Why Outset Medical Shares Are Trading Lower Today

Outset Medical Inc OM implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA review and clearance of a 510(k).
The company submitted for changes made since the device's original March 2020 clearance.
Outset has not identified any safety issues with Tablo. It will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings.
Devices already distributed to home users have not been removed, and current users can continue working with their healthcare providers on appropriate treatment.
Related: Outset Medical's Tablo Hemodialysis System Cartridge Receives FDA Approval For Manufacturing In North America.
As a result of the shipment hold, Outset expects Q2 2022 revenue of at least $25 million.
The company anticipates an update on the status of the regulatory review process in Q3.
It will update its 2022 revenue and other financial goals during its next quarterly update in early August.
Until then, the company has suspended its prior guidance.
Price Action: OM shares traded 19.75% lower at $16.38 in premarket on the last check Tuesday.

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