EDAP Announces Approval to Initiate Randomized Clinical Trial Evaluating Focal One® as a Potential Treatment for Rectal Deep Infiltrating Endometriosis

Rhea-AI Summary

EDAP TMS SA (Nasdaq: EDAP) has received approval to start a Phase 3 clinical trial for Focal One high intensity focused ultrasound (HIFU) targeting rectal deep infiltrating endometriosis. The trial, beginning in Q2 2023, will enroll 60 subjects across eight centers in France, assessing acute pelvic pain three months post-treatment. This initiative follows a completed Phase 2 study, with results expected to be presented in early 2023. The CEO emphasized the significance of this trial in building clinical evidence for HIFU as a treatment for this debilitating condition.

Positive

• Approval for Phase 3 trial of Focal One HIFU for rectal deep infiltrating endometriosis.
• Study aims to enroll 60 subjects across eight centers in France.
• Potential to strengthen clinical evidence for HIFU's efficacy in treating endometriosis.

Negative

• None.

 

Study to begin enrolling patients in Q2 2023  

Endometriosis represents significant expansion opportunity for Focal One 

LYON, France, November 30, 2022 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic therapeutic ultrasound, today announced that the Company has received approval from French authorities to initiate a Phase 3 randomized, controlled clinical trial evaluating Focal One high intensity focused ultrasound (HIFU) as a potential treatment for rectal deep infiltrating endometriosis.

Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS, stated, “This is great news and a notable milestone for our Focal One HIFU endometriosis program. This level 1 study – the most rigorous trial design - is a multi-center, double blind, randomized, controlled clinical trial. This study will allow us to continue to build strong clinical evidence demonstrating the efficacy and added value of HIFU for patients suffering from this painful and debilitating condition.

“The study will enroll 60 subjects across eight centers in France, with 30 subjects randomized to each group. The primary efficacy endpoint is acute pelvic pain three months post procedure. At the conclusion of the study, subjects in the other group will be offered HIFU treatment.  We look forward to initiating enrollment in this important study in the second quarter of next year.”

This will be EDAP’s third study evaluating Focal One HIFU for endometriosis. The Company recently completed a Phase 2 study evaluating HIFU as a potential treatment for deep infiltrating endometriosis. The Phase 2 study enrolled 60 subjects across four centers in France. Data from this study is currently being analyzed with the anticipation of the final results on safety and efficacy l being presented at a medical meeting in early 2023.

About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market. EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.focalone.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device, as well as the length and severity of the recent COVID-19 outbreak, including its impacts across our businesses on demand for our devices and services. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
John Fraunces
LifeSci Advisors, LLC
212-915-2568
jfraunces@lifesciadvisors.com

FAQ

What is EDAP TMS planning with its Focal One device?

EDAP TMS is initiating a Phase 3 clinical trial to evaluate Focal One HIFU for treating rectal deep infiltrating endometriosis.

When will the Phase 3 trial for Focal One begin?

Enrollment for the Phase 3 trial is expected to start in Q2 2023.

How many subjects will be involved in the Focal One HIFU trial?

The trial will enroll 60 subjects, with randomization occurring between treatment groups.

What is the primary endpoint of the Focal One trial?

The primary efficacy endpoint is to assess acute pelvic pain three months after the procedure.

What results can we expect from the previous Phase 2 study?

Final results from the Phase 2 study are anticipated to be presented at a medical meeting in early 2023.