Duyuru • 15h
AngioDynamics Receives FDA IDE Approval For RELIEF Feasibility Study Evaluating NanoKnife IRE Platform As Minimally Invasive Treatment For Benign Prostatic Hyperplasia AngioDynamics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) application to initiate the RELIEF study. RELIEF is a feasibility study evaluating irreversible electroporation (IRE), the non-thermal ablation technology delivered by the Company's NanoKnife System, for the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). BPH is among the most prevalent urologic conditions affecting men in the United States, with an estimated 15 million men exhibiting symptoms and more than 300,000 surgical procedures performed annually. BPH can cause lower urinary tract symptoms, including urinary frequency, urgency, weak stream, and incomplete bladder emptying, that impair daily function and quality of life. Current treatment options range from pharmacologic therapy to surgical interventions such as transurethral resection of the prostate (TURP) and newer minimally invasive procedures, underscoring the need for additional approaches that balance effectiveness with preservation of sexual and urinary function. The NanoKnife System is cleared for the surgical ablation of prostate tissue. In prior clinical experience with IRE in the prostate, physicians observed meaningful improvements in urinary symptoms associated with BPH in patients treated for intermediate-risk prostate disease, an observation that provided clinical rationale for the RELIEF study. The RELIEF study is a prospective, single-arm clinical study that will enroll 40 subjects at up to five clinical sites in the United States. Patients, at six months post-treatment, will be evaluated for the primary endpoints and will also be followed for a total of five years for secondary endpoints. The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to six months post-procedure. The primary safety endpoint is the incidence and severity of device-related adverse events during that period. RELIEF will evaluate the preliminary safety and effectiveness of IRE delivered via the NanoKnife System for the relief of BPH-related symptoms. The results will establish the evidence foundation for future clinical development of IRE as a minimally invasive treatment option for BPH. The study incorporates validated, well-established endpoints such as IPSS, uroflowmetry, and quality-of-life measures, alongside careful monitoring of sexual function and long-term durability through five years of follow-up. In the RELIEF study, electrodes are placed transperineally into predefined treatment zones of the prostate under transrectal ultrasound guidance and general anesthesia. Treatment planning targets the transition zone bilaterally while preserving critical structures, including the neurovascular bundles, external sphincter, and urethra. The NanoKnife System delivers short pulses of electrical energy to create permanent nanopores in cell membranes, resulting in precise, non-thermal ablation of prostate tissue. The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue. United States: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue. Canada: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability. European Union: The NanoKnife System is indicated for the ablation of soft tissue and tumors of the pancreas, kidney, liver, or prostate, including intermediate risk prostate cancer. The NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition. The NanoKnife System when used for the treatment of benign prostate hyperplasia is an investigational device. Limited by United States law to investigational use. Duyuru • May 14
AngioDynamics Announces Two-Year Preserve Trial Data Demonstrating Durable Nanoknife Ire System Outcomes In Intermediate-Risk Prostate Cancer AngioDynamics, Inc. announced two-year results from the PRESERVE pivotal trial (NCT04972097) demonstrating durable oncologic control and a sustained safety profile for the NanoKnife System in the focal ablation of intermediate-risk prostate cancer. The PRESERVE trial is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation (IRE) using the NanoKnife System in 121 patients with Gleason Grade Group 2–3 intermediate-risk prostate cancer, conducted across 17 U.S. clinical centers in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Primary 12-month results, published in European Urology in July 2025, demonstrated an 80% freedom-from-treatment-failure rate among protocol-biopsied patients. At 24 months, the updated findings confirm durability of outcomes: 94.4% of analysis-eligible patients (68 of 72) completed the 24-month assessment, reflecting strong cohort retention. No new treatment failures were identified among patients with available follow-up at 24 months. One patient (1.5%) underwent a clinically indicated biopsy, which was negative for any cancer. 97% of patients (66 of 68) had a PSA at 24 months below their baseline value. No new device- or procedure-related adverse events were reported between the 12- and 24-month assessments. The 24-month PRESERVE data complement an international long-term evidence base for focal IRE, including median five-year outcomes from a 2023 international multi-institutional cohort demonstrating sustained oncologic control and preservation of functional outcomes. PRESERVE Trial — 24-Month Results Summary: Focal IRE Ablation Using the NanoKnife System for Intermediate-Risk Prostate Cancer. Study Design: Parameter Detail. Trial Name PRESERVE (NCT04972097). Study Type Prospective, single-arm, pivotal IDE study. Technology NanoKnife System — Focal Irreversible Electroporation (IRE). Population Gleason Grade Group 2–3 (Gleason 3+4 or 4+3), clinical stage =T2c intermediate-risk prostate cancer. Sites 17 U.S. clinical centers. Partner Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Sponsor AngioDynamics, Inc. Key 24-Month Results: Endpoint Result. Total Enrolled 121 patients. 