EDAP EDAP TMS S.A.

3.31
-0.01  -0%
Previous Close 3.31
Open 3.28
52 Week Low 1.46
52 Week High 5.39
Market Cap $96,312,876
Shares 29,141,566
Float 29,141,566
Enterprise Value $76,700,245
Volume 40,466
Av. Daily Volume 107,710
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Drug Pipeline

Drug Stage Notes
Ablatherm-HIFU (High Intensity Focused Ultrasound)
Cancer - Low risk, localized prostate cancer
Approved
Approved
Approved November 9 2015

Latest News

    • Company completes four Focal One sales, including three bundled sales that combine Focal One® with Exact Imaging's ExactVu micro ultrasound imaging solution
    • Company recorded an additional three stand-alone ExactVu purchase orders at major centers

    LYON, France, July 15, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, today provided an update on recent sales successes that occurred during the second quarter and early third quarter.

    During the second quarter, the company added Edouard Herriot University Hospital in Lyon, France, and Ochsner Medical Center in New Orleans, Louisiana, to its roster of highly regarded Focal One hospital customers. Notably, both sales also included the ExactVu micro…

    • Company completes four Focal One sales, including three bundled sales that combine Focal One® with Exact Imaging's ExactVu micro ultrasound imaging solution
    • Company recorded an additional three stand-alone ExactVu purchase orders at major centers

    LYON, France, July 15, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, today provided an update on recent sales successes that occurred during the second quarter and early third quarter.

    During the second quarter, the company added Edouard Herriot University Hospital in Lyon, France, and Ochsner Medical Center in New Orleans, Louisiana, to its roster of highly regarded Focal One hospital customers. Notably, both sales also included the ExactVu micro ultrasound system as bundled deals. Early in the third quarter, the company completed another bundled sale to Mount Sinai Health System in New York, a world-renowned cancer center and influential reference site for the company. Also, in the early days of the third quarter, EDAP sold a Focal One system to Keck Medical Center of University of Southern California (USC). Keck Medicine of USC was the first institution to adopt EDAP's first generation high intensity focused ultrasound (HIFU) system, Ablatherm, when the technology was approved by the FDA in 2015, and has decided to upgrade to the latest generation HIFU by acquiring Focal One.

    "Following a temporary pause in sales activity during the second quarter as hospitals and physicians focused on combating COVID-19, we are experiencing a strong rebound as parts of the U.S. and Europe ease pandemic-related restrictions," stated Marc Oczachowski, Chairman and Chief Executive Officer of EDAP. "We are particularly pleased to see that our distribution partnership with Exact Imaging, which we just announced in May, is having an immediate and positive impact on our sales and pipeline. This confirms the value and interest in a unique ‘end-to-end' solution for the urology suite, from diagnosis through treatment. EDAP is the only company with such an offering."

    "We believe these recent sales successes, which include both new highly-regarded customers and long-time customers upgrading to our latest HIFU technology, speak to the superiority of our technology, and we are optimistic that we can sustain this momentum through the back half of the year," Mr. Oczachowski concluded.        

    The company will provide a more detailed update on recent sales and pipeline activities during its second quarter update conference call in August.

    About EDAP TMS SA

    A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology 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 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. 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 sustained  activity of our lithotripsy business, 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

    Investor Contact

    Jeremy Feffer

    LifeSci Advisors, LLC

    212-915-2568

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  1.  

    Appointment adds significant medical technology executive and board leadership experience


    LYON, France, June 30, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, announced today that veteran medical technology executive Marie Meynadier has been elected to its Board of Directors, effective June 30, 2020, following a vote by the company's shareholders. Ms. Meynadier has more than 20 years of experience in medical technology operations and leadership and most recently served as Chief Executive Officer of EOS Imaging.    

    Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented, "Marie has broad experience as both senior executive and director in…

     

    Appointment adds significant medical technology executive and board leadership experience



    LYON, France, June 30, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, announced today that veteran medical technology executive Marie Meynadier has been elected to its Board of Directors, effective June 30, 2020, following a vote by the company's shareholders. Ms. Meynadier has more than 20 years of experience in medical technology operations and leadership and most recently served as Chief Executive Officer of EOS Imaging.    

    Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented, "Marie has broad experience as both senior executive and director in the medtech field, in particular in the capital equipment area, and we are very pleased that she has joined our Board. We look forward to her insights and contributions as we refine our research and development programs and work to efficiently expand our HIFU technology into other high-value indications where improved patient outcomes are badly needed."

