EDAP Announces Record Q4 US Focal One Placements

Company preliminarily reports nine Focal One Placements in the U.S., including seven sales

LYON, France, January 5, 2023 — EDAP TMS SA (NASDAQ: EDAP) (the “Company”), the global leader in robotic energy-based therapies, announced today that the Company experienced robust demand for its Focal One HIFU technology in the fourth quarter of 2022, placing nine Focal One machines in the U.S. The breadth of new placements also continues to be strong, comprising a mix of both academic medical centers and community hospitals.

Marc Oczachowski, Chairman and Chief Executive Officer of EDAP TMS, stated, “Our strong Q4 Focal One performance reflects the hard work of Ryan and the U.S. organization that he has assembled. In 2023, we plan to continue to build upon this success and market momentum for Focal One HIFU technology.”

Ryan Rhodes, Chief Executive Officer of EDAP Technomed Inc., stated, “We had a very successful fourth quarter, which I believe reflects the growing awareness of Focal One as a necessary treatment option to be offered to appropriate patients as part of the comprehensive management of prostate cancer. In the U.S., clinicians and leading hospitals are expanding access to the non-invasive treatment with Focal One which offers patients excellent oncologic outcomes while maximizing their quality of life.”  

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
917-355-2395
jfraunces@lifesciadvisors.com