Outset Medical Announces Shipment Hold on New Tablo Systems for Home Use Pending FDA Review and Clearance of Recent 510(K) Submission
14 June 2022 - 6:01AM
Business Wire
Investor Webcast and Conference Call
Scheduled for 5:00 p.m. EST
Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “company”)
today announced it has implemented a shipment hold on the
distribution of its Tablo Hemodialysis System for home use pending
the Food and Drug Administration’s (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. 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 $25 million. The company
anticipates an update on the status of the regulatory review
process in the third quarter and to provide an update to its 2022
revenue and other financial goals during its next quarterly update
in early August. Until then, the company has suspended its prior
guidance.
Webcast and Conference Call Details
Outset will host a conference call today at 2:00 p.m. PT/ 5:00
p.m. ET to discuss today’s updates. The dial-in numbers are (833)
614-1409 for domestic callers and (914) 987-7130 for international
callers. The conference ID is 9710708. A live webcast of the
conference call will be available on the Investor Relations section
of the Company's website at https://investors.outsetmedical.com.
The webcast will be archived on the website following the
completion of the call.
Forward-Looking Statements
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 Securities and Exchange Commission,
including Outset’s latest annual and quarterly reports. Because
forward-looking statements are inherently subject to risks and
uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of their date and, except to the extent
required by law, the Company undertakes no obligation to update
these statements, whether as a result of any new information,
future developments or otherwise.
About Outset Medical, Inc.
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 Outset Medical, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20220613005756/en/
Investor Contact Jim Mazzola 858-342-8272
jmazzola@outsetmedical.com
Media Contact Nicole Shannon
nshannon@outsetmedical.com
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