ANN ARBOR–HistoSonics Inc., 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, 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.
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 today. Results of the study, recently published in the International Journal of Hyperthermia, 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.
The published 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.
HistoSonics also announced it has 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, Minn.and has hired additional personnel across all functions to prepare for upcoming growth.
HistoSonics has offices in Ann Arbor and Minneapolis. More at : www.histosonics.com.