The Edison Histotripsy System, which received FDA De Novo clearance in October 2023, uses non-invasive focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors at a sub-cellular level and without the invasiveness or toxicity of traditional procedures. To date, almost 2,000 patients have been treated with histotripsy at over fifty leading U.S. medical centers and others in the UAE and Hong Kong. Clinical data, including outcomes from the #HOPE4LIVER trial, have demonstrated a 90% local tumor control rate at 12 months across all tumor types treated, comparing favorably to existing therapies and setting a strong precedent for continued payer adoption.

“This expanded Highmark coverage marks another critical step in delivering histotripsy to more patients who urgently need safe, non-invasive options,” said Mike Blue, President and CEO of HistoSonics. “Highmark’s decision not only reinforces the clinical value of our technology but also helps establish broader payer confidence as we continue working to expand access nationwide.”

Highmark’s decision to cover histotripsy, effective July 1st, 2024, joins a growing list of commercial insurers recognizing histotripsy’s safety and efficacy, following earlier coverage from Blue Cross Blue Shield of Michigan. In addition, the United Network for Organ Sharing (UNOS) recognizes histotripsy as an approved loco-regional therapy option for patients awaiting liver transplantation.

The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable liver tumors using histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease, including cancer, nor has it assessed outcomes such as local tumor control, five-year survival, or overall survival.

The device should only be used by physicians who have completed HistoSonics-provided training, and its use should be guided by the clinical judgment of a qualified and appropriately trained physician. For a complete list of warnings, precautions, and clinical trial results, including reported adverse events, please refer to the device’s Instructions for Use.