X-1 Automated Peritoneal Dialysis (APD) Cycler
Kidney Failure / End-Stage Renal Disease (ESRD)
ApprovedActive
Key Facts
Indication
Kidney Failure / End-Stage Renal Disease (ESRD)
Phase
Approved
Status
Active
Company
About Byonyks Medical Devices
Byonyks Medical Devices, founded in 2018 and headquartered in San Diego, is a private medical device company developing innovative home-based peritoneal dialysis systems. The company's core achievement is FDA 510(k) clearance for its X-1 APD Cycler, a key milestone that allows it to enter the US market. Byonyks aims to disrupt the stagnant dialysis industry by offering advanced technology designed to improve patient outcomes, preserve kidney function, and lower costs, aligning with a major US government push to shift 80% of dialysis patients to home-based care. The company is led by a team with deep experience in dialysis device development and commercialization.
View full company profile