Universal Biosensors receives FDA approval for its blood coagulation device

Aussie biosensor company Universal Biosensors (ASX: UBI) has received the US FDA 510(k) and CLIA Waiver approval for its Xprecia Prime Coagulation Analyzer as a Class II device.

Xprecia Prime is a portable coagulation monitoring device that provides fast and accurate PT/INR testing (measuring how long it takes for blood to clot) specifically for patients on vitamin K antagonist oral anticoagulation therapies like Warfarin.

The approval enables UBI to distribute Xprecia Prime to healthcare settings, including hospitals, clinics, and doctor’s offices in the USA. It allows for PT/INR testing across the full range of 0.8 – 8.0 INR (international normalised ratio) for both 510(k) clearance and CLIA Waiver. Medical devices are typically considered Class II, posing a moderate to high risk to patients.

UBI CEO John Sharman said, “Approval to sell Xprecia Prime in the USA is a historic moment for UBI. It represents more than 10 years of research & development work and many millions of dollars of investment. This is the first time the FDA have granted a CLIA Waiver by Application to any coagulation device, and it is [a] testament to the performance of Xprecia Prime. The number of PT/INR tests performed in clinics is the largest part of the USA market so to have won unrestricted access to all clinics and hospitals across the USA is a major achievement.”

In the USA, over six million patients are prescribed warfarin (Coumadin), with annual sales of more than 140 million PT/INR test strips. This FDA approval marks UBI’s inaugural entry into the lucrative US market, which is fully reimbursed. 

Universal Biosensors anticipate that Xprecia Prime will qualify for reimbursement under existing Medicare, Medicaid, and private health insurance codes. UBI is currently in talks for sales and distribution agreements.

In CY24, UBI plans on raising about $12.5 million in capital to support its ongoing product development, working capital needs, and ongoing costs related to Xprecia Prime’s American entry. 

In CY24, the Company reported revenue of $6.6 million against a loss of $6.7 million. This loss is a major improvement on its CY22 loss of $26.8 million. UBI experienced strong sales growth across the portfolio, marking its first $1m+ sales month in December 2023.

Besides making products for the medical industry, Universal Biosensors also has a Sunday brunch-esque endeavour—a wine tester. UBI’s Sentia is a portable testing device that is changing laboratory testing in the wine industry by providing medical-grade biosensor technology. It accurately measures six key compounds in wine—Free SO2, Glucose, Fructose, Malic Acid, Acetic Acid, and Titratable Acidity—delivering major cost savings and productivity gains to the global wine industry which would otherwise require testing via a laboratory.

Th Company also has Petrackr, a blood glucose monitoring product for dogs and cats with diabetes globally. Prior to Xprecia Prime, there was Xprecia Stride—UBI’s initial PT/INR monitoring device, initially introduced by Siemens in 2015 and later distributed by UBI starting in the first half of 2021. Xprecia Prime is its second-generation device. It obtained European approval in February 2022 and commenced sales in the first half of 2022. 

Now, with the US FDA approval, the Company is ready to launch the commercial sale of its blood coagulation device. Next on the agenda? Detecting heavy metals and other impurities in water.