24-Month Analysis-Eligible 72 patients. 24-Month Completers 68 of 72 (94.4%). New Treatment Failures (12–24 mo) 0. Clinically Triggered Biopsies 1 (negative for any cancer). PSA Below Baseline at 24 Months 66 of 68 (97%). New Device/Procedure-Related AEs (12–24 mo) 0. 12-Month Primary Endpoint (Reference): Endpoint Result. Freedom from Treatment Failure 80% among protocol-biopsied patients. Publication European Urology, July 2025 (George et al.). With a growing body of prospective U.S. pivotal data and long-term international evidence supporting the safety and efficacy of focal IRE, the NanoKnife System continues to gain traction as a meaningful treatment option for men with intermediate-risk prostate cancer who seek durable oncologic control while preserving quality of life. AngioDynamics is advancing the NanoKnife IRE System evidence base and the reimbursement infrastructure needed to bring this option to more patients and physicians across care settings. The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue. United States: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue. Canada: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability. European Union: The NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer. Reported Earnings • Apr 05
Third quarter 2026 earnings released: US$0.19 loss per share (vs US$0.11 loss in 3Q 2025) Third quarter 2026 results: US$0.19 loss per share (further deteriorated from US$0.11 loss in 3Q 2025). Revenue: US$78.4m (up 8.9% from 3Q 2025). Net loss: US$8.08m (loss widened 83% from 3Q 2025). Revenue is forecast to grow 4.8% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 6% per year whereas the company’s share price has increased by 3% per year. Duyuru • Apr 02
Angiodynamics, Inc. Provides Earnings Guidance for Fiscal Year 2026 AngioDynamics, Inc. provided earnings guidance for fiscal year 2026. For the period, the company expects net sales of $313.5 million to $315.5 Million compared to previous guidance of $312 million to $314 Million as of January 6, 2026. Duyuru • Mar 19
AngioDynamics, Inc. to Report Q3, 2026 Results on Apr 02, 2026 AngioDynamics, Inc. announced that they will report Q3, 2026 results Pre-Market on Apr 02, 2026 Reported Earnings • Jan 07
Second quarter 2026 earnings: EPS and revenues exceed analyst expectations Second quarter 2026 results: US$0.15 loss per share (improved from US$0.26 loss in 2Q 2025). Revenue: US$79.4m (up 9.0% from 2Q 2025). Net loss: US$6.35m (loss narrowed 41% from 2Q 2025). Revenue exceeded analyst estimates by 3.9%. Earnings per share (EPS) also surpassed analyst estimates by 33%. Revenue is forecast to grow 4.8% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 12% per year but the company’s share price has only fallen by 6% per year, which means it has not declined as severely as earnings. Breakeven Date Change • Jan 07 The 3 analysts covering AngioDynamics previously expected the company to break even in 2028. New consensus forecast suggests losses will reduce by 15% per year to 2027. The company is expected to make a profit of US$700.0k in 2028. Average annual earnings growth of 82% is required to achieve expected profit on schedule.
Duyuru • Dec 23
AngioDynamics, Inc. to Report Q2, 2026 Results on Jan 06, 2026 AngioDynamics, Inc. announced that they will report Q2, 2026 results Pre-Market on Jan 06, 2026 Recent Insider Transactions • Oct 23
Senior VP recently bought US$118k worth of stock On the 21st of October, Lawrence Weiss bought around 10k shares on-market at roughly US$11.81 per share. This transaction amounted to 12% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$190k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Oct 12
CEO, President & Director recently bought US$112k worth of stock On the 9th of October, James Clemmer bought around 10k shares on-market at roughly US$11.15 per share. This transaction amounted to 1.9% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Major Estimate Revision • Oct 09
Consensus EPS estimates fall by 11% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -US$0.773 to -US$0.86 per share. Revenue forecast unchanged at US$309.8m. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target broadly unchanged at US$18.50. Share price was steady at US$11.12 over the past week. Reported Earnings • Oct 02
First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2026 results: US$0.27 loss per share (improved from US$0.32 loss in 1Q 2025). Revenue: US$75.7m (up 12% from 1Q 2025). Net loss: US$10.9m (loss narrowed 15% from 1Q 2025). Revenue exceeded analyst estimates by 4.2%. Earnings per share (EPS) missed analyst estimates by 5.4%. Revenue is forecast to grow 6.3% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has only fallen by 12% per year, which means it has not declined as severely as earnings. Duyuru • Oct 02
