Enpath (NASDAQ:NPTH)
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Enpath Medical Provides Update on Myopore Rx(TM) Steroid Lead
Status with FDA
Company's Appeal Denied
MINNEAPOLIS, July 14 /PRNewswire-FirstCall/ -- Enpath Medical, Inc.
(NASDAQ:NPTH) today reported that the Office of Device Evaluation (ODE) at the
U.S. Food and Drug Administration (FDA) has denied the Company's appeal of the
decision by the ODE staff that the pending Pre-Market Application (PMA) for the
Company's Myopore Rx(TM) steroid lead is not approvable as currently submitted.
The FDA has indicated that human clinical results would be required in order
to grant marketing clearance of the Myopore Rx.
As discussed in detail in the Company's April 21, 2005 earnings release, the
Company originally filed the submission in July 2004 and had been proceeding on
the understanding that the FDA would grant approval based upon the originally
determined regulatory pathway of a Paper Pre-Market Approval -- a less
burdensome approach that does not include prospective human clinical data. The
Company received a non-approvable letter in December 2004 requesting human
clinical data, and after discussions with the FDA regarding the reasons for the
letter, filed an appeal which was heard on June 1. The Company has received a
response to its appeal that the FDA will not overturn the original decision and
would maintain its position that it will require human clinical trials in order
to process Enpath's application.
Jim Hartman, Chairman and CEO of Enpath Medical, stated, "We are very
disappointed that the FDA has maintained this position, which is contrary to
the criteria for approval that was established with the FDA at the start of the
application process in early 2004. It is not feasible for us to undertake
human clinical trials at this late date in the development process, due to the
substantial cost and time required. We are meeting with our distribution
partners to evaluate possible strategies moving forward and also exploring
other options with the FDA, although limited, which might gain marketing
clearance of this product.
"The Myopore Rx steroid lead has been successfully launched in the countries of
the European Union (EU) by one of our partners and the feedback from physicians
has been very positive," Hartman continued. "That partner has substantially
increased the size of its first reorder and we are now working with this
company to gain approval in countries outside the EU. The FasTac(R) Flex
delivery tool for the steroid lead is being reviewed for approval in Europe and
we anticipate European approval and the initial launch of that product through
this same partner in the third quarter of 2005.
"Meanwhile, our research and development pipeline is full with introducer
enhancements, neurostimulation projects and various steerable and fixed curve
guide catheters for a variety of applications. Last week we learned that
patient enrollment for a clinical study involving one of our fixed curve
sophisticated introducers had been initiated bringing to a total of five the
number of companies engaged in human use studies that are either underway or
planned to commence in the near term," Mr. Hartman concluded.
The Company also stated that while it met the revenue guidance targets for the
second quarter set forth in its first quarter financial results release, it
expects to report a modest loss for the second quarter resulting from continued
significant research and development expenditures incurred in processing the
appeal to the FDA and in accelerating development activities on a steerable
sheath application to meet certain milestones of another potential key partner
for this product.
Earnings Conference Call and Webcast
The Company announced that it will release its second quarter 2005 financial
results before the market opens on Thursday, July 21, 2005. The management
team of Enpath Medical will host a conference call to discuss the results
beginning at 1:30 P.M. Central Time, also on Thursday, July 21, 2005. To
participate, domestic participants should dial 800-257-1927 and international
participants should dial 303-262-2138. A recording of the conference call will
be available approximately one hour after the conclusion of the call and can be
accessed for seven days. To access the replay, please dial 1-800-405-2236 for
domestic callers and 303-590-3000 for international callers; please reference
the pass code 11035104#.
The conference call will also be webcast live on the company's web site,
http://www.enpathmed.com/ , and may be accessed by clicking on the 2nd Quarter
2005 Earnings Call icon. An audio replay will be archived on the Enpath
website for one year.
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: Enpath's ability to complete development of its Myopore Rx steroid
epicardial lead and FasTac Flex delivery tool and obtain regulatory approval to
market these devices in a number of countries; the ability of Enpath and its
distribution partners to successfully introduce the Myopore Rx and FasTac Flex;
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 dependence upon a limited number of key customers
for its revenue; 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 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: Investors, Doug Sherk, +1-415-896-6820, or Jennifer Beugelmans,
+1-415-896-6817, both of EVC Group, Inc.
Web site: http://www.enpathmed.com/