EDAP Announces Record Preliminary Fourth Quarter and Full-Year 2022 Revenue

Record full-year 2022 total preliminary unaudited revenue of €55.1 million ($58.0 million) represents an increase of 25.1% over full-year 2021, driven by 58.1% HIFU growth

Record Q4 2022 total preliminary unaudited revenue of €15.8 million ($16.2 million) versus €14.0 million ($15.9 million) for Q4 2021

Maintains strong balance sheet with cash and cash equivalents of €63.1 million ($67.5 million) as of December 31, 2022

LYON, France, February 14, 2023 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today announced preliminary unaudited fourth quarter and full year 2022 revenue and other financial highlights.

“We finished 2022 with strong fourth quarter and full year revenue, driven by successful execution of our U.S. Focal One HIFU business,” said Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS. “We sold 15 Focal One machines in 2022, as compared to seven in 2021. This notable increase further validates the growing momentum and interest amongst leading clinicians and hospital providers in offering Focal One as a necessary treatment option to select prostate cancer patients.”

Ryan Rhodes, Chief Executive Officer of EDAP Technomed Inc., stated, “We recorded nine Focal One transactions in the U.S. during the fourth quarter, including six machine sales and three operating leases. As our pipeline continues to strengthen, we see a good mix of both large academic medical centers as well as community hospitals who understand the necessity and value of providing access to Focal One Robotic HIFU technology to an appropriate subset of prostate cancer patients. In addition, the Medicare reimbursement increase that went into effect on January 1^stappropriately allows more providers to consider the investment in obtaining HIFU technology. We believe these actions together will continue to support our growing US commercial momentum in 2023.”

This announcement assumes the following EUR-to-USD exchange rates:

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