One of the best performers on the Australian share market on Tuesday was the LBT Innovations Limited (ASX: LBT) share price.
The medical technology company's shares finished the day a massive 136% higher at 16.5 cents but were as much as 243% higher to 24 cents at one stage.
Why did the LBT Innovations share price rocket 243% higher?
Investors were fighting to get hold of the company's shares yesterday after it announced that its 50%-owned joint venture company, Clever Culture Systems, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its APAS Independence instrument with associated urine analysis module.
According to the release, the FDA clearance is the final regulatory milestone for the instrument, meaning Clever Culture Systems can now commence with sales in the United States.
Management believes that the APAS Independence instrument is the only commercially available instrument for the automatic reading of culture plates in the United States.
In light of this milestone being achieved, the Clever Culture Systems business will now bring forward its US commercialisation and sales activities.
What is the APAS Independence instrument?
The release explains that APAS Independence is a fully automated instrument with the ability to process over 200 culture plates per hour. This is at least three times faster than manual culture plate reading.
The instrument can differentiate culture plates showing bacterial growth from those that are not, without the need for highly skilled microbiologist assistance.
This is key to the clinical utility of the instrument that enables the instrument to be truly autonomous, and without the need for further intervention.
What is the market opportunity?
There are over 5,000 clinical laboratories in the United States, making it the single largest pathology market in the world.
Management estimates that there are more than 1,500 laboratories in this market that exceed the daily culture plate volume that would make the commercial return on investment for the purchase of an APAS Independence attractive.
Previous presentations have suggested a purchase price of ~US$300,000 for APAS Independence, which would make its target market worth around US$450 million.
Elsewhere in the medtech industry on Tuesday, the Nanosonics Ltd (ASX: NAN) share price dropped 4.5% and the Pro Medicus Limited (ASX: PME) share price fell just over 2%.
