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Mon, May 12, 2025, 11:42 AM 2 min read
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US-based HistoSonics has secured the first major insurance coverage for its histotripsy system, amid media speculation of a $2.5bn sale.
Healthcare payor Blue Cross Blue Shield of Michigan (BCBSM) and health plan option Blue Care Network have created a new medical policy that covers non-thermal histotripsy using the HistoSonics’ Edison system for the treatment of primary and metastatic liver tumours.
The policy coverage took effect on 1 February 2025, giving 4.5 million residents in Michigan early access to the treatment if eligible. A broader policy will go into effect on 1 July 2025. The coverage is a win for the treatment modality as HistoSonics looks to grapple for market share amongst more established surgical techniques.
Founded in 2009 with technology developed by the University of Michigan, HistoSonics received US Food and Drug Administration (FDA) approval in October 2023 for its Edison system, which uses short pulses of focused ultrasound energy to mechanically destroy and liquefy affected tumours. The therapy, which is delivered via a robotic arm, does not carry the same invasiveness or toxicity as traditional approaches. Edison is the only FDA-approved histotripsy system currently on the market.
A 12-month follow-up analysis from the HOPE4LIVER study demonstrated a 90% local tumour control rate observed across all treated tumours, regardless of type or origin. This, HistoSonics says, compares favourably to the current standard of care of local regional therapies at the one year follow-up mark. Current surgical approaches used to kill liver tumours include radiofrequency ablation, microwave ablation, and cryoablation.
The company is conducting further clinical trials to expand the system’s use into kidney and pancreatic cancer treatment.
The Edison system has been adopted at over 50 medical centres in the US to treat over 1,500 patients.
“Liver tumours are often a leading cause of death for patients with serious cancers, and it’s critical that they have access to safe, effective and non-invasive treatment options,” said HistoSonics’ CEO Mike Blue.
“This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumours across the US.”
The coverage is set against a backdrop of acquisition talk, with the Financial Times reporting that major medtech companies are eyeing the histotripsy specialist.
Medtronic, GE HealthCare, and Johnson & Johnson (J&J) are all reported to be evaluating the business. Through its investment arm, J&J has been a long-time backer of HistoSonics, the latest cash injection occurring via the participation in a $102m Series D round in August 2024.
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