EDAP Announces Publication of Focal One Endometriosis Study in the Journal Ultrasound in Obstetrics & Gynecology

Study confirms feasibility of using Focal One HIFU to treat rectal endometriosis

LYON, France, December 19, 2019 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in therapeutic ultrasound, today announced that Focal One data has been accepted for publication in the journal of Ultrasound in Obstetrics & Gynecology. Data from the Phase 1 study confirm the feasibility of using EDAP’s Focal One high intensity focused ultrasound (HIFU) technology for the treatment of deep invasive endometriosis (DIE).

Endometriosis affects nearly 10% of women of childbearing age, which is approximately 176 million women worldwide. Digestive endometriosis affects 20% of these women. It is one of the most symptomatic forms of the disease, mostly when the rectum is involved, and is responsible for a significant decline in quality of life. The symptoms of endometriosis include pain during menstrual cycles and ovulation, defecation during or after sexual intercourse, infertility, and can impact general physical, mental, and social wellbeing. When medical treatments are ineffective, surgical resection remains the standard despite significant adverse events. Focal One HIFU, as a minimally invasive ablative procedure, may prove to be a real benefit for these women who have no effective therapeutic options today.

Professor Gil Dubernard, Head of the Gynecologic Department, Croix-Rousse University Hospital, Lyon, commented, “Having our publication accepted by this renowned journal is a great recognition of our clinical investigation work on HIFU for the treatment of rectal endometriosis. We are very enthusiastic to be pioneering this non-invasive approach that will change the strategy of treatment for rectal endometriosis by combining great potential of efficacy with fewer side effects. We believe that for a numerus of patients, HIFU treatment will replace surgery in this indication. We now look forward to initiating the next clinical study to confirm our expectation in terms of efficacy and safety of HIFU for this indication. We are writing a new chapter in the treatment of digestive endometriosis.”

Marc Oczachowski, Chief Executive Officer of EDAP, said, “We are very pleased with the acceptance for publication of these data from the endometriosis study utilizing Focal One. This is clearly a great milestone in the ongoing development of our HIFU technology and it is consistent with our vision and strategy to expand our novel therapeutic ultrasound technology into additional indications. The results from this initial study are very promising, and our clinical teams are now focused on commencing the next phase of our clinical investigation in endometriosis to further confirm its safety and efficacy.”