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EDAP Hosting Key Opinion Leader Call on Focal One® and ExactVu™

·6 min read

Call to be Held Tuesday, September 22nd @ 8am Eastern Time

LYON, France, September 15, 2020 -- EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that it will host a key opinion leader (KOL) call on its two lead commercial products, Focal One® and ExactVu, on Tuesday, September 22nd at 8am Eastern Time.

The call will feature a presentation by Key Opinion Leaders (KOL) Brian Miles, MD (Houston Methodist) and Laurence Klotz, MD (Sunnybrook Health Sciences Centre) who will discuss the opportunity for the Focal One® High Intensity Focused Ultrasound (HIFU) system and the ExactVu micro-ultrasound. Drs. Miles and Klotz will be available to answer questions at the conclusion of the call.

EDAP TMS's management team will also give an update on the sales successes they are seeing for both stand-alone solutions as well as bundled deals, as well as the additional pipeline expansion opportunities that exist for these technologies beyond prostate cancer.

By combining the latest imaging and ablation technologies, Focal One® brings the answer to current requirements for ideal focal therapy: accurate MRI and 3D Biopsy image fusion, non-invasive approach, as well as precise and efficient HIFU energy. This is the industry’s first end-to-end solution for the urology suite.

The ExactVu micro-ultrasound platform provides the most practical solution as a new tool for urologists or radiologists to perform targeted biopsies within a standard urological workflow and is the only ultrasound-based imaging tool with published data demonstrating prostate cancer diagnostic capabilities similar to MRI. The unique 29MHz frequency allows urologists to visualize details unseen before in any prostate ultrasound image, detect suspicious areas in real-time and take a biopsy sample as representative of the level of aggressiveness of the cancer.

To register for the call, please click here.

Brian J. Miles, MD is a board-certified urologist at Houston Methodist in Houston, Texas. Dr. Miles is a Professor of Urology at Weill Cornell Medical College of Cornell University and Baylor College of Medicine. Additionally, he is the Medical Director of Robotic Surgery at The Methodist Hospital and the physician in charge of Surgical Robot Training. Having served as the Director of the Urology Residency Program at Baylor College of Medicine, he continues to educate and provide professional direction to medical students, urology residents, and fellow urologists. Dr. Miles specializes in urologic oncology, especially cancer of the prostate.

Dr. Miles’ primary focus and interest in clinical practice and research is in the detection and surgical treatment of prostate cancer, bladder cancer and kidney cancer. As one of the leading authorities in Texas and the country in the use of the daVinci robot surgical system, he has performed over 2,200 robotic prostatectomies (removal of the prostate), and many robotic cystectomies (removal of the bladder), and partial nephrectomies (removal of part of the kidney) procedures. In addition, Dr. Miles is the physician instructor for surgeons wishing to learn this procedure in the Houston metropolitan area. He also travels widely as a lecturer, surgeon, and consultant on urological cancers to many foreign countries.

Dr. Miles has authored of over one hundred and seventy-five, peer-reviewed scientific papers and book chapters, and have worked with Dr. Peter Scardino as the associate editor of the landmark textbook, Comprehensive Textbook of Genitourinary Oncology. Dr. Miles is consistently listed in Best Cancer Doctors in America, America’s Top Doctors, Best Doctors in America and Texas Super Doctor in Texas Monthly.

Dr. Laurence Klotz was educated at the University of Toronto, Ontario, where in 1977 he obtained his MD. Dr. Klotz completed his residency at the University of Toronto in 1983. Subsequently, he was a Fellow in Uro-Oncology and Tumor Biology at the Memorial Sloan Kettering Cancer Center in New York, completing it in 1985. Dr. Klotz then returned to Sunnybrook Health Sciences Centre in Toronto. He is an Associate Scientist at the Sunnybrook Research Institute, the past Chief of Urology, Professor of Surgery at the University of Toronto, and holds the Sunnybrook Chair of Prostate Cancer Research.

Dr. Klotz is a widely published uro-oncologist (470 peer review publications, 6 books). His basic research interests have included research in the role of micronutrients and diet in prostate cancer prevention, and translational research in biomarkers and imaging. His research lab has been active for 30 years, producing several patents and a biotech company. His clinical research interests have been in the areas of active surveillance, image guided therapy, molecular biomarkers, and androgen receptor targeted therapy. He has led numerous randomized trials in prostate cancer.

Dr. Klotz was awarded the Queen’s Jubilee Medal in 2013 for meritorious public service, and the University of Toronto Department of Surgery Lister Prize for outstanding research contributions and the Society of Urologic Oncology Medal in 2014. In 2015 he received Canada’s highest civilian award, the Order of Canada, and the Harold Warwick Prize from the Canadian Cancer Society for international contributions to cancer control. The AUA presented him the Richard Williams Award for outstanding contributions in urologic oncology in 2016. He has received Lifetime Achievement Awards from the University of Toronto in 2017 and the Canadian Urological Association in 2019. He also received the Huggins medal from the SUO in 2019.

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
+33 4 72 15 31 50

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC