Key Points
- A group of private and public investors has acquired focused ultrasound manufacturer HistoSonics, valuing the company at $2.25 billion.
- The company’s Edison® Histotripsy System has been used to treat more than 2,000 patients at over 50 active centers worldwide.
HistoSonics – a leader in the field of treating liver tumors with their novel noninvasive histotripsy platform technology – executed a majority stake acquisition by a group of globally recognized private and public investors, valuing the company at $2.25 billion. The sale was led by K5 Global, Bezos Expeditions, and Wellington Management.
“This is the most significant milestone to date in the evolution of focused ultrasound as a transformative treatment for a wide range of life-threatening and disabling conditions,” said Neal F. Kassell, MD, founder and chairman of the Focused Ultrasound Foundation. “It’s the breakthrough we have all been anticipating. As the first ‘unicorn’ in the field, HistoSonics represents the North Star—commercially validating the potential of focused ultrasound and paving the way for the success of every other stakeholder in the ecosystem.”
HistoSonics developed and commercialized the Edison® Histotripsy System, which noninvasively destroys tissue without heating. In October 2023, Edison was granted US Food and Drug Administration (FDA) clearance to treat liver tumors, marking the first time the use of histotripsy earned regulatory approval worldwide. It has now been used to treat more than 2,000 patients at over 50 active centers in the US, as well as in the United Arab Emirates and Hong Kong.
HistoSonics will continue to be led by President and Chief Executive Officer, Mike Blue, and his executive team. Mr. Blue will also assume the role of Chairman of the Board upon closing.
“Our relentless focus as a company has been speed, scale, and the urgency to offer patients a better option than any they have today,” said Mr. Blue. “This new group of partners backs category-defining companies that transform entire industries. Their support gives us the firepower to accelerate our momentum, expand into new clinical indications, and reach even more patients around the world who urgently need our breakthrough therapy.”
According to the press release, HistoSonics plans to pursue treating kidney, pancreas, and prostate indications. They have completed enrollment in a study of 67 patients with kidney tumors in their #HOPE4KIDNEY trial and hope to secure FDA clearance with their kidney application in late 2026. Additionally, the company continues to enroll patients in their GANNON trial where histotripsy is being used to noninvasively destroy and liquefy pancreatic tumors. The company also plans to install the Edison system at 50 new sites by year-end.