Outset Medical (Nasdaq: OM) stock lost about a third of its value today – a day after the company announced it was withholding shipments of its Tablo hemodialysis system for home use.
OM shares were down more than 31% at $13.88 apiece at midday today. mass deviceit is MedTech 100 Indexwhich includes shares of the world’s largest medical device companies, fell slightly.
The San Jose, Calif.-based company said the shipping suspension was the result of FDA review and clearance pending a 510(k) submission for changes made since the release. initial authorization of the Tablo system in March 2020.
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 previously distributed devices from the home, and current users can continue to work with their healthcare providers on appropriate treatment.
Due to the shipping suspension, Outset Medical suspended its previous guidance and said it now expects second-quarter revenue of at least $25 million; Wall Street analysts expected $34.1 million.
Outset Medical expects an update on the regulatory review process in the third quarter, with plans to update its full-year guidance in early August.