A new soundwave device created by HistoSonics, a company founded by University of Michigan researchers, has been approved by the U.S. Food and Drug Administration for treating tumors in the liver. According to HistoSonics, the device, called Edison, offers patients a less invasive treatment option compared to surgery, chemotherapy or radiation.
The FDA approval for Edison comes after the researchers completed the #HOPE4Liver clinical trial, which treated 44 patients with liver lesions using Edison. The researchers found the Edison device striked and reduced patients’ tumors 95.5% of the time, with only three patients reporting side effects, all of which were minor.
Zhen Xu, professor of biomedical engineering and co-founder of HistoSonics, spoke with The Michigan Daily about how histotripsy uses external ultrasound pulses to destroy targeted tissue. Xu said the pulses rapidly expand and collapse gas pockets within the target tissue, destroying it in a process called cavitation.
“(Histotripsy) produces very high local mechanical stress to basically pull cells apart within millimeter accuracy,” Xu said. “So it can be used, as you can imagine, for noninvasive surgery. The cellular debris actually is absorbed by the body over time. So over time, the treated region is literally just like you have surgically removed the tissue. It’s actually gone.”
Xu said histotripsy is the first non-invasive, non-ionizing and non-thermal method available to break down tissues in the liver, making it a promising option with minimal side effects for patients with tumors.
“We found that histotripsy can treat tumors where we (need to) preserve critical structures like the major vessels, neurovascular bundles (and bile) ducts,” Xu said. “They are more resistant to histotripsy damage. So (histotripsy) actually allows us to potentially treat high-risk locations near critical organs or structures that cannot be achieved by the current approach.”
Eli Vlaisavljevich — who worked with HistoSonics while doing his Ph.D. and postdoctoral work, and continues to collaborate with them while working as a professor at Virginia Tech — told The Daily the technology can offer patients options that previously weren’t available.
“A lot of patients can’t get surgery because of the progression of the disease, the number of tumors (or) the location of tumors,” Vlaisavljevich said. “With histotripsy, you can significantly improve their quality of life and outcomes and survival.”
According to Xu, HistoSonics is working to expand the use of histotripsy to treat other types of tumors.
“There is a clinical trial on using the same device, the Edison device, to treat renal tumors,” Xu said. “The plan is to extend that same device to treat pancreatic cancer, hopefully in a year. And then we also are doing a lot of research on many other cancer types. For example, we are doing research in our lab to treat brain tumors.”
In an interview with The Michigan Daily, Ryan Miller, manager of advanced systems at HistoSonics and U-M alum, said this device will positively impact patients with tumors in the future.
“The safety of the device was proven throughout the clinical trials,” Miller said. “We are just really excited to have the FDA grant and to put this amazing new technology into the hands of physicians to help patients.”
The University, along with Xu and several other HistoSonics researchers, has financial interest in the company, which was established with support from U-M Innovation Partnerships and the Coulter Translational Research Program. Xu said the HistoSonics team is working hard to get insurance companies to approve histotripsy treatment.
“So I think (HistoSonics is) doing this one by one,” Xu said. “They are now getting (approval), I think, from Medicare and then they are moving one major medical insurance at a time.”
Vlaisavljevich said the success of this clinical trial will help support future research with histotripsy.
“Now that the device is approved, you’ll see a lot more clinical data come out because hopefully you’ll see more and more patients getting this therapy now,” Vlaisavljevic said. “And we’ll continue to learn about the effectiveness of histotripsy because of (that) clinical data.”