US-based HistoSonics has secured the primary main insurance coverage protection for its histotripsy system, amid media hypothesis of a $2.5bn sale.
Healthcare payor Blue Cross Blue Protect of Michigan (BCBSM) and well being plan possibility Blue Care Community have created a brand new medical coverage that covers non-thermal histotripsy utilizing the HistoSonics’ Edison system for the remedy of major and metastatic liver tumours.
The coverage protection took impact on 1 February 2025, giving 4.5 million residents in Michigan early entry to the remedy if eligible. A broader coverage will go into impact on 1 July 2025. The protection is a win for the remedy modality as HistoSonics seems to be to grapple for market share amongst extra established surgical strategies.
Based in 2009 with expertise developed by the College of Michigan, HistoSonics acquired US Meals and Drug Administration (FDA) approval in October 2023 for its Edison system, which makes use of quick pulses of centered ultrasound vitality to mechanically destroy and liquefy affected tumours. The remedy, which is delivered through a robotic arm, doesn’t carry the identical invasiveness or toxicity as conventional approaches. Edison is the one FDA-approved histotripsy system presently available on the market.
A 12-month follow-up evaluation from the HOPE4LIVER examine demonstrated a 90% native tumour management fee noticed throughout all handled tumours, no matter kind or origin. This, HistoSonics says, compares favourably to the present commonplace of care of native regional therapies on the one 12 months follow-up mark. Present surgical approaches used to kill liver tumours embrace radiofrequency ablation, microwave ablation, and cryoablation.
The corporate is conducting additional scientific trials to develop the system’s use into kidney and pancreatic most cancers remedy.
The Edison system has been adopted at over 50 medical centres within the US to deal with over 1,500 sufferers.
“Liver tumours are sometimes a number one explanation for loss of life for sufferers with severe cancers, and it’s essential that they’ve entry to secure, efficient and non-invasive remedy choices,” stated HistoSonics’ CEO Mike Blue.
“This milestone marks an essential precedent, and we count on extra states and payers to comply with in increasing entry to histotripsy for sufferers with liver tumours throughout the US.”
The protection is about in opposition to a backdrop of acquisition discuss, with the Monetary Occasions reporting that main medtech corporations are eyeing the histotripsy specialist.
Medtronic, GE HealthCare, and Johnson & Johnson (J&J) are all reported to be evaluating the enterprise. By way of its funding arm, J&J has been a long-time backer of HistoSonics, the most recent money injection occurring through the participation in a $102m Sequence D spherical in August 2024.
