ANGLE PLC (AIM:AGL, OTCQX:ANPCY) said it is in ‘regular and constructive’ dialogue with the US regulator as it awaits approval for its liquid biopsy technology.
It is initially seeking sign-off from the Food & Drug Administration for its Parsortix system to be used to assess women with metastatic breast cancer.
Additional information requests supporting the De Novo application have been made by the FDA with dialogue described as ‘constructive and supportive’.
“Importantly, both pharma services and research use product sales are expected to accelerate should the company receive FDA clearance of the Parsortix system,” said ANGLE.
The comment was made as the company weighed in with results for 2021 – a period in which the company opened clinical laboratories in the UK and the US and launched its pharma services business.
In that time it has processed over 26,000 samples using Parsortix, which is able to capture circulating tumour cells for analysis by doctors and researchers.
Its £1mln of revenues for the 12 months ended December 31 came mainly from the research use of the liquid biopsy system.
As is common for companies at the very start of the commercial journey, ANGLE was lossmaking in 2021 – to the tune of £15mln.
However, it exited the period with almost £32mln in the bank after raising £20mln last summer.