HistoSonics® Publishes Results of its Pivotal #HOPE4LIVER Trials
Adoption of its Novel Non-Invasive Therapy Surges After FDA Clearance
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)
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.
About HistoSonics
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN.
For more information on the Edison Histotripsy System please visit: www.histosonics.com/. For patient related information please visit: www.myhistotripsy.com/.
“The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors” published in Radiology by Mishal Mendiratta-Lala, et.al. is licensed under CC BY 4.0.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240903641498/en/
Website: https://histosonics.com/
Contact
HistoSonics
Josh King
Vice President of Marketing
608.332.8124
Joshua.king@histosonics.com
This news is a press release provided by HistoSonics. Korea Newswire follows these editorial guidelines.
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