AngioDynamics Reports Positive DIRECT Study Results for NanoKnife IRE in Pancreatic Cancer and Announces New CPT Code for 2027
AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow through the vascular system, expanding cancer treatment options, and improving patients’ quality of life, has announced two important milestones for irreversible electroporation (IRE), the non-thermal ablation technology delivered through its NanoKnife System. The developments include the publication of overall survival findings from the DIRECT study in The Oncologist and the establishment of a new Category I Current Procedural Terminology (CPT®) code for open IRE ablation of pancreatic tumors, scheduled to take effect on January 1, 2027.
The DIRECT study publication reports clinical outcomes among patients with Stage III pancreatic ductal adenocarcinoma (PDAC) treated with standard-of-care systemic therapy alongside an IRE-based treatment strategy. According to the reported findings, patients treated within the IRE-based strategy experienced longer median overall survival than patients who received standard-of-care systemic therapy without IRE. The analysis also found longer median progression-free survival in the IRE group.
Separately, the new Category I CPT code approved by the American Medical Association (AMA) CPT Editorial Panel establishes a standardized mechanism for reporting open IRE ablation of pancreatic tumors, including imaging guidance. The code is expected to become effective at the beginning of 2027 and represents another development in the procedural coding framework for IRE technology.
Together, these milestones advance the clinical evidence and procedural reporting infrastructure surrounding IRE while AngioDynamics continues to focus its commercial investment for the NanoKnife System on prostate cancer.
DIRECT Study Published in The Oncologist
The peer-reviewed article presenting overall survival results from the DIRECT study has been published in The Oncologist. The publication is available under DOI: 10.1093/oncolo/oyag416.
DIRECT was a multicenter clinical study conducted at 18 sites across the United States under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE). The study evaluated an IRE-based treatment strategy in patients with Stage III PDAC, comparing outcomes between patients who received standard-of-care systemic therapy plus IRE and those who received standard-of-care systemic therapy without IRE.
Pancreatic ductal adenocarcinoma is a particularly challenging cancer to treat, and locally advanced disease can be difficult to manage because the tumor may involve or lie close to major blood vessels and other critical structures. Stage III PDAC often requires a multidisciplinary approach that may include systemic therapy, local treatment strategies, and careful assessment of whether surgical intervention is appropriate.
Systemic therapy plays a central role in treating pancreatic cancer, including by targeting cancer cells beyond the primary tumor. Local treatment approaches, meanwhile, are intended to address disease at the tumor site. Research into combining these approaches seeks to determine whether selected patients may benefit from additional local tumor control as part of an overall treatment plan.
The DIRECT study contributes prospective, multicenter evidence to this area of research by examining outcomes associated with the addition of IRE to standard-of-care systemic therapy. However, the study was non-randomized, meaning that treatment allocation was not determined through random assignment. Its results therefore demonstrate an association between the IRE-based strategy and the observed clinical outcomes rather than definitive proof that IRE caused the survival differences.
Overall Survival Findings Favor the IRE-Based Treatment Strategy
The analysis included 137 patients with Stage III PDAC. Of these, 99 were treated within an IRE-based strategy, while 38 received standard-of-care systemic therapy without IRE.
The principal finding was a difference in median overall survival between the two groups. Patients treated within the IRE-based strategy had a median overall survival of 28 months from diagnosis, compared with 15 months among patients who received standard-of-care treatment without IRE.
The reported difference in median overall survival was 13 months, favoring the group treated with the IRE-based strategy. Overall survival is an important endpoint in oncology research because it measures the time patients live following a defined starting point, in this case diagnosis, regardless of the cause of death.
The study investigators also conducted statistical analyses to account for measured differences between the patient groups. Following adjustment, the IRE-based strategy remained associated with longer survival, including an average of five additional months of survival during the first 24 months.
These adjusted findings provide additional context for interpreting the results because patients in non-randomized studies may differ in ways that influence outcomes. Factors related to patient selection, disease characteristics, treatment timing, and overall clinical status can affect comparisons between treatment groups.
