MINNEAPOLIS– HistoSonics announced today that Highmark Blue Cross Blue Shield has approved insurance coverage for the company’s non-invasive liver tumor treatment, expanding access to approximately 7 million members across New York, Delaware, Pennsylvania, and West Virginia. The move includes four new positive medical policy decisions for the use of the Edison® Histotripsy System.
“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.”
The Edison System, which received FDA De Novo clearance in October 2023, utilizes focused ultrasound energy to mechanically destroy and liquefy targeted tissue at a sub-cellular level. Unlike traditional liver tumor treatments, histotripsy is non-invasive and free from radiation or thermal toxicity. So far, nearly 2,000 patients have been treated using the technology across more than 50 U.S. medical centers, as well as in the UAE and Hong Kong.
Clinical outcomes from the ongoing #HOPE4LIVER trial have shown a 90% local tumor control rate at 12 months across various tumor types, underscoring the technology’s effectiveness and aiding in the expansion of insurance coverage. Highmark joins Blue Cross Blue Shield of Michigan and other payers in recognizing histotripsy as a viable treatment option.
The therapy is also acknowledged by the United Network for Organ Sharing (UNOS) as an approved loco-regional treatment for patients awaiting liver transplantation.
While the Edison System is cleared for the mechanical destruction of liver tumors, the FDA has not yet evaluated its efficacy for specific conditions such as cancer or long-term survival outcomes. Its use is restricted to physicians who have undergone specialized training provided by HistoSonics and should be guided by professional clinical judgment.
With this latest coverage expansion, HistoSonics continues to advance its mission to provide innovative, non-invasive cancer treatment options to patients nationwide.
