• Initiatives focused on making HIFU procedures broadly accessible to both Medicare and commercially insured patients 

LYON, France, March 3, 2021 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, announces today that the company has selected Medical Technology Partners (MTP) and Argenta Advisors, two leading reimbursement consultancies, to further expand coverage, accelerate market access and secure future payment rates for the company’s Focal One high intensity focused ultrasound (HIFU) procedure in the US. The announcement follows the establishment of a Category 1 CPT code, and physician reimbursement for HIFU, that went into effect on January 1, 2021.  

Marc Oczachowski, EDAP's Chairman and Chief Executive Officer, said: “Following the previously announced establishment of a Category 1 CPT code and reimbursement to physicians performing ablation of malignant prostate tissue with HIFU in the US, we are pleased to partner with Argenta Advisors and Medical Technology Partners to leverage this important reimbursement mechanism and make Focal One as broadly accessible to as many patients as possible, whether Medicare or commercially insured. Both firms have a track record of helping technologies like ours quickly get to the next level. We look forward to combing their strengths with ours to assist hospitals, physicians and patients with coverage and reimbursement of HIFU while in parallel working with medical directors and other payer decision makers toward the creation of universal automatic coverage policies. We continue to believe that Focal One HIFU addresses a significant unmet need in the prostate cancer treatment continuum and we are confident that these initiatives will yield the positive results that we envision.”

Jerry Stringham, Chief Executive Officer of MTP, said: “This announcement represents an extension of our four-year relationship with EDAP that resulted in the successful creation of a reimbursable C-Code for HIFU in 2017 and a Category 1 CPT code which took effect this past January. The growing body of published clinical evidence supporting the use of Focal One for prostate cancer is impressive and makes this an ideal time to solidify insurer coverage.  We look forward to continuing to work with Marc and the EDAP team to further expand HIFU access and utilization in the US.”        

About Medical Technology Partners (MTP)

Medical Technology Partners is a reimbursement consulting firm founded in 1998.  MTP has worked with over 190 different medical device manufacturers with particular expertise in urology and with prostate cancer technologies.  

About Argenta Advisors

Argenta has been helping life science companies develop and implement reimbursement strategies for nearly 20 years. In addition to working with over 200 startups and small to midsize companies, Argenta has worked with half of the 10 largest medical device manufacturers. Argenta’s team, composed of industry leaders, clinicians, and former payer decision-makers, helps technology move from policy to practice.

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

Source: EDAP TMS S.A.