Key Points
- HistoSonics has obtained regulatory approvals for their #HOPE4LIVER US and #HOPE4LIVER Europe clinical trials.
- Researchers are studying histotripsy to noninvasively destroy liver tumors.
- Patient enrollment will likely begin early this year at up to seven sites across Europe and six US sites.
HistoSonics has announced that it has received approval to begin its #HOPE4LIVER Europe clinical trial in collaboration with leading multi-disciplinary liver experts across Europe. The multi-center, open label, single arm trial will investigate the safety and efficacy of using the company’s new platform – a sonic beam therapy platform utilizing histotripsy – to noninvasively and mechanically destroy liver tumors. The company expects to begin enrolling patients early this year and expects to have up to seven sites participate in select European countries.
Patients in the trial will undergo histotripsy to destroy up to three primary or metastatic liver tumors in a single session. Trial investigators will then conduct follow-up to evaluate the safety and efficacy of their treatments. The company expects to use the data from this trial to support a submission for European regulatory approval.
This will be the company’s second clinical trial in Europe, building on the THERESA Study recently conducted in Barcelona, Spain.
In October 2020, HistoSonics announced that a similar trial – the #HOPE4LIVER US study– had earned approval in the United States. Tampa General Hospital was the first site to earn approval by their Internal Review Board to begin enrolling patients, however up to five other US sites are expected to join the study in the coming months.