EDAP TMS SA has announced the completion of its HIFI study, which evaluates the efficacy of its Focal One robotic High-Intensity Focused Ultrasound (HIFU) system against traditional radical prostatectomy (RP) surgery for localized prostate cancer. This milestone marks a significant advancement in non-invasive cancer treatment options, potentially offering patients an alternative with fewer side effects.
Earlier reports highlighted the promise of Focal One in reducing surgical risks. The latest findings reinforce its effectiveness, demonstrating comparable survival rates to RP while enhancing patients’ quality of life.
Does Focal One Offer a Non-Surgical Alternative?
Focal One employs high-performance imaging and precise HIFU technology to target prostate cancer cells with submillimeter accuracy. This precision spares surrounding healthy tissue, thereby maintaining urinary and sexual functions.
“In our [non-invasive] approach, there is no surgery, no blood loss, no cutting, no radiation,”
stated Ryan Rhodes, EDAP’s CEO.
What Were the HIFI Study Results?
The seven-year HIFI study included 3,328 patients across 46 centers, with 1,967 receiving Focal One treatment. Results published in European Urology revealed that at 30 months, the salvage treatment-free survival rate was higher in the HIFU group (90%) compared to the RP group (86%). Additionally, patients treated with Focal One experienced better urinary continence and erectile function.
What Are EDAP’s Future Plans for Focal One?
Following regulatory clearance in multiple countries, EDAP plans to expand Focal One’s applications beyond prostate cancer. Ongoing studies are exploring its use in treating benign prostatic hyperplasia (BPH) and deep infiltrating endometriosis, aiming to broaden the system’s therapeutic potential.
The introduction of Focal One adds a valuable option for prostate cancer patients, balancing effective treatment with improved post-procedural quality of life. By minimizing invasive procedures, EDAP addresses both medical and personal aspects of cancer care, potentially setting a new standard in the field.
Focal One’s success in this study underscores the importance of technological innovation in medical treatments. As healthcare systems continue to seek efficient and patient-friendly solutions, robotic HIFU systems like Focal One may become increasingly integral to cancer therapy protocols.
