EDAP Announces Live Procedure Broadcast of Focal One High Intensity Focused Ultrasound (HIFU) to Global Clinical Audience

Planet edap Inc.
Apr 10,2023

EDAP Announces Live Procedure Broadcast of Focal One High Intensity Focused Ultrasound (HIFU) to Global Clinical Audience

Leading Center Demonstrates Focal HIFU as a Tool in The Management of Prostate Cancer

Webcast scheduled for Tuesday, April 18th at 12:00 p.m. PDT (3:00 p.m. EDT)

LYON, France, April 10, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today announced that the Company will host a webcast that will feature a live procedure broadcast of its Focal One HIFU as a potential treatment for ablating cancer tissue in patients who are diagnosed with prostate cancer. The webcast is scheduled for Tuesday, April 18th at 12:00 p.m. PDT (3:00 p.m. EDT).

The procedure will be performed by Andre Abreu, MD and Amir H. Lebastchi, MD, Assistant Professors of Clinical Urology at Keck Medicine of the University of Southern California (USC).

“Our team is privileged to work closely with world-class academic medical centers like USC that are leading advances in the care of men with prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP U.S. “We believe focal therapy is the fastest growing emerging treatment option with the ability to offer excellent oncologic results while maintaining maximum quality of life. Teaching and sharing best practices in new clinical treatments are critical to ensuring more patients can avail themselves of the latest technologies with the absolute best results. We deeply appreciate the patient, physicians, staff and institution sharing this vision of teaching to help other centers adopt this advance with Focal One Robotic HIFU.”

“USC Urology is committed to developing new modalities that improve patient outcomes when facing prostate cancer,” said Dr. Inderbir Gill, urologist with Keck Medicine of USC and Chairman and Distinguished Professor of the Catherine and Joseph Aresty Department of Urology at Keck School of Medicine of USC. “We were the first U.S. institution to acquire EDAP’s innovative technology for using non-invasive ultrasound energy to precisely ablate prostate tissue, and we continue to lead in developing this emerging field through clinical research and patient care. We welcome colleagues from around the world to join our team in growing our collective knowledge of the best uses for robotic high intensity focused ultrasound to precisely treat appropriate patients with excellent results.” 

For more information and to register for the webinar, please visit www.focalone.com.

Andre Luis de Castro Abreu, MD has expertise in MRI/TRUS fusion prostate biopsy and focal therapy, including High Intensity Focused Ultrasound (HIFU) and Cryoablation, for prostate cancer. He performs “per-lesion” active surveillance for prostate cancer with a detailed 3D mapping of the prostate and cancer location. Dr. Abreu also performs robotic surgery for prostate, kidney and bladder cancers, as well as practicing general urology. During his clinical fellowship at USC, he was involved in more than 400 complex robotic urologic surgeries, treating cancers and benign diseases, and performed more than 1,500 3D prostate biopsies.

Dr. Abreu has authored many book chapters and more than 85 peer-reviewed publications in various prestigious medical journals. In addition, Dr. Abreu has presented many abstracts on such topics as robotic and laparoscopic urologic surgery, as well as focal therapy, active surveillance and image-guided biopsies. He serves as a reviewer for several journals in the field of urology.

Dr. Abreu earned his six-year medical degree, in five-year general surgery and urology in Brazil. He then moved to the United States and received his two-year clinical fellowship training at Keck School of Medicine at USC, after being a research scholar for four years at the USC Institute of Urology.

Amir Lebastchi, MD, joined Keck Medicine of USC after completing a residency in urology at the University of Michigan and a fellowship in urological oncology with the National Cancer Institute of the National Institutes of Health. He is dedicated to using the most effective, minimally invasive techniques for urological malignancies.

Dr. Lebastchi's research has been published in numerous medical journals, including the New England Journal of Medicine, JAMA Surgery, Nature Reviews Urology and European Urology. He is an invited reviewer for leading medical journals. His goal is to offer patient-centered, compassionate and state-of-the-art care to all his patients.

Dr. Lebastchi has a special interest in MRI/TRUS fusion-guided prostate biopsies, a technique that combines magnetic resonance imaging (MRI) and an ultrasound probe. He also specialized in focal therapy for prostate cancer, including noninvasive techniques such as High Intensity Focused Ultrasound (HIFU) and cryoablation. Dr. Lebastchi performs robotic surgery for prostate, kidney and bladder cancer, as well as practicing general urology.

A recognized leader in the global therapeutic ultrasound market. EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies 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 Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.comus.hifu-prostate.com and www.focalone.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. 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 and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

Other 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.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

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