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): October 4, 2016

 

Tandem Diabetes Care, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Registrant’s telephone number, including area code: (858) 366-6900

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:

 

 

 

 

 

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Item 8.01 Other Events

On October 4, 2016, we issued a press release announcing that we have begun to take orders for our next generation t:slim X2^TM insulin pump. The 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.

 

 

 

 

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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.

 

 

 

 

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INDEX TO EXHIBITS

 

 

 

 

 

 

 

Media Contact:

Steve Sabicer

714-907-6264

ssabicer@thesabicergroup.com

 

Investor Contact:

Susan Morrison

858-366-6900 x7005

smorrison@tandemdiabetes.com

 

FOR IMMEDIATE RELEASE

Tandem Diabetes Care Now Taking Orders for Next-Generation t:slim X2 Insulin Pump

San Diego, October 4, 2016 – Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced that it is now accepting orders for its next-generation t:slim X2™ Insulin Pump.  The t:slim X2 Pump boasts an advanced Bluetooth radio and is optimized for use with Tandem’s recently approved Tandem Device Updater, used to update software and add new features from a personal computer as they are approved by the Food and Drug Administration (FDA).¹ Shipments of the t:slim X2 Pump are expected to begin late October 2016.

“We are making rapid product development advancements, and the t:slim X2 Insulin Pump is the first and only available insulin pump that can be remotely updated to provide customers access to future features and technologies outside of the typical insurance pump replacement cycle,” said Kim Blickenstaff, president and Chief Executive Officer of Tandem Diabetes Care. “Integration with the Dexcom G5® Mobile continuous glucose monitoring system, and a predictive low glucose suspend (PLGS) algorithm, are among the first features we plan to release as remote software updates on the t:slim X2 platform.”

The t:slim X2 Pump is the newest addition to the Company’s family of innovative insulin pumps.  All Tandem pumps feature a high-contrast color touchscreen with a streamlined, user-friendly interface.  This provides people rapid access to frequently used features, while making these features simple to learn and simple to use.² Each Tandem product utilizes modern technology, such as a built-in rechargeable battery and micro-USB port for convenient charging and fast data transfers.

 

Additional features of the t:slim X2 Pump include:

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The t:slim X2 Pump will replace Tandem’s first-generation t:slim® Insulin Pump.  The Company will continue to support current t:slim Pumps, in addition to the t:slim G4™ and t:flex® Insulin Pumps.

The t:slim X2 Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater. An application for use in younger populations is currently under review by the FDA.

For additional product and safety information, or to begin the order process, visit www.tandemdiabetes.com/tslimX2

or call (877) 801-6901, Monday – Friday between 6am and 5pm Pacific Time

 

About the Tandem Device Updater

The Tandem Device Updater, cleared by the FDA in July 2016, is a tool for the remote update of Tandem insulin pump software from a personal computer. The first use of the Tandem Device Updater is to provide t:slim® Insulin Pumps purchased before April 2015 with a free update to the latest software features. This updated software began shipping on new t:slim Pumps as of April 2015 and includes a variety of product enhancements for convenience and flexibility. Future software improvements and enhancements for Tandem pumps will be implemented through the Tandem Device Updater as they are approved for commercial distribution.

 

Insulin Pump Use and Diabetes

Diabetes is a chronic, life-threatening disease that affects more than 29 million people in the United States, or nearly 1 in 10 Americans.  Tandem estimates that more than 3 million people in the United States require daily administration of insulin and are candidates for pump therapy. More than 425,000 Americans with type 1 diabetes use an insulin pump, or approximately 27% of the type 1 diabetes population. In addition, approximately 125,000 Americans with type 2 diabetes use an insulin pump, a small fraction of the type 2 diabetes population.

 

About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with diabetes who use insulin. The Company manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements, and the t:slim G4™ Insulin Pump, the first continuous glucose monitoring-enabled pump with touch-screen simplicity. Tandem is based in San Diego, California.

 

Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2, #tslimG4, #tflex, #tconnect, and $TNDM.

Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.

Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

 

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t:slim, t:flex, and Tandem Diabetes Care are registered trademarks, and t:slim X2 and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G5 are registered trademarks of Dexcom, Inc. All other trademarks are the property of their respective owners.

 

Forward Looking Statement

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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things: the anticipated commencement of shipments of the t:slim X2 Insulin Pump in late October 2016; the Company’s plans to complete the development and obtain regulatory approval of future features to release on the t:slim X2 platform as remote software updates, including integration with the Dexcom G5 Mobile CGM system and a PLGS algorithm; and the Company’s plans to utilize the Tandem Device Updater to update software and add new features to the t:slim X2 pump from a personal computer as they are approved by the FDA. These statements are subject to numerous risks and uncertainties, including the Company’s ability to commence commercial scale manufacturing of the t:slim X2 pump on a timely basis, the Company’s reliance on third-party suppliers the Company’s ability to source various product components in sufficient quantities that meet the Company’s quality requirements, the Company’s ability to complete the development of integration of the Dexcom G5 Mobile CGM and the PLGS algorithm with the t:slim X2 pump, the Company’s ability to utilize the Tandem Device Updater as intended, the Company’s ability to obtain regulatory approvals for future products and product features generally, as well as other risks identified in Tandem’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other documents that Tandem files with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.  

 

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