Focal One Robotic HIFU procedure now covered by France's national universal health system.

EDAP TMS SA has secured reimbursement for its Focal One Robotic HIFU procedure in France's national universal health system. The procedure is now covered for the treatment of prostate cancer, including as a primary treatment and a salvage treatment option following radiotherapy. This milestone allows increased patient access to the non-invasive treatment.

EDAP TMS SA, a global leader in robotic energy-based therapies, has secured reimbursement for its Focal One Robotic High Intensity Focused Ultrasound (HIFU) procedure in France's national universal health system. This milestone allows increased patient access to the non-invasive treatment for prostate cancer, including as a primary treatment and a salvage treatment option following radiotherapy.

The French Ministry of Health has awarded reimbursement for the Focal One Robotic HIFU procedure, specifically for the treatment of localized prostate cancer and as a salvage treatment following radiotherapy. The reimbursement covers eligible patients and is effective as of September 1, 2025. EDAP TMS SA expects this to accelerate reimbursement for Focal One in additional European countries and drive further adoption of the technology.

The positive results from the groundbreaking HIFI Study, sponsored by the French Urology Association, provided critical scientific evidence to secure reimbursement for Focal One. The study demonstrated the effectiveness of the Focal One procedure in managing prostate cancer. Additionally, the Level 1 evidence from the FARP Study, presented at the American Urological Association Annual Meeting, is expected to further accelerate demand for the Focal One platform.

EDAP TMS SA's Chief Executive Officer, Ryan Rhodes, stated, "Securing reimbursement for Focal One in France represents an important commercial milestone for our company, allowing a significant number of prostate cancer patients access to an effective, non-invasive treatment for managing their prostate cancer."

EDAP TMS SA develops, manufactures, promotes, and distributes minimally invasive medical devices using ultrasound technology. The Focal One® is the leading prostate focal therapy controlled by urologists and has the potential to expand to multiple indications beyond prostate cancer.

For more information about the results from the HIFI Study, please visit hifistudy.com.

References:
[1] https://www.stocktitan.net/news/EDAP/edap-receives-hifu-reimbursement-for-prostate-cancer-in-x1hq29we86t6.html