ANN ARBOR—HistoSonics, developer of a non-invasive sonic beam therapy, 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 science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted 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, who is principal investigator of the #HOPE4LIVER trial. It represents the first histotripsy procedure performed in the #HOPE4LIVER US Study.
“We are extremely excited to have successfully performed the first non-invasive histotripsy tumor treatment in the United States,” Davis said. “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 to 30 percent 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 United States who have primary liver tumors has increased 43 percent in the past 16 years and is expected to grow another 40 percent 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 percent of patients with advanced disease from another site. Histotripsy may provide benefits to these patients due to its unique non-invasive, non-thermal, and non-ionizing destructive capabilities.
“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,” HistoSonics president and CEO Mike Blue said. “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 U.S. 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.
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy using 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 the continued development of its Edison Platform, global clinical studies, and new strategic projects including future clinical applications and platforms. HistoSonics has offices in Ann Arbor and Minneapolis.
More at www.histosonics.com/ .