EDAP announces the reimbursement of Focal One® HIFU increased to


Proposed rule, if adopted for CY23would increase Medicare payment for a Focal One HIFU procedure completed on an outpatient basis to the hospital

LYON, France, July 18, 2022 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in energy-based robotic therapies, today announced that the Centers for Medicare and Medicaid Services (CMS) has released its proposed Ambulatory Prospective Payment System (OPPS) reimbursement rule for calendar year 2023 (CY23).

For a hospital performing Focal One HIFU prostate removal on an outpatient basis, the proposed rule would increase the level of reimbursement to an Ambulatory Payment Classification (APC) Level 6, from the current APC Level 5. This would result in an increase in reimbursement to a hospital performing a High-Intensity Focused Ultrasound (HIFU) procedure on a Medicare patient to $8,711 per procedure on a national average, locally adjusted for salary index, from $4,506 $ currently as the national average adjusted locally according to the salary index.

The increase to APC Level 6 has positive implications for patients beyond Medicare as many commercial payers have begun to cover focal HIFUs for their limbs. Commercial payment and access policies are influenced by Medicare policy and reimbursement decisions.

Ryan Rhodes, CEO of EDAP US, said, “This proposed rule reflects the realization of the appropriate value of HIFU across the continuum of prostate care, particularly in comparison to more invasive treatments like radical surgery or radiotherapy. If the final rule maintains the increased reimbursement levels proposed here, we believe it would be an important catalyst in accelerating access for facilities and their patients to the benefits of focal HIFU.

Comments on the proposed rule are expected by September 30, and the final rule is expected in November. The final rule policies and payout rates will generally go into effect on January 1, 2023.


A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes minimally invasive medical devices worldwide 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 has introduced the Focal One® in Europe and the United States as an answer to all requirements for an ablation ideal of prostate tissue. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company to offer a complete solution from diagnosis 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 stones by extracorporeal shock wave lithotripsy (ESWL). For more information about 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. These 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 nothing guarantees that the planned events will occur or that the objectives set 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 commercial potential of our lithotripsy device. , as well as the duration and severity of the recent COVID-19 outbreak, including its impacts in our business on demand for our devices and services. Factors that could cause such a difference may also include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and, in particular, in the Forward-Looking Information” and “Risk Factors”. in the company’s annual report on Form 20-F.

Company details
Blandine Comfort
Investor Relations / Legal Affairs
+33 4 72 15 31 50
[email protected]

Contact Investor
John Fraunces
LifeSci Advisors, LLC
[email protected]


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