EDAP Provides Corporate Update on US Focal One Installation Growth

Company announces several key U.S. Focal One installations during Q4

LYON, France, January 5, 2022 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today provided an update on recent Focal One placements and the initiation of treatments at select new customer sites in the US.

During the company’s third quarter 2021 conference call in November, EDAP announced that it had sold a Focal One device to the University of California at San Diego (UCSD) during the fourth quarter. The sale to UCSD is now the third Focal One placement into the prestigious UC healthcare system, following previously announced sales to UC San Francisco and UC Irvine.

In addition, the company is today announcing that additional Focal One installations have occurred during the fourth quarter to five prestigious academic and integrated health network reference centers. These include Brigham and Women’s Hospital in Boston, Cedars-Sinai Health System in Los Angeles, Henry Ford Health System in Detroit, Duke University in North Carolina and Prisma Health in South Carolina.

Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: “The robust growth in Focal One programs that we experienced during the fourth quarter of 2021 gives us tremendous optimism heading into the new year. It’s very encouraging to see such growth in market adoption less than six months after the significant restructuring of and investment in our U.S. operations which included the addition of Ryan Rhodes as the new CEO of EDAP Technomed Inc., our U.S. subsidiary.”

Ryan Rhodes, CEO of EDAP U.S., said, “We enter 2022 with tremendous momentum led by the adoption of Focal One by several renowned institutions in the fourth quarter that can act as reference sites. We continue to assemble and grow a strong commercial and service organization in the US. We believe that focal therapy is becoming a necessary part of any comprehensive prostate oncology program, and that Focal One is uniquely positioned to deliver robotically-controlled, precise and non-invasive treatment under the direction of urologists.”

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