HistoSonics has been named one of the “Fierce 15” in 2022 by Fierce Medtech.
According to the outlet, HistoSonics was chosen because it is “on the cusp of commercializing its so-called Edison, a device that uses sonic beams to create a wholly noninvasive procedure in liver cancer patients, a process known as histotripsy.”
HistoSonics has submitted clinical trial results from sister trials in the US and Europe investigating the use of the Edison platform to treat liver tumors. The initial analyses indicate the studies met both primary endpoints of safety and efficacy in destroying targeted tumors.
The company is now planning a clinical trial to evaluate the safety and efficacy of their platform to target and destroy primary renal tumors.
In 2021, the Edison platform was granted Breakthrough Device Designation by the FDA in October 2021. The Breakthrough Devices Program was established to allow fast-tracking of novel devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Since 2012, the Fierce 15 has spotlighted the most exciting startups in medtech. Others that made the list are exploring artificial intelligence to personalize medicine, the intersection of healthcare and wearable solutions, and simplifying genome sequencing, to name a few.