MINNEAPOLIS -- HistoSonics, (www.histosonics.com), the developer and manufacturer of the Edison® Histotripsy System, announced today the publication of the company’s pivotal clinical trials data in Radiology. The prospective, international, multi-center, single arm #HOPE4LIVER Trials were designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular carcinoma) and metastatic liver tumors. Safety and efficacy were measured against performance goals established using extensive real-world evidence from ablative therapies. The analysis included 49 targeted tumors in 44 patients: 18 with primary liver tumors and 26 with metastatic tumors from the colon, rectum, breast, pancreas, and other primary origins.

Histotripsy patient Marie and her husband Steve after Marie’s histotripsy treatment of her liver tumors by Evan S.K. Ong, M.D., MS, FACS, with Providence Swedish in Seattle after the FDA De Novo grant. (Photo: Business Wire)
Histotripsy patient Marie and her husband Steve after Marie’s histotripsy treatment of her liver tumors by Evan S.K. Ong, M.D., MS, FACS, with Providence Swedish in Seattle after the FDA De Novo grant. (Photo: Business Wire)
The trials met the co-primary endpoints for technical success and safety. In the evaluable analysis at ≤ 36 hours post procedure, the histotripsy treatment completely covered the tumor in 42/44 tumors (95.5%), as evaluated by the independent core laboratory indicating that histotripsy destroys liver tumors sufficient to cover a physician’s planned treatment volume. This outcome is key as the investigators treated both primary and metastatic disease and represented a diverse group of liver experts with no prior experience performing histotripsy, signaling a quick learning curve. The safety endpoint was achieved with only 3/44 (6.8%) of patients reporting a procedure-related major complication within the first 30-days post histotripsy procedure. All participants were required to have either not responded to, relapsed from, and/or been intolerant of other local-regional therapies, thus the patient population was not typical of those who undergo ablative therapies. Successfully achieving these co-primary endpoints in patients with more advanced disease further highlights the safety profile and technical success of histotripsy. Data from #HOPE4LIVER were submitted to the US FDA as part of the HistoSonics market access submission resulting in an October 2023 FDA De Novo grant for the non-invasive destruction of liver tumors using histotripsy.

Clifford Cho MD, #HOPE4LIVER Co-National Principal Investigator, Professor of Surgery and Chief Medical Officer at the University of Michigan Health-West Medical Center added, “As a liver surgeon with the insights learned in our laboratory about the enormous and varied potential benefits of histotripsy, it was professionally rewarding to see histotripsy utilized to benefit such a diverse patient population in the #HOPE4LIVER Trials.”

Tim Ziemlewicz MD, Assistant Professor of Radiology at the University of Wisconsin and Co-National Principal Investigator added, “The fact that this trial supported the first FDA authorization for the treatment of liver tumors using this unique new histotripsy platform is incredibly gratifying.”

As a result of these early data, HistoSonics initiated planned commercialization of the Edison System in the first half of 2024, rapidly establishing histotripsy programs in leading academic and private institutions across the US and globally. To date, the accelerated clinical adoption of histotripsy has led to hundreds of histotripsy procedures completed by liver surgeons, interventional radiologists, and radiation oncologists with a high rate of success. These data are being prepared for publication later this year. Furthermore, longer-term 12-month efficacy data from #HOPE4LIVER is in analysis and in preparation for publication.

Centers adopting the Edison Histotripsy System in their routine clinical practice have recognized the unique benefits to both patients and their institution. “Edison clearly represents the future of liver-directed therapies realized; non-invasive, precise, effective and with an excellent initial safety profile, histotripsy potentially has all of the benefits of traditional tumor treatments, but without all of the disadvantages,” said Evan S.K. Ong, M.D., MS, FACS, surgical oncologist and hepatic-biliary specialist with Providence Swedish in Seattle.

Brian Fuller, Senior Director, Clinical Operations at Providence Mission Hospital in Mission Viejo, California said, “Histotripsy has been a true game changer for Mission Hospital and the patients we service. The clinical impact we have seen at Providence Mission is well publicized and is truly amazing. Also impressive has been the impact on screening awareness and overall elevation of our oncology programs. Additionally, HistoSonics has given us a big boost in physician and caregiver engagement.”

HistoSonics recently announced its plans to enroll patients in a novel Master Study design by the end of the year. The study and post market clinical program, called BOOMBOX, aims to collect data across all clinical use cases, and liver tumor pathologies, observing the use of histotripsy across all stages of liver disease. This comprehensive study is in addition to the company’s active Investigator Sponsored Research (ISR) program and other company directed studies in new indications.

The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events.