Histosonics Testing its Tumor Tissue-Killing Tech on Pancreatic Growths

HistoSonics has treated the first patients with pancreatic tumors in a trial designed to evaluate the safety of histotripsy, a non-invasive technology that destroys targeted tumor tissue using focused ultrasound.

The GANNON trial aims to determine the efficacy of HistoSonics’ Edison Histotripsy System in up to 30 patients with inoperable pancreatic adenocarcinoma tumors diagnosed with unresectable locally advanced disease (Stage 3) or those where a small number of tumors have spread to other parts of the body (Stage 4).

The GANNON trial is being conducted at Sant Pau Hospital in Barcelona, Spain, led by Dr. Santiago Sánchez Cabús, clinical head of Hepatopancreatobilliary Surgery at the Hospital de Sant Pau and professor of Surgery at the Autonomous University of Barcelona.

“Histotripsy has the potential to revolutionize treatment for patients with pancreatic tumors that were previously considered to be untreatable with traditional approaches. Its novel mechanism of action targets both the tumor and surrounding fibrotic tissue, offering new hope for patients with advanced disease, who represent the majority of cases,” HistoSonics Medical Director Joan Vidal-Jove, M.D., said.

Pancreatic tumors are one of the most difficult to treat, affecting more than 510,000 people worldwide annually, and an estimated 66,440 patients diagnosed in the United States alone in 2024.^1,2 With the highest mortality rate of any major tumor type, pancreatic tumors are currently the third leading cause of tumor-related death in the United States, following lung and colon, and is expected to become the second by 2030.²

With a five-year relative survival rate of 13% across all stages of disease progression and limited surgical options for most patients, new treatment modalities such as histotripsy are urgently needed. Fewer than 20% of patients suffering from pancreatic tumors are eligible for surgery due to the disease’s progression upon diagnosis. Pancreatic tumors are often surrounded by dense, impenetrable fibrotic tissue that limits the effectiveness of systemic or pharmacologic therapies, due to lack of penetration to effectively reach and target the tumor cells.^2,3

“Most patients with pancreatic tumors face limited treatment options and are ineligible for surgery due to advanced stage of disease,” HistoSonics President/CEO Mike Blue stated. “We believe histotripsy provides a non-invasive option to target tumors that were previously considered untreatable. Our goal is to expand the potential of histotripsy in multiple tumor types, delivering meaningful improvements in outcomes for patients and families. Our early research from the GANNON trial will inform us and our physician partners in optimizing histotripsy to make a significant impact on patient lives.”

The Edison System use in treating pancreatic tumors is strictly investigational.

The Edison System is intended to non-invasively mechanically destroy liver tumors, including the partial or complete destruction of unresectable liver tumors through histotripsy. The U.S. Food and Drug Administration has not evaluated the Edison System for treating any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, five-year survival or overall survival).

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing its Edison System in the United States and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Mich., and Minneapolis, Minn.

References
¹ Globocan 2022: https://gco.iarc.fr/today/en/fact-sheets-cancers
² Source for statistics: American Cancer Society: Cancer Facts & Figures 2024 and Pancreatic Treatment Options
³ Norton J, Foster D, Chinta M, Titan A, Longaker M. Pancreatic Cancer Associated Fibroblasts (CAF): Under-Explored Target for Pancreatic Cancer Treatment. Cancers. 2020; 12(5):1347.