    Ms. Meynadier stated, "I have had and continue to have the privilege of working alongside teams that produce truly groundbreaking and life-saving technologies, and I would firmly place EDAP's high-intensity focused ultrasound in that category. Together with the Company's recently announced partnership with Exact Imaging, I believe EDAP's end-to-end Focal One® solution represents a significant advancement in the treatment and ablation of not only prostate tissue, but other soft tissue indications as well. I look forward to working with the EDAP team and my fellow Board members to help the Company realize its vast potential."

    Ms. Meynadier currently serves on the Boards of Directors of several medical technology companies in Europe and North America. From 1999 through 2019, she served at EOS Imaging as its CEO and led the company through a period of rapid worldwide sales growth, increasing at a CAGR of 32% from 2012 to 2017. Prior to EOS Imaging, Ms. Meynadier served as CEO at Biospace Lab, a preclinical imaging company she developed and turned to profitability. Ms. Meynadier received a degree in electrical engineering from Sup Télécom, Paris, and her Ph.D. in physics from Ecole Normale Supérieure Ulm, Paris.

    About EDAP TMS SA

    A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology 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 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. 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 sustained  activity of our lithotripsy business, 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

    Investor Contact

    Jeremy Feffer

    LifeSci Advisors, LLC

    212-915-2568

     

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    • Seasoned medical technology sales and marketing professional brings more than 25 years of experience to the EDAP team
    • Joins EDAP from Exact Imaging to lead the recently announced global distribution agreement between the two companies

    LYON, France, May 28, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, announced today the appointment of Frank Van Hyfte as Vice President of Global Sales and Marketing. Mr. Van Hyfte joins EDAP from Exact Imaging, where he most recently served as Executive Vice-President of Worldwide Sales and Marketing. On May 12, 2020, EDAP announced that the Company had entered into an exclusive worldwide distribution agreement with Exact Imaging to integrate Exact's…

    • Seasoned medical technology sales and marketing professional brings more than 25 years of experience to the EDAP team
    • Joins EDAP from Exact Imaging to lead the recently announced global distribution agreement between the two companies

    LYON, France, May 28, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy-based therapies, announced today the appointment of Frank Van Hyfte as Vice President of Global Sales and Marketing. Mr. Van Hyfte joins EDAP from Exact Imaging, where he most recently served as Executive Vice-President of Worldwide Sales and Marketing. On May 12, 2020, EDAP announced that the Company had entered into an exclusive worldwide distribution agreement with Exact Imaging to integrate Exact's ExactVu™ and other micro ultrasound diagnostic products in EDAP's offering in the management of prostate cancer as a stand-alone range or in combination with its Focal One high intensity focused ultrasound (HIFU) treatment technology.

    Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: "Frank is a highly accomplished sales leader with a proven track record of success, and I could not be happier that he has joined the EDAP team. Frank is a great addition to our worldwide sales team with his deep specialized experience in prostate cancer and in particular his 16 years at Intuitive Surgical, where he contributed to building the Da Vinci robot into the current success that we know today, as well as his recent experience in launching the Exact Imaging technology. We believe Frank's experience will drive accelerating adoption of our technologies, allowing us to maximize the potential of the Exact Imaging agreement, and helping us further penetrate existing accounts while accelerating growth in our sales pipeline."

    "I am pleased to have this opportunity to lead the EDAP-Exact Imaging sales effort and I am eager to hit the ground running with a new offering that combines Exact Imaging's micro ultrasound diagnostic technology with EDAP's Focal One HIFU-based treatment device," stated Mr. Van Hyfte. "Together, these technologies represent the first true end-to-end solution allowing urologists worldwide to employ the latest advancements in prostate cancer management, from screening and diagnosis through treatment. I look forward to making this highly differentiated solution available to treating physicians around the world."  

    Prior to joining Exact Imaging in 2017, Mr. Van Hyfte served in various sales roles of increasing responsibility at Intuitive Surgical, a leader in robotic assisted minimally invasive surgery, since 2000. Before joining Intuitive, he held sales positions at Autosuture (now part of Medtronic) and Yamanouchi Phasrma (now part of Astellas Pharma). Mr. Van Hyfte received his master's degree in Physical Education, and his master's degree in Motorical Revalidation and Physiotherapy, both from the Ghent University in Belgium.

