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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) announced the publication of the APEX-AV trial results in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI). The trial evaluated the AlphaVac F1885 System for treating acute intermediate-risk pulmonary embolism (PE). Results showed a 35.5% reduction in clot burden and significant reduction in RV/LV ratio with low adverse event rates. The study, involving 122 patients across 25 sites, demonstrated the device's safety and efficacy. The trial was conducted in partnership with the PERT Consortium and led by Dr. William Brent Keeling and Dr. Mona Ranade. The device's unique features, such as its funnel tip and optional wireless navigation, contributed to its success. The AlphaVac F1885 System received FDA clearance in April 2024.
AngioDynamics (NASDAQ: ANGO) reported its Q2 FY2025 financial results, showing notable growth in its Med Tech segment. The company achieved net sales of $73.0 million, representing a 9.2% year-over-year increase. Med Tech net sales grew 25.0% to $31.5 million, while Med Device sales slightly decreased by 0.4% to $41.5 million.
Key highlights include FDA 510(k) clearance for NanoKnife Prostate Tissue Ablation and receipt of CPT Category I Codes for Irreversible Electroporation (IRE). The company reported a GAAP loss per share of $(0.26) and adjusted loss per share of $(0.04), with adjusted EBITDA of $3.1 million.
The company raised its FY2025 guidance, now expecting Adjusted EBITDA of $1.0-$3.0 million and adjusted loss per share of $0.34-$0.38. Gross margin was 54.8%, with Med Tech gross margin at 63.7% and Med Device at 47.8%.
AngioDynamics (NASDAQ: ANGO), a medical technology company specializing in vascular health and cancer treatment solutions, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Jim Clemmer, President and CEO, and Stephen Trowbridge, Executive VP and CFO, will deliver a presentation at the conference on Thursday, January 16, 2025, at 7:30 a.m. PT.
The presentation will be available as a live webcast through the company's investor relations section on their website, with a replay option available after the event. AngioDynamics focuses on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options, and improving patient quality of life.
AngioDynamics (NASDAQ: ANGO) has announced a virtual investor event scheduled for January 8, 2025, at 9:30am ET, following their Fiscal 2025 Second Quarter Financial Results Conference Call. The 60-minute event will showcase the company's NanoKnife™ System, featuring their proprietary irreversible electroporation (IRE) technology.
The presentation will focus on how the NanoKnife System is positioned to become the standard, function-preserving treatment for men with prostate tumors. Leaders from the company's Oncology division will discuss the system's unique mechanism of action, patient care impact, physician and patient advocacy group collaborations, and its market opportunity and commercialization strategy.
AngioDynamics, a medical technology company, specializes in restoring healthy blood flow in the body's vascular system, expanding cancer treatment options, and improving patient quality of life.
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.
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