HistoSonics has announced the treatment of the first patients with pancreatic tumours in the GANNON trial using its Edison Histotripsy System.
The trial evaluates the safety of histotripsy, a non-invasive technology that uses focused ultrasound to target and destroy tumour tissue.
The GANNON feasibility study will include up to 30 patients with inoperable pancreatic adenocarcinoma, either locally advanced (Stage 3) or with limited spread to other areas (Stage 4).
The GANNON trial is being conducted at Sant Pau Hospital in Barcelona, Spain, under the leadership of Santiago Sánchez Cabús, clinical head of hepatopancreatobiliary surgery at the Hospital de Sant Pau and a professor of surgery at the Autonomous University of Barcelona.
The privately held medical device company said histotripsy has a five-year relative survival rate of 13% across all stages and limited surgical options.
HistoSonics CEO and president Mike Blue said: “Most patients with pancreatic tumours face limited treatment options and are ineligible for surgery due to advanced stage of disease.
“We believe histotripsy provides a non-invasive option to target tumours that were previously considered untreatable.
“Our goal is to expand the potential of histotripsy in multiple tumour 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 optimising histotripsy to make a significant impact on patient lives.”
The Edison System is designed for the non-invasive mechanical destruction of liver tumours, including the partial or complete destruction of unresectable liver tumours via histotripsy.
The system received FDA investigational device exemption approval in February last year. Two months later, HistoSonics announced the first kidney tumour treatment with the system in the UK.
In October 2023, the FDA granted marketing authorisation for the Edison System.
HistoSonics is focused on commercialising the Edison System in the US and select global markets for liver treatment.
The company is also expanding histotripsy applications to other organs, including the kidney, pancreas, and more.
In August this year, the medical device company completed an oversubscribed $102m Series D funding round to support the introduction of the Edison Histotripsy System.