    About EDAP TMS SA

    A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology 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 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. 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 sustained  activity of our lithotripsy business, 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

    Investor Contact
    Jeremy Feffer
    LifeSci Advisors, LLC
    212-915-2568

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    • Maintains strong balance sheet with EUR 18.5 million (USD 20.3 million) in cash as of March 31, 2020
    • Signs exclusive worldwide distribution agreement with Exact Imaging to combine their innovative micro-ultrasound technology with Focal One to offer an end-to-end focal therapy solution for the diagnosis and management of prostate cancer
    • Announces strategic refocusing of future development programs towards high intensity focused ultrasound (HIFU) and related growth opportunities
    • Company to host a conference call tomorrow, May 14 at 8:30 am EDT

    LYON, France, May 13, 2020 -- EDAP TMS SA (NASDAQ:EDAP) (the "Company"), the global leader in robotic energy based therapies, announced today financial results for the first quarter of 2020 and provided…

    • Maintains strong balance sheet with EUR 18.5 million (USD 20.3 million) in cash as of March 31, 2020
    • Signs exclusive worldwide distribution agreement with Exact Imaging to combine their innovative micro-ultrasound technology with Focal One to offer an end-to-end focal therapy solution for the diagnosis and management of prostate cancer
    • Announces strategic refocusing of future development programs towards high intensity focused ultrasound (HIFU) and related growth opportunities
    • Company to host a conference call tomorrow, May 14 at 8:30 am EDT

    LYON, France, May 13, 2020 -- EDAP TMS SA (NASDAQ:EDAP) (the "Company"), the global leader in robotic energy based therapies, announced today financial results for the first quarter of 2020 and provided an update on strategic and operational developments. 

    Marc Oczachowski, EDAP's Chief Executive Officer, said: "Through the first months of 2020, we continued to advance toward our goal of becoming the leading developer of therapeutic ultrasound solutions in urology while also implementing strategic initiatives intended to provide a superior customer offering and drive long-term growth. We are very pleased to have announced a global exclusive distribution agreement with Exact Imaging, a leading innovator in advanced ultrasound technologies. In addition to representing a real advancement in the precise and reliable diagnosis of lesions within the prostate, their ExactVu™ product and its unique micro-ultrasound technology perfectly complements our state-of-the-art Focal One therapeutic offering. By combining these, EDAP is the first and only company to offer urologists a complete end-to-end solution from diagnosis through treatment in the modern management of prostate cancer.    

    "Regarding our first quarter results, we expected and did experience a deceleration in both procedure volumes and new system sales as hospitals around the world worked to fight the COVID-19 pandemic. However, we are seeing early signs that certain markets are returning to a more normalized business environment, an indication that prostate cancer procedures that had been previously delayed will now resume. As far as system sales, Focal One represents a significant capital outlay for a hospital and as a result, hospitals have been postponing significant technology investments during the COVID outbreak. We strongly believe that many of these sales will ultimately be completed this year. In the meantime, we have continued to grow our pipeline of projects and leads during the worst of the pandemic.

    "After an extensive review of our different businesses, including HIFU, Distribution and ESWL, we have decided to strengthen and refocus our development efforts towards HIFU for both prostate applications and beyond. As a part of this initiative, we will be revisiting our lithotripsy R&D investment strategy (to include discontinuation of Endo-UP platform). Based on recent trends, we believe it is important to shift and narrow our R&D focus and marketing towards HIFU and Distribution, as these have shown strong growth and have the potential for future growth and contribution. Importantly, our Lithotripsy business generates significant and steady cash flow for the company that can finance future HIFU development, and we intend to sustain this cash flow by continuing to sell and support our state of the art Sonolith range of devices. But given the opportunities in HIFU that are in front of us, and our technology leadership position, we believe now is the right time to pivot more fully toward that business and to accelerate HIFU expansion," Mr. Oczachowski concluded.

    First Quarter 2020 Results

    Total revenue for the first quarter 2020 was EUR 7.6 million (USD 8.4 million), a 24.9% decrease compared to EUR 10.1 million (USD 11.5 million) for the first quarter of 2019. First quarter 2020 revenue reflects the impact of the ongoing COVID-19 pandemic on both procedure volumes and equipment sales.

    Total revenue in the HIFU business for the first quarter 2020 was EUR 1.9 million (USD 2.1 million), a 50.2 % decrease compared to EUR 3.9 million (USD 4.4 million) for the first quarter of 2019. The year-over-year decline was due to no Focal One units sold during the first quarter of 2020 compared to four sold in the year ago period. 

    For the three months ended March 31, 2020, total revenue for the UDS division was EUR 5.7 million (USD 6.3 million), a 9.2 % decrease compared to EUR 6.3 million (USD 7.1 million) during the year-ago period.

    Gross profit for the first quarter 2020 was EUR 3.1 million (USD 3.4 million), compared to EUR 4.9 million (USD 5.5 million) for the year-ago period. Gross profit margin on net sales was 40.2% in the first quarter of 2020, compared to 48.0% in the year-ago period. The decline in gross profit year-over-year was due to in part to lower sales in HIFU business as compared to the year-ago period.

