Quanta Dialysis Technologies is a medical technology company focused on developing innovative hemodialysis solutions. The company's flagship product is the Quanta Dialysis System, a compact and portable hemodialysis device designed to provide dialysis care across multiple settings. The system weighs 71 pounds and features an intuitive user interface, making it easier for a broad range of users to operate. The Quanta Dialysis System was FDA-cleared for use in chronic and acute care settings in the US, with capabilities including intermittent hemodialysis, sustained low-efficiency dialysis, and continuous renal replacement therapy. The device supports dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery. In the UK, the system received CE mark approval for both center and home use. Quanta aims to make dialysis more accessible and convenient for patients with end-stage kidney disease. The company submitted a 510(k) premarket notification to the FDA seeking to expand the use of the Quanta Dialysis System to include self-care, in-home hemodialysis in the US.
Key customers and partnerships
The Quanta Dialysis System was commercially available in the UK for both home and hospital use. In the US, the device was FDA-cleared for use in chronic and acute care settings. The company conducted a Home Run study, a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis. Out of 32 evaluable participants who completed the Home Run study, 93% opted to continue using the Quanta Dialysis System in their homes through an IDE extension. Quanta has been working to expand its presence in the US market, with plans to commercialize the device with new software capabilities.
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