AngioDynamics' European Clinical Trial Enhances PE Treatment Options
AngioDynamics Launches New Clinical Trial for PE Treatment
AngioDynamics, Inc. (NASDAQ: ANGO) recently announced the initiation of the RECOVER-AV trial, a significant step for the company as it ventures into the European market with its AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System. This trial is designed to evaluate the device's safety and efficacy in treating acute, intermediate-risk pulmonary embolism (PE), following a successful enrollment completion of the U.S.-based APEX-AV study in late 2023.
Insights into the RECOVER-AV Study
The RECOVER-AV study, which will be conducted across up to 20 hospitals throughout Europe, aims to provide comprehensive insights into the performance of the AlphaVac F1885 System. The primary focus of this study is to assess specific metrics, including the reduction of the right ventricular to left ventricular (RV/LV) ratio within 48 hours post-treatment and monitoring any Major Adverse Events (MAEs) within the seven days following the procedure. Participants will be carefully monitored for a full year, with scheduled assessments at various intervals including 30 days, six months, and one year.
Leadership and Commitment
Dr. Erik Klok and Dr. Andrew Sharp are co-leading the trial, supported by an experienced international advisory board. This marks AngioDynamics' first foray into international research, highlighting their dedication to expanding their treatment options for pulmonary embolism, a significant healthcare concern within the EU, reportedly resulting in approximately 435,000 events annually across major countries.
Details on the AlphaVac System
The AlphaVac F1885 System recently secured CE Mark approval, paving the way for its non-surgical use to remove thromboemboli from pulmonary arteries. AngioDynamics expresses strong commitment to evidence-based treatments, as they continue to innovate and improve the quality of care for patients globally.
Recent Financial Performance of AngioDynamics
In recent quarters, AngioDynamics reported a modest revenue exceeding expectations with a pro forma revenue of $71.1 million. The growth trajectory appears largely driven by their Med Tech division, which recorded fourth-quarter sales of $29.3 million. Additionally, the company unveiled a $15 million share buyback initiative, reflecting positive outcomes from their previously established three-year strategy.
Outlook for Fiscal Year 2025
For the upcoming fiscal year, AngioDynamics has provided an optimistic revenue forecast, estimating figures between $282 million and $288 million. Despite facing challenges leading to a -10.28% revenue growth over the past twelve months, analysts maintain trust in the company’s market potential, as evidenced by a Buy rating from Canaccord Genuity, despite a revised price target.
Strategic Restructuring and Future Growth
Recently, AngioDynamics has undertaken major strategic changes, including the divestment of its Dialysis and BioSentry divisions, as it hones in on its core capabilities. The company’s progress reflects a commitment to refining its portfolio while pursuing the promising prospects within its Med Tech segment.
Innovation on the Horizon
With a focus on future product launches such as AlphaVac, NanoKnife, and Auryon, AngioDynamics is positioned for sustained growth. These advancements speak volumes about the company's direction and determination to continue providing innovative solutions for challenging medical conditions.
Frequently Asked Questions
What is the RECOVER-AV trial?
The RECOVER-AV trial is a clinical study evaluating the AlphaVac F1885 System for treating pulmonary embolism in European patients.
Who is leading the RECOVER-AV trial?
Dr. Erik Klok and Dr. Andrew Sharp are co-leading the trial, with support from an international advisory board.
What are the primary goals of the trial?
The main goals include assessing the reduction of the RV/LV ratio and monitoring Major Adverse Events post-procedure.
What does CE Mark approval mean for the AlphaVac System?
CE Mark approval indicates that the AlphaVac System meets European safety and efficacy standards, allowing for its use in clinical settings.
What is AngioDynamics' revenue outlook for 2025?
AngioDynamics expects revenues between $282 million and $288 million for fiscal year 2025, showing positive growth potential.
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