On October 9, HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the marketing authorization of its platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical devices with no existing predicate. The Edison System is indicated for the noninvasive destruction of liver tumors, including unresectable liver tumors, using a nonthermal, mechanical process of focused ultrasound. The newly issued marketing authorization makes Edison the first and only histotripsy platform available in the United States.
More About Edison
The science of histotripsy uses focused sound energy to produce controlled acoustic cavitation that mechanically destroys and liquefies targeted liver tissue, including tumors, at subcellular levels. The Edison System uses proprietary technology and advanced imaging to deliver personalized, noninvasive histotripsy treatments with precision and control.
The novel mechanism of action of this proprietary technology may provide significant advantages to patients, including the ability of the treatment site to recover and resorb quickly. HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control.
#HOPE4LIVER Trials
FDA authorization was based, in part, on data from the #HOPE4LIVER trials (ClinicalTrials.gov identifier NCT04573881) conducted in 13 trial sites across the United States and Europe. Data pooled from the trials was used to assess the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors.
Histotripsy was noted to have achieved both the primary safety and efficacy endpoints in the pooled data, where 44 patients were evaluated for safety and 44 tumors treated were evaluated for efficacy. Of note was the heterogeneity of the treated patients, 18 of whom had hepatocellular carcinoma and 26 of whom had metastatic tumors to the liver from the colon, rectum, breast, and other primary origins. As recently presented at the annual CIRSE Congress in Copenhagen, a technical success rate of 95.5% was achieved, indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors. Three procedure-related grade ≥ 3 adverse events through 30 days posthistotripsy were observed across all 44 treated patients—representing a complication rate of 6.8%—with each event commonly associated with focal liver therapies and not specific to histotripsy.
“This [authorization] represents over 2 decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible—integrating the many complexities of histotripsy into a completely noninvasive clinical platform,” commented Mike Blue, President and Chief Executive Officer of HistoSonics.
The University of Michigan—who works closely with HistoSonics, with some of its faculty cofounding the company in 2009—also issued a report on the authorization, and touched on the next steps for the use of histotripsy in cancer treatment. Zhen Xu, PhD, Professor of Biomedical Engineering at the university, an inventor of the histotripsy approach, and a cofounder of HistoSonics, commented, “We want to leverage histotripsy’s immunostimulation effects and hopefully combine them with immunotherapy or drug delivery.... That will move histotripsy from a local therapy into one that can treat tumors globally all over the body and eventually into a cure. In terms of the cancer treatment, that will be the next step, and I feel very excited about the potential.”
