Minnesota-based HistoSonics has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration to begin its first clinical trial in the US. The study will be called #HOPE4LIVER.
The trial will investigate the safety and efficacy of using the company’s Edison platform – a sonic beam therapy platform utilizing histotripsy – to noninvasively and mechanically destroy liver tumors in the US.
Patient enrollment for this multi-center, open label, and single arm trial is expected to begin in early 2021. Eligible patients will receive histotripsy to destroy up to three primary or metastatic liver tumors in a single session at seven enrolling sites in the United States. Multidisciplinary liver specialist teams will lead each site.
The US trial will build upon data from the company’s THERESA study, a first-in-human clinical trial in Barcelona, Spain, using the Edison platform to destroy affected tissue in patients with advanced primary and metastatic liver tumors. The positive results of that trial were presented at the 2020 meeting of the Society of Interventional Oncology in February and recently discussed in a HistoSonics webinar.
In the press release, Dr. Joseph Amaral, FACS, HistoSonics’ Vice President of Medical Affairs, said, “Histotripsy is a uniquely differentiated treatment platform that has great promise to transform the care of patients. We are humbled to have such exceptional investigators and leaders in the field involved in our first US study. They, together with the patients who enroll in the study, will potentially pave the path to improved care in the future.”