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TNDM

TNDM

09:18
01/08/18
01/08
09:18
01/08/18
09:18

Tandem Diabetes reports successful completion of t:slim X2 Insulin Pump study

Tandem Diabetes Care reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2 Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom G6 Continuous Glucose Monitoring. This pilot study was the first of three in the National Institute of Health-funded International Diabetes Closed Loop Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in 1Q18. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration. The hybrid closed loop system predicts high and low blood sugar levels and adjusts insulin delivery accordingly throughout the day, while still allowing the user to manually bolus for meals. In addition to basal insulin adjustments, the system also automates correction boluses. The hybrid closed loop software developed by TypeZero includes a series of algorithms developed from initial research conducted at the University of Virginia. To date, this technology has been used in more than 30 clinical studies involving more than 450 participants, with data referenced in a number of journal articles.The IDCL Trial started in late 2016 and is expected to include up to 360 adults with type 1 diabetes across all of its studies. Earlier phases of the IDCL used a Tandem insulin pump and Dexcom G5 sensor as part of a blood glucose control system that combined these devices with a smartphone running TypeZero's inControl closed loop algorithms. The latest series of studies, now using the fully-integrated system, began with the supervised 36 to 48-hour pilot study in 5 subjects conducted at the University of Virginia. The next study, scheduled to take place in early 2018, will be a two-week, at-home study with enrollment at seven centers across the U.S. A pivotal trial is planned to take place at these same centers following successful completion and review of the two-week study.

TNDM TNDM

10/05/17
PIPR
10/05/17
NO CHANGE
PIPR
J&J exit from insulin pumps a 'clear win' for Medtronic, says Piper Jaffray
After Animas, one of Johnson & Johnson's (JNJ) companies, announced that it intends to discontinue the manufacturing and sale of insulin pumps and selected Medtronic (MDT) as its transition partner, Piper Jaffray analyst Matt O'Brien called the news a "clear win" for Medtronic. For DexCom (DXCM), which has partnered with Animas, this decision is likely a modest negative, while Insulet (PODD) and Tandem (TNDM) may be able to capture some share from Animas pump patients who look for other therapeutic options, added O'Brien.
10/05/17
COWN
10/05/17
NO CHANGE
COWN
J&J exit 'great opportunity' for Insulet and Tandem, says Cowen
Cowen analyst Doug Schenkel says close to 10% of the U.S. insulin pump market is up for grabs over the next two years after Johnson & Johnson's (JNJ) Animas announced it is exiting the pump business. Medtronic (MDT) is likely to get the majority of patients initially, but the news is a "great opportunity" for Insulet (PODD) and Tandem Diabetes Care (TNDM), Schenkel tells investors in a research note. The analyst sees risk for Dexcom (DXCM), but believes the vast majority of its users will remain, regardless of pump choice.
10/10/17
WEDB
10/10/17
NO CHANGE
Target $17
WEDB
Outperform
Tandem Diabetes price target lowered to $17 from $50 at Wedbush
Wedbush analyst Tao Levy lowered his price target for Tandem Diabetes to $17 from $50 to reflect the risk of further dilution as it seeks to improve its cash position. He reiterates an Outperform rating on the shares.
11/21/17
PIPR
11/21/17
NO CHANGE
PIPR
Piper says selection for Lilly 'diabetes ecosystem' a clear positive for Dexcom
Piper Jaffray analyst Matt O'Brien said it was news to him that Eli Lilly (LLY) is developing a diabetes pump and smart pen as part of its "diabetes ecosystem" plans. The company's selection of Dexcom's (DXCM) CGM as part of their integrated system is a clear positive for Dexcom, while Lilly's launch of an integrated system in the U.S. market is a modest negative for Insulet (PODD) and Tandem Diabetes (TNDM) given it will create a competitive headwind starting in 2021, added O'Brien.

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