EDAP Announces University of Washington Medicine to Launch Focal One® Robotic HIFU Program

Brings advanced focal ablation to prostate cancer patients in the Pacific Northwest

LYON, France, September 28, 2021 — EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy-based therapies, today announced that University of Washington Medicine has acquired the company’s Focal One® high intensity focused ultrasound (HIFU) technology for the precise ablation of prostate tissue. UW Medicine will implement the focal therapy program with Focal One at its UW Medical Center location.

“We are pleased that UW Medicine has chosen to offer Focal One Robotic HIFU to their patients,” said Marc Oczachowski, Chairman and Chief Executive Officer of EDAP. “Our technology continues to be broadly adopted globally by leading academic medical centers in the field of urology as part of a comprehensive and state-of-the-art approach to prostate cancer care.”

Advances in imaging, targeted biopsies and energy therapies have increased the applicability of focal treatments which have the potential to treat targeted tissue while sparing key structures. Focal One® is the most advanced system for the precise ablation of prostate tissue using HIFU. In addition, HIFUsion® proprietary software combines pre-operative MRI and 3D biopsy data with real-time ultrasound to provide a complete image for treatment planning. The Focal One platform also offers a fully robotic system for motorized movements and position adjustments while under the control of a urologist.

“Focal therapy is poised to play an important and growing role in the management of prostate cancer in the United States,” said Ryan Rhodes, Chief Executive Officer of EDAP USA. “Our team is excited to partner with the urologists at UW Medicine to bring the most advanced use of precise ultrasound energy to ablate targeted prostate tissue.”

“UW Medicine is a leader in advancing effective, minimally invasive treatments for men with prostate cancer with the goal of reducing the side effects of treatment,” said Dr. George Schade, associate professor of urology at the University of Washington School of Medicine. “Focal therapy with high intensity focused ultrasound may be an option for select patients with low to intermediate risk localized prostate cancer. We are committed to matching the right treatment with the right patient. The addition of Focal One expands our ability to offer the full spectrum of treatment options for managing prostate cancer.”

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, and us.hifu-prostate.com.

About UW Medicine

UW Medicine is one of the top-rated academic medical systems in the world.  With a mission to improve the health of the public, UW Medicine educates the next generation of physicians and scientists, leads one of the world’s largest and most comprehensive biomedical research programs, and provides outstanding care to patients from across the globe.

The University of Washington School of Medicine, part of the system, leads the internationally recognized, community-based WWAMI Program, which serves Washington, Wyoming, Alaska, Montana and Idaho.  U.S. News & World Report has ranked the school as one of the top two U.S. sites for primary-care training for 25 years. It is also second in the nation in federal research grants and contracts with $930.4 million in total revenue (fiscal year 2019), according to the Association of American Medical Colleges.

UW Medicine has approximately 28,000 employees and revenue of more than $5.6 billion (fiscal year 2020).  Also part of the UW Medicine system are Airlift Northwest and the UW Physicians practice group, the largest physician practice plan in the region. UW Medicine shares in the ownership and governance of the Seattle Cancer Care Alliance with Fred Hutchinson Cancer Research Center and Seattle Children’s, and also shares in ownership of Children’s University Medical Group with Seattle Children’s. For more information on UW Medicine, please visit https://newsroom.uw.edu/

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