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): July 26, 2016
Tandem Diabetes Care, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36189 |
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20-4327508 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer |
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11045 Roselle Street, San Diego, CA |
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92121 |
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(Address of principal executive offices) |
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(Zip Code) |
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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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On July 26, 2016, we issued a press release announcing U.S. Food and Drug Administration (FDA) clearance of an expanded pediatric indication for the t:slim® Insulin Pump, lowering its approved use to children age 6 and older from children age 12 and older. The press release announcing the FDA approval 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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Description |
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99.1 |
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Press release of Tandem Diabetes Care, Inc. dated July 26, 2016. |
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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Tandem Diabetes Care, Inc. |
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Date: July 26, 2016 |
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/s/ David B. Berger |
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David B. Berger |
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Executive Vice President, General Counsel and Secretary |
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Number |
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Description |
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99.1 |
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Press release of Tandem Diabetes Care, Inc. dated July 26, 2016. |
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Exhibit 99.1 |
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® Announces Expanded Pediatric Indication of
t:slim® Insulin Pump for Ages 6 and Older
San Diego, July 26, 2016 – Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and the manufacturer of the t:slim®, t:slim G4™ and t:flex® Insulin Pumps, today announced FDA clearance of an expanded pediatric indication for the t:slim® Insulin Pump, lowering its use to children age 6 and older from children age 12 and older. The t:slim Pump is the first and only touchscreen insulin pump cleared by the U.S. Food and Drug Administration. This expanded pediatric indication applies to the current t:slim Pump features, with no changes to the existing user interface.
“The t:slim Pump has the look and feel of a modern consumer device, which we believe makes it especially well-suited for school-aged children who have grown up in a world of smartphones and tablets,” said Kim Blickenstaff, president and Chief Executive Officer of Tandem Diabetes Care. “This FDA clearance allows us to share this product with a broader group of children with diabetes and their parents, who we think can benefit greatly from our technology.”
The t:slim Pump consistently ranks #1 by pump users in independent patient surveys1. The streamlined, user-friendly interface provides rapid access to the features people use most, eliminating the need for excessive scrolling and button pressing.
Some of the features of the t:slim Pump that stand out most to parents and younger users include:
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Small Size – The t:slim Pump is smaller than other durable pumps making it easy to wear, yet holds up to 300 units of insulin so it can keep up with a child’s changing insulin needs. |
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Durability – The t:slim Pump is made of aluminum, which is extremely durable and light, and the touchscreen is made of high-grade, shatter-resistant glass. The pump is also watertight, so you don’t have to worry about accidental dunks and splashes.2 |
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Insulin on Board (IOB) Calculations – The t:slim Pump tracks the amount of insulin that is still active in the body from previous boluses and uses this information to calculate future boluses. This helps prevent “stacking” insulin doses which can cause low blood sugar (hypoglycemia). |
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Personal Profiles – Up to six personal profiles can be created with unique names to cover a wide variety of situations, including school days, sleepovers, weekends or sport practice. |
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Missed Meal Bolus Reminder – This reminder can be set up to watch for boluses at specific times of day, and trigger a reminder if no bolus is delivered. This is especially helpful for children who may forget to bolus when they are away from home, such as during school lunch periods. |
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Site Reminder – This reminder is a programmable setting that reminds the user when it is time to change their infusion set. A specific time and date can be set for the reminder, which can be very useful for busy families on the go. |
For more information about the t:slim Pump, or to find out about insurance coverage options, please call 877-801-6901, Monday – Friday, 6am – 5pm Pacific Time.
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® 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 CGM-enabled pump with touch-screen simplicity. Tandem is based in San Diego, California.
t:slim, t:flex, and Tandem Diabetes Care are registered trademarks, and t:slim G4 is a trademark of Tandem Diabetes Care, Inc.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim, #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.
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, our belief that the t:slim Insulin Pump is well-suited for school-aged children and that younger members of the diabetes community and their parents can benefit from our technology. These statements are subject to numerous risks and uncertainties, including the ability of younger children and their parents to understand the features made available by t:slim and the potential impact of those
features on diabetes treatment decisions, and their ability to operate t:slim in accordance with applicable operating instructions, 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.
1 dQ&A USA Connections Surveys 2013-2015.
2 IPX7 rating, tested to 3 feet of water for 30 minutes.
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