“Being able to safely target and treat tumors in this advanced patient population, non-invasively and without ionizing radiation means a great deal not only to patients with multi-focal disease but could also provide a bladeless surgical option for patients in earlier stages”, said co-Principal Investigator Joan Vidal-Jove MD, PhD, a surgical oncologist with the Kuhab Institute in Barcelona. Dr. Vidal-Jove’ and Dr. Xavier Serres led the study at the three Barcelona based hospitals that participated in the trial which included, Vall d’Hebron University Hospital, Mutua Terrassa University Hospital and Clinica Diagonal.
The published THERESA Trial results also demonstrated that the histotripsy system could be used to successfully target and treat multiple tumors in the same procedure, or single fraction, with one patient receiving three treatments to 3 distinct tumors, one patient receiving treatment for 2 tumors and the remaining patients having only one tumor treated. “The publication of the THERESA Trial represents a landmark study demonstrating the safety and acute technical success of hepatic histotripsy, and we look forward to results of our next generation histotripsy system in destroying targeted liver tumors in our ongoing #HOPE4LIVER Trials”, says Dr. Joseph Amaral, HistoSonics’ VP of Clinical and Medical Affairs. HistoSonics intends to use data from the #HOPE4LIVER Trials being conducted the US and Europe to support regulatory submission to the FDA in the coming months.
HistoSonics also commented that they have begun meeting with the FDA on their plans for a kidney tumor trial to commence in 2023 and are also currently conducting pre-clinical translational studies in the pancreas. The Company has also recently completed renovation of its manufacturing facility in Plymouth, MN and has hired additional personnel across all functions to prepare for upcoming growth.
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 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, Michigan and Minneapolis, MN.