HistoSonics, (www.histosonics.com), the developer and manufacturer of a completely non-invasive platform and proprietary sonic beam therapy, announced the publication of results from their prospective Phase I clinical trial, named the THERESA Trial, conducted in Barcelona, Spain. The study reported results on eleven targeted tumors in the eight patients treated who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1tumor). Importantly, the primary endpoint of technical success was achieved in all procedures. The secondary safety profile endpoint was achieved as an independent data safety monitoring board identified no device-related adverse events observed up to 30 days after histotripsy.
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The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue at sub-cellular levels. Uniquely, the HistoSonics platform also provides physicians the ability to plan, target, treat and monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists. Results of the study, recently published in the International Journal of Hyperthermia (THERESA Trial), demonstrated that the HistoSonics’ histotripsy system met its co-primary endpoints of acute safety (30 day) and technical success (ability to treat targeted volume of liver tissue) in liver tumors of both primary and secondary origin.
“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.