AngioDynamics, Inc. Revises Earnings Guidance for the Full Fiscal Year 2026 AngioDynamics, Inc. revised earnings guidance for the full fiscal year 2026. For the year, the company expects net sales to be between $308 million to $313 million against previous guidance of between $305 million to $310 million. Duyuru • Sep 27
AngioDynamics, Inc., Annual General Meeting, Nov 10, 2025 AngioDynamics, Inc., Annual General Meeting, Nov 10, 2025. Duyuru • Sep 18
AngioDynamics, Inc. to Report Q1, 2026 Results on Oct 02, 2025 AngioDynamics, Inc. announced that they will report Q1, 2026 results Pre-Market on Oct 02, 2025 Duyuru • Jul 29
Angiodynamics, Inc. Enrolls First Patient in AMBITION BTK Trial Advancing Treatment for Critical Limb Ischemia AngioDynamics, Inc. announced enrollment of the first patient in the Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK). AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon Athe rectomy System combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with Critical Limb IschemIA (CLI). Reported Earnings • Jul 16
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$0.83 loss per share (improved from US$4.59 loss in FY 2024). Revenue: US$292.5m (down 3.8% from FY 2024). Net loss: US$34.0m (loss narrowed 82% from FY 2024). Revenue exceeded analyst estimates by 2.0%. Earnings per share (EPS) also surpassed analyst estimates by 10%. Revenue is forecast to grow 6.5% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 48% per year but the company’s share price has only fallen by 26% per year, which means it has not declined as severely as earnings. Duyuru • Jul 15
AngioDynamics, Inc. Provides Earnings Guidance for the Fiscal Year 2026 AngioDynamics, Inc. provided earnings guidance for the Fiscal Year 2026. For the year, the Company expected net sales to be in the range of $305 Million to $310 million. Duyuru • Jul 07
AngioDynamics, Inc. to Report Q4, 2025 Results on Jul 15, 2025 AngioDynamics, Inc. announced that they will report Q4, 2025 results Pre-Market on Jul 15, 2025 Duyuru • Jun 24
AngioDynamics Announces First Patient Enrolled in Recover-AV Clinical Trial Evaluating AlphaVac F1885 System for Treatment of Acute Pulmonary Embolism AngioDynamics, Inc. announced the first patient has been enrolled in the RECOVER-AV clinical trial, a prospective, multi-center, multi-national, single-arm study evaluating the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute, intermediate-risk pulmonary embolism (PE). The study follows the United States Food and Drug Administration (FDA) 510(k) clearance of the AlphaVac F1885 System for the treatment of PE in the United States in April 2024 and its CE Mark approval in Europe in May 2024. The RECOVER-AV trial is designed to evaluate the safety and efficacy of the AlphaVac F 1885 System in support of its adoption in the Global market, as well as to assess long-term functional outcomes for patients following treatment. This study builds on the results of the Company's U.S.-based APEX-AV trial2, which demonstrated that the AlphaVac F18 85 System is safe and effective for use in intermediate-risk PE patients, with significant improvements in right ventricular function and reduction in clot burden. The AlphaVac F1885 system received CE Mark approval in May 2024 for the non-surgical removal of thrombi oremboli from the pulmonary arteries. The System is designed to support frontline treatment of PE and expand options for healthcare providers managing patients with life-threatening venous thromboembolism. Major Estimate Revision • Apr 09
Consensus EPS estimates upgraded to US$0.93 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.20 to -US$0.925 per share. Revenue forecast steady at US$286.7m. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target up from US$15.33 to US$15.67. Share price fell 12% to US$9.55 over the past week. Reported Earnings • Apr 03
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$0.11 loss per share (improved from US$4.67 loss in 3Q 2024). Revenue: US$72.0m (down 4.2% from 3Q 2024). Net loss: US$4.41m (loss narrowed 98% from 3Q 2024). Revenue exceeded analyst estimates by 2.4%. Earnings per share (EPS) also surpassed analyst estimates by 9.4%. Revenue is forecast to grow 7.4% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 39 percentage points per year, which is a significant difference in performance. Duyuru • Apr 02
AngioDynamics, Inc. Revises Earnings Guidance for the Fiscal Year 2025 AngioDynamics, Inc. revised earnings guidance for the fiscal year 2025. The company now revises net sales to be in the range of $285 to $288 million, up from previously issued guidance of $282 to $288 million, representing growth between 5.3% to 6.4% over fiscal 2024 pro forma revenue of $270.7 million. Duyuru • Mar 19
AngioDynamics, Inc. to Report Q3, 2025 Results on Apr 02, 2025 AngioDynamics, Inc. announced that they will report Q3, 2025 results Pre-Market on Apr 02, 2025 Duyuru • Jan 30
