Welcome to our dedicated page for AngioDynamics news (Ticker: ANGO), a resource for investors and traders seeking the latest updates and insights on AngioDynamics stock.
Founded in 1988 in Queensbury, N.Y., U.S., AngioDynamics, Inc. (NASDAQ: ANGO) is a leading provider of innovative medical devices that serve interventional radiologists, nephrologists, and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease. The company's product portfolio includes market-leading systems such as the NanoKnife® system, radiofrequency ablation devices, and a variety of vascular access, angiographic, dialysis, angioplasty, and embolization products.
AngioDynamics has a strong track record of developing and bringing new technologies to market, maintaining a dynamic presence in the high-growth medical device industry. Recently, the company reported net sales of $78.7 million for the first quarter of fiscal year 2024, including a 13.3% increase in Med Tech net sales driven by the NanoKnife platform. AngioDynamics also completed the sale of its Dialysis and BioSentry Biopsy Tract Sealant System businesses, significantly enhancing its financial flexibility.
In addition to financial growth, AngioDynamics continues to innovate with significant developments such as the APEX-AV study, aimed at evaluating the safety and efficacy of the AlphaVac F1885 System for treating acute pulmonary embolism. The company’s AlphaVac F1885 System has recently received FDA clearance for the treatment of pulmonary embolism, a significant milestone that expands its indication in critical medical scenarios.
With ongoing plans to transition to a fully outsourced manufacturing model and recent divestitures to streamline its portfolio, AngioDynamics is well-positioned to focus on its core strengths and drive long-term profitability. The company's net sales are projected to be between $328 to $333 million for fiscal year 2024, with an anticipated improved gross margin and reduced adjusted loss per share.
AngioDynamics (NASDAQ: ANGO) has announced it will release its fiscal 2025 second quarter financial results on January 8, 2025, before market open. The company will host two key events on the same day: a financial results conference call at 8:00 AM ET and a Virtual NanoKnife System investor event at 9:30 AM ET.
The conference call will be accessible via phone (1-877-407-0784 domestic, +1-201-689-8560 international) and webcast through the company's investor section website. A replay will be available until January 15, 2025, using passcode 13750571. The subsequent NanoKnife event aims to provide investors with deeper insights into the technology and company strategy.
AngioDynamics (NASDAQ: ANGO) has received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation following the successful completion of the PRESERVE clinical study. The pivotal study, which enrolled 121 patients across 17 clinical sites, demonstrated significant effectiveness with 84% of men being free from clinically significant disease at 12 months post-procedure.
The study showed impressive quality of life outcomes, with urinary continence preservation at 95.4% after 12 months and only a 9% decrease in erectile function. The NanoKnife System is the first non-thermal, radiation-free ablation technology for prostate tissue using IRE technology, offering a minimally invasive alternative to conventional treatments.
This clearance represents a significant milestone for treating prostate cancer, which affects approximately 1.5 million new patients annually worldwide.
AngioDynamics (NASDAQ: ANGO) has launched an international multi-center prospective registry study with University College London Hospital (UCLH) to evaluate the NanoKnife® System in treating unifocal intermediate-risk prostate cancer. The study aims to enroll 500+ patients worldwide to validate the system's safety and efficacy. The NanoKnife System offers a non-thermal alternative to conventional radical surgery or radiotherapy, designed to preserve vital structures and minimize impact on quality of life. In 2023, the UK's NICE upgraded the system's status from 'Research Only' to 'Special Arrangements', allowing broader hospital adoption while collecting additional data.
AngioDynamics, Inc. (NASDAQ: ANGO) announced that Irreversible Electroporation (IRE) has received CPT® Category I codes for treating lesions in the prostate and liver. This decision by the American Medical Association's CPT® Editorial Panel will facilitate reimbursement for healthcare providers performing IRE ablation procedures and expand access to the NanoKnife System for patients. The new codes will be effective, with physician Relative Value Units (RVUs) attached, on January 1, 2026.
The NanoKnife System uses IRE technology to destroy targeted cells without thermal energy by delivering high-voltage pulses. This minimally invasive treatment offers advantages over traditional surgery or thermal ablation techniques. The CPT® Category I status is a significant milestone for the NanoKnife System, highlighting the value of AngioDynamics' strategic investments in IRE technology.
