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On Monday, Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a medical device company specializing in diabetes care with a market capitalization of $1.56 billion and impressive revenue growth of 27.65% over the last twelve months, announced that its SteadiSet Infusion Set has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use up to three days. The SteadiSet, designed for one-handed insertion, delivers insulin from a pump to the body and is intended for adults with Type 1 diabetes. According to InvestingPro data, the company maintains a healthy gross profit margin of 52.22%, though profitability remains a challenge.
The product, developed by Capillary Biomedical, LLC, a wholly owned subsidiary of Tandem Diabetes Care, features an integrated inserter with a concealed needle, aiming to streamline the infusion process for patients. The company is also planning to seek FDA approval for an extended use of the SteadiSet for up to seven days, although commercial activities will not commence until this additional clearance is granted. With a current ratio of 2.3, the company maintains strong liquidity to support its development initiatives.
The recent FDA approval comes amidst Tandem Diabetes Care’s ongoing efforts to enhance diabetes management solutions. The company has cautioned that forward-looking statements in the report, such as the anticipated submission for extended use and the timing for commercial activities, involve risks and uncertainties. These include potential delays in FDA clearance and challenges that could affect the product’s market launch.
Investors are advised that actual results could vary significantly from projections due to these risks. Tandem Diabetes Care has stated it will not update forward-looking statements with new information or future events. This news is based on the company’s recent SEC filing.
In other recent news, Tandem Diabetes Care reported its Q1 2025 earnings, revealing a significant miss with an EPS of -1.97 against a forecast of -0.6. Despite this earnings per share miss, the company’s revenue reached $234 million, marking a 22% year-over-year increase and surpassing forecasts. This growth was driven by a 15% rise in U.S. sales and a notable 35% increase in international sales. Canaccord Genuity raised its price target for Tandem Diabetes Care to $59, maintaining a Buy rating, highlighting the company’s strong performance and revenue growth. Analysts from Canaccord Genuity expressed optimism about Tandem’s future, citing the potential for gross margin improvement and the company’s extensive product offerings. Tandem Diabetes Care’s management confirmed its financial guidance and projected 2025 worldwide sales between $997 million and $1 billion, with a gross margin target of 54%. The company is also focusing on product innovations, including the anticipated integration of its t:slim X2 with Abbott’s Libre 3 Plus in Q2/25. Additionally, the Mobi product is under review for CE Mark certification, with an expected international launch in the second half of 2025.
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