HealthTronics Announces Receipt of FDA 510(k) Clearance
2010年6月16日 - 6:15AM
HealthTronics, Inc. (Nasdaq:HTRN), a leading provider of urological
products and services, today announced that its wholly-owned
subsidiary, Endocare, Inc., has received 510(k) clearance from the
U.S. Food and Drug Administration (FDA) for Endocare's Cryocare CS®
Surgical System, including Endocare's variable cryoprobe, known as
the V-Probe®.
James Whittenburg, President and Chief Executive Officer,
commented, "We are very pleased to have received this 510(k)
clearance, which addresses a significant item raised in the FDA
warning letter that Endocare received recently."
About HealthTronics
HealthTronics, Inc. is a premier urology company providing an
exclusive suite of healthcare services and technology, including
urologist partnership opportunities, surgical and capital
equipment, maintenance services and anatomical pathology services.
The Company's product portfolio includes a full line of urology
equipment and products, including lithotripters, cryoablation
products used for the treatment of prostate cancer, surgical lasers
for treatment of BPH, and anatomical pathology services. As a
service provider, HealthTronics offers the latest technology in
lithotripsy services and prostate therapy services, including BPH
treatments and prostate cancer treatments. For more
information, visit www.HealthTronics.com.
The HealthTronics, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5894
Forward-Looking Statements
Cautionary Language: Statements made in this press release that
are not strictly historical, including statements regarding plans,
objectives and future financial performance, are "forward-looking"
statements. Although HealthTronics believes that the expectations
reflected in such forward-looking statements are reasonable, no
assurance can be given that the expectations will prove to be
correct. Factors that could cause actual results to differ
materially from those expressed or implied in the forward-looking
statements include, among others, the risk that demand for and
acceptance of HealthTronics' products or services may be reduced;
the risk of changes in governmental regulations; the impact of
economic conditions; the impact of competition and pricing; and
other factors described from time to time in HealthTronics'
periodic and current reports filed with the Securities and Exchange
Commission. You should not place undue reliance on these
forward-looking statements, which speak only as of the date of this
communication. Unless required by law, HealthTronics
undertakes no obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
CONTACT: HealthTronics, Inc.
Richard A. Rusk, Chief Financial Officer
(512) 328-2892
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