HistoSonics’ recent achievement in expanding insurance coverage for its Edison® Histotripsy System marks a pivotal advancement in non-invasive cancer care. With Highmark Blue Cross Blue Shield issuing four new positive medical policy decisions, approximately 7 million members across New York, Delaware, Pennsylvania, and West Virginia now have access to this FDA-cleared liver tumor treatment. This expansion builds on the system’s October 2023 De Novo clearance from the U.S. FDA, which recognized the Edison System for the mechanical destruction of liver tumors using focused ultrasound—a significant regulatory milestone validating its clinical potential and safety.
The Edison System employs histotripsy, a novel technique that uses focused ultrasound energy to mechanically liquefy targeted tissue without the need for incisions, radiation, or systemic toxicity. This method offers significant advantages over traditional therapies by minimizing complications and recovery time. Clinical data, including results from the HOPE4LIVER trial, have shown promising outcomes, with a 90% local tumor control rate at 12 months. Such performance not only supports clinical adoption but also strengthens payer confidence, encouraging broader integration of histotripsy as a frontline therapy in oncology centers.
Looking ahead, HistoSonics’ expanding reimbursement landscape signals strong momentum for histotripsy’s national and global adoption. Highmark’s policy update joins a growing list of insurers, such as Blue Cross Blue Shield of Michigan, and aligns with histotripsy’s recognition by the United Network for Organ Sharing (UNOS) as a loco-regional therapy for transplant candidates. As more patients seek less invasive and highly effective treatment options, the Edison System’s growing footprint positions HistoSonics at the forefront of next-generation, image-guided tumor therapies, with the potential to redefine liver cancer treatment and improve long-term outcomes.
MedTech Spectrum's Summary
Expanded Insurance Access: Highmark Blue Cross Blue Shield’s new coverage decisions extend access to HistoSonics’ non-invasive Edison® Histotripsy System to approximately 7 million members across four U.S. states, marking a major milestone in reimbursement progress.
Validated Innovation: Backed by FDA De Novo clearance and strong clinical data—such as a 90% local tumor control rate—the system offers a safe, non-invasive alternative to traditional liver tumor treatments, reinforcing its growing clinical and regulatory credibility.
Future Impact: With additional insurers and organizations like UNOS recognizing histotripsy, HistoSonics is poised to transform liver cancer care, supporting broader adoption of this cutting-edge, ultrasound-based therapy in oncology and transplant settings.
