HistoSonics Inc., a developer and manufacturer of a non-invasive platform and sonic beam therapy called histotripsy, announced the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device designation.
The science of histotripsy was developed by ultrasound scientists from the University of Michigan in Ann Arbor as a non-invasive potential alternative to certain surgical procedures. The company has offices in Ann Arbor.
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 company believes the novel mechanism of action of their proprietary technology may offer significant advantages to patients, including equivalent treatment effects throughout the entire treatment volume resulting in precise and predictable treatment zones.
“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 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 trial results cited by Blue 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, the platform allows physicians to monitor the destruction of tissue under continuous real time visualization and control, which is unlike current methods. 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 with the FDA for more than three years in developing pre-clinical and clinical data required for regulatory market authorization and intends to continue collaboration during the investigation device exempt (IDE) study.
The system is investigational and is not available for sale in the United States or Europe. It is limited to investigation use in the approved IDE and European studies.