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EDAP

EDAP TMS

$4.26 /

+0.01 (+0.24%)

09:26
01/09/20
01/09
09:26
01/09/20
09:26

EDAP TMS expects acceleration of global growth in 2020

EDAP TMS issued a letter to shareholders, which read in part, "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 robotic device, Focal One, was cleared by FDA in 2018 for the targeted ablation of cancerous prostate tissue. Focal One addresses the significant unmet medical need that exists between the two extremes in prostate cancer treatment: active surveillance and radical prostatectomy surgery. The latter is highly invasive and can often result in devastating side effects, including incontinence and impotence. With Focal One, the prostate is preserved. The development of Focal One extends our long-standing position as a leading innovator in the field of therapeutic ultrasound, and this is reflected in the growing sales traction that we are seeing in the U.S. and other key markets around the world. 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 annually, of which approximately 180,000 occur in the United States. Even if we employ modest assumptions regarding HIFU and Focal One market share and procedure volumes per device, we believe we are poised to embark on a significant growth trajectory that at its peak, could take a significant share in of a multi-billion dollar PCa treatment market. A significant percentage of this would be recurring, driven by procedure-related disposable kits and device service contracts. Needless to say, this analysis easily justifies our growing optimism. In the United States, despite being in the early stages of our physician outreach and educational programs, and while the number of sales is of course an important metric, it is the quality of the institution - a hospital's ability to act as a reference center to help drive awareness - where initial sales are clearly having an impact. Our Focal One customers include such highly-regarded institutions as Mayo Clinic, Houston Methodist Hospital, University of California at Irvine Medical Center and University of Chicago Medicine, among others. These Focal One sales, combined with our presence at important medical meetings such as the American Urology Association Annual Meeting, are driving accelerating growth in our pipeline of potential U.S. customers. Leading urology centers around the country are realizing that this technology is a key differentiator that helps drive increased patient throughput. 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 Editorial Panel accepted our application to establish a new Category 1 CPT code that will facilitate reimbursement for the ablation of malignant prostate tissue with HIFU technology. Having a definitive path to reimbursement for the Focal One procedure in the U.S. removes significant financial uncertainty on the part of the hospital, as Focal One represents a meaningful capital investment. The AMA's decision will go a long way toward helping close additional sales ahead of January 2021, when reimbursement commences. In parallel with these activities, outside of the United States, we continue to further penetrate existing markets such as Brazil, where we now have five installed Focal One devices. At the same time, we opened substantial new markets with sales to Moscow State University of Medicine, a top urology center in Russia and our first in the region, and Farrer Park Hospital in Singapore, our first in Southeast Asia. We are successfully executing on our multi-faceted growth plan, and as a result, we have now recorded four consecutive quarters of profitability as of September 30, 2019. onger 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 World Congress of Endourology and Lithotripsy. Endo-UP is designed for the complete management of urinary stones by combining a fully dedicated endourology table with X-ray and ultrasound imaging systems, an integrated shockwave generator and holmium laser source. We believe combining all the tools available to surgeons provides them with the ability to select the best approach or combination of approaches depending on the patient and the stone. This represents a true breakthrough in urinary stone management and again reflects our robust research and development capabilities. 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."

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