Outset Medical Announces Shipment Hold on New Tablo Systems for Home Use Pending FDA Review and Clearance of Recent 510(K) Submission
Investor Webcast and Conference Call Scheduled for
Outset has not identified any safety issues with Tablo. The company will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings. Devices that are already distributed to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment.
As a result of the shipment hold, Outset now expects second quarter 2022 revenue of at least
Webcast and Conference Call Details
Outset will host a conference call today at
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s possible or assumed future results of operations and financial position, including expectations regarding projected revenues, statements regarding the Company’s shipment hold of new Tablo shipments for home use including anticipated impacts thereof and potential timing for resuming such shipments and statements regarding the Company’s anticipated regulatory review and approval timeline and process. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release include the Company’s ability to obtain necessary clearances or approvals for its products on a timely basis or at all, as well as other factors which can be found in the Risk Factors section of Outset’s public filings with the
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime and anywhere. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of