EDAP Appoints Vice-President of Global Medical, Regulatory and Quality Affairs in the U.S.
LYON, France, March 6, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, today announced the appointment of Noah J. Bartsch as Vice President of Global Medical, Regulatory, and Quality Affairs.
Mr. Bartsch will be responsible for leading EDAP's Medical, Regulatory, and Quality Affairs operations in the United States to expand and execute the strategy to advance High-Intensity Focused Ultrasound (HIFU) technology adoption and recognition. This will include managing U.S. Food and Drug Administration (FDA) developments, initiating reimbursement coverage for HIFU, and collaborating with Key
Opinion Leaders. He will also lead EDAP's clinical research and regulatory submission strategies worldwide and will be based in EDAP's U.S. headquarters in Austin, Texas. In this position, Mr. Bartsch will become a member of the Global Executive Team for EDAP.
Prior to joining EDAP, Mr. Bartsch was the Global Vice President of Clinical, Regulatory, and Quality Affairs at LDR (Nasdaq: LDRH) where he spent the last 10 years supporting the growth of the French start-up orthopedic spine company into a U.S. market leader. LDR was acquired in July 2016 for one billion U.S. dollars. While at LDR, he worked extensively with the FDA, leading the Premarket Approval (PMA)
submission process and obtaining approval of two PMAs for Class III indications. He managed the related Investigational Device Exemption (IDE) studies and led the clinical publication strategies that supported market adoption and reimbursement coverage. He also achieved several U.S. 510(k) market clearances. His efforts in quality affairs resulted in a mature quality system functioning globally while maintaining compliance with regulations and quality standards worldwide.
Noah Bartsch commented: "There is an opportunity to advance the adoption and utility of HIFU in the United States, along with the rest of the world, as patients and physicians demand less invasive treatments that improve quality of life. EDAP's technology is very promising and will require continued
collaboration with regulatory agencies, insurance providers, and physician users. I am excited to join EDAP at this phase in the company's history and to ultimately provide properly indicated patients with additional treatment options."
Marc Oczachowski, EDAP Chief Executive Officer, added: "We are extremely pleased to have Noah join EDAP's Global Executive Team. With his impressive background and participation in LDR's success, Noah will bring his extensive experience to our clinical and regulatory global developments. Based in the U.S headquarters in Austin, Texas, he will contribute strongly to our U.S. expansion while ensuring continued quality
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm is approved for commercial distribution in Europe and other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more
information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.
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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Source: EDAP TMS SA
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