Announcement • 16h
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. Announcement • 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.