EDAP Announces FDA Breakthrough Device Designation for Focal One® in the Treatment of Deep Infiltrating Rectal Endometriosis
“This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.
- “This designation reflects the FDA’s recognition that deep infiltrating endometriosis remains a significant unmet medical need in women’s health with few treatment alternatives.
- The Focal One system being granted a Breakthrough Device designation underscores the significance of this innovative development for DIE patients.
- In January 2022, EDAP reported positive results from the Phase 2 Endo-HIFU-1R study (N=60) evaluating Focal One HIFU for the treatment of deep infiltrating rectal endometriosis, and this data was included in EDAP’s submission in consideration for receiving Breakthrough Device designation from the FDA.
- In February 2024, EDAP announced the completion of enrollment in a Phase 3 study evaluating Focal One HIFU therapy for the treatment of deep infiltrating rectal endometriosis.