EDAP Announces Plans to Pursue Direct De Novo 510(k) Petition in Lieu of PMA for Its Ablatherm HIFU
2015年3月9日 - 9:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that, based on a recent meeting with
the U.S. Food and Drug Administration ("FDA"), the Company plans to
seek clearance of Ablatherm HIFU by way of a Direct De Novo 510(k)
application as opposed to the Pre-Market Approval ("PMA")
application amendment EDAP had been pursuing.
The Agency indicated that while PMA approval would be required
for specific claims regarding treatment of prostate cancer, a
prostate tissue ablation claim could be cleared via a Direct De
Novo 510(k) application. The De Novo process was introduced by FDA
for instances where a device is novel and there is therefore no
suitable predicate device to support a standard 510(k) submission.
To qualify for the De Novo pathway, the new device must also
present no more than moderate risk. Therefore, the Company plans to
pursue a De Novo pathway based on the discussions with FDA.
Marc Oczachowski, Chief Executive Officer of EDAP TMS SA,
commented: "We are pleased with the outcome of our most recent
meeting with FDA and the ongoing, open dialogue we have maintained
with the Agency throughout the regulatory process. We believe
pursuing a Direct De Novo 510(k) Petition is an opportunity for
more expeditious clearance of Ablatherm HIFU technology in the
United States. Our team is now diligently focused on preparing the
De Novo application."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® 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 lieu of a PMA for Ablatherm 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.
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 uncertainties of the U.S. FDA approval 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-approved or marketed in the United States.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
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