Healthcare Industry News: ultrasound
News Release - August 25, 2015
EDAP Provides Formal Response to FDA Addressing All Concerns Raised in July 2015 Ablatherm HIFU LetterFDA De Novo 510(k) Review of Prostatic Tissue Ablation Device to Resume
LYON, France, Aug. 25, 2015 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, today announced that on Friday August 21, 2015, it submitted a complete, formal response to the U.S. Food and Drug Administration ("FDA") "Deficiency List" (as such communications about a regulatory filing are officially termed).
The FDA review of EDAP's Direct De Novo 510(k) petition had been on hold pending submission of the response. It will allow FDA to resume review.
Marc Oczachowski, Chief Executive Officer of EDAP TMS SA, commented: "As anticipated, we were able to provide a complete formal response to the FDA's requests in an expeditious manner, which has enabled them to resume active review of our Direct De Novo petition. A major component of the response was completion of the reprocessing validation tests, which have all passed. We look forward to the ongoing review of our submission, and plan to continue working closely with FDA to move the process forward."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm(R) for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer outside the U.S. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU 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-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada. EDAP TMS is currently pursuing a Direct De Novo 510(K) petition in parallel to a PMA for Ablatherm clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One(R), dedicated to focal therapy of prostate cancer. Focal One(R) 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(R) 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 uncertainties of the U.S. FDA clearance process, 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. Ablatherm-HIFU treatment is in clinical trials, but not FDA-cleared or marketed in the United States.
Source: EDAP TMS
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