AngioDynamics Secures FDA Clearance for NanoKnife System in Prostate Cancer Treatment
AngioDynamics, Inc. (NASDAQ: ANGO), a leader in medical technology innovation, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its NanoKnife System for prostate tissue ablation. This clearance marks a pivotal step forward in the treatment of intermediate-risk prostate cancer, offering a minimally invasive option that prioritizes preserving critical functions and improving patients’ quality of life.
FDA Approval Backed by Clinical Success
The FDA clearance follows the completion of the pivotal PRESERVE clinical study, which assessed the safety and effectiveness of the NanoKnife System for ablating prostate tissue in patients with intermediate-risk prostate cancer (PCa). Conducted in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), the study enrolled 121 patients across 17 clinical sites.
Results from the study were compelling, demonstrating that 84% of patients were free from in-field, clinically significant disease 12 months post-procedure. The NanoKnife System also showcased a strong quality-of-life profile, with 95.4% of patients maintaining urinary continence and only a 9% reduction in the ability to maintain erections sufficient for intercourse.
“These results validate the robust safety and clinical efficacy of the NanoKnife System, reinforcing findings from more than 32 clinical studies involving over 2,600 patients globally,” said Jim Clemmer, President and CEO of AngioDynamics.
Redefining Prostate Cancer Care
The NanoKnife System uses irreversible electroporation (IRE) technology, a non-thermal and radiation-free method, to selectively target and ablate prostate tissue while minimizing damage to surrounding areas. Unlike traditional treatments that often result in life-altering complications, such as incontinence and erectile dysfunction, the NanoKnife System preserves critical functions, offering a transformative alternative for patients.
Prostate cancer remains the second most common cancer in men worldwide, with approximately 1.5 million new cases diagnosed annually. Many patients seek alternatives to radical treatments, which can lead to long-term urological side effects. The NanoKnife System aims to meet this need by providing a less invasive, function-preserving option.
Accelerating Adoption and Global Reach
AngioDynamics is launching comprehensive education and awareness campaigns to drive the adoption of the NanoKnife System. These efforts include hands-on training for physicians and innovative patient outreach initiatives to ensure broader access to the technology.
“This FDA clearance is the first step in realizing our vision to make the NanoKnife System the standard, function-preserving treatment for prostate tumors,” said Clemmer. “Our goal is to redefine the standard of care for prostate health and deliver outcomes that improve patients’ quality of life.”
As AngioDynamics expands its global footprint, the NanoKnife System represents a revolutionary leap forward in prostate cancer care, providing new hope for patients and advancing the fight against one of the most prevalent cancers in men.
Read original press release here
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