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Benzinga
Benzinga
Business
Vandana Singh

Why Outset Medical Shares Are Trading Lower Today

  • Outset Medical Inc (NASDAQ:OMimplemented 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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