HistoSonics has announced a substantial management-led majority stake acquisition by a consortium of investors, including public and private entities, with a transaction that values the company at around $2.25bn.

This strategic move is set to expedite the company’s growth and facilitate the expansion of the Edison Histotripsy System into new clinical indications and markets, according to a company release.

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The company will continue under the leadership of CEO and president Mike Blue, alongside his executive team.

Blue will also become the chairman of the board on the closing of the transaction.

Blue said: “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.”

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The deal enables HistoSonics to broaden its therapeutic reach, targeting not only liver tumours but also pancreas, prostate, and kidney conditions.

Established in 2009, the company envisions a future where histotripsy can be applied to a wide array of clinical applications, treating both benign and malignant conditions.

The Edison system has reportedly been used to treat over 2,000 individuals at more than 50 US medical centres so far, with plans to install another 50 systems by the year’s end.

The system is intended for the non-invasive destruction of liver tumours, including unresectable liver tumours, leveraging a non-thermal, mechanical process of focused ultrasound.

In October 2023, the company secured marketing authorisation from the US Food and Drug Administration (FDA) for its Edison histotripsy platform.

The company is backed by preclinical and clinical research across several organ systems.

HistoSonics is actively enrolling subjects in clinical trials for kidney, liver, and pancreas tumours, with further trials slated to begin shortly.

The investment syndicate features Bezos Expeditions, K5 Global, and Wellington Management, along with Alpha JWC Ventures and other existing investors such as Venture Investors Health Fund and Alpha Wave Ventures.

Lumira Ventures and Early Stage Partners are also part of the investor group.

Financial advisory services for HistoSonics were provided by Citi, with Fox Rothschild acting as legal advisers. The investment syndicate was advised by Morgan Stanley & Co and Cooley, with assistance from Orrick while Wilson Sonsini Goodrich & Rosati advised HistoSonics’ major existing shareholders.

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