Nevertheless, statistical adjustment cannot eliminate all potential sources of bias, particularly when some relevant differences may not have been measured or fully accounted for. The results should therefore be interpreted in the context of the study design and the need for further clinical investigation.
Progression-free survival and serious adverse events
The DIRECT study also evaluated progression-free survival, which measures the time patients live without their disease progressing. Median progression-free survival was nine months in the IRE group, compared with six months in the standard-of-care group.
This finding suggests that the IRE-based treatment strategy was associated with a longer period before disease progression in the analyzed population. However, as with the overall survival results, the non-randomized design limits the conclusions that can be drawn about the treatment’s direct effect.
The analysis also reported serious adverse events, defined as Grade 3 or higher. Such events occurred in 56% of patients in the IRE group and 71% of patients in the standard-of-care group.
Although the reported proportion of serious adverse events was lower in the IRE group, these figures should not be interpreted as proof that adding IRE reduces treatment-related complications. The groups differed in size, and the non-randomized design does not establish a causal relationship between treatment strategy and adverse event rates. A comprehensive assessment of safety requires consideration of the types, severity, timing, and attribution of individual events, as well as differences in the patients receiving each treatment.
Overall, the reported survival, progression-free survival, and safety findings provide additional evidence for researchers evaluating IRE as part of multimodal treatment strategies for selected patients with locally advanced pancreatic cancer.
Clinical Experts Emphasize the Need for Further Pancreatic Cancer Research
Robert C.G. Martin II, M.D., Ph.D., Director of the Division of Surgical Oncology at the University of Louisville School of Medicine and an investigator in the DIRECT study, highlighted the challenges associated with locally advanced pancreatic cancer and the importance of understanding the role of local treatment following induction chemotherapy.
Martin said the DIRECT study provides prospective, multicenter evidence that an IRE-based treatment strategy was associated with longer overall survival, including in analyses accounting for measured differences in patient selection and treatment timing.
He also emphasized that the study’s non-randomized design means it cannot establish that IRE caused the observed survival difference. According to Martin, the findings support further prospective evaluation of IRE and its consideration within multidisciplinary treatment planning for appropriately selected patients.
Multidisciplinary care is particularly important in pancreatic cancer because treatment decisions may involve medical oncologists, surgical oncologists, radiation oncologists, radiologists, and other specialists. These teams evaluate the extent of disease, treatment response, patient fitness, and the potential benefits and risks of different therapeutic approaches.
Rohan Jeyarajah, M.D., Chair of the Department of Surgery at TCU Burnett School of Medicine and Past President of the Americas Hepato-Pancreato-Biliary Association (AHPBA), also emphasized the importance of continued research into multimodal cancer treatment.
Jeyarajah noted that evaluating local therapies alongside systemic treatment is important for advancing the understanding of how these approaches may fit into care for patients with locally advanced pancreatic cancer. He stressed that generating meaningful clinical evidence is essential to informing future treatment strategies and improving the understanding of treatment options in multidisciplinary settings.
The comments from the investigators reflect a broader need for further research to clarify which patients may benefit from local tumor-directed therapies, how such treatments should be integrated with systemic therapy, and how their potential benefits and risks compare with existing treatment approaches.
NanoKnife System Uses Non-Thermal Irreversible Electroporation
The NanoKnife System delivers irreversible electroporation, a non-thermal tissue ablation technology designed to disrupt cellular integrity through electrical pulses rather than relying primarily on heat to destroy tissue.
IRE is being investigated and used in selected clinical settings as a local treatment approach. Its non-thermal mechanism distinguishes it from thermal ablation technologies, which destroy tissue by applying heat or cold. However, the suitability of IRE depends on the specific clinical indication, tumor characteristics, patient condition, and applicable regulatory and clinical considerations.
In pancreatic cancer, the proximity of tumors to important blood vessels and other anatomical structures can complicate local treatment decisions. Research into non-thermal ablation approaches has therefore attracted interest among clinicians investigating additional options for selected patients with locally advanced disease.
