LATHAM, N.Y. - AngioDynamics , Inc. (NASDAQ: NASDAQ:ANGO), a medical technology company, has initiated the RECOVER-AV trial to assess the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System's safety and efficacy in treating acute, intermediate-risk pulmonary embolism (PE) in the European market. This follows the U.S.-based APEX-AV study, which concluded enrollment in December 2023 and reported the AlphaVac F1885 System as safe with positive effects on right ventricular function and clot reduction.
The RECOVER-AV study is a single-arm trial enrolling Europe-based patients at up to 20 hospital sites. Its primary goals include evaluating the reduction of the right ventricular/left ventricular (RV/LV) ratio within 48 hours post-procedure and monitoring the incidence of Major Adverse Events (MAEs) within seven days. Participants will be tracked for one year, with assessments at 30 days, six months, and 12 months.
The trial is co-led by Dr. Erik Klok and Dr. Andrew Sharp (OTC:SHCAY), with support from an international advisory board. This study marks AngioDynamics' first international research effort, aiming to expand treatment options for PE, a condition with an estimated 435,000 annual events in the six largest EU countries, where it presents more acutely than in the U.S.
AngioDynamics' AlphaVac F1885 System, which received CE Mark approval in Europe in May, is designed for non-surgical removal of thromboemboli from pulmonary arteries. The company emphasizes its commitment to providing evidence-based treatments globally.
This news is based on a press release statement. AngioDynamics' forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from expectations. The company's SEC filings detail risk factors that may influence its performance.
In other recent news, medical device company AngioDynamics reported a slight revenue beat in its quarterly financial results, with pro forma revenue of $71.1 million. The revenue growth was primarily driven by the Med Tech business, which achieved sales of $29.3 million in the fourth quarter of fiscal year 2024. AngioDynamics also announced a share buyback plan worth up to $15 million, reflecting the success of their three-year strategy.
Furthermore, AngioDynamics provided revenue guidance for fiscal year 2025, estimating between $282 million and $288 million. This aligns with Canaccord Genuity's forecast, who despite lowering its price target for AngioDynamics, maintained a Buy rating due to the company's potential.
In addition to earnings and revenue results, AngioDynamics has undergone significant strategic changes. The company divested several of its business units, including its Dialysis and BioSentry businesses, and discontinued certain products. These developments aim to optimize the company's portfolio and focus on its core business.
Finally, AngioDynamics is expected to see steady growth, with momentum in its Med Tech segment and upcoming products like AlphaVac, NanoKnife, and Auryon. These are recent developments that continue to shape the trajectory of the company.
InvestingPro Insights
As AngioDynamics, Inc. (NASDAQ: ANGO) embarks on its European clinical trial for the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System, the company's financial health and market performance may influence its ability to sustain such international research efforts. According to InvestingPro data, AngioDynamics holds a market capitalization of approximately $309.73 million, showcasing its mid-cap status in the medical technology sector.
Despite facing challenges such as a negative revenue growth of -10.28% over the last twelve months as of Q4 2024, the company maintains a strong gross profit margin of 50.9%. This indicates that while AngioDynamics has experienced a decrease in revenue, it still retains a significant portion of its sales as gross profit. Moreover, the company's stock has seen a substantial return over the last six months, with a 36.94% total price return, suggesting investor confidence in its growth potential.
InvestingPro Tips highlight that AngioDynamics has more cash than debt on its balance sheet and possesses liquid assets that exceed short-term obligations, which may provide a stable financial foundation for its ongoing clinical trials. Furthermore, the company's high shareholder yield is a positive sign for investors looking for returns on their investment. It's worth noting that AngioDynamics does not pay a dividend, aligning with its strategy of reinvesting earnings into growth initiatives like the RECOVER-AV study.
For those interested in a deeper analysis, InvestingPro offers additional tips, including insights on earnings revisions and profitability expectations. Currently, there are 9 additional InvestingPro Tips available, which can be explored further to understand AngioDynamics' financial outlook and investment potential.
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