HistoSonics receives FDA approval for its ultrasound device that destroys liver tumors without surgery

HistoSonics, histotripsy technology, liver cancer, de novo clearance, ultrasound

In a groundbreaking move, the FDA has granted clearance to histotripsy technology, marking a significant milestone for HistoSonics and its Edison system, which employs focused ultrasound waves to noninvasively target and eliminate specific tissues or tumors. This innovative approach represents a significant leap in medical technology, with HistoSonics’ platform being approved for the destruction of primary and metastatic liver tumors, even those previously deemed inoperable.

Liver cancer diagnoses are on the rise, yet only a fraction of patients qualify for surgical removal due to factors such as multiple tumors, compromised liver function, or other health impediments. The Edison system uses focused sonic beams to target tissue, inducing rapid expansion and collapse of gas bubbles within the tissue, leading to its breakdown and liquefaction.

Integral to the entire process, from pre-treatment planning to real-time visualization, are advanced imaging technologies, facilitated through a strategic distribution partnership with GE HealthCare. This collaboration places Edison systems on GE’s ultrasound carts, enhancing accessibility and clinical utility.

Recent clinical trial results demonstrated the remarkable effectiveness of histotripsy treatment. In a cohort of 44 patients with liver cancer or metastatic liver tumors, a technical success rate of 95.5% was achieved. Notably, only three procedure-related adverse events occurred within a month of histotripsy treatment, and they were common to other liver cancer treatments rather than being specific to the novel technology.

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“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. 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.” 

– CEO Mike Blue 

The development of the core technology behind the Edison system commenced at the University of Michigan in 2001 and culminated in HistoSonics receiving the FDA’s breakthrough-device designation in the fall of 2021. The company secured substantial venture capital funding, including an $85 million investment led by Johnson & Johnson Innovation at the end of the previous year.

HistoSonics is not resting on its laurels; the company has initiated a phase 1 trial targeting kidney tumors with histotripsy technology. Moreover, it has ambitious plans to expand the Edison platform’s applications to pancreatic cancer and other malignancies in the near future. This groundbreaking technology represents a promising advancement in the fight against cancer.

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