At near 16-month highs shares of medical device firm Tandem Diabetes Care (TNDM 22.55, +2.24, +11.0%) trade markedly higher in reaction to last night’s approval by the U.S. Food and Drug Administration (FDA) of the company’s flagship t:slim X2 Insulin Pump with Basal-IQ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).
The company plans to launch its new product with Dexcom’s (DXCM 101.16, +1.42, +1.4%) G6 continuous glucose monitoring (CGM) integration, which requires no fingersticks for calibration or diabetes treatment decisions and was the first CGM device to receive the iCGM designation from the FDA earlier this year. Tandem expects the t:slim X2 Pump with Basal-IQ technology to be available in August 2018, and all in-warranty t:slim X2 users in the United States will have the option to add the new feature free of charge via remote software update.
One of the main attractions of the Dexcom G6 CGM integration, is that the Basal-IQ feature works with no fingersticks required for mealtime dosing or calibration. Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking, and the ability to share real-time CGM data with up to 5 followers.
Tandem’s Basal-IQ algorithm is designed to look 30 minutes into the future to predict where glucose levels are heading. The device suspends insulin delivery when low glucose is predicted, then automatically resumes insulin delivery once glucose levels begin to rise.
What this basically means is that TNDM’s pump is designed to both use insulin on a more optimized basis, and offer a ‘fingerstick’ free reading for diabetic patients. The approval is being seen as a gamechanger by many on the Street as the automated insulin system is the first of its kind to be approved by the FDA.
Shares are up nearly 840% over the past 26 weeks, and post gains north of 50% thus far in June.