- Universal Biosensors (UBI) recruits the last patient for its prothrombin time (PT/INR) blood coagulation clinical study
- The study will provide clinical evidence on the performance of UBI’s Xprecia Prime coagulation device
- Universal Biosensors will use the results to apply for US FDA approval and it expects to lodge the application in the current quarter
- The study will be conducted at five clinical sites in the US
- Shares in UBI are up 9.62 per cent, trading at 28.5 cents as of 2:00 pm AEDT
Universal Biosensors (UBI) has completed enrolment for its “Xprecia Prime” prothrombin time (PT/INR) blood coagulation clinical study.
The company officially recruited the last patient of its 360-patient study which is designed to provide clinical evidence as to the performance and safety of Xprecia Prime.
Xprecia Prime is Universal Biosensors’ coagulation device which provides rapid PT/INR results.
The evidence will then be used in UBI’s 510K submission to the US Food and Drug Administration (FDA), which is expected to be lodged during the current quarter.
CEO John Sharman said completing enrolment is a key milestone for the future of UBI’s coagulation business after spending more than a decade developing its point-of-care coagulation platform.
“UBI’s existing coagulation product (Xprecia Stride) has insignificant sales in the US which represents about 50 per cent of the estimated global US$1 billion (A$1.4 billion) PT/INR market,” Mr Sharman said.
“We expect an approval to sell Xprecia Prime in the US will add significant value to our coagulation business into the future.”
The clinical study protocol was discussed at a FDA pre-submission meeting and patients were enrolled across the prescribed PT/INR measuring ranges.
The study will be conducted at five clinical sites in the US.
Shares in UBI were up 9.62 per cent, trading at 28.5 cents as of 2:00 pm AEDT.
