The U.S. Food and Drug Administration has approved using sound waves to interrupt down tumors—a method called histotripsy—in humans for liver treatment.

Pioneered on the University of Michigan, histotripsy offers a promising alternative to cancer treatments comparable to surgery, radiation and chemotherapy, which regularly have significant negative effects. Today, FDA officials awarded clearance to HistoSonics, an organization co-founded in 2009 by U-M engineers and doctors for using histotripsy to destroy targeted liver tissue.

A human trial underway since 2021 on the U-M Rogel Cancer Center and other locations has treated patients with primary and metastatic liver tumors via histotripsy, demonstrating the technology’s ability to fulfill the testing’s primary effectiveness and safety targets.

Histotripsy is an exciting recent technology that, even though it is in early stages of clinical use, may provide a noninvasive treatment option for patients with liver cancer. Hopefully it may be combined with systemic therapies for a synergistic therapeutic effect.”

Mishal Mendiratta-Lala, professor of radiology with Michigan Medicine and principal investigator on the trial at U-M

HistoSonics can now market and sell its histotripsy delivery platform, called Edison, to hospitals and medical professionals to be used in liver treatments. The corporate is headquartered in Minneapolis, while its advanced research and development is situated in Ann Arbor.

Histotripsy works by utilizing targeted ultrasound waves to form microbubbles throughout the tumor. The forces created as those bubbles form and collapse cause the mass to interrupt apart, killing tumor cells and leaving the debris to be cleaned up by the immune system.

What that would mean for patients is treatment without the physical toll of radiation or chemotherapy, fewer concerns with drug compatibility, far shorter recovery times than with surgery and fewer treatment discomfort.

This is feasible since it is way easier to be certain that histotripsy treatments are hitting the tumor, and never healthy tissue, in comparison with radiation or invasive procedures. Histotripsy relies on focusing acoustic waves of high energy ultrasound to pay attention the energy enough to form bubbles, and the Edison machine can be certain that region is confined to the tumor. In contrast, radiation affects every little thing in its path through the body.

As well as, the histotripsy system has onboard diagnostic ultrasound imaging, the sort used to see babies within the womb. It’s used to plan and observe the treatment in real time. Physicians have a live view of the “bubble cloud” and the way tissue is responding to the therapy.

And histotripsy’s potential advantages transcend tumor destruction. Within the last 12 months, a pair of preclinical studies in rodents suggest that within the clean-up process, the immune system learns the best way to discover cancer cells as threats. This will enable the body to proceed fighting the initial tumor and help activate a natural immune response to the cancer.

In the primary study, even after destroying only 50% to 75% of the liver tumor volume by histotripsy, the rats’ immune systems were capable of clear away the remainder, with no evidence of reoccurrence or metastases in greater than 80% of animals.

Earlier this 12 months, a second study showed that histotripsy breaks down the cancer cell wall’s “cloak”—revealing proteins that the immune system can use to discover threats, often called antigens. These antigens are removed during surgery or destroyed during chemotherapy and radiation. By as a substitute destroying a cancer cell’s outer wall, histotripsy lays bare the tumor antigens for the immune system to discover and use for targeted attacks on other cancer cells.

We would like to leverage histotripsy’s immuno stimulation effects and hopefully mix them with immunotherapy or drug delivery.”

Zhen Xu, U-M professor of biomedical engineering, an inventor of the histotripsy approach and a co-founder of HistoSonics

“That may move histotripsy from an area therapy into one which can treat tumors globally everywhere in the body and eventually right into a cure. By way of the cancer treatment, that will likely be the following step, and I feel very excited concerning the potential.”

Mendiratta-Lala, Xu and the University of Michigan have a financial interest in HistoSonics. The corporate was formed with support from U-M’s Coulter Translational Research Program and Innovation Partnerships, U-M’s hub for research commercialization.