Outset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use.
OM shares were down more than 31% to $13.88 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.
The San Jose, California–based company said the shipment hold was the result of a pending FDA review and clearance of a 510(k) submitted for changes made since the Tablo system’s original March 2020 clearance.
Outset Medical said it has not identified any safety issues with Tablo — and will continue to ship the device for use in chronic and acute healthcare settings. The company has not removed already distributed devices from home, and current users can continue to work with their healthcare providers on appropriate treatment.
As a result of the shipment hold, Outset Medical suspended prior guidance and said it now expects Q2 revenue of at least $25 million; Wall Street analysts had expected $34.1 million.
Outset Medical expects an update on the regulatory review process in Q3, with plans to update its full-year guidance in early August.