The DIRECT study adds to the evidence base by evaluating outcomes associated with an IRE-based treatment strategy in a multicenter U.S. patient population. The findings do not establish IRE as a replacement for standard-of-care systemic therapy, nor do they demonstrate definitive superiority over other treatment approaches. Instead, they provide evidence that may help inform future studies and multidisciplinary discussions.
AngioDynamics said the publication and coding developments represent progress in work initiated before the company aligned its commercial strategy around prostate cancer.
New Category I CPT Code for Open Pancreatic IRE to Take Effect in 2027
In addition to the DIRECT study publication, AngioDynamics announced that the AMA CPT Editorial Panel has approved a new Category I CPT code describing open ablation of pancreatic tumors using IRE, including imaging guidance.
The final code number and descriptor are expected to be published by the AMA. The code is scheduled to take effect on January 1, 2027.
CPT codes are used to identify and report medical procedures and services. A standardized code for open pancreatic IRE provides a defined mechanism for documenting the procedure in the healthcare billing and reporting system.
The development follows the implementation of Category I CPT codes for liver IRE and prostate IRE on January 1, 2026. These codes include CPT 47384 for liver IRE and CPT 55877 for prostate IRE, as referenced in the company’s announcement.
The pancreatic code represents another step in establishing procedural reporting infrastructure for IRE across selected treatment areas. Standardized coding can help healthcare providers report procedures consistently and can support the administrative processes associated with documenting and billing for medical services.
However, the introduction of a Category I CPT code does not automatically establish insurance coverage or guarantee reimbursement. Coverage and payment depend on individual payer policies, insurance plans, applicable medical necessity criteria, the site of service, and other relevant requirements. Healthcare providers must continue to verify coverage and reimbursement requirements with the appropriate payers.
Coding and Coverage Developments Expand the Reporting Framework for IRE
AngioDynamics also referenced Palmetto GBA’s final Local Coverage Determination L40205, which became effective July 5, 2026. The policy addresses coverage for appropriately selected patients with favorable intermediate-risk prostate cancer and metastatic colorectal cancer to the liver who meet the specified criteria.
The company cited this development alongside the implementation of the liver and prostate IRE CPT codes as part of the broader evolution of the coding and coverage environment surrounding IRE.
These developments are distinct from the clinical evidence generated by the DIRECT study. While the study provides information about outcomes associated with IRE in pancreatic cancer, procedural coding establishes a reporting mechanism and payer coverage policies determine whether particular services qualify for coverage under specified conditions.
Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, said prostate cancer remains the company’s commercial priority for the NanoKnife System and that its commercial investment is concentrated in that area.
Serna explained that the DIRECT study publication and the new pancreatic Category I CPT code reflect work initiated before the company aligned its commercial strategy around prostate cancer. He welcomed the publication of the research and the establishment of a defined reporting mechanism for open pancreatic IRE procedures beginning in January 2027.
According to Serna, these milestones contribute to the clinical evidence base for IRE and provide greater clarity regarding procedural reporting.
AngioDynamics Continues to Advance IRE Research and Infrastructure
The DIRECT study publication and the new pancreatic IRE CPT code represent two distinct developments in the evolving landscape of non-thermal ablation technology.
The clinical publication reports an association between an IRE-based strategy and longer overall survival among patients with Stage III PDAC. Median overall survival was 28 months in the IRE group, compared with 15 months in the standard-of-care group, while median progression-free survival was nine months and six months, respectively.
At the same time, the new Category I CPT code is expected to provide a standardized mechanism for reporting open pancreatic IRE procedures beginning January 1, 2027. The code may support procedural documentation, although it does not guarantee payer coverage or payment.
For AngioDynamics, these milestones reflect continued work to develop the clinical evidence and procedural reporting framework surrounding the NanoKnife System. The company remains focused commercially on prostate cancer while the published DIRECT findings contribute to ongoing research into local treatment strategies for pancreatic cancer.
Further prospective research will be important to clarify the role of IRE in pancreatic cancer, identify patients most likely to benefit, and determine how the technology should be integrated into multidisciplinary treatment pathways.
About the NanoKnife System
The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage electrical 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.1 Visit nanoknife.com for full product information.
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.
About AngioDynamics, Inc.
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. For more information, visit angiodynamics.com.