Tandem Diabetes Care Inc. filed SEC Form 8-K: Other Events
$TNDM
Medical/Dental Instruments
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2025
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Registrant’s telephone number, including area code: (858 ) 366-6900
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Item 8.01. Other Items
On May 9, 2025, SteadiSet Infusion Set (SteadiSet) received 510(k) clearance from the United States Food and Drug Administration (FDA) for up to three days of use. SteadiSet is a wearable infusion set that delivers insulin from an insulin pump to the body and features an integrated inserter with a hidden needle designed for one-handed insertion. SteadiSet is designed to provide adult patients with Type 1 diabetes continuous insulin delivery during the indicated use period. The submission was made by Capillary Biomedical, LLC (CapBio), a wholly owned subsidiary of Tandem Diabetes Care, Inc. (the Company). The Company intends to submit, through CapBio, a separate 510(k) submission to the FDA to extend the indicated use time of SteadiSet to up to seven days. Commercial activities for SteadiSet are not anticipated to start until after FDA clearance of the extended use time.
Forward-Looking Statements
This report 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. These forward-looking statements relate to the intended submission of a separate 510(k) notification in support of SteadiSet Infusion Set for up to seven days of use, and the anticipated timing for commercial activities. These forward-looking statements are subject to numerous risks and uncertainties, including risks associated with a 510(k) notification submission and FDA clearance, the risk that we may encounter other challenges that may delay commercial launch, risks related to the competitive landscape, and other risks identified under the “Risk Factors” heading of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or review any forward-looking statement in this report because of new information, future events or other factors.
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| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Tandem Diabetes Care, Inc. | ||||||||
| By: | /s/ SHANNON M. HANSEN | |||||||
| Shannon M. Hansen | ||||||||
| Executive Vice President, Chief Legal, Privacy & Compliance Officer and Secretary | ||||||||
Date: May 12, 2025
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