HistoSonics Targets Pancreatic Tumors in New Feasibility Study
Just about a year ago, Plymouth-based HistoSonics earned federal approval to begin selling technology designed to destroy liver tumors. This week, the medtech startup unveiled plans to use the same technology to conquer pancreatic tumors.
On Monday, HistoSonics announced that it has successfully treated patients with pancreatic tumors using the Edison system, technology that uses ultrasound to “liquefy” tumors in the body. The patients are part of a new feasibility study in Spain that officially kicked off on Dec. 10. Known as the “GANNON trial,” the study seeks to evaluate the safety of Edison in treating pancreatic tumors in up to 30 patients.
Why Spain? Although the company has a strong presence here in the Midwest, HistoSonics has a history with the European country. The startup’s 2018 feasibility trial for treating liver tumors, for instance, took place in Barcelona. HistoSonics’ medical director, Dr. Joan Videl-Jove, is a surgical oncologist in Barcelona, and he served as a principal investigator in that earlier study.
HistoSonics’ method of treating tumors relies on a process known as “histotripsy,” which the company defines as “a novel non-invasive technology that destroys targeted tumor tissue using focused ultrasound.”
In a news release issued Monday, the company noted that pancreatic tumors have the highest mortality rate of any major tumor type.
“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, in the release. “We believe histotripsy provides a non-invasive option to target tumors that were previously considered untreatable.”
In October 2023, HistoSonics earned the FDA’s “de novo classification,” which permitted the company to begin marketing the Edison system for destroying liver tumors. Notably, the FDA hasn’t yet formally evaluated Edison for treating disease; the agency’s earlier classification sticks with the more general term of “destruction of liver tumors.”
