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Outset Medical Inc (NASDAQ:OM) shares plummeted more than 21% after-hours Monday following the company’s announcement, according to which it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the FDA’s review and clearance of recent 510(k) submission.
The company now expects Q2/22 revenue of at least $25 million due to the shipment hold. An update on the status of the regulatory review process is expected in Q3. The company will provide an update on its 2022 revenue and other financial goals during its next quarterly update in early August. Until then, it has suspended its prior guidance.
The company has not identified any safety issues with Tablo and will continue to market and ship it for use by healthcare professionals in chronic and acute care settings. Already distributed devices to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment.