AngioDynamics, Inc. Initiates AMBITION BTK RCT and Registry to Advance Treatment for Critical Limb Ischemia AngioDynamics, Inc. announced the start of a Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK). AMBITION BTK is a multicenter, randomized controlled trial (RCT) designed to evaluate the clinical outcomes of the Auryon Atherectomy System in combination with standard balloon angioplasty compared to standard balloon angioplasty alone for the treatment of infrapopliteal lesions in patients with critical limb ischemia. The trial will enroll up to 200 subjects across up to 30 hospital-based sites. Additionally, up to 1,500 subjects treated with the Auryon Atherectomy System at the same sites who do not meet the eligibility criteria of the RCT will be enrolled in a companion Registry. Lower extremity peripheral artery disease (PAD) affects more than 230 million adults worldwide and is associated with an increased risk of various adverse clinical outcomes. In its most severe form, critical limb ischemia patients are often treated with lower extremity amputation (LEA). The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK) and In-Stent Restenosis (ISR) and to date, it has been used to treat more than 100,000 patients in the United States and worldwide. AMBITION BTK builds upon the positive outcomes of a prior multicenter, prospective trial that evaluated the safety and effectiveness of the Auryon laser atherectomy system in treating BTK lesions in patients with limb ischemia. The earlier study successfully treated 61 complex, calcified lesions across four U.S. centers in 60 patients, achieving strong clinical outcomes with minimal complications. These results demonstrated the System's ability to safely and effectively address challenging BTK cases, leading to the development of the AMBITION BTK RCT and Registry. The technology underlying the Auryon Atherectomy System has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified. The System uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation. On February 1, 2025, the Company will host its inaugural Cardiovascular Scientific Forum (CVSF). The event will bring together leading physicians and thought leaders in the cardiovascular field to present groundbreaking research, discuss emerging clinical trends, and showcase advancements shaping the future of patient care, including the AMBITION BTK RCT and Registry. Major Estimate Revision • Jan 15
Consensus EPS estimates fall by 13% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.94 to -US$1.06 per share. Revenue forecast unchanged at US$284.9m. Medical Equipment industry in the US expected to see average net income growth of 22% next year. Consensus price target up from US$13.00 to US$15.33. Share price fell 8.8% to US$11.80 over the past week. Duyuru • Jan 14
AngioDynamics, Inc. Announces Publication of Apex-Av Trial Results in JSCAI AngioDynamics, Inc. announced the publication of the results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI). The article, "Novel Mechanical Aspiration Thrombectomy in Patients with Acute Pulmonary Embolist: Results from the Prospective APEX-AV Trial," was published December 27, 2024. In December 2023, AngioDynamics announced the completion of patient enrollment in its APEX-AV trial, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, immediate-risk PE across 25 hospital-based sites in the United States to assess the AlphaVac F1885 System for the treatment of PE. In April 2024, the United States Food and Drug Administration (FDA) cleared the AlphaVac F18 85 System for the treatment of PE". Price Target Changed • Jan 10
Price target increased by 18% to US$15.33 Up from US$13.00, the current price target is an average from 3 analysts. New target price is 25% above last closing price of US$12.30. Stock is up 105% over the past year. The company is forecast to post a net loss per share of US$0.92 next year compared to a net loss per share of US$4.59 last year. Reported Earnings • Jan 10
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.26 loss per share (improved from US$0.72 loss in 2Q 2024). Revenue: US$72.8m (down 7.9% from 2Q 2024). Net loss: US$10.7m (loss narrowed 63% from 2Q 2024). Revenue exceeded analyst estimates by 2.7%. Earnings per share (EPS) missed analyst estimates by 18%. Revenue is forecast to grow 7.0% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 62 percentage points per year, which is a significant difference in performance. New Risk • Jan 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Duyuru • Dec 20
AngioDynamics, Inc. to Report Q2, 2025 Results on Jan 08, 2025 AngioDynamics, Inc. announced that they will report Q2, 2025 results Pre-Market on Jan 08, 2025 Duyuru • Dec 10
AngioDynamics Receives FDA Clearance for the NanoKnife® System for Prostate Tissue Ablation AngioDynamics, Inc. announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NanoKnife System for prostate tissue ablation. The Company received clearance for the NanoKnife System for prostate tissue ablation following the completion of the pivotal PRESERVE clinical study and submission of results to the FDA in September. The study evaluated the safety and effectiveness of the system for ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa). Conducted in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), PRESERVE enrolled 121 patients across 17 clinical sites. The PRESERVE clinical study met its primary effectiveness endpoint demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12-months post-procedure, 84.0% of men were free from in-field, clinically significant disease. In addition, the study demonstrated strong quality of life outcomes with short-term urinary continence being preserved (96.6% at baseline, 95.4% at 12-months) and the ability to maintain erections sufficient for intercourse only decreasing 9% compared to baseline (80.7% to 71.7%). The study’s results validated the robust safety and clinical efficacy profile of the NanoKnife System, reinforcing findings from more than 32 clinical studies performed around the world involving over 2,600 patients. Prostate cancer is the second most common cancer in men worldwide, with approximately 1.5 million new cases diagnosed annually. Many of these patients seek alternatives to radical procedures that can lead to significant, long-term urological side effects. The NanoKnife System is the first and only non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment. The NanoKnife System delivers an innovative alternative to conventional radical surgery or radiotherapy, which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the system is engineered to preserve vital structures inside and outside the prostate, offering patients improved outcomes, reduced recovery times, and enhanced quality of life. Duyuru • Oct 25
