EDAP Fully Redeems $8.0 Million Long-Term Debt
2013年6月14日 - 10:00PM
EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic
ultrasound, announced today the full redemption of its $8.0 million
outstanding long-term debt by using a portion of the net proceeds
from the $12.0 million private placement executed on May 28, 2013.
Marc Oczachowski, Chief Executive Officer, commented, "With the
full debt redemption initiative completed, our balance sheet is
successfully streamlined through the elimination of the 9% annual
interest paid quarterly and the removal of the redemption
obligation ahead of the June 2014 maturity. We intend to invest the
remaining net proceeds balance in the expansion of our U.S.
operations in preparation of potential approval of our
Ablatherm®-HIFU for the treatment of localized prostate cancer, as
the Pre-Market Approval (PMA) application is currently under review
by U.S. FDA."
"The 100-day meeting with the FDA held on June 3 provided a
discussion forum with the FDA regarding our PMA application. Based
on this meeting as well as the FDA's device review process and
associated 'Review Clock', EDAP anticipates a panel meeting next
year."
Mr. Oczachowski concluded, "With its strengthened balance sheet
and expansion programs on track, EDAP is now well positioned to
execute its growth strategy that leverages the tremendous market
potential of its medical technologies both in the US and in the
rest of the world."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) treatment of localized prostate cancer. 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 and
commercialized in Europe as a treatment for prostate cancer and is
currently under regulatory review in the U.S. following submission
of the Pre-Market Approval Application in February 2013 after the
completion of a multi-center U.S. Phase II/III clinical trial under
an Investigational Device Exemption (IDE) granted by the FDA. The
Company also develops its HIFU technology for the potential
treatment of certain other types of tumors. EDAP TMS SA also
produces and commercializes medical equipment (the Sonolith® range)
for treatment of urinary tract stones using extra-corporeal
shockwave lithotripsy (ESWL). 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
contains forward-looking statements that involve risks and
uncertainties. Such statements are based on management's current
expectations and are subject to a number of uncertainties,
including the uncertainties of the FDA PMA review process, our
ability to expand our U.S. operations and execute our growth
strategy and the market potential for our medical technologies, as
well asrisks that could cause actual results to differ materially
from those described in these forward-looking statements. Factors
that may cause such a difference 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:
Stephanie Carrington
The Ruth Group
646-536-7017
scarrington@theruthgroup.com
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