LYON, France - EDAP TMS SA (NASDAQ: NASDAQ:EDAP), a company specializing in therapeutic ultrasound, announced today that the US Food and Drug Administration (FDA) has awarded its Focal One platform Breakthrough Device designation for treating deep infiltrating endometriosis (DIE), a condition affecting a significant number of women globally.
The Focal One Robotic High-Intensity Focused Ultrasound (HIFU) system, previously cleared by the FDA in June 2018 for prostatic tissue ablation, is now recognized for its potential in addressing the severe form of endometriosis that can deeply penetrate pelvic organs and cause debilitating pain. The Breakthrough Device designation is aimed at expediting the development and review process for medical devices that promise to provide more effective treatment for life-threatening or irreversibly debilitating diseases.
EDAP's CEO, Ryan Rhodes, highlighted the FDA's acknowledgment of the unmet medical need in women's health and the company's commitment to expanding the use of its proprietary technology beyond prostate disease. The Focal One system offers a non-invasive alternative to conventional surgery, potentially reducing morbidity and improving quality of life.
Data from the Phase 2 Endo-HIFU-1R study, which included 60 participants, was instrumental in securing the FDA's designation. The study reported significant symptom reduction and quality of life improvements post-treatment, with most participants experiencing no or minor adverse events.
The ongoing Phase 3 trial, which is a comparative, randomized, double-blind study, completed enrollment in February 2024. It focuses on evaluating the efficacy of the HIFU treatment in reducing acute pelvic pain in 60 patients, with results expected later in 2024.
Endometriosis is a chronic disease that affects an estimated 10-12% of women of reproductive age, where tissue similar to the uterine lining grows outside the uterus, often leading to pain and infertility. The Focal One system's latest recognition by the FDA underscores its potential as an innovative treatment for DIE patients.
This news is based on a press release statement from EDAP TMS SA, which continues to develop and distribute minimally invasive medical devices using ultrasound technology for various pathologies. The company also produces equipment for the treatment of urinary tract stones and is actively engaged in the therapeutic ultrasound market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.