AngioDynamics, Inc. Announces the Launch of an International Multi-Center Prospective Registry Study AngioDynamics, Inc. announced the launch of an international multi-center prospective registry study to assess the long term effects of treating men with unifocal intermediate-risk prostate cancer with the NanoKnife System in partnership with the University College London Hospital (UCLH). Approximately 40% of all diagnosed prostate cancer cases are classified as intermediate risk. In the first year after surgery, 36% of men report urinary leakage, and 95% are affected by erectile dysfunction (70% described as moderate/severe). The NanoKnife System delivers an innovative alternative to conventional radical surgery or radiotherapy, each of which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the NanoKnife system is engineered to preserve vital structures inside and outside the prostate, offering patients effective treatment of tumors, low complication rates, and minimal impact on quality of life. AngioDynamics is conducting the international multi-center prospective registry study in partnership with UCLH. UCLH is the largest center for robotic prostate surgery in the U.K. and a leading provider of focal therapy, radiotherapy, robotic surgery, and active surveillance treatment options for men with prostate cancer. Additionally, UCLH was the first facility in the National Health Service to use the NanoKnife System to treat prostate cancer, and provide standardized patient selection, treatment, and long-term follow-up. The study will enroll a minimum of 500 patients worldwide to confirm the multiple single-center published papers indicating that the NanoKnife System is safe and effective in the treatment of targeted tumors, and the prevention or delayed need for radical intervention in the preservation of patient quality of life. Complementing the ongoing Randomized Controlled Trial studies evaluating NanoKnife versus radical treatment, this investigator-initiated trial will closely monitor patients post-treatment, measuring critical quality of life metrics and tracking any necessary follow-up interventions. In addition to quality of life, the study will assess overall and prostate-specific mortality rates. Recent Insider Transactions • Oct 10
CEO, President & Director recently bought US$121k worth of stock On the 7th of October, James Clemmer bought around 20k shares on-market at roughly US$6.03 per share. This transaction amounted to 4.4% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. James has been a buyer over the last 12 months, purchasing a net total of US$188k worth in shares. Major Estimate Revision • Oct 10
Consensus EPS estimates fall by 16% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.81 to -US$0.94 per share. Revenue forecast unchanged at US$283.9m. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target down from US$13.33 to US$13.00. Share price fell 21% to US$6.08 over the past week. Breakeven Date Change • Oct 06
No longer forecast to breakeven The 3 analysts covering AngioDynamics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$1.20m in 2027. New consensus forecast suggests the company will make a loss of US$2.00m in 2027. Reported Earnings • Oct 03
First quarter 2025 earnings: EPS misses analyst expectations First quarter 2025 results: US$0.32 loss per share (down from US$1.15 profit in 1Q 2024). Revenue: US$67.5m (down 14% from 1Q 2024). Net loss: US$12.8m (down 128% from profit in 1Q 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 32%. Revenue is forecast to grow 7.2% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 37 percentage points per year, which is a significant difference in performance. Duyuru • Oct 03
AngioDynamics, Inc. Provides Earnings Guidance for the Year 2025 AngioDynamics, Inc. provided earnings guidance for the year 2025. For fiscal year 2025, the Company continues to expects net sales to be in the range of $282 to $288 million, representing growth of between 4.2% to 6.4% over fiscal 2024 pro forma revenue of $270.7 million. New Risk • Sep 29
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Duyuru • Sep 27
AngioDynamics, Inc., Annual General Meeting, Nov 12, 2024 AngioDynamics, Inc., Annual General Meeting, Nov 12, 2024. Duyuru • Sep 19
AngioDynamics, Inc. to Report Q1, 2025 Results on Oct 03, 2024 AngioDynamics, Inc. announced that they will report Q1, 2025 results at 9:30 AM, US Eastern Standard Time on Oct 03, 2024 Major Estimate Revision • Jul 23
Consensus EPS estimates upgraded to US$0.81 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.19 to -US$0.81 per share. Revenue forecast steady at US$284.4m. Medical Equipment industry in the US expected to see average net income growth of 17% next year. Consensus price target broadly unchanged at US$13.33. Share price rose 20% to US$7.13 over the past week. Reported Earnings • Jul 17
