Here’s a breakdown of the key information from the provided text:
Key News:
Highmark Blue Cross blue Shield expands coverage: Highmark will now cover HistoSonics’ Edison® Histripsy System for liver tumor treatment for approximately 7 million members across four states (New York, Delaware, Pennsylvania, and West Virginia).
Edison® System Overview: This system uses non-invasive focused ultrasound to destroy liver tumors by liquefying them at a cellular level, avoiding the risks of conventional treatments.
Positive Clinical Results: Nearly 2,000 patients have been treated with the system globally. The #Hope4Liver study showed a 90% local tumor control rate at 12 months, exceeding results from existing therapies.
Growing Acceptance: Highmark joins Blue Cross Blue Shield of Michigan in recognizing the technology.The United Network for Organ Sharing (UNOS) also now approves histripsy as a loco-regional therapy for liver transplant candidates.
FDA Status: The Edison system received FDA approval under the Novo procedure in October 2023. However, the FDA has not yet evaluated the system for specific disease treatment or validated long-term clinical outcomes (like 5-year survival).
Company Information:
HistoSonics: The manufacturer of the Edison® Histripsy System.
* Mike Blue: Chairman and CEO of HistoSonics,who stated the Highmark decision is a “major advance” in patient access.