VIENNA, May 24, 2016 — Baxter International Inc. (NYSE:BAX), a leading provider of dialysis therapies, previewed THERANOVA, a new class of dialysers1,2 with the potential to significantly advance renal care, at the 53rd Congress of the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA).
THERANOVA is an innovative dialyser, designed to extend the range of toxins that can be filtered from the blood during haemodialysis. THERANOVA dialysers are indicated for treatment of chronic and acute renal failure by haemodialysis.
People with end-stage kidney disease retain toxins, including mid-sized and large solutes that may affect a range of biological functions and contribute to elevated cardiovascular risk.3 Standard haemodialysis is effective at removing small solutes, such as urea, but is ineffective in removing larger toxins.4
In data being presented at the Congress, the permeability and selectivity properties of the THERANOVA membrane demonstrated significantly higher mean overall toxin clearance compared to the currently marketed high-flux dialysers (Abstract #SP416).
In vitro studies show that the THERANOVA dialyser delivers clearances of large uremic toxins (such as β-2 microglobulin) that are equivalent to and may exceed those of a hemodiafilter used in high-volume hemodiafiltration (HDF) mode.5,6 HDF is a dialysis therapy that also targets larger molecules.
“Our ultimate goal is to introduce innovations that will enable haemodialysis to more closely mimic the function of the natural kidney,” said Marcus Schabacker, corporate vice president and chief scientific officer, Baxter. “With THERANOVA, we are introducing an innovative dialyser that has the potential to improve care for the more than two million people globally who rely on haemodialysis. THERANOVA offers clinicians a more efficient way to deliver haemodialysis without sacrificing performance.”
In addition to its unique filtration profile, THERANOVA was designed to work with most standard haemodialysis machines. This eliminates the need for special equipment and ultrapure fluids, which is required for HDF. By providing HDF performance from a standard haemodialysis treatment, while avoiding the costs and complexity associated with high-volume HDF, THERANOVA has the potential to raise the standard of care for haemodialysis patients.
Building on 60 years of scientific expertise in haemodialysis and advanced membrane technology, Baxter researchers developed THERANOVA at its R&D facility in Hechingen, Germany.
Baxter has completed regulatory clearance for THERANOVA in Europe (CE marking), Australia and New Zealand, among other countries. It will be available in select countries in 2016, with additional launches planned for 2017. THERANOVA is not currently available in the United States.
For prescription only. For safe and proper use of THERANOVA, refer to the complete instructions in the Operator's Manual.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This release includes forward-looking statements concerning THERANOVA, one of Baxter’s dialysis membranes, including expectations regarding the planned launch of THERANOVA, its potential impact on patients and benefits associated with its 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: actions of regulatory bodies and other governmental authorities; satisfaction of regulatory and other requirements; product quality or patient safety issues; changes in laws 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.
1Boschetti-de-Fierro A, et al. MCO membranes: Enhanced selectivity in high-flux class. Sci Rep 2015; 5:18448.
2Krause B, et al. Highly selective membranes for blood purification. Abstract accepted for Euromembrane Congress; Aachen (Germany) 2015. [Abstract E139].
3Leypoldt K, et al; Clearance of Middle Molecules during Haemodialysis and Haemodiafiltration: New Insights. Nephrology Dialysis Transplantation (2012); 27 (12): 4245-4247. doi: 10.1093.
4Tattersall and Ward; Online Haemodiafiltration: Definition, Dose Quantification and Safety Revisited; Nephrology Dialysis Transplantation (2013); 10.1093.
5Boschetti-de-Fierro A, et al. MCO membranes: Enhanced selectivity in high-flux class. Sci Rep 2015; 5:18448.
6Boschetti-de-Fierro A, et al. Enhanced HD membrane reaches equivalent performance as HDF. Abstract accepted at the 52nd EDTA-ERA congress London (United Kingdom) 2015. [Abstract FP489].