HistoSonics Edison histotripsy system
The Edison histotripsy system. [Image courtesy of HistoSonics]

HistoSonics announced today that the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms.

Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced the first kidney tumor treatment with its novel therapy system.

The company believes Edison’s mechanism of action could provide significant advantages to patients. Those include the ability of the treatment site to recover and resorb quickly. Additionally, the platform enables physicians to monitor the destruction of tissue under continuous, real-time visualization and control.

Minneapolis-based HistoSonics says the de novo nod makes Edison the first and only histotripsy platform available in the U.S.

The company said it supported its bid for authorization with data from its HOPE4LIVER trials in the U.S. and Europe. It evaluated the clinical safety and efficacy of histotripsy in destroying targeted primary and secondary liver tumors. Histotripsy achieved both primary safety and efficacy endpoints in pooled data from 44 subjects.

Edison’s indication covers the non-invasive destruction of liver tumors. That includes unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound. HistoSonics said it also expanded its commercial and operational capacity in advance of commercial activities.

“This is HistoSonics’ most meaningful milestone to date,” said Mike Blue, president and CEO of HistoSonics. “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. This is a fantastic day for patients who will benefit from the novel advantages of histotripsy, and I commend the FDA for working so expeditiously with us throughout the review process.”