HistoSonics beams up FDA de novo nod for liver tumor-destroying ultrasound

For the first time, the FDA has given the green light to histotripsy technology, which uses focused ultrasound waves to noninvasively destroy a designated tissue or tumor.

The de novo clearance went to HistoSonics, whose Edison system relies on histotripsy technology to attack tumors in the liver.

The Fierce 15 honoree’s platform is cleared to destroy both primary and metastatic liver tumors, including those that couldn’t be otherwise removed surgically. The Edison system could therefore help fill a sizable gap, since only a fraction of patients are typically eligible for surgery—whether because they have multiple tumors, poor liver function or other health issues that might impede a surgery’s success—while liver cancer diagnoses are expected to keep rising in the coming years, according to HistoSonics.

The system works by sending out sonic beams to specific areas of tissue. That ultrasound energy creates pressure around the tissue that creates gas bubbles and forces them to rapidly expand and collapse, helping break down and liquify the targeted tissue.

The entire process—from pre-treatment planning to real-time visualization—is helped along by imaging technologies, thanks to a long-standing partnership with GE HealthCare.

Clinical trial results recently shared by the company showed that doctors were able to achieve a technical success rate of 95.5% in targeting and destroying malignant tissue in 44 patients with either liver cancer or tumors that had spread to the liver from cancers based elsewhere in the body. Only three procedure-related adverse events occurred within a month of histotripsy treatment in the trial, and all were common among other liver cancer treatments, per HistoSonics, rather than specific to the new technology.

“This is HistoSonics’ most meaningful milestone to date and represents over two decades of tireless efforts, from its inception at the University of Michigan in 2001, overcoming what was once thought to be impossible—integrating the many complexities of histotripsy into a completely non-invasive clinical platform,” CEO Mike Blue said in the company’s announcement Monday about the FDA clearance.

The company “is building its own commercial team and will be the sole distributor of the Edison histotripsy system in the U.S.,” a HistoSonics spokesperson said in a statement sent to Fierce Medtech.

“We have been thoughtfully adding professionals with deep domain experience in operations, market development and education and are prepared to begin scheduling physician training immediately,” Blue added in the announcement, describing how the company has spent the last year preparing for the Edison platform’s commercial launch.

Development of the technology at the core of the Edison system began at the University of Michigan in 2001. Two decades later, HistoSonics earned the FDA’s breakthrough-device designation for the system in the fall of 2021.

That development process was fueled by tens of millions in VC support, including an $85 million injection at the end of last year that was led by Johnson & Johnson Innovation.

And HistoSonics’ work isn’t done: Earlier this year, the company began a phase 1 trial applying its histotripsy technology to kidney tumors, and it aims to further expand the Edison platform’s reach to pancreatic and other cancers in the future.

Editor's note: This story was updated to add additional comment from HistoSonics and to clarify the nature of its relationship with GE HealthCare.