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 – Company Announcement

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

DEERFIELD, Ill.–(BUSINESS WIRE)–May 29, 2024–
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.
   

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Mo Tracy, (224) 554-9270

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Source: Baxter International Inc.