Total company second quarter 2021 revenue of approximately EUR 10.4 million (USD $12.4 million) increased 11.8% year-over-year; first half 2021 total company revenue of EUR 20.7 million (USD $24.8 million) increased 22.5%
During the second quarter, U.S. HIFU treatment volumes increased 79% over the comparable period in 2020
Ended the second quarter 2021 with cash and cash equivalents of EUR 45 million (USD $53.3 million)
Announced hiring of veteran robotic medical device executive Ryan Rhodes as Chief Executive Officer of the company's U.S. subsidiary, EDAP Technomed Inc.
Company to report full second quarter financial and operating results on Wednesday, August 25, and host a conference call on Thursday, August 26 at 8:30am ET

LYON, France, August 4, 2021 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, reports today select preliminary unaudited second quarter financial and operating results. The company anticipates reporting total second quarter revenue of approximately EUR 10.4 million (USD $12.4 million), representing an increase of 11.8% over EUR 9.3 million (USD $10.3 million) in the second quarter of 2020. First half total company revenue of EUR 20.7 million (USD $24.8 million) increased 22.5% over EUR 16.9 million (USD $18.7 million) for the first half of 2020.

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: "While the effects of the COVID pandemic continued to impact hospital capital equipment timelines and our overall HIFU revenue during the second quarter, we made steady progress building further clinical validation with leading reference centers. We are seeing a robust pipeline of Focal One opportunities and believe several leading institutions will begin offering treatments during the second half of the year."

"Notwithstanding the weakness in hospital capex, however, we were very pleased to see significant growth – 79% - in our U.S. treatment volumes, a metric that we regard as a key leading indicator of HIFU utilization. The significant growth in the number of treatments performed is a very positive trend that reflects accelerating adoption of HIFU in the US. With the successful financing that we completed in April, we exited the second quarter with cash of more than $53 million and are well financed to continue to execute against our U.S. growth and expansion plans."

Management plans to release full second quarter 2021 financial and operating results after the close of the market on Wednesday, August 25 and host a conference call and webcast the following day.

Q2 2021 Conference Call and Webcast Details:

Thursday, August 26^th @ 8:30am Eastern Time

Domestic:        877-451-6152

International:        201-389-0879

Passcode:        13721942

Webcast:         http://public.viavid.com/index.php?id=145982

Note: exchange rates used in the conversion of EUR to USD are: H1 2021=1.2008, 1H 2020=1.1063, Q2 2021=1.2024, Q2 2020=1.1093

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, and us.hifu-prostate.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

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

EDAP Announces Select Preliminary Unaudited Second Quarter 2021 Results