering price per pre-funded warrant and accompanying warrants is $12.5958 per pre-funded warrant and accompanying warrants. Each pre-funded warrant has an exercise price of $0.0042 per pre-funded warrant and was immediately exercisable.
Removed
The Company's requested a hearing to request additional time to meet the Stockholder Equity Requirement which stayed any further delisting action by the Staff pending the ultimate outcome of the hearing.
Added
The Series B Warrants have an exercise price of $12.60 and will be exercisable for a period of five years following the receipt of stockholder approval which was obtained on August 4, 2025, as required by the applicable rules and regulations of Nasdaq.
Removed
The Common Stock will remain listed and eligible for trading on Nasdaq at least pending the ultimate conclusion of the hearing process. 45 Table of Contents On June 27, 2024, we effected a 1-for-35 reverse stock split of our outstanding Common Stock.
Added
The Series A Warrants contain a one-time reset of the exercise price in the event that the Company implemented the 2025 Reverse Stock Split equal to the greater of: (i) 20% of the combined public offering price per share of Common Stock and accompanying warrants in the offering and (ii) the lowest daily volume weighted average price for the five trading days immediately following the date of the implementation of the 2025 Reverse Stock Split.
Removed
Under the new rules, if a company falls out of compliance with the $1.00 minimum bid price after completing reverse stock splits over the immediately preceding two years that cumulatively result in a ratio one for 250 shares, the company will not be able to avail itself of any compliance periods and Nasdaq will instead require the issuance of a Staff delisting determination, which is appealable to a hearings panel.
Added
After the reverse stock split was effectuated on July 3, 2025, the reset exercise price of the Series A warrants was set at $7.00 per share and there were no further contractual exercise price adjustments following the reverse split.
Removed
Our ability to remain listed on Nasdaq may be negatively impacted by this Nasdaq rule.
Added
The Series B Warrants include a zero cash exercise option allowing holders of a Series B Warrant the right to receive, without payment of any additional cash to the Company, an aggregate number of shares equal to the number of shares of Common Stock that would be issuable upon a cash exercise of such Series B Warrants.
Removed
On July 18, 2024, the Company received a letter from the Staff informing the Company that it had regained compliance with the Minimum Bid Price Requirement, but that because it was still non-compliant with the Stockholder’s Equity Requirement the hearing would continue as scheduled as to the matter of the Stockholder’s Equity Requirement.
Added
The Series A warrants were valued using the Monte Carlo Simulation Model utilizing US Treasury Rates, Volatility rates, Common Stock price and assumptions around date and likelihood of a reverse split exercise price adjustment. The Series B warrants were valued using the Common Stock price given the zero-exercise price.
Removed
On July 23, 2024, the Company addressed the Panel and presented its plan of compliance for the Stockholder’s Equity Requirement to the Panel and on August 8, 2024, the Company was notified by Nasdaq that the Panel had granted the Company’s request for continued listing, subject to, among other things, the Company’s filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, evidencing compliance with the Stockholder’s Equity Requirement.
Added
The valuation at issuance was $10.6 million for the Series A warrants and $3.9 million for the Series B warrants, and on June 30, 2025, was $10.0 million for the Series A warrants and $3.7 million for the Series B warrants, representing a warrant liability decrease of $0.8 million from issuance.
Removed
On November 12, 2024, we filed our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 evidencing compliance with the Stockholder’s Equity Requirement. On December 17, 2024 we received a letter from the Staff indicating that the Company regained compliance with the Stockholder’s Equity Requirement, as required by the Panel.
Added
The $0.8 million warrant liability decrease from issuance has been reported on the condensed consolidated statement of operations as a “Change in fair value of warrant liability.” The total warrant valuation of $14.5 million exceeded the gross proceeds of $5.0 million.
Removed
The letter also indicated that pursuant to Nasdaq Listing Rule 5815(d)(4)(B), the Company will be subject to a Mandatory Panel Monitor for a period of one year from the date of the letter.

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