HistoSonics announced the results of its pivotal #HOPE4LIVER trials, showcasing the Edison Histotripsy System’s effectiveness in non-invasively destroying liver tumors. The trials, published in Radiology, involved 44 patients and 49 tumors — ranging from primary liver cancers to metastatic tumors.
The Edison Histotripsy System uses focused ultrasound, creating a “bubble cloud” to mechanically destroy tumors non-invasively, preserving healthy tissue. Unlike surgery or thermal ablation, it offers a precise and safe alternative, ideal for treating difficult-to-reach or inoperable tumors.
The goal of the study was to evaluate the system’s technical success and safety against established performance standards from ablative therapies, which are also non-invasive therapies that use heat or cold to destroy tumors.
The results were impressive: histotripsy treatment successfully covered 42 out of 44 tumors (95.5 percent), meeting the co-primary endpoint for technical success. The independent core lab confirmed the tumors were destroyed within the planned treatment volume. Importantly, the safety endpoint was achieved as well, with only 6.8 percent of patients reporting major complications within 30 days of treatment. Given that many patients had not responded to or had relapsed from other treatments, these outcomes could be significant.
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According to Dr. Evan SK Ong, surgical oncologist and hepatic-biliary specialist with Providence Swedish in Seattle, the Edison Histotripsy System offers a non-invasive, precise and effective approach with a strong safety profile. It retains the advantages of traditional tumor treatments while eliminating many of their drawbacks.
After receiving US Food and Drug Administration (FDA) De Novo clearance, the Edison Histotripsy System rapidly transitioned from trials to real-world use. By mid-2024, hundreds of procedures had been completed successfully, demonstrating the system’s growing adoption.
Related: HistoSonics’ Kidney Cancer Trial Using Non-Invasive Histotripsy Gets FDA Nod
Earlier this year, it was used in the world’s first real-word liver treatment and as an investigational device in the first kidney treatment at the #HOPE4KIDNEY Trial.
Looking forward, HistoSonics is preparing to publish 12-month efficacy data from #HOPE4LIVER and will launch the BOOMBOX Master Study to collect comprehensive data across various liver tumor types. Ongoing Investigator Sponsored Research (ISR) programs aim to expand histotripsy’s clinical use into other organs like the kidney and pancreas.
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