HistoSonics announced today that it has received approval to initiate the company’s second European clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tumors, from outside of the body. The study, similar to HistoSonics’ recent FDA approved #HOPE4LIVER U.S. Study, is a multi-center, open label, single arm trial to evaluate the safety and efficacy in destroying liver tumors and will build upon the company’s first-in-man THERESA Study recently conducted in Barcelona, Spain. The company expects to begin enrolling patients in early 2021.
In Europe, the outlook for patients with primary liver tumors remains dismal with the 3-year survival rates estimated to be between 47.3% for patients under surveillance, and as low as 21.8% for those found while not already under surveillance.
The company intends to have up-to seven enrolling sites in select European countries. Each site will be led by experienced clinical investigators and multi-disciplinary liver specialists. Patients eligible for the #HOPE4LIVER European study will undergo non-invasive histotripsy in order to destroy up-to 3 primary or metastatic liver tumors in a single session and will be followed by the trial investigators to evaluate the safety and efficacy of their treatments. Successful completion of #HOPE4LIVER is expected to be used to support a European regulatory submission, and the company plans to immediately expand the use of its platform in additional solid tumors after completion of the US and European liver studies.
Dr. Luigi Solbiati of Humanitas Research Hospital in Milan, Italy, and co-Principal Investigator of #HOPE4LIVER Trial, commented, “I am particularly glad to be the principal investigator of this trial, given that all the participating centers across Europe have outstanding reputations for clinical medicine and research.” Solbiati added, “Histotripsy’s non-invasive approach and novel mechanical destruction of tumors provide potential for this procedure to become a leading technology in interventional therapies.”
Joe Amaral, MD, HistoSonics’ Vice President of Medical Affairs, also commented, “I am excited to work with our co-Principal Investigators, Dr. Solbiati, a true pioneer of ablative locoregional therapy, and Dr. Guido Torzilli, world-renowned liver surgeon. These experts, as well as the other leading European cancer centers participating in the trial provide extensive liver treatment experience and have been innovators in locoregional therapies.” In addition, Dr. Amaral commented, “The successful completion of the European #HOPE4LIVER Clinical Trial will bring us one step closer to achieving Histosonics promise of providing patients with revolutionizing interventional care.”
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.