    Operating expenses were EUR 4.5 million (USD 5.0 million) for the first quarter of 2020, compared to EUR 4.7 million (USD 5.3 million) for the same period in 2019.

    Operating loss for the first quarter of 2020 was EUR 1.5 million (USD 1.6 million), compared to an operating profit of EUR 0.2 million (USD 0.2 million) in the first quarter of 2019. The financial impact related to discontinuation of R&D lithotripsy programs is under evaluation and will be reflected in the future quarters.

    Net loss for the first quarter of 2020 was EUR 1.3 million (USD 1.4 million), or EUR (0.04) per diluted share, as compared to net income of EUR 0.3 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

    As of March 31, 2020, the Company recorded a strong cash position of EUR 18.5 million (USD 20.3 million).

    Conference Call

    An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT on Thursday, May 14, 2020. Please refer to the information below for conference call dial-in information and webcast registration.

    Conference Call & Webcast
    Thursday, May 14, 2020 @ 8:30am Eastern Time

    Domestic:                             877-451-6152
    International:                      201-389-0879
    Passcode:                             13703225
    Webcast:                              http://public.viavid.com/index.php?id=139678

    Following the live call, a replay will be available on the Company's website, www.edap-tms.com under "Investors Information."

    About EDAP TMS SA

    A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology 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 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. 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 devices, 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 may also 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
    bco

    Investor Contact
    Jeremy Feffer
    LifeSci Advisors, LLC
    212-915-2568

    EDAP TMS S.A.
    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Amounts in thousands of Euros and U.S. Dollars, except per share data)

      Three Months Ended:   Three Months Ended:
      March 31,
    2020
    Euros
     

     
    March 31,
    2019
    Euros
      March 31, 
    2020
    $US
      March 31, 
    2019
    $US
    Sales of medical equipment

    Net Sales of RPP and Leases
    4,125

    1,255
      6,546

    1,371
      4,551

    1,385
      7,432

    1,556
    Sales of spare parts, supplies and
    Services
     

    2,228
       

    2,215
       

    2,458
       

    2,515
    TOTAL NET SALES 7,608   10,131   8,394   11,503
    Other revenues 2   -   2   -
    TOTAL REVENUES 7,610   10,131   8,295   11,503
    Cost of sales (4,548)   (5,266)   (5,018)   (5,979)
    GROSS PROFIT 3,062   4,865   3,378   5,523
    Research & development expenses (1,042)   (1,013)   (1,150)   (1,150)
    S, G & A expenses (3,480)   (3,644)   (3,839)   (4,137)
    Total operating expenses (4,522)   (4.657)   (4,989)   (5,287)
    OPERATING PROFIT (LOSS) (1,460)   208   (1,611)   236
    Interest (expense) income, net (20)   (31)   (22)   (35)
    Currency exchange gains (loss), net 289   265   319   301
    INCOME (LOSS) BEFORE TAXES AND MINORITY INTEREST (1,191)   443   (1,315)   503
    Income tax (expense) credit (116)   (115)   (128)   (131)
    NET INCOME (LOSS)

     
    (1,308)   328   (1,443)   372

     
    Earning per share – Basic (0.04)   0.01   (0.05)   0.01
    Average number of shares used in computation of EPS 29,141,566   28,997,866   29,141,566   28,997,866
    Earning per share – Diluted (0.04)   0.01   (0.05)   0.01
    Average number of shares used in computation of EPS for positive net income

     
    29,141,566   29,656,133   29,141,566   29,656,133

    NOTE:  Translated for convenience of the reader to U.S. dollars at the 2020 average three months' noon buying rate of 1 Euro = 1.1033 USD, and 2019 average three months noon buying rate of 1 Euro = 1.1353 USD

    EDAP TMS S.A.
    UNAUDITED CONSOLIDATED BALANCE SHEETS HIGHLIGHTS
    (Amounts in thousands of Euros and U.S. Dollars)

      Mar. 31,
    2020
    Euros
        Dec. 31,
    2019
    Euros
    Mar. 31,
    2020
    $US
    Dec. 31,
    2019
    $US
     
    Cash, cash equivalents and short-term investments 18,450     20,886 20,323 23,449  
    Total current assets 39,188     42,097 43,168 47,263  
    Total current liabilities 16,664     17,493 18,356 19,640  
    Shareholders' Equity 25,896     27,359 28,526 30,716  

    NOTE: Translated for convenience of the reader to U.S. dollars at the noon buying rate of 1 Euro = 1.1016 USD, on March 31, 2020 and at the noon buying rate of 1 Euro = 1.1227 USD, on December 31, 2019

