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Flying Brands on track for commercial roll-out of StoneChecker software later this year

The medical imaging specialist said it is “excited” for the rest of the year, with approval from US regulators for its StoneChecker software expected soon
kidney x ray
Flying Brands in now revenue producing following the acquisition of Imaging Biometrics

Flying Brands Ltd (LON:FBDU) has a “high expectation” that US regulators will give the thumbs-up to its kidney stone medical imaging software StoneChecker.

The company is awaiting clearance from the US Food and Drug Administration, which is expected in the “near term”.

WATCH: Flying Brands' David Smith on product pipeline and Stonechecker FDA application

Once approved, the group aims to launch the software in the US, India and China by the end of the year while commercial sales in the UK are expected to begin in the fourth quarter.

To support the commercial roll-out of the kidney stone analysis programme, which received European CE clearance last December, Flying Brands raised £500,000 through a share placing over summer.

Away from StoneChecker, Flying Brands snapped up Imaging Biometrics back in March, which it has described as a “major move” into the growing medical imaging market.

US-based IB, which has been managing the CE marking and US FDA clearance process for StoneChecker, specialises in the design and manufacture of advanced visualisation software solutions using quantitative imaging endpoints/biomarkers.

Importantly, the acquisition means Flying Brands is now a revenue producing business.

In the six months through to the end of June, sales came in at £126,000 (H1 17: nil), although pre-tax losses widened to £371,000 (H1 17: £281,000) reflecting the StoneChecker approval process.

IN-DEPTH: Flying Brands

“When I was approached by Flying Brands to become their COO, and the CEO of their operating businesses, what immediately struck me was the opportunity to be the architect in the way that healthcare is delivered,” said operating chief executive David Smith, who joined last month.

“This is an opportunity for a leap in healthcare, not the creeping change I have previously successfully delivered.”

Shares were flat at 2.4p on Monday morning.

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