AngioDynamics, Inc. a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease and oncology, today announced that the United States Food and Drug Administration (FDA) approved the Company’s investigational device exemption (IDE)

application for its NanoKnife® Irreversible Electroporation “Direct IRE Cancer Treatment” clinical study (DIRECT).

The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. In January 2018, the FDA granted the Company’s NanoKnife System a Breakthrough Device Designation under the 21st Century Cures Act.

The DIRECT study design demonstrates our commitment to provide an option that addresses a pressing unmet need for patients with Stage III pancreatic cancer,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics. “We are confident that our comprehensive approach, crafted through a constructive dialogue with the FDA, will generate meaningful data for clinicians, patients, payors and other stakeholders who are equally committed to fighting this disease, and we are dedicated to the idea that the standard of care for this deadly disease can—and should—improve.”

The NanoKnife System is a next-generation ablative technology that physicians have identified as an innovative treatment for pancreatic cancer, as evidenced by 42 publications documenting more than 800 patients that have been treated for Stage III pancreatic cancer with NanoKnife technology between 2012 to 2019.

The NanoKnife System received 510(k) clearance from the FDA for the surgical ablation of soft tissue in 2008. Unlike other ablative technologies, the NanoKnife System utilizes low-energy, direct-current electrical pulses to permanently open pores in target cell membranes and does not rely on thermal effects. These permanent defects in the cell membranes result in cell death. The treated tissue is then removed by the body's natural processes in a matter of weeks, mimicking natural cell death.

AngioDynamics’ DIRECT study will feature a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, allowing participating sites to obtain coverage for procedures performed as well as related routine costs.

The DIRECT study comprises a Randomized Controlled Trial (RCT) at up to 15 sites and a real-world evidence, next-generation registry (RWE) at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.

The RCT component of the DIRECT study will illustrate the promise of the NanoKnife System by isolating variables in a controlled setting. Recognizing that results from a hyper-controlled setting do not always translate to clinical practice, the study also includes a RWE component to provide clinicians, patients, and payors with data generated in a real-world setting.

As part of the DIRECT clinical study, AngioDynamics is launching AngioDIRECT.com to facilitate the enrollment of participants. The online platform will provide patients and their families with information about pancreatic cancer and details about the study. It will also feature a physician locator to help prospective participants and referring healthcare professionals identify clinical study locations.

Existing evidence that has accumulated over the last 10 years has shown that Irreversible Electroporation is an effective adjunctive treatment for patients with locally advanced pancreatic cancer,” said Dr. Robert C.G. Martin, Co-Principal Investigator of the DIRECT Study and Surgical Oncologist at the University of Louisville. “We anticipate that this trial will demonstrate how the NanoKnife System can be utilized to enhance the quality of life for patients with Stage III pancreatic cancer.”

I’ve had promising experience utilizing Irreversible Electroporation as a treatment option for pancreatic cancer patients,” said Dr. Govindarajan Narayanan, Co-Principal Investigator of the DIRECT Study and Chief of Interventional Oncology at the Miami Cancer Institute. “We expect that the results of this trial will lead to a widely available alternative treatment option for advanced pancreatic cancer patients.”

There are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States annually. Total deaths due to pancreas cancer are projected to increase dramatically to become the second leading cause of cancer-related deaths before 20302.The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs, and less than 20 percent of patients are candidates for surgical resection at time of diagnosis1. Approximately 35 to 40 percent of patients will present with Stage III and 45 to 55 percent with metastatic disease1. Regardless of the stage of pancreatic cancer, it is one of the least survivable cancers, and survival rates have not improved substantially for more than forty years1. For all stages combined, the five-year relative survival rate is 8 percent and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3 percent1.

There are limited treatment options for Stage III and IV disease, with chemotherapy and/or radiotherapy considered the standard of care3. There have been advancements in both techniques, but this has come at the cost of greater toxicity3, limiting the number of patients that are candidates for treatment.