HistoSonics has announced the successful treatment of the first patients with pancreatic tumors using its Edison Histotripsy System as part of the GANNON trial. This marks a significant expansion for the company, which previously focused on treating liver tumors with the system.
The GANNON trial, led by Dr. Santiago Sánchez Cabús at Sant Pau Hospital in Barcelona, Spain, is evaluating the safety of histotripsy in up to 30 patients diagnosed with unresectable locally advanced (Stage 3) or metastatic (Stage 4) pancreatic adenocarcinoma. Histotripsy is a novel, non-invasive technology that utilizes focused ultrasound to mechanically destroy targeted tumor tissue.
Addressing Unmet Needs in Pancreatic Cancer
Pancreatic cancer remains one of the most challenging malignancies to treat, with over 510,000 people affected globally each year. In the United States alone, an estimated 66,440 new cases were diagnosed in 2024. The disease has the highest mortality rate among major cancers and is projected to become the second leading cause of cancer-related death in the U.S. by 2030.
The five-year relative survival rate for pancreatic cancer is only 13%, and fewer than 20% of patients are eligible for surgery due to disease progression at diagnosis. Furthermore, pancreatic tumors are often surrounded by dense fibrotic tissue, which limits the effectiveness of systemic therapies.
Histotripsy: A Novel Approach
The Edison system uses histotripsy, a unique method of focused ultrasound, to create a "bubble cloud" that mechanically destroys and liquefies targeted tumors. This non-invasive approach could offer an alternative for patients who are not candidates for surgery, radiation, or chemotherapy.
According to Joan Vidal-Jove, M.D., Medical Director at HistoSonics, "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."
Trial Details and Future Directions
The GANNON trial (NCT06282809) is a feasibility study designed to assess the safety of histotripsy for pancreatic tumor ablation. HistoSonics plans to use the data from this trial to optimize histotripsy and expand its application to other organs.
"Most patients with pancreatic tumors face limited treatment options and are ineligible for surgery due to advanced stage of disease," said Mike Blue, HistoSonics CEO and President. "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."
