FocalTherics launches endometriosis HIFU programme in Europe
FocalTherics has launched the first commercial endometriosis programme using its Focal One Robotic HIFU platform in Europe, treating initial patients at Toulouse University Hospital in France. The procedures were performed by Professor Elodie Chantalat, Head of Gynaecology at the hospital, with Professor Gil Dubernard of Croix-Rousse University Hospital in Lyon serving as proctor. Dubernard is credited with pioneering the use of Focal One for deep infiltrating endometriosis.
The Nasdaq-listed medical device company said the Toulouse launch forms part of a broader European expansion, with more than ten hospitals currently in its active clinical training pathway across Europe, the United Kingdom, and Latin America.
The technology and the unmet need
Focal One Robotic HIFU uses high-intensity focused ultrasound combined with real-time imaging to ablate endometriosis lesions on the bowel and rectum without incisions. The system received CE Mark in March 2025 specifically for posterior deep infiltrating endometriosis. FocalTherics positions the approach as an organ-sparing, function-preserving alternative to conventional surgery, which the company says carries significant morbidity and extended recovery times.
Deep infiltrating endometriosis affects an estimated 38 million women worldwide, according to company data. A 2016 publication in Minerva Ginecologica cited in the release found that approximately 91 per cent of women with the condition would prefer a non-surgical alternative, though readers should note this figure originates from a study on hormonal therapy rather than a direct patient preference survey on HIFU specifically.
Chief executive Ryan Rhodes said the treatment "has the potential to transform the treatment paradigm for this debilitating disease by reducing the morbidity commonly associated with conventional surgical approaches." The Biotech Times has softened the company's characterisation of Focal One as uniquely transformative, given that the commercial programme is at an early stage and no comparative clinical data against standard surgical care has been published to date.
Market context and competitive landscape
Focused ultrasound is an increasingly active area within gynaecology, with several groups exploring HIFU and related ablative modalities for uterine fibroids, adenomyosis, and endometriosis. The endometriosis device market remains less crowded than fibroids, where Insightec's ExAblate platform holds a well-established position. FocalTherics' ability to leverage the same hardware for both endometriosis and prostate cancer, the system's established indication, offers a commercial efficiency that single-indication devices cannot match.
However, CE Mark approval does not guarantee procedure volumes. Reimbursement pathways across European health systems vary considerably, and clinician training requirements for robotic HIFU represent a meaningful adoption barrier. The company acknowledged as much in its forward-looking risk disclosures. Investors will watch procedure uptake metrics, named hospital launches, and any move toward prospective clinical registries as key indicators of whether the endometriosis indication can become a material revenue contributor alongside the existing prostate cancer business.