false0001438133 0001438133 2019-12-13 2019-12-13



 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
____________________________
FORM 8-K
____________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 13, 2019
 
____________________________
Tandem Diabetes Care, Inc.
(Exact name of registrant as specified in its charter)
 
___________________________
 
Delaware
001-36189
 
20-4327508
(State or other jurisdiction
of incorporation)
(Commission
File Number)
 
(I.R.S. Employer
Identification No.)
11075 Roselle Street
 
 
92121
San Diego
California
 
 
(Zip Code)
(Address of principal executive offices)
 
 
 
 Registrant’s telephone number, including area code: (858366-6900
N/A
(Former name or former address, if changed since last report)
____________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Symbol
Name of Exchange on Which Registered
Common Stock, par value $0.001 per share
TNDM
NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
____________________________



Item 8.01    Other Events.

On December 13, 2019, the U.S. Food and Drug Administration (FDA) cleared our t:slim X2TM insulin pump with Control-IQTM technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL), and the first system cleared to deliver automatic correction boluses in addition to adjusting insulin delivery to help prevent high and low blood sugar.

On December 13, 2019 we issued a press release announcing the FDA clearance and planned commercial launch of the t:slim X2 insulin pump with Control-IQ technology. The accompanying press release is attached hereto as Exhibit 99.1 and is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 9.01    Financial Statements and Exhibits

(d)     Exhibits.

 Number
 
Description
 
 
 
99.1
 
 
 
 






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/ David B. Berger
 
 
David B. Berger
 
 
Executive Vice President, Chief Legal & Compliance Officer
Date: December 13, 2019
 




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