HistoSonics announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its new therapy platform. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.
“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that our platform offers significant advantages over existing approved or cleared alternatives, per FDA requirements,” said Mike Blue, President and CEO of HistoSonics. “Early and ongoing clinical results are promising and suggest that our ability to precisely destroy targeted liver tissue, completely non-invasively, and without the challenges associated with ionizing radiation or other locoregional therapies, provides advantages to patients and physicians that don’t exist today, and we look forward to working with the FDA to make the technology accessible as quickly as possible.”
The company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including equivalent treatment effect throughout the entire treatment volume resulting in precise and predictable treatment zones. Early clinical and pre-clinical results also suggest that histotripsy largely preserves critical structures such as the liver capsule, and larger vessels and ducts within or adjacent to the treated volume of tissue. Additionally, histotripsy enables the treating physicians the ability to monitor the destruction of tissue under continuous real time visualization and control, unlike any modality that exists today. The Breakthrough Designation will allow the company to engage with the FDA in a prioritized review during the regulatory market authorization process.
HistoSonics has worked cooperatively with the FDA for over 3 years in developing pre-clinical and clinical data required for regulatory market authorization and intends to continue collaborating with the Agency throughout the ongoing Investigational Device Exemption (IDE) Study, #HOPE4LIVER US, which is designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumors. The company plans to share US and European #HOPE4LIVER Study data and results with FDA to demonstrate the benefits of histotripsy in a broad patient population.
The HistoSonics System is investigational and is not available for sale in the United States or Europe. It is limited to investigational use in the approved IDE and European studies.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.