HistoSonics , maker of the Edison® Tissue Ablation System , today announced that Highmark Blue Cross Blue Shield has issued four new positive medical policy decisions for the use of Tissue Ablation technology in the treatment of liver tumors. The decisions expand coverage to Highmark’s commercial insurance plans in four states: New York, Delaware, Pennsylvania and West Virginia, making HistoSonics’ non-invasive treatment options available to approximately 7 million members.
The Edison tissue destruction system received De Novo approval from the U.S. Food and Drug Administration (FDA) in October 2023. It uses non-invasive focused ultrasound energy to mechanically destroy and liquefy target tissues and tumors at the subcellular level without the invasiveness or toxicity of traditional surgery. To date, nearly 2,000 patients have been treated with tissue destruction at more than 50 top medical centers in the United States and medical institutions in the United Arab Emirates and Hong Kong. Clinical data, including the results of the #HOPE4LIVER trial, showed that the 12-month local tumor control rate reached 90% in all tumor types treated, which is better than existing therapies and lays a solid foundation for continued adoption by medical insurance payers.
Highmark’s expanded coverage marks another critical step in our efforts to bring tissue destruction to more patients who urgently need safe, non-invasive treatment options,” said Mike Blue, president and CEO of HistoSonics. “As we continue our efforts to expand access to treatment nationwide, Highmark’s decision not only demonstrates the clinical value of our technology, but also helps to build confidence among a broader range of payers.
Highmark’s decision to cover tissue ablation therapy takes effect on July 1, 2024. Previously, Blue Cross Blue Shield of Michigan had included the technology in its coverage, and now more and more commercial insurance companies recognize its safety and effectiveness, including Highmark. In addition, the United Network for Organ Sharing (UNOS) has listed tissue ablation technology as an approved local regional treatment option for patients awaiting liver transplantation.
The Edison® System is intended for noninvasive mechanical destruction of liver tumors, including partial or complete ablation of unresectable liver tumors using tissue destruction. The FDA has not evaluated the Edison System for the treatment of any specific condition, including cancer, or for outcomes such as local tumor control rate, 5-year survival, or overall survival.
This device should only be used by physicians who have completed the training provided by HistoSonics and its use should be based on the clinical judgment of a qualified physician who has undergone professional training. For a complete list of warnings, precautions, and clinical trial results (including reported adverse events), please refer to the device instructions for use.
HistoSonics Company Overview
HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary acoustic beam therapy utilizing tissue ablation, 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 the Edison System for liver treatments in the U.S. and select global markets, while expanding the use of tissue ablation to other organs such as the kidney, pancreas and prostate. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, Minnesota. For more information on the Edison Tissue Ablation System, please visit: www.histosonics.com . For patient information, please visit: www.myhistotripsy.com .
