"Reducing the risk of hypoglycemia has been the most requested feature of automated insulin delivery in our market research, due to the severity of the complications when left untreated. The data from this study supports our mission to improve the lives of people with diabetes through new innovations, such as the t:slim X2 Pump with Basal-IQ technology," said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. "These results will support a PMA submission that we are on track to submit this quarter, and we continue to prepare for a launch in summer of 2018, pending FDA review and approval."About the PROLOG Study The PROLOG study was a multi-center, randomized crossover clinical trial comparing two 3-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension. The study included 103 participants with type 1 diabetes age 6 to 72 at four research centers across the United States and was coordinated by the Jaeb Center for Health Research in Tampa, Florida. The mean A1C of participants entering the study was 7.3 percent, with the majority already using a pump (83%) and/or CGM (84%). The primary endpoint of the study was to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem's PLGS feature. About Tandem Diabetes Care, Inc. Tandem Diabetes Care, Inc. ( www.tandemdiabetes.com) is a medical device company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experience. The Company takes an innovative, user-centric approach to the design, development and commercialization of products for people with diabetes who use insulin. Tandem manufactures and sells the t:slim X2™ Insulin Pump, the only pump capable of remote feature updates using a personal computer, now available with Dexcom G5® Mobile CGM integration, and the t:flex® Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California. Tandem Diabetes Care and t:flex are registered trademarks, and t:slim X2 is a trademark 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 StatementThis 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, whether the data from the PROLOG study will be adequate to support a future regulatory filing by Tandem, the anticipated timing of a PMA submission for the t:slim X2 with BASAL-IQ and the planned launch of t:slim X2 with BASAL-IQ in the summer of 2018. These statements are subject to numerous risks and uncertainties, including the risk that the data from the PROLOG study may not be adequate to support a future regulatory approval of the t:slim X2 with BASAL-IQ, that the approval of the t:slim X2 with BASAL-IQ may not occur when expected or that Tandem may encounter other challenges that may delay the commercial launch of t:slim X2 with BASAL-IQ, as well as other risks identified in Tandem's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, respectively, and other documents that we file 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 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.