Full year 2024 earnings: EPS in line with analyst expectations despite revenue beat Full year 2024 results: US$4.59 loss per share (further deteriorated from US$1.33 loss in FY 2023). Revenue: US$303.9m (down 10% from FY 2023). Net loss: US$184.3m (loss widened 252% from FY 2023). Revenue exceeded analyst estimates by 3.8%. Earnings per share (EPS) were mostly in line with analyst estimates. Revenue is forecast to grow 5.6% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 59% per year but the company’s share price has only fallen by 35% per year, which means it has not declined as severely as earnings. Breakeven Date Change • Jul 17
Forecast to breakeven in 2027 The 3 analysts covering AngioDynamics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 77% per year to 2026. The company is expected to make a profit of US$1.20m in 2027. Average annual earnings growth of 98% is required to achieve expected profit on schedule. Duyuru • Jul 09
AngioDynamics, Inc. to Report Q4, 2024 Results on Jul 16, 2024 AngioDynamics, Inc. announced that they will report Q4, 2024 results Pre-Market on Jul 16, 2024 Recent Insider Transactions • Apr 09
CEO, President & Director recently bought US$67k worth of stock On the 8th of April, James Clemmer bought around 10k shares on-market at roughly US$6.70 per share. This transaction amounted to 2.6% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Price Target Changed • Apr 05
Price target decreased by 10.0% to US$13.50 Down from US$15.00, the current price target is an average from 4 analysts. New target price is 92% above last closing price of US$7.03. Stock is down 26% over the past year. The company is forecast to post a net loss per share of US$4.61 next year compared to a net loss per share of US$1.33 last year. Board Change • Apr 05
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Karen Licitra was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Duyuru • Apr 05
AngioDynamics, Inc. Provides Sales Guidance for the Fiscal Year 2024 AngioDynamics, Inc. provided sales guidance for the Fiscal Year 2024. For the year, the company expects net sales to be in the range of $270 million to $275 million which reflects the recent divestiture of the PICC and Midline businesses and discontinuance of the RadioFrequency ablation and Syntrax businesses, which accounted for approximately $50 million of the prior revenue guidance of $320 to $325 million. The Company expects gross margin to be approximately 52.0% to 54.0%. Duyuru • Apr 02
Angiodynamics Announces Settlement of All Patent Litigation with C.R. Bard, Inc AngioDynamics, Inc. announced that it has entered into a settlement agreement with Becton, Dickinson and Company (BD) to resolve all outstanding patent litigation with C.R. Bard, Inc., an affiliate of BD. Under the terms of the settlement, BD will grant a license to AngioDynamics under certain of BD’s port patents and AngioDynamics will grant BD a license under certain of AngioDynamics’ catheter patents. AngioDynamics will make a one-time lump sum payment to BD in the amount of $7 million, $3 million of which will be paid within five days and the balance of which will be payable of installments over the next 12 months. AngioDynamics will also make six minimum annual payments to BD of $2.5 million through February 2029, and potential additional payments if six percent (6%) of annual net sales of AngioDynamics’ port products exceed the minimum payment. The parties will participate in the pending appeal before the Federal Circuit of the case titled C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. v. AngioDynamics, Inc. (C.A. 15-00218–JFB; and CAFC appeal No. 23-2056) and a contingent payment of $3 million will be due from AngioDynamics to BD if the Federal Circuit reverses or vacates the District Court’s findings of invalidity with respect to the patent claims at issue the case. The agreement contains mutual covenants not to sue and releases. Neither party admitted any liability in connection with the settlement agreement. The agreement concludes a multi-year patent dispute between the parties. Duyuru • Mar 20
AngioDynamics, Inc. to Report Q3, 2024 Results on Apr 04, 2024 AngioDynamics, Inc. announced that they will report Q3, 2024 results Pre-Market on Apr 04, 2024 Duyuru • Feb 16
Angiodynamics, Inc. Announces Board Changes AngioDynamics, Inc. announced that on February 8, 2024 the Board appointed Wesley Johnson as the new chair of the Audit Committee and Jan Stern Reed as the new chair of the Nominating, Compliance and Corporate Governance Committee. James Clemmer resigned from his position as a Class II director on the Board and was immediately re-appointed as a Class I director with a term expiring at the Company’s 2025 Annual Meeting of Stockholders. The resignation and reappointment of Mr. Clemmer was effected solely for the purpose of rebalancing each class of directors to consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire Board, and for all other purposes, Mr. Clemmer’s service on the Board is deemed to have continued uninterrupted. Duyuru • Dec 08
AngioDynamics, Inc. to Report Q2, 2024 Results on Jan 05, 2024 AngioDynamics, Inc. announced that they will report Q2, 2024 results Pre-Market on Jan 05, 2024 Duyuru • Dec 07
