EDAP Issues Letter to Shareholders
EDAP Issues Letter to Shareholders
Recaps significant progress made in 2019 and previews expectations for accelerating global growth in 2020
To my fellow shareholders:
As we turn the page on 2019, I thought this would be a good opportunity to recap our recent progress as well as to preview what we expect to be a very exciting 2020 and beyond. Recall that our latest generation high Intensity Focused Ultrasound (HIFU) robotic device, Focal One®, was cleared by
We have conducted extensive research on the global addressable market for HIFU, and specifically Focal One, and have concluded that the opportunity in front of us is substantial. Around the world, it is estimated that there are roughly 680,000 newly diagnosed cases of localized prostate cancer (PCa) annually, of which approximately 180,000 occur in
A significant catalyst to further adoption of Focal One in the U.S. occurred in June of last year, when we learned that the American Medical Association’s CPT®
In parallel with these activities, outside of
Longer term, we see opportunity to leverage our state-of-the-art ablation technology into new indications as well. One example is using robotic Focal One HIFU to treat deep rectal endometriosis. We are in ongoing discussions with French regulators to initiate a Phase 2 clinical trial designed to show the safety and efficacy of our technology.
We also successfully expanded our product portfolio with the recent introduction of our brand-new Endo-UP Endourology Platform at the 2019
As a result of the solid foundation that we built over the past several years, we enter 2020 with significant momentum and an opportunity to offer our disruptive breakthrough technologies to patients and physicians around the world.
In closing, I would like to thank the EDAP team who have gotten us to this point, and you, our shareholders, for your continued support. We are very optimistic about the future and look forward to keeping you apprised of our progress as we work to bring new non-invasive therapeutic options to patients while increasing the long-term value of our company.
Chief Executive Officer
A global leader in Robotic Energy-based therapies for 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.
In addition to historical information, this press release may contain 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, regulatory approvals, market acceptance and the continued market potential for our HIFU and lithotripsy devices. Factors that may cause such a difference also may include, but are not limited to, those described in the Company's filings with the
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Source: EDAP TMS S.A.