EDAP TMS SA (NASDAQ: EDAP) announced the publication of its HIFI-2 study results in European Urology Oncology, evaluating salvage high-intensity focused ultrasound treatment for localized prostate cancer recurrence following radiotherapy.

The prospective, multicenter trial included 531 patients treated across more than 30 centers using the company's Focal One Robotic HIFU system. The study represents what the company describes as the largest prospective dataset in this clinical setting.

The study showed 71% androgen deprivation therapy-free survival at 30 months. In patient subgroups with lower pre-HIFU PSA levels and intermediate-risk disease characteristics, the therapy-free survival rate reached 84%. The treatment demonstrated low rates of severe complications and preserved quality of life with no significant deterioration at 12 months.

"This large prospective multicenter study demonstrates that salvage HIFU can achieve clinically meaningful oncologic control while maintaining an acceptable safety profile in patients with localized recurrence after radiotherapy," said Dr. Guillaume Ploussard, the study's first author.

EDAP TMS CEO Ryan Rhodes stated that the results provide evidence supporting Focal One as a treatment option for patients facing recurrence after radiotherapy. The company noted that NCCN guidelines recommend HIFU as a treatment option for patients with prostate recurrence, and Medicare and commercial payors provide coverage for the procedure.

The study was published in European Urology Oncology, a journal focused on genitourinary malignancies research that publishes six times annually in electronic format.