AngioDynamics, Inc. Completes Patient Enrollment in Apex-Av Study Assessing Alphavac F1885 System in Treatment of Pulmonary Embolism AngioDynamics, Inc. announced the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a clinical study aimed at evaluating the safety and efficacy of the Company's AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in the treatment of acute intermediate-risk pulmonary embolism (PE). PERT represents the third-leading cause of cardiovascular mortality in the United States. APEX-AV is a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States. The primary efficacy endpoint of the APEX-AV Study is the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint is the rate of Major Adverse Events (MAEs), including device-related death and major bleeding within the first 48 hours. Patients will be followed for 30 days post-index procedure. AngioDynamics initiated the APEX-AV Study in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium™. The study is led by co-Principal Investigators William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™ and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. Pulmonary embolism (PE) can be a life-threatening condition that affects around 900,000 people in the United States every year.2 In most cases, PE is caused by blood clots in the legs, called deep vein thrombosis, that travel to the lungs.2 Patients with submassive or intermediate-risk PE account for 35% to 55% of hospitalized patients with PE and have a mortality rate of 3 to 14%. Duyuru • Oct 06
Angiodynamics, Inc. Provides Earning Guidance for Fiscal Year 2024 AngioDynamics, Inc. provided earning guidance for fiscal year 2024. The Company continues to expect its fiscal year 2024 net sales to be in the range of $328to $333 million and gross margin to be approximately 50% to 52%. For comparison, pro forma revenue, gross margin, and adjusted loss per share for FY23 when excluding the assets divested to Merit Medical were $306.3 million, 50.5%, and $0.43, respectively. Reported Earnings • Oct 05
First quarter 2024 earnings: EPS and revenues exceed analyst expectations First quarter 2024 results: EPS: US$1.15 (up from US$0.33 loss in 1Q 2023). Revenue: US$78.7m (down 3.5% from 1Q 2023). Net income: US$45.9m (up US$58.9m from 1Q 2023). Profit margin: 58% (up from net loss in 1Q 2023). Revenue exceeded analyst estimates by 1.3%. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 7.9% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 76% per year but the company’s share price has fallen by 14% per year, which means it is significantly lagging earnings. Duyuru • Sep 29
AngioDynamics, Inc., Annual General Meeting, Nov 14, 2023 AngioDynamics, Inc., Annual General Meeting, Nov 14, 2023, at 12:00 US Eastern Standard Time. Agenda: To consider and vote upon a proposal to elect four Class II directors, for a term of three years; to consider and vote upon a proposal to ratify the appointment of AngioDynamics' independent registered public accounting firm for the fiscal year ending May 31, 2024; to consider and vote upon a "Say-on-Pay" advisory vote on the approval of the compensation of AngioDynamics' named executive officers; to consider and vote upon a proposal to amend the AngioDynamics, Inc. 2020 Equity Incentive Plan to, among other things, increase the number of shares available for issuance; to hold a "Say-On-Pay Frequency" advisory vote on a non-binding resolution to determine the frequency our shareholders will be asked to approve the compensation of our named executive officers; and transact such other business as may properly come before the Annual Meeting or any adjournment or postponement thereof. Price Target Changed • Sep 26
Price target increased by 12% to US$17.33 Up from US$15.50, the current price target is an average from 3 analysts. New target price is 138% above last closing price of US$7.29. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$0.89 next year compared to a net loss per share of US$1.33 last year. Duyuru • Sep 13
AngioDynamics, Inc. to Report Q1, 2024 Results on Oct 04, 2023 AngioDynamics, Inc. announced that they will report Q1, 2024 results Pre-Market on Oct 04, 2023 Duyuru • Aug 17
AngioDynamics, Inc. Receives FDA Breakthrough Device Designation for the AngioVac System for the Non-Surgical Removal of Right Heart Vegetation AngioDynamics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company's AngioVac System for the proposed indications for use to include the non-surgical removal of vegetation from the right heart. The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives exist. Target vessels for the thrombus/embolus extraction include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Heart. Under the Breakthrough Device designation, AngioDynamics will engage with the FDA to achieve this new expanded indication for the non-surgical removal from the right heart. The accelerated pathway expedites assessment and review processes of the AngioVac System and allows for more interactive and timely communication with the FDA, efficient and flexible clinical study design, FDA review team support, Agency senior management engagement and priority review. Duyuru • Aug 04
