EDAP Announces End of the Year Focal One® Sales

• Among December deals closed, two major US institutions have purchased Focal One
• University of California, San Francisco Medical Center and Cleveland Clinic become latest to adopt Focal One high intensity focused ultrasound (HIFU) technology
• Sales include a bundled sale with ExactVu^TM as well as stand-alone Focal One sale, reflecting leverage of exclusive distribution agreement with Exact Imaging signed in May 2020

LYON, France, December 30, 2020 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy- based therapies, announced today two new Focal One sales to leading U.S. healthcare institutions. The company announced a bundled sale of Focal One and Exact Vu to the University of California, San Francisco Medical Center (UCSF) and a Focal One sale to Cleveland Clinic. Both sales were completed during the fourth quarter.  

Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: “We are excited to welcome UCSF and Cleveland Clinic to our large and growing roster of renowned health institutions that have implemented our cutting-edge Focal One HIFU technology. These sales reflect the growing adoption of HIFU in prostate cancer management, and the growing interest in non-invasive and quality of life preservation technologies. We are also pleased to have completed these transactions in the context of a resurgence in COVID-19 cases. We strongly believe it is important for hospitals and healthcare systems to invest in ambulatory technologies that lead to minimal side effects, limit the risk of ICU care and keep patients safe. With these sales completed during the fourth quarter, we are poised to enter 2021 with renewed momentum.”      

EDAP will provide a further update on these sales and other corporate developments during its regularly scheduled Q4 2020 results conference call in March.

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