HistoSonics Edison® Histotripsy System Treats First Pancreatic Tumor Patients in GANNON Trial

Feasibility Trial Evaluates Safety of Histotripsy to Destroy Pancreatic Tumors

HistoSonics, the developer and manufacturer of the Edison® Histotripsy System, announced today the first patients with pancreatic tumors were successfully treated in the company sponsored GANNON trial. The feasibility trial is designed to evaluate the safety of histotripsy, a novel non-invasive technology that destroys targeted tumor tissue using focused ultrasound, 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).

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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.

Pancreatic tumors are one of the most difficult to treat, affecting over 510,000 people globally each year, and an estimated 66,440 patients diagnosed in the United States alone in 2024¹,². 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 2030².

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 progression of disease at the time of 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

“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,” said Joan Vidal-Jove, M.D., Medical Director, HistoSonics.

“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,” said Mike Blue, HistoSonics CEO and President. “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 use of the Edison System in pancreatic application is limited to investigational use.

About the Edison® System

The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.

About HistoSonics

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 their Edison System in the US 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, Michigan and Minneapolis, MN.

For more information on the GANNON Trial please reference NCT06282809 at: GANNON Trial Information on ClinicalTrials.gov. For information on the Edison Histotripsy System please visit: www.histosonics.com/. For patient related information please visit: www.myhistotripsy.com/.

¹Globocan 2022: https://gco.iarc.fr/today/en/fact-sheets-cancers

²Source for statistics: American Cancer Society: Cancer Facts & Figures 2024 and Pancreatic Treatment Options

³Norton 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.

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