LATHAM, N.Y. - AngioDynamics , Inc. (NASDAQ: NASDAQ:ANGO), a medical technology company, announced the FDA clearance of its AlphaVac F1885 System for the treatment of pulmonary embolism (PE), a condition that affects nearly 900,000 Americans annually and is a leading cause of cardiovascular death.
The FDA's expanded indication allows the AlphaVac F1885 System to be used in the non-surgical removal of thrombi or emboli from the venous vasculature, providing an additional treatment option for patients with PE. This is expected to reduce thrombus burden and improve heart function.
The clearance follows the completion of the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study in December 2023. The study, which enrolled 122 patients at 25 U.S. hospital sites, assessed the safety and efficacy of the AlphaVac F1885 System in treating acute, intermediate-risk PE.
Results from the APEX-AV study showed a significant reduction in the right ventricle to left ventricle (RV/LV) ratio 48 hours after the procedure and a 35.5% mean reduction in clot burden. The study also reported a low rate of major adverse events (MAEs), which included major bleeding and serious device-related clinical deterioration.
Dr. William Brent Keeling and Dr. Mona Ranade, who led the APEX-AV study, praised the rapid patient enrollment and the safety and efficacy outcomes, indicating a strong need for such technologies in PE treatment algorithms.
The AlphaVac F1885 System, which also includes an ergonomic handle and a large bore cannula, was highlighted by Dr. John M. Moriarty of the PERT Consortium as a crucial step forward in the treatment of PE patients.
This announcement is based on a press release statement and does not imply endorsement of AngioDynamics' claims. The company has cautioned that forward-looking statements in the release are subject to risks and uncertainties. For further risk information, AngioDynamics directs to its website.
InvestingPro Insights
AngioDynamics, Inc. (NASDAQ: ANGO), has recently made headlines with its FDA clearance for the AlphaVac F1885 System, which is poised to enhance treatment options for pulmonary embolism. Let's delve into some financial metrics and insights that might interest investors following this announcement.
The company's financial health appears robust, with InvestingPro data indicating a market capitalization of $242.32 million. Despite facing challenges in profitability, as reflected by a negative P/E ratio of -17.32, AngioDynamics holds more cash than debt on its balance sheet, which is a positive sign for financial stability. Additionally, the firm's liquid assets exceed its short-term obligations, suggesting a comfortable liquidity position.
InvestingPro Tips reveal that AngioDynamics does not pay a dividend, which could be a consideration for income-focused investors. Furthermore, the company's high shareholder yield is a metric that may appeal to those looking for potential shareholder value. For investors interested in a deeper analysis, there are over six additional InvestingPro Tips available at InvestingPro, which could provide a more comprehensive understanding of AngioDynamics' investment profile.
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