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HistoSonics Non-Invasive Edison Histotripsy System. Image credit: HistoSonics

The policy, effective October 21, 2025, expands insurance coverage across Elevance Health's commercial, Medicare, and Medicaid plans in 14 states, including California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia, and Wisconsin, broadening access to HistoSonics' incisionless, non-thermal therapy for approximately 45.4 million members.

"This coverage expansion by Elevance Health represents another critical milestone in increasing access to histotripsy for patients who urgently need non-invasive treatment options," said Mike Blue, Chairman and CEO of HistoSonics. "We are deeply grateful to our clinical partners who continue to generate strong evidence validating the safety, precision, and effectiveness of histotripsy, and to the growing number of payers recognizing its value in improving outcomes for patients with liver tumors. Liver metastases contribute to nearly half of all cancer-related deaths worldwide, highlighting the urgent need for non-invasive solutions that can improve both survival and quality of life."

The Edison(R) Histotripsy System, which received FDA De Novo authorization in October 2023 for the non-thermal destruction of liver tumors, uses focused ultrasound energy to mechanically destroy and liquefy targeted tissue at the cellular level without incisions, radiation, or heat. Clinical data from the #HOPE4LIVER pivotal trial, have demonstrated a 90% local tumor control rate at 12 months1 across tumor types treated, comparable to existing ablative therapies while reducing complications and recovery time. Additional long-term follow-up and registry data are currently being collected to further validate these outcomes in broader real-world use.

Elevance Health's decision follows a growing wave of payer adoption as histotripsy continues to gain traction nationwide. The expanded coverage builds on prior decisions from multiple Blue Cross Blue Shield plans and complements recognition by the United Network for Organ Sharing (UNOS), which includes histotripsy as an approved loco-regional therapy option for patients awaiting liver transplantation.

The Edison(R) System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable tumors using histotripsy. The FDA has not evaluated the system for the treatment of any specific disease, including cancer, nor 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 complete warnings, precautions, and clinical trial results, please refer to the device's Instructions for Use.

About HistoSonics

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, MI and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: www.histosonics.com. For patient-related information please visit: www.myhistotripsy.com.

References:

1 The #HOPE4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors: 1-year update of clinical outcomes" published in Annals of Surgery by Ziemlewicz, et.al. is licensed under CC BY-NC-ND.

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