Nuwellis Announces Peer-Reviewed Publication of Clinical Trials Analysis Advocating the Use of Ultrafiltration for Heart Failure Patients Resistant to Diuretics

Rhea-AI Summary

Nuwellis, Inc. (Nasdaq: NUWE) recently announced a peer-reviewed publication supporting ultrafiltration as a viable treatment for acute decompensated heart failure (ADHF), particularly for patients unresponsive to diuretics. The publication, featured in Cardiorenal Medicine Journal, reviewed data from seven trials involving 771 patients, highlighting ultrafiltration's advantages in efficient fluid removal without harming renal function. This method could reduce hospital readmissions and alleviate healthcare costs associated with ADHF. Nuwellis aims to establish ultrafiltration as the standard of care through increased awareness and clinical evidence.

Positive

• Publication supports ultrafiltration as a safe and effective treatment for ADHF.
• Data from seven trials with 771 patients demonstrate clinical benefits of ultrafiltration.
• Potential for reduced hospital readmissions and lower healthcare costs.
• Nuwellis aims to increase awareness and establish ultrafiltration therapy as the standard of care.

Negative

• None.

MINNEAPOLIS, March 21, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the peer-reviewed publication of an analysis of available ultrafiltration clinical trials with findings that support ultrafiltration as a safe and effective therapeutic option for acute decompensated heart failure (ADHF) patients who are resistant to diuretics or who have a history of multiple hospitalizations for fluid overload. The publication highlights the scale of clinical burden: “ADHF has the highest rate of hospital readmissions among all medical conditions and portends a significant financial burden on healthcare systems worldwide.”¹

The publication, “Extracorporeal Ultrafiltration for Acute Heart Failure,” featured in Cardiorenal Medicine Journal, includes the review of pooled data from seven randomized controlled trials of ultrafiltration with a total of 771 patient participants. A. Kazory, et al, highlight the clinical application and value of ultrafiltration, including:

• Predictable, adjustable, and more efficient fluid removal with ultrafiltration compared to diuretics, without clinically adverse impact on renal function, leads to a reduction in hospital readmissions and financial burden;
• Applicability of ultrafiltration therapy in other clinical settings, such as cardiac surgery, burn and other specialty units, where active and prompt volume management is of utmost importance; and
• Expansion of use of ultrafiltration into outpatient centers and other ambulatory settings.
  

John Jefferies, M.D., Chief Medical Officer of Nuwellis, said, “Hospitalizations for ADHF are primarily driven by fluid overload, with nearly 50% of these patients leaving the hospital with inadequate or minimal weight loss, in part due to unpredictability of diuretic therapy. As such, it also has the highest rehospitalization rate among all medical conditions.” Dr. Jefferies added, “Ultrafiltration, however, provides an opportunity to overcome the shortcomings of diuretics, as the Aquadex^® system’s decongestion technique safely provides for adjustable fluid and sodium removal. It can also be considered early after admission, with volume and rate of fluid removal specific to patient characteristics for more predictable results, which diuretics often times cannot achieve.”

“We are excited to add this peer-reviewed analysis of ultrafiltration trials to our growing body of clinical evidence, which we are leveraging to change practice guidelines to make Aquadex the standard of care for fluid overload and increase its use across multiple specialty units in hospitals and outpatient centers,” said Nestor Jaramillo, President and CEO of Nuwellis. “In the last six months we have announced various new publications demonstrating results that favor ultrafiltration over IV diuretics when using Nuwellis’ Aquadex system. This publication is different because it outlines the reasons why healthcare providers should use ultrafiltration and the consequences of not using it to treat ADHF. We look forward to increased sales momentum as we expand awareness of the benefits of ultrafiltration over diuretics using the arguments presented by the authors.”

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 www.nuwellis.com or visit us on LinkedIn.

About the Aquadex SmartFlow^® System 
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies. 

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 2023 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 impact of the COVID-19 pandemic, 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 as a result of new information, future events or otherwise. 

¹ Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204

CONTACTS

INVESTORS:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com

MEDIA:
Annika Parish
Health+Commerce
annika@healthandcommerce.com

FAQ

What is the significance of the recent publication regarding NUWE?

The publication supports ultrafiltration as an effective treatment for acute decompensated heart failure (ADHF), offering potential benefits over traditional diuretics.

How many clinical trials were analyzed in the NUWE publication?

The publication reviewed data from seven randomized controlled trials involving a total of 771 patients.

What are the expected outcomes of using ultrafiltration for ADHF patients?

Ultrafiltration may lead to more efficient fluid removal, reduced hospital readmissions, and lower financial burdens on healthcare systems.

What is Nuwellis' goal following the publication of the analysis?

Nuwellis aims to increase awareness of ultrafiltration therapy benefits and establish it as the standard of care for fluid overload management.

What challenges does NUWE face in implementing ultrafiltration treatment?

Nuwellis may encounter challenges in gaining physician acceptance and navigating market competition for ultrafiltration therapy.