EDAP Announces Multiple Oral Presentations at the 21st International Symposium on Therapeutic Ultrasound

Rhea-AI Summary

EDAP TMS SA (Nasdaq: EDAP) announced three significant presentations on its high intensity focused ultrasound (HIFU) technology at the 21st Annual International Symposium on Therapeutic Ultrasound (ISTU) from June 7-10, 2022, in Toronto. Topics include the efficacy of TR-HIFU in treating rectal endometriosis, monitoring techniques for HIFU lesions in prostate cancer, and a preclinical evaluation of a dual-mode ultrasound-guided HIFU probe. The findings suggest potential advancements in minimally invasive treatments and enhance EDAP's position in the therapeutic ultrasound market.

Positive

• Three oral presentations at ISTU highlight the advancements in HIFU technology.
• The TR-HIFU study indicates feasibility as a minimally invasive treatment for rectal endometriosis.
• New monitoring techniques for HIFU lesions could improve clinical outcomes in prostate cancer.

Negative

• None.

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 21^st 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.

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 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.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
John Fraunces
LifeSci Advisors, LLC
212-915-2568
jfraunces@lifesciadvisors.com

 

FAQ

What presentations is EDAP delivering at the ISTU 2022?

EDAP is presenting three key studies on its HIFU technology at ISTU 2022, focusing on TR-HIFU for rectal endometriosis, lesion monitoring techniques, and a new ultrasound-guided HIFU probe.

When is the ISTU 2022 symposium taking place?

The 21st Annual International Symposium on Therapeutic Ultrasound (ISTU) is being held from June 7-10, 2022.

What findings were presented regarding TR-HIFU at ISTU 2022?

The TR-HIFU study presented at ISTU 2022 showed its feasibility as a treatment for symptomatic rectal endometriosis, suggesting it could be a less invasive alternative to surgery.

What is the significance of lesion monitoring techniques presented by EDAP?

EDAP's study on lesion monitoring techniques is significant as it aims to improve HIFU control in clinical applications, enhancing the treatment of prostate cancer.