Enpath Medical Receives FDA Marketing Clearance for Steerable Sheath
July 21 2005 - 7:59AM
PR Newswire (US)
Enpath Medical Receives FDA Marketing Clearance for Steerable
Sheath Announces Exclusive License & Supply Agreement
MINNEAPOLIS, July 21 /PRNewswire-FirstCall/ -- Enpath Medical Inc.
(NASDAQ:NPTH) announced today that it has received FDA marketing
clearance for the Company's steerable sheath and has signed an
exclusive license and supply agreement with Bard Electrophysiology,
a division of C. R. Bard, Inc. ("Bard") for distribution of this
product in the electrophysiology ("EP") market. Although terms of
the agreement were not disclosed, the Company stated the agreement
was subject to the completion of intellectual property due
diligence and Enpath attaining CE mark approval for the device. "We
are enthusiastic about this new opportunity because we believe Bard
is well positioned in the EP market, in part through its long-term
focus on the therapeutic treatment of cardiac arrhythmias," said
James D. Hartman, Chairman and CEO of Enpath. "Enpath's steerable
sheath technology will enhance the delivery of diagnostic and
therapeutic devices in the heart. Therapeutic EP is a large and
rapidly growing market and it fits directly with Enpath's mission
to develop innovative delivery systems that improve the quality of
patient care." The Food and Drug Administration 510(k) marketing
clearance is for Enpath's steerable sheath as a stand-alone device
for a number of procedural indications including interventional
coronary, peripheral vascular and carotid artery access. The
Company is in early discussions with other potential partners
regarding distribution of iterations of the product for other
attractive market segments. About Enpath Medical Enpath Medical,
Inc., headquartered in Plymouth, Minnesota, is a leader in the
design, development, manufacture and marketing of percutaneous
delivery systems and stimulation leads technologies. Its products
include venous vessel introducers, epicardial and endocardial
stimulation leads, safety needles and other products for use in
pacemaker, defibrillator, catheter and infusion port procedures as
well as neuromodulation and hearing restoration markets. Its
products are sold worldwide through partnering relationships with
other medical device companies. Safe Harbor This news release
contains forward-looking statements as defined by the Private
Securities Litigation Reform Act of 1995. Certain important factors
could cause results to differ materially from those anticipated by
some statements made herein. All forward-looking statements involve
risks and uncertainties. A number of factors that could cause
results to differ materially are discussed in our Annual Report on
Form 10-K for the year ended December 31, 2004, as well as in our
quarterly reports on Form 10-Q and Current Reports on Form 8-K.
Among the factors that could cause results to differ materially are
the following: the ability of Enpath and Bard to successfully
negotiate and execute a definitive license and supply agreement;
the ability of Enpath to obtain FDA marketing approval or clearance
for its steerable sheath, the ability of Enpath to complete the
integration of the BCI operations; Enpath's dependence upon a
limited number of key customers for its revenue; Enpath's ability
to complete development of its Myopore Rx steroid epicardial lead
and FasTac Flex delivery tool and obtain FDA and European approval
to market these devices; the ability of Enpath and its distribution
partners to successfully introduce the Myopore Rx and FasTac Flex;
the ability of Enpath's customers to successfully develop and
market therapies that utilize the Company's advanced delivery
systems; Enpath's dependence upon licensing agreements with third
parties for the technology underlying some of its products;
Enpath's ability to effectively manufacture its products, including
the new Myopore Rx steroid lead and the FasTac Flex delivery
device, in anticipated required quantities; Enpath's ability to
develop or acquire new products to increase its revenues; Enpath's
ability to attract and retain key personnel; introduction of
competitive products; Enpath's ability to successfully protect its
intellectual property against misappropriation or claims of
infringement by third parties; government regulatory matters;
economic conditions; and Enpath's ability to raise capital. All
forward- looking statements of Enpath, whether written or oral, and
whether made by or on behalf of Enpath, are expressly qualified by
these cautionary statements. In addition, Enpath disclaims any
obligation to update forward-looking statements to reflect events
or circumstances after the date hereof. DATASOURCE: Enpath Medical,
Inc. CONTACT: Jim Hartman of Enpath Medical, Inc., +1-763-577-2212,
or Investors, Doug Sherk, +1-415-896-6820, or Jennifer Beugelmans,
+1-415-896-6820, both of EVC Group Web site:
http://www.enpathmed.com/
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