EDAP Announces Focal One® HIFU Reimbursement Raised to

Final rule significantly raises Medicare reimbursement to U.S. hospitals performing a Focal One HIFU prostate ablation procedure

LYON, France, November 1, 2022 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic therapeutic ultrasound, today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has released its final outpatient prospective payment system (OPPS) reimbursement rule for calendar year 2023 (CY23), which becomes effective on January 1^st.

For a hospital performing a Focal One HIFU prostate ablation on an outpatient basis, the final rule increases the reimbursement level to an Ambulatory Payment Classification (APC) level 6, as compared to APC level 5 currently. This will increase reimbursement to a hospital performing a HIFU procedure on a Medicare patient to $8,558 per procedure as compared to $4,506 currently as a national average, adjusted locally based on the wage index. This represents an increase of more than 90% over the current reimbursement level.

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, stated, “We are very pleased that CMS recognizes the true value of HIFU in this important indication, as reflected in the significant increase in reimbursement that will go into effect on January 1^st. We view this as a very positive step forward for the prostate cancer patients who can benefit from this novel therapy.”

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, “This final rule change is a significant development in achieving appropriate reimbursement for facilities offering their patients a precise treatment with Focal One HIFU. We expect that this change will serve as a major catalyst towards accelerating broader access and adoption of Focal One across the U.S.”

As previously noted, the increase to APC level 6 has positive implications for patients beyond Medicare since many commercial payors have begun to cover focal HIFU for their members. Commercial payment…