Minneapolis-based HistoSonics designed the Edison platform to use focused ultrasound energy to provide histotripsy for the noninvasive destruction of tumors. Using a robotic arm, Edison mechanically destroys and liquifies targeted tissue and tumors without the invasiveness or toxicity of traditional procedures. The platform received its first FDA de novo authorization in the U.S. in 2023 to treat liver tumors. It’s the first and only histotripsy platform cleared for clinical use globally.
See Editor-in-Chief Chris Newmarker interview HistoSonics CEO Mike Blue during a keynote interview at DeviceTalks Minnesota, May 4, 2026 at the University of Minnesota’s McNamara Alumni Center. Register here.
The WOLVERINE prospective feasibility study looks at Edison in the treatment of symptomatic BPH. BPH is an interesting space, with a number of various treatments across a range of disciplines making waves recently.
ProVerum and Zenflow announced FDA approvals for their implant-based technologies that treat BPH in December 2025. In January of this year, Butterfly Medical also said it completed the final 12-month follow-up for all patients in a study of its prostatic retraction device for BPH. Meanwhile, this month, robotic technology developer Procept launched its BPH-treating system internationally and Prodeon won FDA clearance for its nitinol device for BPH.
The first cases with Edison for BPH took place at Prince of Wales Hospital in Hong Kong, a teaching hospital for The Chinese University of Hong Kong. HistoSonics expects the trial to enroll and treat up to 20 patients. Following treatment, patients undergo imaging within 72 hours to assess the immediate treatment effect. Then, investigators will follow patients longitudinally to further evaluate safety and procedural outcomes.
Mike Blue, chair and CEO, HistoSonics, said:
“BPH affects millions of men worldwide and most of the existing treatment options require invasive procedures or lengthy recovery times. We believe histotripsy’s ability to mechanically destroy targeted tissue, completely non-invasively, has the potential to transform how BPH is treated. In addition, this milestone represents significant progress in our pursuit to expand the unique benefits of histotripsy over a significant number of serious clinical conditions throughout the body.”
