New Study Published in Current Problems in Cardiology Highlights Statistically Significant Reduction in Heart Failure Readmissions at 60 days when using the Aquadex Ultrafiltration Therapy

Rhea-AI Summary

Nuwellis, Inc. (Nasdaq: NUWE) announced the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60-day hospital readmission rates for patients with acutely decompensated heart failure (ADHF). The study, conducted in a community hospital setting, analyzed data from 30 patients and found:

• Significant volume loss and weight reduction without adverse renal effects
• Statistically significant reduction in rehospitalization rates at 60 days (16.7% vs. 26.7%, p=0.013)
• 40% decrease in ADHF readmissions in 30 days and 59% in 60 days following therapy
• Stable renal function post-ultrafiltration

These results highlight the potential of Aquadex therapy to improve patient outcomes and reduce healthcare costs associated with heart failure management.

Positive

• Statistically significant reduction in 60-day heart failure readmission rates (16.7% vs. 26.7%, p=0.013)
• 40% decrease in ADHF readmissions in 30 days and 59% in 60 days following Aquadex therapy
• Significant volume loss and weight reduction in patients without adverse renal effects
• 30% revenue growth reported in Nuwellis' core business in Q2 earnings release
• Potential cost savings of $3,975 per patient for hospitals using Aquadex therapy

Negative

• None.

Insights

Cardiology Expert

This study presents compelling evidence for the efficacy of Aquadex ultrafiltration therapy in managing acutely decompensated heart failure (ADHF). The 59% reduction in 60-day readmissions is particularly striking, suggesting significant improvements in patient outcomes and potential cost savings for healthcare systems.

However, it's important to note the small sample size of 30 patients, which may limit the generalizability of these findings. Future larger-scale studies will be necessary to confirm these results across diverse patient populations. The stable renal function observed is reassuring, addressing a common concern with fluid removal therapies in heart failure patients.

Healthcare Economics Analyst

The economic implications of this study are substantial. With heart failure costing the U.S. healthcare system $60 billion annually, any intervention that can significantly reduce readmissions has enormous potential. The reported $3,975 savings per patient is noteworthy, especially when considering the 24% national readmission rate and associated Medicare penalties.

However, we must consider the initial implementation costs of Aquadex therapy and weigh them against long-term savings. The 30% revenue growth in Nuwellis' core business suggests growing market adoption, but widespread implementation will require further economic analyses and possibly changes in reimbursement structures.

Medical Device Industry Analyst

For Nuwellis, this study represents a significant validation of their Aquadex technology in a real-world setting. The positive outcomes in a community hospital environment are particularly valuable, as they demonstrate the therapy's potential for widespread adoption beyond specialized centers.

However, investors should note that while the results are promising, market penetration may still face challenges. The disclosure of financial interests by some study authors in Nuwellis warrants consideration, although the company's non-involvement in funding the research adds credibility. The 30% revenue growth is encouraging, but sustained growth will depend on continued clinical validation and successful market expansion strategies.

MINNEAPOLIS, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients with fluid overload, is pleased to announce the publication of a new study in Current Problems in Cardiology demonstrating the effectiveness of Aquadex® ultrafiltration therapy in reducing 60 day hospital readmission rates for patients with acutely decompensated heart failure (ADHF) who are otherwise resistant to diuretic treatment.

The study, conducted by Viswanath R. Chinta, MD, Dr. John L. Jefferies, MD, MBA, MPH, and fellow researchers, is titled “Outcomes of Ultrafiltration in community-based hospitals” and sought to evaluate and validate the role of a newly implemented Aquadex ultrafiltration therapy program in a community hospital setting. The study analyzed data from 30 patients who underwent this therapy during the program's first year. The primary objective was to assess whether ultrafiltration with Aquadex could reduce the high readmission rates commonly observed in patients with refractory ADHF.