Angiodynamics, Inc. Completes Enrollment for Preserve Clinical Study AngioDynamics, Inc. announced the completion of enrollment and final treatment in its Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE). The PRESERVE study was initiated by AngioDynamics, Inc. in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Final patient enrollment in the study was initially announced during AngioDynamics’ Fiscal 2023 Fourth Quarter and Full-Year Financial Results conference call on July 12, 2023. Co-Principal Investigators leading the study are Jonathan Coleman, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center, and Arvin George, MD, Urologic Surgeon, University of Michigan. The PRESERVE study will have its primary endpoint analysis at 12 months following treatment. In 2023, the American Cancer Society estimates that there will be about 288,300 new cases of prostate cancer and about 34,700 deaths from the disease in the U.S. It is estimated that 1 out of every 8 men will be diagnosed with prostate cancer during their lifetime, and prostate cancer is more likely to develop in older and non-Hispanic Black men. It is American men's second leading cause of death. The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted tissue, delivering precise treatment margins while preserving vital structures by retaining the structural integrity of the targeted tissue. The delivery of non-thermal energy allows for the preservation of the extra-cellular matrix, facilitating post-ablation histological and functional tissue regeneration. The PRESERVE study’s primary objectives are determining the NanoKnife System’s ablation effectiveness by measuring the negative in-field biopsy rate at 12 months and determining the NanoKnife System’s procedural and post-procedural safety profile by evaluating adverse event incidence, type and severity through 12 months. The study enrolled and treated 121 patients in 17 facilities across the United States. Recent Insider Transactions Derivative • Jul 28
CEO, President & Director exercised options and sold US$102k worth of stock On the 19th of July, James Clemmer exercised options to acquire 11k shares at no cost and sold these for an average price of US$8.92 per share. This trade did not impact their existing holding. For the year to May 2017, James' total compensation was 13% salary and 87% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since September 2022, James' direct individual holding has increased from 337.78k shares to 379.75k. Company insiders have collectively sold US$174k more than they bought, via options and on-market transactions in the last 12 months. Duyuru • Jul 25
AngioDynamics, Inc. Announces Addition of Lorinda Burgess to Board of Directors AngioDynamics, Inc. announced the appointment of Lorinda Burgess to the Company’s Board of Directors. Ms. Burgess brings over 35 years of management, financial, and global operations experience, including over 15 years at Medtronic, Inc., where she was responsible for the company’s Americas Region as CFO, Vice President of Finance. While at Medtronic, Ms. Burgess led optimization initiatives that drove operational efficiencies and significant cost reductions. Ms. Burgess was most recently Chief Financial Officer and Vice President of Finance for the Americas Region at Medtronic, Inc., a Fortune 200 global medical device company with more than $30 billion in annual revenues. Prior to this role, Ms. Burgess also served as Vice President of Customer Care for the Americas and Western Europe at Medtronic, Inc. and Vice President of Finance for the Cardiovascular Group’s Sales and Marketing function. Ms. Burgess earned a Bachelor of Arts in Communication and Political Science from the University of Michigan and a Master’s in Business Administration from Ohio State University. Ms. Burgess is a member of the Board of Directors for Stepan Company. With Ms. Burgess’ appointment, AngioDynamics’ total number of directors will increase to nine members. Major Estimate Revision • Jul 19
Consensus EPS estimates fall by 52%, revenue upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$323.0m to US$328.7m. Forecast EPS reduced from -US$0.46 to -US$0.70 per share. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target up from US$15.50 to US$16.50. Share price fell 2.0% to US$9.74 over the past week. Duyuru • Jul 13
AngioDynamics, Inc. Provides Financial Guidance for the Fiscal Year 2024 AngioDynamics, Inc. provided financial guidance for the fiscal year 2024. The company anticipates that fiscal year 2024 revenue will be in the range of $328 million to $333 million. Breakeven Date Change • Jul 13
No longer forecast to breakeven The analyst covering AngioDynamics no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$15.7m in 2026. New forecast suggests the company will make a loss of US$8.00m in 2026. Reported Earnings • Jul 13
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: US$1.33 loss per share (further deteriorated from US$0.68 loss in FY 2022). Revenue: US$338.8m (up 7.1% from FY 2022). Net loss: US$52.4m (loss widened 98% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 48%. Revenue is forecast to grow 2.3% p.a. on average during the next 2 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 67% per year but the company’s share price has only increased by 1% per year, which means it is significantly lagging earnings growth. Duyuru • Jun 21
AngioDynamics, Inc. to Report Q4, 2023 Results on Jul 12, 2023 AngioDynamics, Inc. announced that they will report Q4, 2023 results at 9:30 AM, US Eastern Standard Time on Jul 12, 2023 New Risk • Jun 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: US$37m Forecast net loss in 2 years: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. This is currently the only risk that has been identified for the company. 