EDAP TMS SA : EDAP Announces the Purchase of Focal One® HIFU by Maimonides Medical Center, Brooklyn, NY

Planet edap Inc.
Jan 18,2019

EDAP TMS SA : EDAP Announces the Purchase of Focal One® HIFU by Maimonides Medical Center, Brooklyn, NY

Maimonides Medical Center to Become the First Hospital on the East Coast of the US to Acquire Focal One Technology and Offer the World's Most Advanced HIFU Prostate Treatment

LYON, France - January 18, 2019 - EDAP TMS SA (Nasdaq: EDAP) today announced that Brooklyn, New York'sMaimonides Medical Center has become the second hospital in the United States, and the first on the East Coast, to acquire the groundbreaking Focal One high intensity focused ultrasound (HIFU) technology, the world's most advanced non-invasive prostate ablation device. Maimonides Medical Center urologists were recently trained on the use of Focal One and will begin to schedule the outpatient treatments for eligible patients with localized prostate cancer in February 2019.

"I have long been convinced that focal therapy is potentially an ideal option for some men with prostate cancer, in much the same way lumpectomy has replaced complete ablation of the breast for many women with breast cancer," said David A. Silver, MD, Chief of urology at Maimonides Medical Center, and Director of the Maimonides Prostate Center. "Shortly after Focal One was cleared by the FDA, I saw HIFU treatments in Montreal where physicians have treated more than 100 patients. It was clear to me that Focal One was the perfect tool to achieve a focal ablation, meaning we can treat the cancer, preserve the prostate, and enable our patients to maintain their quality of life. The move from whole-gland therapy to focal therapy represents a real paradigm shift in the way we approach prostate cancer."

Implementing Focal One is consistent with the hospital's goal of continuously enriching and expanding its services with the most leading-edge technology available to meet the needs of its patients.

"At Maimonides Medical Center, we're delighted to be the first on the East Coast to acquire this breakthrough technology," said Kenneth Gibbs, president and CEO of Maimonides. "When our cancer experts told us that this is a game-changer for many of our prostate cancer patients, we did not hesitate. This precision technology clearly places our program among the most advanced in the world-right here in Brooklyn, New York."

"We are extremely enthusiastic to count Maimonides Medical Center as the first to embrace our Focal One technology in the Eastern US. Shortly after the first US device sold a few weeks ago, this new Focal One sale confirms the appeal our technology represents for the US market," commented Marc Oczachowski, Chief Executive Officer of EDAP TMS.

About the Maimonides Medical Center
Maimonides Medical Center is nationally recognized for clinical excellence across all major specialties. Our accomplished physicians are known for innovation and strengthening our teaching and research programs. With 711 beds, the Medical Center is dedicated to bringing patients the most advanced care available-anywhere. Maimonides continues to grow in response to evolving models of care and the needs of our communities, and is home to Brooklyn's only full-service Cancer Center and its only Children's Hospital. According to the federal government, Maimonides is a "Top 10" hospital nationally for patient survival rates. To learn more about the clinical programs at Maimonides, please visit www.maimonidesmed.org.

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 and 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 www.edap-tms.com, and us.hifu-prostate.com.

Forward-Looking Statements
In addition to historical information, this press release may contain 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. 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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LifeSci Advisors, LLC

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Source: EDAP TMS S.A.