HistoSonics announced a management-led acquisition of a majority stake by a group of private and public investors, valuing the Minneapolis-based histotripsy therapy platform developer at approximately $2.25bn.

The consortium includes K5 Global, Bezos Expeditions, and Wellington Management, among others.

The transaction also sets the stage for the expansion of the Edison System into new clinical areas and international markets.

HistoSonics’ current president and CEO, Mike Blue, will continue to lead the company and will also become chairman of the board after the deal closes.

Blue said: “Our relentless focus as a company has been speed, scale, and the urgency to offer patients a better option than any they have today.

“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.”

The company aims to broaden its focus from liver tumours to include kidney, pancreas, and prostate conditions. HistoSonics envisions its histotripsy technology being applied to a variety of clinical uses, addressing both benign and malignant conditions.

Founded in 2009, HistoSonics received FDA De Novo clearance in October 2023. The Edison System employs non-invasive focused ultrasound energy to mechanically destroy targeted tissue and tumours at a sub-cellular level, offering an alternative to traditional invasive procedures.

To date, more than 2,000 patients have been treated using the Edison System at over 50 major US medical centres, with plans for an additional 50 installations by the end of the year.

The company is currently enrolling patients in clinical trials for liver, kidney, and pancreas tumours, with the HOPE4KIDNEY Trial (NCT05820087) and the GANNON Trial (NCT06282809) underway.

HistoSonics plans to initiate further trials in the near future, supported by extensive research across multiple organ systems.

The investment syndicate also includes prominent global firms such as Alpha JWC Ventures, alongside existing investors like Alpha Wave Ventures and Johnson & Johnson’s corporate venture capital arm, JJDC.

Citi acted as the financial advisor and Fox Rothschild as the legal advisor for HistoSonics. Morgan Stanley & Co. served as the financial advisor to the investors, with Cooley and Orrick providing legal counsel. Wilson Sonsini Goodrich & Rosati advised the existing major shareholders of HistoSonics.