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EDAP Reports Second Quarter 2021 Results and Provides Operational Update - Total revenue for the first half 2021 of EUR 20.7 million ( USD $ 24.8 million ) increased 22.5 % over the same period of the prior year Net income was EUR 0.4 million ( USD 0.4 million ) , or EUR 0.01 per diluted share , for the first half of 2021 Cash balance of EUR 45 million ( USD $ 53.3 million ) as of June 30 , 2021 Second quarter U.S. HIFU treatment volumes increased 79 % over the comparable period in 2020 ; strong leading indicator of Focal One adoption CMS Advisory Panel on Hospital Outpatient Payment ( HOP panel ) , at its summer meeting , unanimously recommended increasing reimbursement for HIFU prostate ablation to APC Level 6 in 2022 from Level 5 currently Company to host a conference call tomorrow , August 26 , at 8:30 am ET LYON , France , August 25 , 2021 -- EDAP TMS SA ( Nasdaq : EDAP ) ( the " Company " ) , a global leader in robotic energy - based therapies , announced today unaudited financial results for the second quarter of 2021 and provided an update on strategic and operational developments . Marc Oczachowski , EDAP's Chairman and Chief Executive Officer , said : “ We were very pleased during the second quarter to see continued strong growth in U.S. Focal One treatment volumes , a metric that we believe reflects accelerating HIFU adoption as a prostate cancer treatment alternative . While the ongoing COVID pandemic continues to weigh on hospital capital spending , we nonetheless continued to build a robust pipeline of Focal One and ExactVu pipeline opportunities , and we are optimistic that we will close additional high - profile sales this year . “ On the reimbursement front , just a few days ago , the CMS HOP panel voted unanimously in favor of increasing reimbursement for HIFU prostate ablation to APC Level 6 next year from Level 5 currently . Even if the HOP panel has only an advisory role to CMS , we believe this is a strong signal and further recognition of the value of HIFU in this indication . We hope this will be taken into account by CMS when building the final rule , which will be published in December of this year . If this is the case , reimbursement for Focal One HIFU would increase from an average of approximately $ 4,500 per procedure this year to an average of approximately $ 8,500 per procedure in 2022. This increase , if implemented , could be a significant catalyst to accelerating Focal One sales in 2022 and beyond . “ Importantly , our U.S. expansion plans , led by new U.S. subsidiary CEO Ryan Rhodes , are progressing and we are well financed with more than $ 53 million on our balance sheet . I believe we are poised for a strong back half of the year and accelerating HIFU momentum heading into 2022. " For the first six months 2021 Results Total revenue for the first half of 2021 was EUR 20.7 million ( USD 24.8 million ) , an increase of 22.5 % compared to total revenue of EUR 16.9 million ( USD 18.7 million ) for the same period in 2020 . Total revenue in the HIFU business for the first six months of 2021 was EUR 3.8 million ( USD 4.6 million ) , a decline of 15.1 % as compared to EUR 4.5 million ( USD 4.9 million ) for the first six months of 2020 . Total revenue in the LITHO business for the first six months of 2021 was EUR 5.2 million ( USD 6.2 million ) , a decline of 11.8 % from EUR 5.9 million ( USD 6.5 million ) for the first six months of 2020 . Total revenue in the Distribution business for the first six months of 2021 was EUR 11.7 million ( USD 14.0 million ) , a 79.0 % increase compared to EUR 6.5 million ( USD 7.2 million ) for the first six months of 2020 . Gross profit for the first six months of 2021 was EUR 8.6 million ( USD 10.3 million ) , compared to EUR 7.4 million ( USD 8.2 million ) for the year - ago period . Gross profit margin on net sales was 41.6 % in the first six months of 2021 , compared to 43.9 % in the year - ago period . The decrease in gross profit year - over - year was due to lower sales effect on fixed costs , particularly in the HIFU business . Operating expenses were EUR 8.8 million ( USD 10.5 million ) for the first six months of 2021 , compared to EUR 8.5 million ( USD 9.5 million ) for the same period in 2020 . Operating loss for the first six months of 2021 was EUR 0.2 million ( USD 0.2 million ) , compared to an operating loss of EUR 1.2 million ( USD 1.3 million ) for the same period in 2020 .