Ann: US FDA Grants Approval for APAS-LBT.AX, page-242

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LBT soars after US FDA approves its plate assessment system
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An automated imaging and analysis system which can ''read'' microbiology culture plates faster than a human is behind a sharp jump in the share price of LBT Innovations. Jamie Smetkowski

by Simon Evans
Shares in medical technology firm LBT Innovations surged on Monday after the company received an important approval from the United States.
The group is headed by Brent Barnes, who joined as chief executive in August after 11 years at Cochlear, the cochlear implant firm which has a market capitalisation of $8 billion.
LBT Innovations is a small fish in comparison with a market capitalisation of just $40 million.
Its shares soared on Monday by 95 per cent to 37¢, from a previous close of 19¢, after it told the market its automated plate assessment system had received clearance from the US Food and Drug Administration. The spike, to the stock's highest point in nine years, took gains in the past year to 164 per cent.

Mr Barnes said on Monday that the FDA had established a new category for the approval because there was no other device like it.
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"This is a brand-new indication the FDA has now created," he said.
LBT Innovations is in a joint venture with Swiss firm Hettich known as Clever Culture Systems, which has gained the FDA clearance.
Two-part process

The Automated Plate Assessment System enables microbiology labs to diagnose and report infectious diseases much faster than human microbiologists who are analysing culture plates after incubation.

Mr Barnes wouldn't comment specifically on how much faster the automated system was than humans.
"It automates a manual process that a microbiologist does," Mr Barnes said. It consists of a two-part process. The first is an imaging station and the second is "clever" software which is able to determine colony growth on a culture plate in the laboratory.
Mr Barnes said the joint venture was in talks with several diagnostic companies about potential distribution. "We are in discussions with several global diagnostics companies," he said.
Mr Barnes took up the role as chief executive of LBT in early August. He was previously general manager of Asian Growth Markets for Cochlear and during his 11-year career with that company was based in both Singapore and the United States.

He said it had always been his ambition to be a chief executive at some point in his career and he had been lured across by the substantial opportunities at LBT.
"The CEO thing is relevant. It was also the opportunity to lead a company with such exciting technology and opportunities," he said.
Mr Barnes said the former Cochlear chief executive Chris Roberts, who stepped down in 2015 from that role after 11 years, had been a role model.
"He's a bit of a mentor for me," Mr Barnes said.