HistoSonics revealed today that they have successfully treated their first set of patients with pancreatic tumors, utilizing their Edison histotripsy system. This milestone is part of the GANNON trial and signifies the Minneapolis-based company’s venture into a new area of medical treatment. Previously, the Edison system was crafted for liver tumor therapy.
Edison is an advanced therapy platform offering image-guided precision treatments through cutting-edge imaging and proprietary sensing technologies. Known for its non-invasive, individualized approach, the system introduces a revolutionary technique called histotripsy. This innovative method employs high-frequency, short-duration ultrasound pulses to form a “bubble cloud,” effectively breaking down and liquefying target tissue.
Seen as a viable alternative to conventional treatments such as surgery, radiation, and chemotherapy, histotripsy has gained traction in oncology. In February 2023, the system secured FDA investigational device exemption, followed by the first kidney tumor treatment a month later. By October 2023, Edison obtained de novo authorization from the FDA.
HistoSonics is now pursuing further investigational work under the GANNON trial, intending to treat up to 30 patients who are diagnosed with inoperable pancreatic adenocarcinoma at Stage 3 or patients with limited metastasis at Stage 4. The clinical trial, led by Dr. Santiago Sánchez Cabús, is based at Sant Pau Hospital in Barcelona, Spain.
According to CEO and President Mike Blue, “Many patients with pancreatic cancer lack viable treatment options, as their condition is often too advanced for surgical remedies. We are optimistic that histotripsy offers a non-invasive alternative to target previously untreatable tumors. Our mission is to broaden the application of histotripsy across various tumor types, significantly enhancing outcomes for patients and their families.”