AngioDynamics (NASDAQ: ANGO) reported financial results for Q1 FY2025, ending August 31, 2024. Net sales reached $67.5 million, a 1.1% increase year-over-year. Med Tech sales grew 8.7% to $28.0 million, while Med Device sales decreased 3.6% to $39.5 million. The company reported a GAAP loss per share of $0.31 and an adjusted loss per share of $0.11.
Key highlights include:
- Submission for FDA 510(k) clearance for NanoKnife's Prostate Tissue indication
- CE Mark Approval in Europe for the Auryon System
- Initiation of RECOVER-AV Clinical Trial in Europe for AlphaVac
For FY2025, AngioDynamics expects net sales between $282-$288 million, representing 4.2%-6.4% growth over FY2024 pro forma revenue. The company anticipates an adjusted EBITDA loss of $2.5 million to $0 and an adjusted loss per share of $0.38 to $0.42.
AngioDynamics, Inc. (NASDAQ: ANGO) has launched the RECOVER-AV clinical trial to evaluate the AlphaVac F18⁸⁵ System for treating acute, intermediate-risk pulmonary embolism (PE) in the European market. This multi-center, multi-national study follows the successful APEX-AV trial in the US, which showed significant improvements in right ventricular function and clot burden reduction.
The RECOVER-AV trial will enroll patients across up to 20 European hospital sites, focusing on the reduction of the right ventricular/left ventricular ratio and major adverse events. Patients will be followed for 12 months to assess functional outcomes. This study is significant given the higher prevalence and acuity of PE in Europe compared to the US.
The AlphaVac F18⁸⁵ System recently received CE Mark approval in Europe for non-surgical removal of thrombi or emboli from pulmonary arteries. The trial is led by renowned experts in vascular medicine and cardiology, supported by an international Scientific Advisory Board.
AngioDynamics (NASDAQ: ANGO), a medical technology company specializing in vascular health and cancer treatment, has announced its plans to release fiscal 2025 first quarter financial results on October 3, 2024, before the market opens. The company will host a conference call at 8:00 am ET on the same day to discuss the results. Investors can participate by dialing 1-877-407-0784 (domestic) or +1-201-689-8560 (international). A webcast will be available on the company's website, and a recording of the call can be accessed until October 10, 2024, using the passcode 13748896.
AngioDynamics (NASDAQ: ANGO) has received European CE Mark approval for its Auryon Atherectomy System, a revolutionary solid-state laser technology for treating Peripheral Artery Disease (PAD). This approval enables the company to enter the European market, expanding its reach in the global PAD market valued at $1.1 billion.
The Auryon System, which received FDA clearance in 2020, has already treated over 50,000 patients in the US. Clinical studies have shown its effectiveness in treating various lesion types with minimal vessel wall impact. The system uses a 355nm wavelength laser platform, allowing for targeted biological reactions without thermal ablation.
Recent studies, including the PATHFINDER registry, have demonstrated the system's safety and efficacy in treating complex PAD cases, showing significant improvements in patient outcomes.
AngioDynamics, Inc. (NASDAQ: ANGO), a leading medical technology company focused on vascular health and cancer treatment, has announced its participation in two upcoming investor conferences. The company will attend the 9th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference on August 12, 2024, and present at the Canaccord Genuity 44th Annual Growth Conference on August 13, 2024, at 10:00 am.
Investors can access a live webcast of the Canaccord Genuity presentation through the 'Investors' section of AngioDynamics' website. These conferences provide an opportunity for the company to showcase its innovative medical technologies and engage with potential investors.
AngioDynamics reported its fiscal year 2024 Q4 and full-year results, showing pro forma net sales of $71.1 million for Q4 (1.9% YoY growth) and $270.7 million for FY2024 (5.3% YoY growth). The company's Med Tech segment saw strong growth, with Q4 sales up 11.3% YoY to $29.3 million. However, AngioDynamics reported a GAAP net loss of $13.4 million in Q4 and $184.3 million for the full year.
Key highlights include FDA clearance and CE Mark approval for the AlphaVac F18 System for pulmonary embolism treatment, a $15 million share repurchase program, and the completion of several strategic divestitures. The company also initiated a transition to a fully outsourced manufacturing model to drive efficiencies and cost savings.
For fiscal year 2025, AngioDynamics expects net sales between $282-$288 million, representing 4.2-6.4% growth over FY2024.
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