New Case Series Demonstrates Potential of Aquadex Therapy for End-Stage Liver Disease Patients with Fluid Overload
- Positive findings for Aquadex SmartFlow® system in treating end-stage liver disease patients
- Promising new market opportunity for Nuwellis, Inc.
- No catheter-related bloodstream infections or circuit complications attributed to aquapheresis access
- None.
Insights
The recent findings on the Aquadex SmartFlow system's efficacy in treating end-stage liver disease patients represent a significant stride in fluid overload management. Fluid overload, particularly in liver disease, is a critical condition that can severely impact patient morbidity and mortality. The ability of Aquadex to facilitate fluid removal when diuretics fail is noteworthy. In the context of liver disease, diuretic resistance is a common and challenging issue, as diuretics can lose effectiveness over time, leading to a treatment gap for patients with end-stage liver disease.
The study's indication that Aquadex can improve patient mobility and facilitate discharge from intensive care units could potentially reduce hospital stay durations and associated healthcare costs. Moreover, the absence of catheter-related bloodstream infections or circuit complications in the case series is a positive safety signal. This could be particularly relevant for healthcare providers when considering the risk-benefit profile of introducing aquapheresis therapy into their treatment regimen.
However, it is crucial to note that the study is a single-center retrospective case series, which may not be generalizable. Larger, randomized controlled trials would be necessary to firmly establish the efficacy and safety of Aquadex in this patient population. Nevertheless, the initial data could spark interest among healthcare providers seeking alternative treatments for fluid overload in end-stage liver disease patients.
The potential for Aquadex to serve as an alternative treatment for fluid overload in end-stage liver disease patients has economic implications for the healthcare industry. If Aquadex can reduce the need for paracentesis, a procedure to remove fluid from the peritoneal cavity, it could potentially lower procedural costs and improve patient comfort and outcomes. Furthermore, if Aquadex therapy can decrease the length of ICU stays and hospital admissions, this could result in significant cost savings for healthcare facilities.
Given that 4.5 million adults in the U.S. have been diagnosed with liver disease, the market opportunity for Aquadex could be substantial. The ability to treat a broader patient population without needing additional FDA clearances enhances the product's marketability and could lead to increased adoption rates. It is important to monitor how these early findings translate into real-world utilization and whether they can indeed result in cost-effective care.
From an economic standpoint, it would be beneficial to conduct a cost-benefit analysis comparing Aquadex therapy to traditional management of fluid overload in end-stage liver disease. Such analysis would help to understand the financial implications for both healthcare providers and payers and could further influence the integration of Aquadex into standard treatment protocols.
The publication concerning the Aquadex system's application in end-stage liver disease patients may have a positive impact on Nuwellis, Inc.'s market position. The ability to address a previously unmet medical need can differentiate Aquadex in the competitive medical device landscape. Moreover, the mention of no additional regulatory clearances needed from the FDA for this application suggests a smoother path for market penetration.
Investors and stakeholders should consider the potential for increased demand for Aquadex, as it could lead to an uptick in sales and market expansion. However, it is essential to track how Nuwellis capitalizes on this opportunity and whether they can effectively communicate the benefits of Aquadex to clinicians and decision-makers in healthcare settings.
Considering the size of the patient population and the chronic nature of liver disease, there is a continuous need for effective treatment options. If Aquadex gains traction in clinical practice, it could also open avenues for further research and development, possibly leading to enhancements of the device or new therapeutic applications. The company's stock performance may reflect the market's perception of the potential growth opportunities presented by these findings.
Early findings suggest Aquadex as a potential solution to safely and effectively remove fluid volume for liver disease patients who don’t respond to diuretics
MINNEAPOLIS, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the publication of new data demonstrating the potential value of the Aquadex SmartFlow® system’s aquapheresis therapy when treating patients with fluid overload as a result of end-stage liver disease. The publication, “Utilization of Aquapheresis Among Hospitalized Patients with End-Stage Liver Disease: A Case Series and Literature Review,” is a single-center retrospective case series featured in Clinical Transplantation.
“This study presents an exciting new market opportunity for Nuwellis, and we look forward to gathering additional data demonstrating how Aquadex can benefit these patients,” said Nestor Jaramillo, Jr., president and chief executive officer of Nuwellis. “Four and a half million adults in the U.S. have been diagnosed with liver disease.1 To date, there has been little to no clinical evidence gathered demonstrating the benefits of aquapheresis for patients with liver disease. This publication lays the foundation for a new clinical application already within our current labeling that requires no additional regulatory clearances from the FDA.”
The case series assessed the utilization of aquapheresis therapy with Aquadex in the intensive care unit (ICU) setting at Mount Sinai Hospital between January 2020 and July 2023. Fourteen severely ill patients with end-stage liver disease were treated with aquapheresis during this period. The most common cause of liver disease was alcohol-related, with nine of the 14 patients presenting with alcohol-associated cirrhosis. Key findings from the case series include:
- Six patients were able to receive physical therapy following treatment to help improve their mobility while in the ICU.
- Five patients were transferred out of the ICU following treatment, three of whom were discharged from the hospital.
- There were no catheter-related bloodstream infections or circuit complications attributed to aquapheresis access.
“For clinicians treating patients with end-stage liver disease, it can be an enormous challenge to safely and effectively remove fluid when patients don’t respond to or can’t tolerate diuretic therapy,” said John Jefferies, M.D., chief medical officer of Nuwellis. "In such cases, fluid removal via aquapheresis can enhance patients' mobility and allow them to receive more effective physical therapy. This can reduce cirrhosis-related frailty and enhance their ability to receive a life-saving liver transplant in a more timely manner."
Patients with end-stage liver disease are currently treated with diuretics, but studies show that the longer a patient is on diuretics, the less effective they become.2,3 End-stage liver disease patients are also prone to developing ascites, which requires paracentesis – a painful procedure using a needle to remove fluid from the peritoneal cavity. In this case series, Aquadex was shown to provide a potential additional solution to mitigate these clinical gaps.
Aquadex is proven to simply, safely, and precisely remove excess fluid from patients suffering from fluid overload who have not responded to conventional medical management, including diuretics. Providers can specify and adjust the rate of fluid removed for each individual patient, resulting in a gradual reduction of excess fluid. The device’s built-in, customizable hematocrit monitoring technology provides real-time measurement of percent blood volume changes that can be tailored to individual patients’ needs. A customizable fluid removal rate is particularly important for pediatric patients who have a small amount of blood in their bodies. The Aquadex system is cleared by the U.S. Food and Drug Administration (FDA) for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit ir.nuwellis.com or visit us on LinkedIn or X.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
CONTACTS
Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
Media:
Dunia Cristan
Health+Commerce
dunia@healthandcommerce.com
1 CDC. Chronic Liver Disease and Cirrhosis. https://www.cdc.gov/nchs/fastats/liver-disease.htm
2 Felker MG and Mentz RJ. J Am Coll Cardiol. 2012;59(24):2145-53.
3 Doering A, et al. Int J Emerg Med. 2017;10(17).
FAQ
What is the potential value of the Aquadex SmartFlow® system in treating end-stage liver disease patients?
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