Tandem Diabetes Care Presents Findings From Predictive Low Glucose Suspend (PLGS) Feasibility Study And Announces Approval Of Investigational Device Exemption (IDE) For Pivotal Trial

SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today presented results from a feasibility study for its predictive low glucose suspend (PLGS) algorithm, designed to suspend insulin delivery when low blood sugar is predicted. The data was presented by Dr. Gregory Forlenza of the Barbara Davis Center for Diabetes during an oral abstract presentation at the 77^th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, CA.

“Our goal remains to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA later this year, and we continue to plan for launch of this product in early 2018, subject to FDA approval.”

The overnight, hospital-based study recruited 10 subjects with type 1 diabetes ages 18 to 30 years old at the Barbara Davis Center for Diabetes and Stanford University. Participants started on the PLGS system in the evening, and low glucose was induced via increased basal insulin overnight. The system performed as expected during the study, successfully suspending insulin delivery when continuous glucose monitoring (CGM) values were predicted to be below 80 mg/dL in the next 30 minutes, and subsequently resuming insulin when CGM values began to rise. No hypoglycemic events were observed during the study, defined as reference glucose values <60 mg/dL, and peak CGM values two hours after suspension averaged 91 mg/dl, reflecting normal glycemic control without rebound hyperglycemia.

“The Tandem predictive low glucose suspend algorithm was extremely effective in anticipating low blood sugar and modulating insulin delivery accordingly,” said Gregory Forlenza, MD, Assistant Professor of Pediatrics at the Barbara Davis Center for Diabetes. “The touchscreen on the Tandem pump was simple to read and interpret, and this algorithm requires minimal interaction to operate. Based on this study, we are enthusiastic about the potential for this product, and we look forward to seeing data from the upcoming pivotal trial.”

“The results from this feasibility study are very encouraging. The IDE for our pivotal trial, which will use the predictive low glucose suspend algorithm on a t:slim X2™ Pump with Dexcom G5® Mobile CGM integration, was approved by the FDA in May, and we look forward to starting enrollment soon,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “Our goal remains to submit our t:slim X2 Pump with predictive low glucose suspend to the FDA later this year, and we continue to plan for launch of this product in early 2018, subject to FDA approval.”

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 touchscreen simplicity. Tandem is based in San Diego, California.

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Tandem Diabetes Care is a registered trademark, 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 include statements regarding the Company’s plans to commence enrollment in the pivotal trial for the PLGS algorithm soon, submit the PLGS algorithm to the FDA later this year and launch the product in early 2018. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including the Company’s ability to coordinate and implement the appropriate training of personnel at each clinical trial site for the performance of the study, the Company’s reliance on third parties to commence the enrollment for the clinical trial when anticipated and to devote sufficient resources to the completion of the study, the Company’s ability to successfully complete clinical trials for new products when anticipated (or at all), the potential that the results of any such clinical trials may not be sufficient to support regulatory approvals for new products as anticipated and the Company’s ability to obtain regulatory approvals for future products and product features generally. Other risks and uncertainties are identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other documents that the Company 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.