Outset Medical has announced clearance by the US Food and Drug Administration (FDA) of its previously disclosed 510(k) submission and resumption of Tablo haemodialysis system shipments for home use.
The company also reported financial results for the second quarter ended 30 June 2022 and provided financial guidance for 2022. Revenue for the second quarter totalled US$25.1 million, in line with guidance provided on 13 June 2022. Gross margin for the second quarter was 15.1%, compared to 4.2% in the second quarter of 2021 and 14.5% in the first quarter of 2022.
“We are pleased to begin supporting new patients in the home again and helping them achieve autonomy and control over where and when they dialyse,” said Leslie Trigg, chair and chief executive officer. “As we look to the second half of the year, we see no change in underlying demand for Tablo. However, we have reflected in our guidance the staffing and inflationary pressures our provider customers are facing, as well as the work we need to do to regain commercial momentum following release of the Tablo ship hold.”