Key Points
- HistoSonics’ #HOPE4LIVER clinical trial results proved the treatment is safe, leading the US FDA to clear its Edison system for the treatment of liver tumors.
- The company also launched a new website to help patients learn more about histotripsy and find a treatment site.
The initial results from HistoSonics’ #HOPE4LIVER clinical trials have been published in Radiology. The prospective, international, multi-center, single arm trials investigated the safety and efficacy of using the company’s Edison platform to noninvasively and mechanically destroy liver tumors with histotripsy.
The paper compiles data from two concurrent clinical trials that took place in the US, the UK, and Europe. In all, six UK/European sites and eight sites in the US participated. The paper includes treatment data from 49 targeted tumors in 21 US and 23 European participants (with mean age of 64 years). Of the 49 targeted tumors, 18 were primary liver tumors and the remaining 26 were metastatic lesions that originated in the colon, rectum, breast, pancreas, and other locations.
The trials met their predetermined co-primary endpoints for both technical success and safety. The maximum tumor diameter treated was 1.5 ± 0.6 cm, and post-procedure scans showed that the histotripsy treatment completely covered the volume of the tumor in 95.5% of participants. A low rate of 6.8% of patients reported a major complication within the first month after the procedure.
Of note, no participating #HOPE4LIVER trial site had performed histotripsy prior to the trial, signaling a trend in a quick learning curve among new users. The study investigators also recruited a diverse patient population and were able to deliver histotripsy accurately and precisely to the targeted tumor with an adequate margin, as demonstrated with the high rate of technical success.
These data led the US Food and Drug Administration to clear HistoSonics’ Edison system for the treatment of liver tumors in October 2023. Notably, this was the first time a focused ultrasound mechanism of action other than thermal ablation earned regulatory approval anywhere in the world.
Today, histotripsy is available at 20 sites in the US and one site in the United Arab Emirates, and additional sites are being added.
Read HistoSonics’ Press Release
Resources for Patients
The company recently launched a new website – called myhistotrispy.com – to help educate patients on histotripsy and help them locate treatment sites. The website offers an overview of histotripsy and features patient stories, a form to help determine if histotripsy is right for you, and resources to find a doctor near you.