LYON, France, June 6, 2022 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that three oral presentations will be delivered on its HIFU developments at the 21st Annual International Symposium on Therapeutic Ultrasound (ISTU), which is being held June 7-10, in Toronto and virtually.
Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said, “We are very pleased to have several noteworthy abstracts presented at this year’s ISTU annual meeting. We believe that high intensity focused ultrasound has broad clinical utility, well beyond our Focal One core prostate cancer technology platform, and we look forward to presenting these compelling findings.”
Details of the presentations are as follows:
Transrectal High-intensity focused ultrasound (TR-HIFU) for the management of rectal Deep Infiltrating Endometriosis: Results of phase I clinical trials
Date: Wednesday, June 8
Presenter: Gil Dubernard, MD PhD, Hospices Civils de Lyon
Pr. Dubernard will present the multicentric prospective 60-patient study designed to confirm the feasibility of transrectal HIFU treatment for patients with symptomatic rectal endometriosis and to assess its safety and clinical efficiencies. The investigators conclude that HIFU can be a feasible therapy for rectal endometriosis and could be an interesting minimally invasive alternative to surgery for the treatment of rectosigmoid endometriosis if its efficacy and safety are confirmed.
Comparison of HIFU lesion monitoring techniques based on B-mode images
Date: Thursday, June 9
Presenter: Thomas Payen, LabTau/EDAP
Different monitoring techniques will be presented based on B-mode (ultrasound) images acquired for HIFU lesion detection and applied in the context of prostate cancer. Lesion monitoring is crucial to HIFU control in clinical applications. However, open-access, ultrafast US scanners are generally not available in this setting. Four techniques based on B-mode ultrasound images were developed and compared, including passive elastography (“PE”). The investigators concluded that PE demonstrated precise lesion detection, independent from uncontrolled bubble appearance.
Preclinical Evaluation of a Dual-Mode CMUT Probe for Ultrasound-Guided HIFU Treatment
Date: Thursday, June 9
Presenter: Ivan Suarez-Castellanos, PhD, LabTAU – INSERM – Université de Lyon
Dr. Suarez-Castellanos demonstrates the technical feasibility of using an ultrasound-guided high intensity focused ultrasound (USgHIFU) probe, fully developed using capacitive micromachined ultrasonic transducers (CMUTs). The HIFU-CMUT array showed tissue ablation capabilities with volumes compatible with localized cancer targeting, while allowing integration of an imaging array for improved visualization of targeted tissues (versus clinical device), thus providing assets for further development of focal therapies.
About The Annual International Symposium on Therapeutic Ultrasound (ISTU) Meeting
Established in 2001, the International Society for Therapeutic Ultrasound (ISTU) provides a foundation for international collaboration on issues related to therapeutic ultrasound. ISTU’s principal mission is to foster the diffusion of knowledge concerning the scientific and clinical aspect of therapeutic ultrasound. ISTU promotes international development and collaboration in the general field of therapeutic ultrasound including research, development, commercialization, clinical application, education, and standardization for the benefit of patients across the world. For more information on ISTU 2022 please visit https://istu.org/istu-2022-toronto/
About EDAP TMS SA
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.com, us.hifu-prostate.com and www.focalone.com.
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 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.
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