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SAN DIEGO - Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a prominent insulin delivery and diabetes technology company with a market capitalization of $2.13 billion and revenue growth of 10.75% over the last twelve months, announced today that their latest automated insulin delivery (AID) algorithm, Control-IQ+ technology, has received clearance from the U.S. Food and Drug Administration (FDA) for use in adults with type 2 diabetes aged 18 and over. According to InvestingPro data, the company maintains strong liquidity with a current ratio of 2.9, though it faces near-term profitability challenges. Control-IQ+, which is already approved for type 1 diabetes, is an enhancement of the existing Control-IQ algorithm and has been adapted to consider a broader range of weight and total daily insulin dosages. The company expects to make the technology available to both new and current customers in the U.S. in March 2025.
Control-IQ+ is designed to work with Tandem’s insulin delivery systems, the t:slim X2 and Tandem Mobi, which aim to deliver improved glycemic control. Studies, including those published in the New England Journal of Medicine, have shown that the technology can lead to better glycemic management, more time in the desired blood sugar range, and improved sleep for type 1 diabetes patients. InvestingPro analysis indicates the company is currently trading near its Fair Value, with 9 analysts recently revising their earnings expectations downward. Subscribers can access 7 additional ProTips and comprehensive financial analysis on the platform.
The FDA’s decision is based on a pivotal trial involving over 300 individuals with type 2 diabetes. The study compared the use of the t:slim X2 pump equipped with Control-IQ+ technology to a control group using multiple daily injections. Both groups were monitored with the Dexcom (NASDAQ:DXCM) G6 Continuous Glucose Monitoring System throughout the trial. With the company’s next earnings report scheduled for February 26, 2025, investors can access detailed analysis and forecasts through InvestingPro’s comprehensive Research Report, one of 1,400+ available for top US stocks. The complete results of this study will be presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes in Amsterdam, the Netherlands, in March 2025.
Dr. Jordan Pinsker, Chief Medical (TASE:BLWV) Officer, highlighted the significance of providing this advanced technology to the millions of Americans with type 2 diabetes, many of whom rely on intensive insulin therapy. The expansion of Control-IQ+ to type 2 diabetes patients represents Tandem’s commitment to improving diabetes management options for a population with historically limited choices.
This news is based on a press release statement from Tandem Diabetes Care, Inc. The company cautions that the forward-looking statements in the press release are subject to various risks and uncertainties and that actual results may differ from those projected. The safety information provided by Tandem emphasizes that Control-IQ+ is not intended for use by individuals under certain age thresholds or those requiring very low daily insulin doses. Users are advised to follow the instructions for each component of the system to avoid potential risks of hypoglycemia or hyperglycemia.
In other recent news, Tandem Diabetes Care has been the subject of several notable developments. The company has reported strong third-quarter sales, surpassing expectations by approximately 9%, and demonstrated solid gross profit results, according to Morgan Stanley (NYSE:MS). This financial performance has led Morgan Stanley to upgrade Tandem Diabetes from Equalweight to Overweight, setting a price target of $45. Meanwhile, TD Cowen maintained a Buy rating on the stock but adjusted its price target to $40, citing future growth opportunities in 2025.
Tandem Diabetes is preparing to submit its application for a type 2 diabetes product to the FDA by the end of 2024, with hopes for clearance in early 2025. This expansion is projected to double the company’s Total (EPA:TTEF) Addressable Market, with the potential for significant sales growth. Additionally, the integration of Tandem’s pump with the Libre 3 glucose monitoring system is anticipated to be a major advancement, especially for users of the Libre system who do not currently use a pump. The compatibility of Tandem’s Mobi pump with Android devices is also expected to enhance its market reach. These developments reflect Tandem Diabetes’ strategic initiatives to capitalize on emerging opportunities in the diabetes care market.
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