    EDAP TMS S.A.
    UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
    THREE MONTHS ENDED MARCH 31, 2020
    (Amounts in thousands of Euros)

       

    HIFU Division
       

    UDS Division
         

    Reconciling Items
     
    Total After Consolidation
     
     

    Sales of goods
     

    578
       

    3,547
             

    4,125
     
    Sales of RPPs & Leases 924   331         1,255  
    Sales of spare parts & services 421   1,808         2,228  
    TOTAL NET SALES

     
    1,922   5,686         7,608  
    Other revenues

     
    2   -         2  
    TOTAL REVENUES 1,924   5,686         7,610  
    GROSS PROFIT
    (% of Total Revenues)
    783  40.7% 2,279  40.1%       3,062  40.2%
    Research & Development (543)   (499)         (1,042)  
    Total SG&A plus depreciation (1,262)   (1,820)     (397)   (3,479)  
     

    OPERATING PROFIT (LOSS)
     

    (1,023)
       

    (39)
         

    (397)
       

    (1,460)
     

     

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    • Exact Imaging is a leading developer of ultra-high-resolution micro-ultrasound diagnostic technologies
    • Micro-ultrasound ExactVu™ is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRI
    • Combination of Exact Imaging's micro-ultrasound and EDAP's Focal One® represents the most complete offering for the focal management of prostate cancer
    • Represents a potentially meaningful new growth driver for EDAP 

    LYON, France, May 12, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy based therapies, announced today that the company has signed an exclusive worldwide distribution agreement with Exact Imaging, a developer of high resolution micro-ultrasound…

    • Exact Imaging is a leading developer of ultra-high-resolution micro-ultrasound diagnostic technologies
    • Micro-ultrasound ExactVu™ is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRI
    • Combination of Exact Imaging's micro-ultrasound and EDAP's Focal One® represents the most complete offering for the focal management of prostate cancer
    • Represents a potentially meaningful new growth driver for EDAP 

    LYON, France, May 12, 2020 -- EDAP TMS SA (NASDAQ:EDAP) ("the Company"), the global leader in robotic energy based therapies, announced today that the company has signed an exclusive worldwide distribution agreement with Exact Imaging, a developer of high resolution micro-ultrasound imaging technologies. Under the terms of the agreement, EDAP will market Exact Imaging's micro-ultrasound diagnostic devices alongside its Focal One high intensity focused ultrasound (HIFU) treatment solution. The combination of these technologies represents the most complete end-to-end solution, from diagnosis through treatment, available to urologists today.     

    Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: "We are very excited to announce this exclusive worldwide partnership with Exact Imaging. Integrating their ExactVu diagnostic device with our range of innovative and state of the art product lines at a global distribution level will allow us to continue to drive growth in our distribution business, which has grown by more than 200% over the past five years. In addition to being a great stand-alone product and a unique ultrasound solution, clinical studies have reported a diagnostic accuracy similar to MRI in identifying prostate cancer. Further, a recently published study observed an improvement in diagnostic accuracy when ExactVu micro-ultrasound was added to MRI. ExactVu has a number of synergies with Focal One, and the combination of both makes EDAP the only company able to offer a complete solution from diagnostic to treatment for the focal management of prostate cancer. We are eager to commence this partnership and look forward to leveraging the combination of these two leading technologies to drive HIFU adoption and growth."

    Randy AuCoin, President and Chief Executive Officer of Exact Imaging, stated: "We are very excited to enter into this agreement with EDAP. EDAP's position as a leader in the urology market, its HIFU technology, and its track record of innovation in providing minimally invasive therapy solutions to prostate cancer patients provide an excellent complement to Exact Imaging's technology. In addition, EDAP's network of subsidiary companies and distribution partners provide an exciting opportunity for Exact Imaging to reach new customers worldwide. We look forward to a long and mutually beneficial partnership."

    About EDAP TMS SA

    A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology 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 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.

    About Exact Imaging

    Exact Imaging is the world's leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging's ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and target biopsies at those areas.  For those cases where MRI might assist, the FusionVu™ micro-US/MRI fusion application operates on the ExactVu micro-ultrasound platform and facilitates fast, simple MRI fusion-based targeting with the guidance of the micro-ultrasound system's 70-micron real-time resolution. The ExactVu micro-ultrasound system including the FusionVu application has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)), and Canada (Health Canada medical device license).  For more information on Exact Imaging, please visit their website www.exactimaging.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

    Investor Contact
    Jeremy Feffer
    LifeSci Advisors, LLC
    212-915-2568

    Exact Imaging Contact
    Randy AuCoin
    President & CEO
    +1.705.927.0512

    www.exactimaging.com

     

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