Therapy Areas: Devices
AngioDynamics Completes Enrollment for PRESERVE Clinical Study
10 August 2023 - - US-based medical technology company AngioDynamics, Inc. (NASDAQ: ANGO) has completed 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 company said.

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 US 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 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.

The NanoKnife System utilizes Irreversible Electroporation 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. Visit for full product information.

Visit for risk information. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.

The NanoKnife System, when used for the treatment of prostate cancer, is an investigational device. It is limited by United States law to investigational use.

AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients.

The company's innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs.

Created, owned and operated by its members, the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) is a clinical research investigator network of more than 400 members from more than 200 clinical sites in the US and Canada.

This national alliance of academic and community based uro-oncologists is committed to furthering urology research. The SUO-CTC is a registered 501c3 not-for-profit corporation and has a cooperative relationship with the Society of Urologic Oncology.