Sonic Beam Therapy for Liver Gets ‘Breakthrough’

FDA has granted HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its use to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat. The designation was made based on early clinical and pre-clinical results suggesting that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and ducts within or adjacent to the treated volume of tissue, according to the company. “Additionally, histotripsy enables the treating physicians the ability to monitor the destruction of tissue under continuous real time visualization and control, unlike any modality that exists today,” it says. The company has an ongoing IDE study called #HOPE4LIVER US, which is designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumors.