New Cohort Study Data Shows Baxter’s Expanded Hemodialysis – Known as HDx Therapy – Is Associated With Approximately 25% Lower Mortality Rate for up to Four Years

Rhea-AI Summary

Baxter announced that its expanded hemodialysis (HDx) therapy, enabled by the Theranova dialyzer, has shown to reduce all-cause mortality by approximately 25% over four years compared to high-flux hemodialysis (HF HD). The findings come from a cohort study involving 1,092 dialysis patients in Colombia, presented at the ERA-EDTA Congress. Of these, 533 patients received HF HD, while 559 received HDx therapy. The study emphasized HDx therapy's efficiency in removing large-middle molecule uremic toxins, linked to inflammation and cardiovascular issues in dialysis patients. HDx therapy uses the MCO membrane for better filtration and is compatible with existing HD machines, simplifying its implementation in clinics. Over 14 million HDx treatments have been conducted worldwide.

Positive

• HDx therapy reduced all-cause mortality by approximately 25% over four years compared to HF HD.
• Study involved a substantial sample size of 1,092 dialysis patients, enhancing reliability.
• HDx therapy effectively removes large-middle molecule uremic toxins, reducing inflammation and cardiovascular risks.
• Baxter's Theranova dialyzer is compatible with existing HD machines, avoiding the need for special equipment.
• HDx therapy can be easily integrated into existing clinic workflows.
• More than 14 million HDx treatments have been conducted globally, indicating widespread adoption and trust.

Negative

• Study to 11 Baxter Renal Care Services Centers in Colombia, which may affect generalizability.
• Observational cohort study design may involve inherent biases and confounding variables.
• No financial data provided on the comparative cost-effectiveness of HDx therapy versus HF HD.

Insights

Medical Research Analyst

Baxter's four-year cohort study on HDx therapy presents compelling evidence that this advanced hemodialysis method is associated with a significant reduction in mortality risk compared to traditional high-flux hemodialysis. This is particularly consequential for the kidney care field, where minimizing mortality and comorbidities is a critical objective. The study's broad patient base and extended duration add robust statistical power to the findings, thus making the results highly reliable.

HDx therapy's capability to remove larger middle molecules more effectively than conventional methods is noteworthy. These molecules are often linked to inflammation and cardiovascular diseases, common complications in dialysis patients. Such improved clearance could lead to better overall patient outcomes and a reduction in healthcare costs associated with managing these complications in the long term.

The seamless integration of HDx therapy with existing dialysis machines is an operational advantage. It eliminates the necessity for clinics to invest in new equipment, thereby lowering the barrier for adoption. This ease of implementation could drive broader utilization of HDx therapy, potentially improving patient outcomes on a wider scale.

Given these factors, this study indicates a promising advance in dialysis treatment, with tangible benefits for both patients and healthcare providers in terms of improved health outcomes and operational efficiency.

Market Research Analyst

The introduction of Baxter’s HDx therapy, backed by a four-year study showing a 25% lower mortality rate, positions the company uniquely in the kidney care market. The data suggests a significant competitive edge over traditional high-flux hemodialysis systems. This could attract more healthcare providers to adopt Baxter's Theranova dialyzer, potentially increasing Baxter’s market share.

The simplicity of integrating HDx therapy into existing dialysis infrastructure is a strong selling point. Clinics can adopt this advanced therapy without incurring the additional costs of new equipment, which is a considerable advantage, especially in cost-sensitive markets.

As awareness of HDx therapy grows, driven by these promising clinical outcomes, Baxter may see substantial uptake in both established and emerging markets. This increased adoption could translate into solid revenue growth and improved financial performance over the medium to long term.

Investors should note that while the results are promising, the adoption rate will be important in determining the financial impact. Monitoring how quickly and widely this technology is adopted will be key to assessing its true market potential.

Financial Analyst

The new data from Baxter's study on HDx therapy is likely to have a positive impact on the company's financial outlook. A 25% reduction in mortality rates is a significant improvement, making their Theranova dialyzer a potentially preferable choice for clinics and healthcare providers. This innovation not only strengthens Baxter's product portfolio but also enhances its competitive positioning within the renal care market.

The ability to use HDx therapy with existing high-flux hemodialysis machines without additional equipment investments is a strategic advantage. It could drive faster adoption rates and more extensive market penetration, which could, in turn, lead to increased revenue streams.

Given the high cost of managing kidney disease and its complications, the longer-term financial benefits for healthcare systems adopting HDx therapy could be substantial. Investors should keep an eye on Baxter's upcoming earnings reports for indications of how the roll-out of HDx therapy is impacting sales and overall financial performance.

Furthermore, the study's results may spur further research and development, potentially leading to new innovations and improvements in dialysis treatments, thereby enhancing Baxter’s long-term growth prospects.

