Baxter Highlights New Home Dialysis and HDx Therapy Data in 14 Clinical Presentations at Kidney Week 2022

• Controlled study at 21 hospitals shows remote patient management reduces adverse events for home peritoneal dialysis patients
• New ex vivo study demonstrates superior performance of the Theranova dialyzer in effectively balancing higher removal of large middle-molecule toxins and albumin stability during hemodialysis

Baxter International Inc. (NYSE:BAX), a global innovator in kidney care, advanced scientific exchange with 14 new data presentations about the role innovation plays in increasing access to and quality of home dialysis and expanded hemodialysis (HDx) care at Kidney Week 2022, Nov. 3-6, Orlando, Florida. Key data highlighted include:

• A study indicating a significant reduction in all-cause mortality and fluid balance, and cardiovascular and metabolic related adverse events, in home automated peritoneal dialysis (APD) patients with Sharesource remote patient management (RPM) versus APD patients without RPM, “Adverse Events and Hospitalizations with Remote Patient Monitoring of Patients on Automated Peritoneal Dialysis” [Abstract #FR-PO504].

• A simulated dialysis study indicating expanded hemodialysis (HDx) enabled by Theranova demonstrates the best balance when aiming to achieve higher clearance of larger molecular weight middle molecules while minimizing albumin loss, “On the Removal of Middle Molecules and Albumin Loss: An Ex Vivo Evaluation of Commercial Dialyzers” [Abstract #SA-PO405].

“With a growing global deficit between the number of patients with kidney disease and those receiving care, we believe a combination of collaboration, education and innovation is necessary to help increase both access to and quality of care,” said Peter Rutherford, MB BS, PhD., vice president, Medical Affairs, Baxter Renal Care. “Scientific exchange is an important part of the collaboration and education initiatives, which we are very pleased to support at this year’s Kidney Week.”

Sharesource Remote Patient Management

Baxter’s Sharesource RPM digital health platform allows healthcare professionals to monitor their patients’ home dialysis treatments, and then remotely adjust therapy without the need for patients to make unplanned visits to the clinic. Sharesource is currently serving more than 50,000 patients, across more than 70 countries on Baxter’s APD cyclers. The RPM study [Abstract #FR-PO504] presented at Kidney Week 2022 was a cluster randomized, controlled trial, at 21 hospitals across Mexico, where care units were randomly assigned to treat their APD patients with or without RPM.

HDx Enabled by Theranova

HDx enabled by Theranova removes a wider range of molecules from the blood than traditional HD filters, like high-flux membranes, by targeting the effective removal of large middle molecules (up to 45,000 Da),^1,2,3 while selectively retaining essential proteins and maintaining stable albumin levels.^4,5,6 These middle molecules have been linked to the development of inflammation, cardiovascular disease, and other co-morbidities in dialysis patients.^7,8

The new Theranova data [Abstract #SA-PO405] comes from a simulated study that evaluated the challenges associated with increased removal of larger middle molecules while avoiding clinically relevant albumin loss during a dialysis session. During the study, four commercial dialyzers with comparable surface areas were carefully evaluated for solute clearance and albumin loss during four-hour simulated hemodialysis treatments under standardized conditions.

Theranova had significantly higher small and large middle molecule clearance (up to 2-3 times higher for YKL40) than two of the other dialyzers as well as lower albumin loss. One dialyzer cleared a higher volume of large middle molecules, but demonstrated albumin loss more than double that observed with Theranova. The study shows further assessment of the dialyzer’s performance in clinic studies is necessary to better understand the benefits of these findings.

HDx enabled by Theranova is currently available in 54 countries across Europe, Latin America, Asia, Africa and in the United States and Canada. More than nine million dialysis treatments have been performed worldwide using Theranova in more than 850 clinics. The U.S. Food and Drug Administration granted Theranova a De Novo application in 2020, which established it as a new class of dialyzer technology with unique performance standards.

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

Rx Only: For safe and proper use of the devices mentioned herein, refer to the Instructions for Use.

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 Twitter, LinkedIn and Facebook.

This release includes forward-looking statements concerning potential benefits associated with Sharesource and Theranova. 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: demand for and market acceptance for new and existing products; product development risks; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics/pandemics, regulatory actions or otherwise); 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 Form 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter, Sharesource and Theranova are registered trademarks of Baxter International Inc.

¹ Hutchison CA, Wolley M. The Rationale for Expanded Hemodialysis Therapy.

² Kirsch AH, Lyko R, Nilsson LG, et al. Performance of hemodialysis with novel medium cut-off dialyzers.

³ Boschetti-de-Ferro MCO membranes.

⁴ Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transpl 2017; 32(1):165-72.

⁵ Krishnasamy R et al. Trial evaluating mid cut-off value membrane clearance of albumin and light chains in hemodialysis patients (REMOVAL-HD): a safety and efficacy study. ASN 2018 Kidney Week Abstract TH-PO353.

⁶ Bunch A, et al. Long Term Effects of Expanded Hemodialysis (HDx) on Clinical and Laboratory Parameters in a Large Cohort of Dialysis Patients. ASN 2018 Kidney Week Abstract FR-PO766.

⁷ Ronco C, et al. Blood Purif. 2017;44(2):I-VIII.

⁸ Hutchison CA, et al. Contrib Nephrol. 2017;191:142-152.

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Baxter Highlights New Home Dialysis and HDx Therapy Data in 14 Clinical Presentations at Kidney Week 2022; #AccessKidneyCare, #KidneyWK