Universal Biosensors, Inc (ASX: UBI) shares are having a day to remember on Tuesday.
At the time of writing, the ASX healthcare stock is up 72% to 27.5 cents.
Why is this ASX healthcare stock jumping?
Investors have been fighting to get hold of the medical device company's shares after it made a major announcement.
According to the release, Universal Biosensors has received FDA 510(k) and CLIA Waiver approval for its Xprecia Prime Coagulation Analyzer as a Class II device.
The Xprecia Prime Coagulation Analyzer is Universal Biosensors' second generation, new and improved coagulation monitoring device. Xprecia Prime fits into your palm, is portable, accurate, and easy to use.
The company advised that this approval allows it to sell Xprecia Prime into health care professional settings such as hospitals, clinics, and doctor's offices in the USA.
'Historic moment'
The ASX healthcare stock's CEO, John Sharman, was delighted with the news. He 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.
Sharman also highlights that this is the first time a coagulation device has been granted a CLIA Waiver. He adds:
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.
What now?
Sharman notes that the product has a huge addressable market and that revenue generation could be on way. He explains:
There are more than 6 million patients who take warfarin (coumadin) in the USA1 and more than 140 million2 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.
