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EDAP Reports Third Quarter 2021 Results and Provides Operational Update Year - to - date revenue of approximately EUR 30.1 million ( USD 35.9 million ) increased 14.4 % year - over - year Q3 revenue of EUR 9.4 million ( USD 11.1 million ) , flat with Q3 2020 , reflecting lingering impact of COVID - 19 on capital equipment sales Year - to - date US HIFU treatment volumes increased 58 % over the comparable period in 2020 ; strong leading indicator of Focal One adoption by urologists Strong cash position of EUR 45.4 million ( USD 52.6 million ) Company to host a conference call tomorrow , Thursday , November 18 , at 8:30 am ET LYON , France , November 17 , 2021 -- EDAP TMS SA ( Nasdaq : EDAP ) ( the " Company " ) , a global leader in robotic energy - based therapies , announced today unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments . Marc Oczachowski , EDAP's Chairman and Chief Executive Officer , said : “ We are pleased with the continued strong growth in U.S. HIFU treatment volumes , which increased 58 % year - to - date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists . Regarding our third quarter revenue , the COVID - 19 pandemic continued to weigh on hospital capital spending , and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world . Our leading indicators are strong , we are well financed , and I believe we are well positioned to exit the year with renewed momentum . ” Nine Months 2021 Results Total revenue for the nine months ended September 30 , 2021 was EUR 30.1 million ( USD 35.9 million ) , an increase of 14.4 % from total revenue of 26.3 million ( USD 29.8 million ) for the same period in 2020 . Total revenue in the HIFU business for the nine months ended September 30 , 2021 was EUR 5.7 million ( USD 6.8 million ) , a decline of 18.9 % as compared to EUR 7.1 million ( USD 8.0 million ) for the nine months ended September 30 , 2020 . Total revenue in the LITHO business for the nine months ended September 30 , 2021 was EUR 7.7 million ( USD 9.1 million ) , an decrease of 7.4 % from EUR 8.3 million ( USD 9.4 million ) for the nine months ended September 30 , 2020 . Total revenue in the Distribution business for the nine months ended September 30 , 2021 was EUR 16.7 million ( USD 19.9 million ) , a 52.4 % increase compared to EUR 11.0 million ( USD 12.4 million ) for the nine months ended September 30 , 2020 . Gross profit for the nine months ended September 30 , 2021 was EUR 12.2 million ( USD 14.6 million ) , compared to EUR 11.4 million ( USD 12.8 million ) for the year - ago period . Gross profit margin on net sales was 40.6 % for the nine months ended September 30 , 2021 , compared to 43.2 % for the comparable period in 2020. The decrease in gross profit year - over - year was due to lower sales effect on fixed costs , particularly in the HIFU business .