Key Points
- The data are from the US and European prospective, multi-center trials called #HOPE4LIVER.
- Since FDA clearance in 2023, HistoSonics’ Edison histotripsy system has been used to treat more than 1,000 patients with liver tumors.
HistoSonics recently released 12-month data from the US and European prospective, international, multi-center, single arm trials called #HOPE4LIVER. These research studies investigated the safety and efficacy of using the company’s histotripsy platform to noninvasively and mechanically destroy primary and metastatic liver tumors with histotripsy.
The trials enrolled 47 patients across 14 centers in the US, UK, Italy, and Germany. Nineteen participants presented with primary liver tumors, and the remaining 28 participants had metastatic tumors of the liver, with most having primary cancer in the colon or rectum (39.3%). In all, 52 tumors were treated.
The 12-month data were recently published in the Annals of Surgery. These data build upon the preliminary results that were published in Radiology in September 2024. At that time, it was reported that the trials met their predetermined co-primary endpoints for both technical success and safety.
Researchers found that after 12-months, participants experienced a 90% local tumor control rate across all treated tumors regardless of tumor type or origin. Overall survival at one year was 73.3% for patients with primary liver cancer, and 48.6% in patients with metastatic disease.
The paper notes that both the tumor control and survival rates are comparable to current standard of care therapies. Also notable, the recent data indicate that histotripsy can avoid damage to blood vessels and bile ducts within the treated area.
Data from the early #HOPE4LIVER studies resulted in the Edison system receiving US Food and Drug Administration (FDA) clearance in October 2023. Since FDA clearance, HistoSonics has since commercialized its Edison Histotripsy System at institutions in the United States, Hong Kong and the United Arab Emirates, with those centers responsible for treating well over 1000 patients with liver tumors to date.
Beyond these clinical trial data, a recent article published in the Journal of Gastrointestinal Surgery, analyzed safety outcomes within 30 days of the procedure and found that the histotripsy safety profile “compares favorably with that of other liver-directed and surgical therapies for the treatment of liver tumors.” There have also been case reports describing the potential utility of histotripsy as an effective bridging therapy for patients who are awaiting liver transplantation.