Page 1

Exhibit 99.1 EDAP Reports First Quarter 2021 Results and Provides Operational Update Generated record first quarter revenue of EUR 10.3 million ( USD 12.4 million ) , an increase of 35.4 % year - over - year Increased gross margin year - over - year to 42.4 % , contributing to a profitable quarter Raised gross proceeds of approximately $ 28 million through an underwritten offering of American Depository Shares ( ADSs ) Strong cash position of EUR 24.4 million ( USD 28.6 million ) as of March 31 , 2021 , excluding $ 28 million of gross proceeds raised in April Company to host a conference call tomorrow , May 12 , at 8:30 am ET LYON , France , May 11 , 2021 -- EDAP TMS SA ( Nasdaq : EDAP ) ( the “ Company ” ) , a global leader in robotic energy - based therapies , announced today unaudited financial results for the first quarter of 2021 and provided an update on strategic and operational developments . Marc Oczachowski , EDAP's Chairman and Chief Executive Officer , said : “ We are thrilled to have completed a successful offering in April which , added to our existing strong cash position , provides funding to achieve potentially value - creating milestones across all aspects of our business . We are acutely focused on driving accelerating growth in the US by building market access and coverage now that our Category 1 CPT code is in place . We also continue to advance our Phase 2 endometriosis program and have now opened a second trial site in France where we commenced patient treatments last week . " While we continue to experience some effect of COVID - 19 on our operations , we are pleased with the global performance of our business as compared to the first quarter of last year . We grew revenue by 35.4 % , expanded our gross margin to 42.4 % , and generated a profitable quarter for the company . We also saw continued growth in our Focal One and HIFU treatments in the US , reflecting increasing awareness and adoption of our next generation HIFU technology . " “ In summary , with our strong balance sheet and US growth initiatives continuing to gain traction , I believe we are well positioned to drive growing adoption of HIFU for the management of prostate cancer in 2021 , " Mr. Oczachowski concluded . First Quarter 2021 Results Total revenue for the first quarter 2021 was EUR 10.3 million ( USD 12.4 million ) , an increase of 35.4 % compared to total revenue of EUR 7.6 million ( USD 8.4 million ) for the same period in 2020 . Total revenue in the HIFU business for the first quarter 2021 was EUR 1.8 million ( USD 2.2 million ) , a decline of 6.2 % as compared to EUR 1.9 million ( USD 2.1 million ) for the first quarter of 2020 . Total revenue in the LITHO business for the first quarter 2021 was EUR 2.9 million ( USD 3.5 million ) , roughly flat with EUR 2.9 million ( USD 3.2 million ) for the first quarter of 2020 . Total revenue in the Distribution business for the first quarter 2021 was EUR 5.6 million ( USD 6.7 million ) , a 102.5 % increase compared to EUR 2.8 million ( USD 3.1 million ) for the first quarter of 2020 . Gross profit for the first quarter 2021 was EUR 4.4 million ( USD 5.2 million ) , compared to EUR 3.1 million ( USD 3.4 million ) for the year - ago period . Gross profit margin on net sales was 42.4 % in the first quarter of 2021 , compared to 40.2 % in the year - ago period . The increase in gross profit year - over- year was due to higher sales effect on fixed costs .