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University researchers highlight noninvasive "histotripsy" therapy and commercialization plans
Summary
Dr. Jen Hsu described histotripsy, a noninvasive ultrasound treatment developed at the University of Michigan, outlined claimed clinical benefits and commercialization milestones including an October 2023 FDA approval for liver tumors and plans for more trials and indications.
Dr. Jen Hsu, a University of Michigan biomedical engineer and radiology professor, told the Board of Regents that histotripsy — a noninvasive, mechanically based ultrasound therapy — liquefies targeted tumor tissue without incision and can be delivered under real-time image guidance.
Hsu said the technique, developed at the university, offers high precision and rapid recovery, and she framed it as a platform for treating tumors in the liver, kidney, pancreas, prostate, brain and shallow targets such as skin and breast lesions. "This is the first noninvasive technology to perform the real surgery, meaning mechanically removed tissue," Hsu said.
Why it matters: Hsu described recent clinical and commercial milestones and set out targets for broader adoption. She said the Food and Drug Administration approved histotripsy for treatment of liver tumors in October 2023; that within a year about 30 U.S. hospitals had established clinical programs and that 88 hospitals had purchased systems; and that Histosonics, a university spin-off, has raised substantial capital with an initial public offering planned.
Hsu outlined next steps the university and partners plan to pursue: initiating multiple clinical trials across indications, filing additional patents and expanding educational programs for clinicians and students. She also framed the work as an economic opportunity — forecasting royalty income and job creation tied to commercialization efforts.
Claims and evidence: Much of the article summarizes claims Hsu made to the board. She stated clinical and commercial figures during her presentation and described preclinical evidence that histotripsy can elicit a tumor-specific immune response. When asked about multi-tumor cases, Hsu acknowledged that full results are not yet available, saying preclinical studies show immune effects can be tumor-specific and that future work will combine histotripsy with immunotherapy.
What was not settled: Board members and the presenter described ongoing and planned research and commercialization activities; none of the regulatory or financial projections were independently verified during the meeting. The hospital adoption and funding numbers reported were presented by Hsu as programmatic claims and are recorded here as such.
Next steps: Hsu said the team aims to pursue additional FDA approvals and 5–10 clinical trials and to treat more patients at University of Michigan hospitals in the coming years. The Regents did not take formal action related to histotripsy at this meeting.
