HistoSonics, the developer and manufacturer of a noninvasive platform and sonic beam therapy called histotripsy, has announced that the U.S. FDA has granted the company Breakthrough Device Designation for its new therapy platform. Histotripsy of the liver provides clinicians an 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,” says 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 noninvasively, 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 FDA to make the technology accessible as quickly as possible.”

The company believes the novel mechanism of action may offer advantages to patients, including equivalent treatment effect throughout the entire treatment volume, resulting in precise and predictable treatment zones. Early clinical and preclinical 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 to monitor the destruction of tissue under continuous visualization and control. The Breakthrough Device Designation will allow the company to engage with FDA in a prioritized review during the regulatory market authorization process.

HistoSonics has worked cooperatively with FDA for more than three years to develop preclinical and clinical data required for regulatory market authorization and intends to continue collaborating with the agency throughout the ongoing Investigational Device Exemption 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 U.S. 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.