MASON, Ohio - AtriCure, Inc. (NASDAQ:ATRC), a medical device company focused on developing treatments for atrial fibrillation (Afib) and related conditions, has announced that its AtriClip device has received an expanded indication in Europe. The device is now approved for patients at high risk of thromboembolism where exclusion of the left atrial appendage (LAA) is deemed necessary.
The AtriClip, which aims to exclude and electrically isolate the LAA—a known source of blood clots in Afib patients—has been supported by extensive clinical evidence. This evidence suggests that the use of the device can lead to a reduction in stroke events. The expanded indication is a direct result of over 85 peer-reviewed studies, encompassing the treatment of more than 11,000 patients across various geographies since 2007.
Michael Carrel, President and CEO of AtriCure, expressed that the new indication from the European Commission is a significant validation of the AtriClip device's effectiveness. Carrel cited the treatment of over 550,000 patients globally and the potential for increased adoption of mechanical appendage closure as a means to prevent strokes in high-risk patients.
Professor Dr. Med. Nicolas Doll, Chief Physician of Cardiac Surgery at Schuechtermann-Clinic in Germany, endorsed the AtriClip for its ease of use and long-term stroke prevention benefits. Doll's experience over more than a decade with the AtriClip devices has reinforced the company's claims about its safety and efficacy.
AtriCure is known for providing technologies that address Afib, which affects over 37 million people worldwide. Their product portfolio includes the Isolator® Synergy™ Ablation System, the first FDA-approved device for persistent Afib treatment, and the AtriClip LAA Exclusion System, the most widely sold LAA management device globally.
This news is based on a press release statement from AtriCure, Inc. The company's forward-looking statements are subject to uncertainties that could cause actual results to differ materially, and they caution that they are not obligated to update any forward-looking statements with new information or future events. For more details on the risks associated with these statements, interested parties are directed to AtriCure's official documentation.
In other recent news, AtriCure, a medical device company, reported solid performance in the second quarter of 2024, with total revenue hitting $116 million, marking over 15% year-over-year growth. This increase was seen across its product lines including pain management, open ablation, and appendage management. A significant development was the FDA clearance of the AtriClip FLEX Mini device, which is expected to see swift adoption following its launch later in the year. AtriCure has revised its full-year revenue guidance to between $456 million and $461 million, maintaining a growth rate of roughly 15% compared to the previous year. The company's financial health was further emphasized by generating a positive cash flow of more than $8 million in the quarter and holding $114 million in cash and investments. Despite some pressures on the business starting from late Q1, AtriCure anticipates completing enrollment for the LeAAPS stroke reduction trial by mid-2025 and advancing the adoption of therapies globally, with a particular focus on Europe. The company also predicts a sequential decline in Q3 revenue due to seasonality, but expects a rebound in Q4.
InvestingPro Insights
AtriCure, Inc. (NASDAQ:ATRC) has recently celebrated a milestone with the expanded indication of its AtriClip device in Europe, but what does the financial picture look like for the company? According to InvestingPro, AtriCure operates with a moderate level of debt, which can be a sign of responsible financial management. This is particularly relevant as the company invests in the expansion and adoption of its AtriClip device across new markets.
InvestingPro Data shows a market capitalization of $1.17 billion for AtriCure, reflecting the market's valuation of the company. Despite not being profitable over the last twelve months, the company's revenue growth is strong, with a 17.57% increase in the last twelve months as of Q2 2024. This growth is indicative of the company's ability to increase sales and potentially capture more market share with its AtriClip device.
One of the InvestingPro Tips highlights that analysts do not anticipate the company will be profitable this year, which could be a concern for potential investors. However, this is tempered by the fact that AtriCure's liquid assets exceed its short-term obligations, suggesting that the company has the liquidity to manage its immediate financial needs.
While AtriCure does not pay a dividend to shareholders, reflecting a reinvestment of earnings back into the company's growth, the InvestingPro product includes additional tips for investors. There are currently 5 more tips available on InvestingPro, offering deeper insights into AtriCure's financial health and future prospects.
For those interested in a more comprehensive analysis, additional tips can be found at https://www.investing.com/pro/ATRC, providing valuable information for making informed investment decisions.
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