The SC+ haemodialysis system has been designed to deliver enhanced dialysate flow rates
British medical technology firm Quanta Dialysis Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its haemodialysis system called SC+.
The new system has been designed to offer a dialysis dose equivalent to the current standard of care, as well as in a compact and easy-to-use format suitable for a range of care settings.
Quanta’s system has the potential to deliver improved dialysate flow rates compared to other portable haemodialysis systems that offer conventional three-times-a-week prescriptions, according to the company.
The small and lightweight design of SC+ makes it portable and provide efficient dialysis treatments to the patients, while the simple user interface enables a range of healthcare professionals to access dialysis.
Quanta to launch related products to complement SC+
Quanta is also planning to launch a suite of related products and services to complement SC+ haemodialysis system.
The company will introduce an optional and portable water purification module to help SC+ easily move around and operate in a range of settings with and without a centralised water system.
Quanta will also offer a secure and cloud-based digital health offering, which helps to simplify and automate treatment data capture and reporting, thereby helping to avoid the need for creating and storing manual records.
SC+ was commercially launched in the UK last year following broad clinical piloting with the National Health Service (NHS) in England.
Quanta CEO John Milad said: “Kidney failure is one of the costliest health conditions for the American health system. The imperative for better value in healthcare, coupled with new challenges driven by Covid-19, has amplified the need to reimagine how hemodialysis is delivered across a variety of settings.
“This will be a pivotal year for Quanta as we build our US presence and bring our next generation hemodialysis system to a community ripe with need.”
In July 2019, Quanta secured £38m ($48m) in a first closing of its Series C funding round. The financing round was participated by existing investors was led by a Swiss private family office and btov Partners. It was co-led by Wellington Partners and Seroba Life Sciences.