HistoSonics announced today the treatment of the first patient in the #HOPE4LIVER US Study. The investigational device study was approved by the FDA in the fourth quarter of 2020. The study is designed to evaluate the safety and efficacy of the company’s platform technology, which uses the novel science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors, without invasive incisions or needles entering the patient’s body. The #HOPE4LIVER US Study is a multi-center, open label, single arm trial planned to enroll up-to 45 patients.
The procedure was performed at Tampa General Hospital by Cliff Davis, M.D., assistant professor and director of the Interventional Radiology Residency Program in the USF Health Morsani College of Medicine and principal investigator of the #HOPE4LIVER trial at the TGH site, and represents the first histotripsy procedure performed in the #HOPE4LIVER US Study. Dr. Davis commented, “We are extremely excited to have successfully performed the first non-invasive histotripsy tumor treatment in the United States. The patient tolerated the procedure well and will continue to be followed up by our team per the study protocol. We are eager to continue participating in the study and help the promise of histotripsy to be realized.”
Only 20%-30% of patients with liver tumors are eligible for surgical resection due to the presence of multiple tumors, underlying poor liver function, or general health issues limiting the success of surgery. The number of patients in the US who have primary liver tumors has increased 43% in the past 16 years and is expected to grow another 40% by 2030. Additionally, the liver is second only to lymph nodes as the most common site of metastatic tumors, those that spread from other organs, and estimated to be present in up-to 70% of patients with advanced disease from another site. Histotripsy may provide benefits to these patient due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.
HistoSonics President and CEO Mike Blue added, “Treating the first patient in the #HOPE4LIVER US Study is a tremendous milestone for our company, and we are very grateful to Dr. Davis and the Tampa General team for their commitment to clinical research and leadership in this important trial. We believe our non-invasive solution combined with the potential benefits of histotripsy’s novel mechanism of action, have the potential to change the experience for patients with solid tumors, and this study is the next step in building that evidence. We look forward to continuing our strong partnership with Tampa General Hospital, as well as enrolling patients in our other US sites in the very near future.“
The HistoSonics device is investigational and is not available for sale in the United States. It is limited to investigational use in the approved IDE and European studies.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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 persons 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.