AngioDynamics’ NanoKnife Will Be Evaluated for Prostate Tissue Ablation in FDA-Approved PRESERVE Pivotal Trial

August 11, 2021—AngioDynamics, Inc. announced it has received approval from the FDA for the PRESERVE pivotal trial of its NanoKnife system for ablation of prostate tissue in an intermediate-risk patient population. The trial was initiated by AngioDynamics in partnership with the Society of Urologic Oncology Clinical Trials Consortium, Inc.

According to the company, PRESERVE investigators will evaluate the use of the NanoKnife system as a focal therapy option for prostate cancer patients and assess the system’s safety and effectiveness when used to ablate prostate tissue in intermediate-risk patients. A primary endpoint analysis will be conducted at 12 months after initial treatment.

The study will be led by Coprincipal Investigators Jonathan Coleman, MD, and Arvin George, MD. Dr. Coleman is with Memorial Sloan Kettering Cancer Center in New York, New York, and Dr. George is with University of Michigan in Ann Arbor, Michigan.

“We are excited to be leading this multicenter trial,” commented Dr. Coleman in the company’s announcement. “We anticipate the results of this study will provide valuable evidence to determine the appropriate use of focal therapy in intermediate-risk prostate cancer patients.”

Approval of the study was originally announced during AngioDynamics’ Investor & Technology Day, a virtual event held on July 13, 2021. More details about the PRESERVE study from the event can be accessed here.

AngioDynamics advised that the NanoKnife system uses irreversible electroporation 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 nonthermal energy allows for the preservation of the extra-cellular matrix, facilitating postablation histologic and functional tissue regeneration.