• Four-year study involved more than 1,000 dialysis patients from a large dialysis provider in Colombia
• Study compared Baxter’s HDx therapy enabled by Theranova dialyzer with high-flux hemodialysis

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX), a global innovator in kidney care and vital organ support, today announced new data showing expanded hemodialysis, known as HDx therapy, enabled by Theranova dialyzer, was associated with an approximately 25% lower all-cause mortality risk for up to four years when compared to high-flux hemodialysis (HF HD). The study, “Survival of expanded hemodialysis and high-flux hemodialysis patients in Colombia: a cohort study,” was presented at the 61st Congress of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress, May 23-26.

The new data is from a 48-month observational cohort study involving 1,092 dialysis patients at 11 Baxter Renal Care Services Centers in Colombia. In the study, 533 patients received high-flux hemodialysis and were compared to 559 patients who received HDx therapy. HDx therapy targets the efficient removal of large-middle molecules,^1,2,3,4 allowing for filtration closer to that of the natural kidney.^5,6 Many of these large-middle molecule uremic toxins have been linked to the development of inflammation, cardiovascular disease, and other comorbidities in dialysis patients.^1,2,3,7 HDx therapy uses Baxter’s Theranova dialyzer equipped with the MCO membrane, which filters a wider range of middle molecule uremic toxins from the blood, specifically targeting the large-middle molecules not effectively removed by conventional hemodialysis therapies.

“It is very exciting to see the results of this four-year study, indicating approximately 25% lower mortality for chronic kidney patients with the use of Baxter’s Theranova dialyzer. Dialysis treatments that more closely mimic the natural kidney have been associated with lower comorbidities, offering a protective effect for kidney patients,” said Professor Peter Rutherford, MB BS, PhD, vice president, Medical Affairs, Kidney Care, Baxter.

In addition to its clearance profile, HDx therapy enabled by Theranova dialyzer is as simple to perform as conventional hemodialysis (HD) and was designed to work with all HD machines. This allows clinics to offer HDx therapy using existing resources and eliminates the need for special equipment and added clinic workflow, which is required for HDF. More than 14 million dialysis treatments have been performed worldwide using Theranova dialyzer in more than 850 clinics. More information on Baxter’s HDx therapy can be found at hdxtheranova.com.

ERA-EDTA 2024 presentations can be viewed on the congress website. To access the specific abstract, visit NDT_39_13.pdf and refer to citation ID: gfae069.1521.

About THERANOVA Dialyzer

Theranova dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased effective removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. Theranova dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for Theranova dialyzer and the set should represent less than 10% of the patient's blood volume.

For single use only.

About Baxter

Every day, millions of patients, caregivers, and healthcare providers rely on Baxter's leading portfolio of diagnostic, critical care, kidney care, nutrition, hospital and surgical products used across patient homes, hospitals, physician offices and other sites of care. For more than 90 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, digital health solutions and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on X/Twitter, LinkedIn and Facebook.

Rx only. For the safe and proper use of this device, refer to the Instructions for Use.

This release includes forward-looking statements concerning HDx therapy and Baxter’s Theranova dialyzer equipped with the MCO membrane, including their potential impact on patients and anticipated benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter, HDx, MCO and Theranova are trademarks of Baxter International Inc. or its subsidiaries.

1. Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.
2. Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.
3. Duranton F, et al. European Uremic Toxin Work Group. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul; 23(7):1258-70.
4. Rosner M, et al. Classification of Uremic Toxins and Their Role in Kidney Failure. Clin J Am Soc Nephrol. 2021;16(12):1918-1928.
5. Zweigart C, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334.
6. Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.
7. Ronco C, et al. The rise of Expanded Hemodialysis. Blood Purif. 2017; 44:I–VIII.. Doi: 10.1159/000476012.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240529271887/en/

Media Contact

Mo Tracy, (224) 554-9270

media@baxter.com

Investor Contact

Clare Trachtman, (224) 948-3020

Source: Baxter International Inc.

FAQ

What is the impact of Baxter's HDx therapy on mortality rates?

Baxter's HDx therapy is associated with a 25% lower all-cause mortality risk over four years compared to high-flux hemodialysis.

How many patients were involved in the Baxter HDx therapy study?

The study involved 1,092 dialysis patients, with 533 receiving high-flux hemodialysis and 559 receiving HDx therapy.

What type of dialysis patients were included in the Baxter HDx therapy study?

The study included dialysis patients from 11 Baxter Renal Care Services Centers in Colombia.

What are the benefits of Baxter's Theranova dialyzer in HDx therapy?

The Theranova dialyzer effectively removes large-middle molecule uremic toxins, reducing inflammation and cardiovascular risks.

Is Baxter's HDx therapy compatible with existing hemodialysis machines?

Yes, HDx therapy is designed to work with all conventional hemodialysis machines, eliminating the need for special equipment.

How widely has Baxter's HDx therapy been adopted?

Over 14 million HDx treatments have been conducted worldwide across more than 850 clinics.