Exact Imaging is a leading developer of ultra-high-resolution micro-ultrasound diagnostic technologiesMicro-ultrasound ExactVu™ is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRICombination of Exact Imaging’s micro-ultrasound and EDAP’s Focal One® represents the most complete offering for the focal management of prostate cancerRepresents 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 SAA 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 ImagingExact 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 StatementsIn 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.comInvestor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.comExact Imaging Contact
Randy AuCoin
President & CEO
+1.705.927.0512
raucoin@exactimaging.com
www.exactimaging.com
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