Universal Biosensors, Inc. Sees Surge in Shares Following FDA Approval for Xprecia Prime

Universal Biosensors, Inc. (ASX: UBI) experienced a remarkable intra-day surge in its share price today, reaching $0.30, after the Federal Drug Administration’s (FDA) approval to market Xprecia Prime in the U.S.

The Xprecia Prime Coagulation Analyzer, a compact coagulation monitoring device designed to fit in the palm of one’s hand, received FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval as a Class II device.

The CLIA Waiver enables laboratories, not necessarily medical facilities, to conduct specific tests for patients sanctioned by the FDA.

Notably, this marks the first instance where the FDA has granted a CLIA Waiver by Application for any coagulation device.

Xprecia Prime is poised to be distributed in healthcare professional settings and CLIA-waived facilities, including hospitals, clinics, and doctor’s offices.

The approval encompasses the full measuring range of 0.8 – 8.0 INR for both 510(k) and CLIA Waiver.

Having already been available in Europe for two years, the device is crucial in monitoring the dosage of vitamin K antagonists in patients to ensure safety and efficacy, with potential dangerous bleeding events or thrombosis risks if the dosage exceeds or falls short of the required levels.

CEO John Sharman expressed his enthusiasm, stating, “The FDA’s unrestricted access approval to all clinics and hospitals across the USA is a significant milestone for us,” highlighting the vast market opportunity with over 6 million warfarin (coumadin) patients in the USA, resulting in over 140 million PT/INR test strips sold annually.

Sharman further anticipates that Xprecia Prime will qualify for reimbursement under the existing codes used by Medicare, Medicaid, and US Health insurers.

With a robust pipeline of sales and distribution contracts currently under negotiation, Sharman expects substantial revenue generation for the company following FDA approval.

Universal Biosensors has introduced six new products in the last 12 months, bolstering its portfolio of 11 revenue-generating assets.

The surge in share price is likely to fuel momentum for the ongoing capital-raising efforts, amounting to approximately A$12.5 million.

The capital raising comprises an underwritten pro-rata non-renounceable entitlement offer of new CDIs, as well as a non-underwritten placement to institutional and sophisticated investors.

Universal Biosensors anticipates issuing new CDIs at a price of A$0.15, with provisions for oversubscriptions.

 

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