Baxter Presents Data at 58th ERA-EDTA Congress Indicating Theranova May Reduce Cardiovascular Events and Hospitalizations

Rhea-AI Summary

Baxter International Inc. (NYSE:BAX) has released new data indicating that its Theranova hemodialysis (HDx) therapy may reduce cardiovascular events by 35% and hospitalization rates by 18% among Colombian dialysis patients. This study, presented at the 58^th ERA-EDTA Congress, involved over 1,000 adult patients and suggests improved clinical outcomes for those using HDx therapy. The Theranova device, approved by the FDA, aims to filter a wider range of toxins, potentially reducing associated health risks.

Positive

• HDx therapy via Theranova reduces cardiovascular events by 35%.
• Hospitalization rates decline by 18% for patients using Theranova.
• Study involved over 1,000 adult patients, enhancing data reliability.
• Theranova is used in more than 40 countries.

Negative

• No differences in hospitalization duration or survival were identified.
• Further randomized clinical trials needed to confirm results.

Baxter International Inc. (NYSE:BAX), a global innovator in renal care, announced today new data showing expanded hemodialysis (HDx) therapy enabled by the Theranova dialyzer may reduce cardiovascular events by 35% and hospitalization rates by 18% according to a new, large, multicenter, retrospective study of Colombian dialysis patients treated with long-term HDx compared to propensity-matched patients treated with High-Flux Hemodialysis.¹ The study “Effectiveness of medium cut-off versus high flux dialyzers: An inverse probability weighting cohort study,” [Abstract #MO880] was an oral presentation at the 58^th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress, June 5-8, 2021.

(Photo: Business Wire)

Theranova was designed to deliver HDx therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa),^2,3,4 allowing for filtration closer to that of the natural kidney.^5,6 These large middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.^2,3,4

“Innovation is fueled by continued scientific study and exchange through meetings like the 58^th ERA-EDTA,” said Peter Rutherford, M.D., senior medical director, Baxter Renal Care business. “These new findings support a growing library of evidence that kidney disease patients on HDx therapy enabled by Theranova may experience improved clinical outcomes and lower healthcare resource utilization.”

The new data are from an observational, multicenter, retrospective cohort analysis of more than 1,000 adult prevalent hemodialysis patients followed for up to two years at Baxter Renal Care Services clinics in Colombia. Weighted incidence rate ratios (IRRs) and rates and duration of hospitalization and cardiovascular events according to dialyzer type were obtained using binomial negative regression with the weighting sample. Hospitalization rates and hospitalization days were recorded over two years. While lower hospitalization rates and cardiovascular events were found in association with HDx therapy enabled by Theranova, no differences in hospitalization duration or survival were identified. Randomized clinical trials are needed to confirm the observed effect.

Theranova is currently used in more than 40 countries, including the United States where it was granted a De Novo application. By granting a De Novo, the U.S. Food and Drug Administration (FDA) established a new classification of dialyzer technology with unique performance standards. The U.S. FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For 90 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies 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 Twitter, LinkedIn and Facebook.

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

This release includes forward-looking statements concerning Theranova, including potential benefits associated with its use (including reduced incident of cardiac events and hospitalization rates). 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 and Theranova are registered trademarks of Baxter International Inc.

¹ Molano A. et al. “Effectiveness of medium cut-off Vs high flux dialyzers: An inverse probability weighting cohort study” Abstract presented at the 58 ERA-EDTA Congress. 2021. [MO880]

² Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.

³ Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.

⁴ 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.

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.

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FAQ

What are the benefits of Theranova hemodialysis according to Baxter?

Baxter's Theranova hemodialysis may reduce cardiovascular events by 35% and hospitalization rates by 18%.

What type of study was conducted on Theranova?

An observational, multicenter, retrospective cohort analysis involving over 1,000 adult dialysis patients.

When was the Theranova study presented?

The study was presented at the 58th ERA-EDTA Congress, held from June 5-8, 2021.

In how many countries is Theranova used?

Theranova is currently utilized in more than 40 countries worldwide.

What risks are associated with Baxter's forward-looking statements about Theranova?

Risks include regulatory actions, product quality issues, and changes in laws affecting the device.