Key findings from the study include:

• Significant Volume Loss and Weight Reduction: Patients experienced significant volume loss and weight reduction without adverse renal effects.
• Significant Reduction in Heart Failure Readmissions: The study found a statistically significant reduction in rehospitalization rates for heart failure at 60 days from the initiation of ultrafiltration therapy compared to the pre-ultrafiltration period (16.7% vs. 26.7%, p=0.013). The total number of ADHF readmissions in the 30 days following ultrafiltration therapy decreased by 40%, and by 59% in the subsequent 60 days.
• Stable Renal Function: Serum creatinine levels at 72 hours post-ultrafiltration did not change significantly (-0.01 mg/dL, 95% CI -0.26, 0.23).
  

Dr. Jefferies expressed his enthusiasm for the study's findings, stating, "The results of our study showed success with ultrafiltration in the mainstream setting with reproducible results of significant volume loss without adverse effect, mitigation of recurrent HF admissions and remarkable subjective clinical benefits. The significant reduction in rehospitalization rates, combined with the safety profile observed, marks a notable advancement in the management of acutely decompensated heart failure."

"This study underscores the value of ultrafiltration therapy with Aquadex in managing fluid overload in hospitalized heart failure patients," commented Nestor Jaramillo, President and CEO of Nuwellis. "The positive outcomes reported in this community-based hospital setting demonstrate the broader applicability and effectiveness of Aquadex, which is critical as we continue to expand access to this life-saving therapy in multiple academic and community healthcare centers across the country."

Mr. Jaramillo added, "These study results should be of interest to the many physicians and hospital administrators seeking to reduce the losses associated with heart failure patient care. The statistically significant outcomes reported in this study further reinforce the value of Aquadex. This new evidence comes as we marked 30% revenue growth in our core business, as reported in our second quarter earnings release."

Treating heart failure patients is a complex and costly endeavor. In the U.S., over 6.5 million people suffer from this condition, leading to $60 billion in annual healthcare costs.¹ One million of these patients are hospitalized each year due to fluid overload, spending an average of 8 days in the hospital at a cost of $24,000 per patient.^1,2 DRGs do not fully cover these costs, and a 24% national readmission rate can result in a 2-3% penalty on all Medicare expenses for hospitals. The results of this new research highlight the crucial role that Aquadex ultrafiltration therapy can play in reducing hospitalization and readmission rates, as well as patient length of stay. By doing so, hospitals can save approximately $3,975 per patient and reduce hospitalization mortality.^3,4

The full study is available in the October issue of Current Problems in Cardiology. While certain authors of this paper have disclosed selected financial interests in the Company, Nuwellis did not provide any financial support to any of the authors or the hospital in connection with this research.

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 or X.

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 health care 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 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.

1. Kazory A, Sgarabotto L, Ronco C: Extracorporeal Ultrafiltration for Acute Heart Failure. Cardiorenal Med 2023;13:1-8. doi: 10.1159/000527204
2. From Premier Applied Sciences database
3. Costanzo MR et al. JACC. 2005; 46(11); 2457‐51
4. Costanzo, et. al., ISPOR 23rd Annual Int’l Mtg., May 19‐23, 2018, Baltimore, MD, USA

CONTACTS

Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com

FAQ

What were the key findings of the Aquadex ultrafiltration therapy study for NUWE?

The study found a statistically significant reduction in 60-day heart failure readmission rates (16.7% vs. 26.7%, p=0.013), a 40% decrease in ADHF readmissions in 30 days, and a 59% decrease in 60 days following Aquadex therapy. Patients also experienced significant volume loss and weight reduction without adverse renal effects.

How did Nuwellis (NUWE) stock perform in Q2 2024?

Nuwellis reported 30% revenue growth in its core business, as mentioned in their second quarter earnings release.

What is the potential cost savings for hospitals using Aquadex therapy from Nuwellis (NUWE)?

According to the press release, hospitals can potentially save approximately $3,975 per patient by using Aquadex ultrafiltration therapy, which can reduce hospitalization and readmission rates, as well as patient length of stay.

What is the market size for heart failure treatment that Nuwellis (NUWE) is targeting?

In the U.S., over 6.5 million people suffer from heart failure, leading to $60 billion in annual healthcare costs. One million of these patients are hospitalized each year due to fluid overload, spending an average of 8 days in the hospital at a cost of $24,000 per patient.