- Universal Biosensors (UBI) submits a 510K application to the US FDA for approval to sell Xprecia Prime in the United States
- The application included UBI’s patient study which provided clinical evidence of its portable coagulation monitoring device’s performance and safety
- The company says the submission is an “important step” towards building Xprecia Prime into a “meaningful business”
- Universal Biosensors is down two per cent, trading at 24.5 cents at 2:55 pm AEDT
Universal Biosensors (UBI) has submitted a 510K application to the US Food and Drug Administration (FDA) for approval to sell Xprecia Prime in the US.
Xprecia Prime is UBI’s next-generation portable coagulation testing device, designed for fast and reliable testing of blood clotting.
The application comes after wrapping up its study involving 360 patients, which was conducted over four sites across the US in January this year. The study was designed to provide clinical evidence of the performance and safety of its Xprecia Prime product.
UNI previously told investors it expected to see its Xprecia Prime “win significant market share over time” and its performance was “equal to or better than anything else on the market.”
“UBI has spent more than ten years developing its point-of-care coagulation platform and the submission of our 510K application is an important step towards building Xprecia Prime into a meaningful business,” UBI CEO John Sharman said.
“UBI’s existing coagulation product (Xprecia Stride) has insignificant sales in the
USA, the USA coagulation market represents about 50 per cent of the estimated global US$1 billion PT/INR market,” UBE CEO John Sharman said.
“We expect an approval to sell Xprecia Prime in the USA will add significant value to our
coagulation business into the future.”
UBI shares were down two per cent, trading at 24.5 cents at 2:55 pm AEDT.