October 9, 2023 Charlottesville, VA —The US Food and Drug Administration (FDA) has cleared HistoSonics’ novel therapy platform – called EdisonTM – to treat liver tumors. This is the ninth clinical indication for which focused ultrasound treatment has been approved by the FDA.*
EdisonTM uses histotripsy to noninvasively destroy tissue in the liver and is the first and only such platform available in the US. This is also the first time the use of histotripsy has earned regulatory approval worldwide. The science of histotripsy uses focused ultrasound to produce controlled acoustic cavitation that mechanically destroys and liquifies targeted liver tissue without heating. The method was invented and named by the late Charles A Cain, PhD, and his team at the University of Michigan (UM). The Foundation provided funding for early-stage research at UM that helped establish the feasibility for histotripsy.
The FDA clearance was granted based on data from HistoSonics’ #HOPE4LIVER clinical trials, during which this method was tested in 44 patients with primary and metastatic liver tumors at 14 sites across the US and Europe. The procedure was noted to have achieved both primary safety and efficacy endpoints in the studies.
The trial participants suffered from a variety of liver tumors, including hepatocellular carcinoma tumors and metastatic tumors to the liver from the colon, rectum, breast, and other primary origins. Overall, a technical success rate of 95.5% was achieved, and there were minimal adverse events.
HistoSonics helped to pave the way for an expeditious approval when it secured Breakthrough Device Designation for Edison in 2021. The Breakthrough Devices Program was established to allow fast-tracking of novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“This is HistoSonics’ most meaningful milestone to date and represents over two-decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible – integrating the many complexities of histotripsy into a completely noninvasive clinical platform,” said Mike Blue, HistoSonics’ President and CEO.
“Sadly, the incidence of liver cancer has more than tripled in the last 40 years,” said Foundation Chairman Neal F. Kassell, MD. “Now focused ultrasound can offer hope to these patients. We extend our congratulations to the HistoSonics team for their innovative work in this field, and we are encouraged that this milestone lays the groundwork for the technology to also treat benign and malignant tumors in other organs, such as the pancreas, kidneys, and uterus.”
Emily White, MD, the Foundation’s managing director of operations and editor-in-chief of the Foundation’s State of the Field Report, provides her perspective: “This approval is significant on many levels, but it is noteworthy that this is the first time a mechanism of action other than thermal ablation – or heat energy – has earned regulatory approval anywhere in the world. Overall, there are numerous ways in which focused ultrasound can be used to treat disease, and we expect in the coming years to see many more approvals globally.”
*Focused ultrasound is also approved to treat essential tremor, tremor-dominant Parkinson’s disease, Parkinson’s dyskinesia, prostate cancer, benign prostatic hyperplasia, osteoid osteoma, uterine fibroids, and pain from bone metastases.