Universal Biosensors FDA Approval Announcement

Universal Biosensors, Inc. (ASX: $UBI) has achieved a significant milestone by securing FDA 510(k) and CLIA Waiver approval for its Xprecia Prime Coagulation Analyzer as a Class II device. This approval enables UBI to market Xprecia Prime in healthcare professional settings, including hospitals, clinics, and doctor's offices in the USA, with a full measuring range of 0.8 - 8.0 INR for both 510(k) and CLIA Waiver.

Executive Commentary on FDA Approval

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 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. There are more than 6 million patients who take warfarin (coumadin) in the USA and more than 140 million PT/INR test strips are sold each year. This FDA approval represents the first opportunity in UBI's history to access the lucrative (and fully reimbursed) USA market. Our expectation is Xprecia Prime will qualify under the existing reimbursement codes used by Medicare, Medicaid and USA Health insurers. UBI has a pipeline of sales and distribution contracts already in negotiation and now that we have FDA approval we expect to conclude some, if not all of these contracts, win market share and generate substantial revenue for the company.

Summary of FDA Approval and Outlook

Universal Biosensors, Inc. (ASX: $UBI) has successfully obtained FDA 510(k) and CLIA Waiver approval for its Xprecia Prime Coagulation Analyzer, marking a pivotal moment in the company's history. The approval grants UBI access to the lucrative USA market, with the potential to cater to over 6 million patients taking warfarin in the USA. With more than 140 million PT/INR test strips sold annually, the FDA approval presents a significant revenue opportunity for UBI. The company anticipates that Xprecia Prime will qualify for reimbursement under existing codes used by Medicare, Medicaid, and USA Health insurers. UBI's pipeline of sales and distribution contracts, coupled with the FDA approval, positions the company to secure market share and generate substantial revenue. The outlook for UBI appears promising as it embarks on leveraging this milestone to drive its corporate strategy and expand its presence in the USA market.