EDAP Announces CMS Approval of New Reimbursement Code for HIFU Ablation of the Prostate
May 22 2017 - 9:00AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that the Centers for Medicare and
Medicaid Services (CMS) have established a new billing code for
HIFU ablation of prostate tissue.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/a94c40ad-b3a4-4d46-a5e7-a73a4873fcf9
"We are elated by CMS's decision," said Marc
Oczachowski, EDAP's Chief Executive Officer. “This is another key
milestone in the acceptance and recognition of HIFU technology in
the U.S. as reflected by CMS’s celerity in addressing the dossier,
establishing a c-code and assigning a competitive coverage level.
It will provide a choice between recognized therapies based solely
on clinical need and evidence. The C-code is a significant
achievement and opens the door to broader coverage from different
payers, including private and commercial payers. We will now
transition our efforts toward expanding coverage and physician
education to make our innovative technology available to all
patients in the U.S.”
HIFU ablation of prostate tissue procedures have been assigned
C-code 9747 - ambulatory payment classification (APC) 5376; the
code will take effect July 1st, 2017. C-codes are unique, temporary
pricing codes initially established for the Hospital Outpatient
Prospective Payment System (OPPS). The C-codes are used on Medicare
OPPS claims, and may also be recognized on claims from other
providers or by other payment systems. The code is applicable to
all procedures performed by the Company's HIFU devices, including
whole primary whole gland prostate ablation, partial prostate
ablation or whole and partial salvage ablation.
Mr. Ozachowski added, “I would like to thank Jerry Stringham,
president of the reimbursement strategy consulting firm Medical
Technology Partners for all of his hard work. Jerry has been
instrumental in directing our efforts towards reimbursement. We
look forward to continuing to work with his experienced team while
we pursue additional reimbursement for HIFU procedures.”
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-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, and has received 510(k) clearance by
the U.S. FDA. Ablatherm Fusion is not FDA cleared yet. 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 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.
Investor Contact
CG CAPITAL
Rich Cockrell 877.889.1972
investorrelations@cg.capital
Company Contact
Blandine Confort
Investor Relations / Legal Affairs EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
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