Itasca, IL – Device maker Byonyks has received 510(k) clearance from the Food and Drug Administration for its X1 automated peritoneal dialysis (APD) cycler.
Byonyks is only the third company to obtain marketing clearance from the FDA for an APD cycler, according to Farrukh Usman, founder and CEO of Byonyks.
“Research shows that peritoneal dialysis (PD) preserves residual kidney function longer, and the therapy improves both quantity and quality of life,” Usman said. “Unfortunately, 85% of Americans on dialysis do not receive PD. The FDA’s clearance of X1 heralds a new era.”
According to the U.S. Renal Data System, use of in-center hemodialysis, the most common form of kidney dialysis, has a 10% lower survival rate than peritoneal dialysis. “Our mission is not limited to putting a cycler on the market; Byonyks’ advanced development projects are aimed at significantly improving the clinical outcomes for PD patients and reducing and/or eliminating the many reasons for short tenures on this therapy,” Rod Kenley, Byonyks’ Chief Innovation Officer, said.
Currently, about 86% of the world’s population who need dialysis have no access to it. “Byonyks is a dynamic company driven to improve the lives of our patients through transformative innovation that will improve global access to dialysis, improve biocompatibility, minimize metabolic impact, and reduce the risk of infection, all while decreasing the carbon footprint. That is a grand slam,” Andrew King, MD, Byonyks’ Chief Medical Officer, said.
For more information, visit www.byonyks.com.
References
- FDA 510(k) Clearance Record – K2433710(k)
- Advancing American Kidney Health – U.S. Department of Health & Human Services (ASPE), page 25
2024 USRDS Annual Data Report, Figure 9.11 a,b
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