HistoSonics has raised $250m to accelerate the ongoing commercial expansion of its histotripsy system, months after being acquired by an investor consortium.
Bringing its funding to date to over half a billion, the Minnesota-headquartered company’s funding round was led by its new investor consortium owners, alongside additional investors including Thiel Bio and Founders Fund.
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Made up of investors including K5 Global and Bezos Expeditions, the consortium outlaid $2.25bn to acquire a majority stake in HistoSonics in August. Reports previously circulated that companies, including GE HealthCare and Johnson & Johnson (J&J) were among the interested parties evaluating the business.
HistoSonics’ Edison HistoTripsy System and novel histotripsy therapy platform is designed for the non-invasive destruction of liver tumours. The system delivers focused ultrasound to target and eliminate cancerous liver tissue.
Edison, which received de novo clearance from the US Food and Drug Administration (FDA) in 2023, has been used on over 2,000 patients to date at over 50 US medical centres, with an additional 50 system installations planned by year-end.
Mike Blue, HistoSonics’ CEO, said the latest financing would help the company accelerate global access to its platform and advance its therapy across new clinical applications. HistoSonics has previously highlighted plans to move beyond its initial focus on liver tumours to kidney, prostate, and other indications in the future. In driving this aim, Edison is currently involved in clinical trials evaluating its efficacy in areas beyond the treatment of liver tumours, including trials focused on pancreatic adenocarcinomas (NCT06282809) and solid kidney tumours (NCT05820087).
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By GlobalDataIn May, the system was granted controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA). The UNCA was granted under the UK’s Innovative Devices Access Pathway (IDAP), an initiative launched by the UK Government in 2023 to help fast-track ‘transformative medical technologies’ into the healthcare system.
In the same month, HistoSonics secured the first major insurance coverage for Edison from healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network, with the creation of a new medical policy covering non-thermal histotripsy using the Edison for the treatment of primary and metastatic liver tumours.
